R01hosei Coronavirus.Pdf

令和 2 年度内閣官房健康・医療戦略室請負業務

令和 2 年度

新型コロナウイルス感染症等の新興感染症

に対する研究開発についての調査

調査報告書

令和 3 年 3 ⽉

デロイト トーマツ コンサルティング合同会社

⽬次

本編 1. 調査概要 p. 3 2. 必要機能の全体像 p. 8 3. 他国及び⽇本における新興感染症への平時の取組み P. 11 3-1. 概要 p. 13 3-2. 詳細 3-2-1. 政府 P. 20 3-2-2. 国際機関 P. 49 3-2-3. アカデミア及び企業 P. 51 3-3. 他国からの学び P. 55 4. 他国及び⽇本における新型コロナウイルス感染症への緊急時の取組み P. 57 4-1. 概要及び新型コロナウイルス感染症の研究開発成果 P. 59 4-2. 詳細 4-2-1. 政府 P. 64 4-2-2. 国際機関 P. 88 4-2-3. アカデミア及び企業 p. 90 4-3. 他国からの学び P. 101 5. 成果創出に向けて必要な機能と⽬指す⽔準 P. 104 5-1. 各機能において具備すべき⽔準 P. 106 5-2. 各機能における他国と我が国の現状 P. 110 5-3. ⽬指す⽔準の実現に向けた政策アイディア P. 127

付録 A. 略語 P. 133

・弊社は、貴室と弊社との間で締結された2020年11⽉4⽇付けの請負契約書に基づき、貴室と事前 に合意した⼿続きを実施しました。本報告書は、上記⼿続きに従って、貴室の政策策定の参考資料 として作成されたもので、内容の採否や使⽤⽅法については、貴室⾃らの責任で判断を⾏うものと します。 ・本報告書に記載されている情報は、公開情報を除き、調査対象会社から提出を受けた資料、また、 その内容についての質問を基礎としております。これら対象会社から⼊⼿した情報⾃体の妥当性・ 正確性については、弊社側で責任を持ちません。 ・本報告書における分析⼿法は、多様なものがありうる中でのひとつを採⽤したに過ぎず、その達 成可能性に関して、弊社がいかなる保証を与えるものではありません。本報告書が本来の⽬的以外 に利⽤されたり、第三者がこれに依拠したとしても弊社はその責任を負いません。

1 2 1. 調査概要

3 調査の背景と⽬的 新興感染症に対して、新型コロナウイルス感染症に関する対応に加え、平時か らの各国の対応・体制を把握し、今後の検討の⼀助とする

背景・⽬的

 健康・医療戦略で掲げている、健康⻑寿社会の形成に資する重要な取組として、 新型コロナウイルス感染症対策の推進において、必要な研究開発等の対策を速や かに推進することとされている

 今回の新型コロナウイルス感染症の拡⼤では、緊急に既存抗ウイルス薬の適⽤拡 ⼤の臨床試験を実施するなど、柔軟な対応が実施されたが、今後も同様の問題が ⽣じる可能性は想定され、平時より、新規感染症が発⽣した場合に、速やかに予 防・治療に必要な医薬品を開発・供給するためルール・体制の整備が求められる

 その為、本調査を平時より整備しておくべき研究開発体制や有事に即時に対応で きる研究開発プラットフォームの構築検討を推進するための基本資料とする

調査内容

本調査では、以下の調査・分析を実施している 1. 新興感染症の発⽣時の研究開発に必要な機能の特定 2. 諸外国における診断法、治療薬、ワクチン開発に必要な機能の 整備体制 • 新型コロナウイルス感染症に対する研究開発経緯・進捗状況 • 診断法、治療薬、ワクチンの研究開発に関わる必要な機能の体制整備 • 平時の事前準備状況 • 新興感染症等の有事における政策 • 産学官の役割分担や連携 3. 諸外国と我が国との⽐較分析 4. 我が国への⽰唆と政策⽴案に資する提案、まとめ

4 調査対象及び⽅法 ⽂献・インターネット検索や有識者へのヒアリングを通じて、⽶国・英国・中 国・⽇本の政府・アカデミア・企業の取組みの調査を実施

調査対象

対象機関／国 調査の主眼

⾏政機関 ⽶国  ⾏政としての平時からの対応と、新型コロナウイル 英国 ス感染症の流⾏に伴い各国が実施した政策 中国  産官学の役割分担や相互の連携  各国の制度の特徴、緊急時における政策の主眼 その他（独国）

⽇本

国際機関  平時における新興感染症への対策  新型コロナウイルス感染症対策における対策、各国 WHO、CEPI、等 による国際貢献内容  主要⼤学・研究機関における診断法・治療薬・ワク チンの開発状況 アカデミア  新型コロナウイルス感染症の研究開発成果に繋がっ た平時及び緊急時の取組み 企業  主要企業における診断法・治療薬・ワクチンの開発 診断機器メーカー 状況 治療薬メーカー  新型コロナウイルス感染症の研究開発成果に繋がっ た平時及び緊急時の取組み ワクチンメーカー

調査⽅法

 本調査では、以下の情報ソースを元に調査を実施した  ⽂献・インターネット  専⾨家へのヒアリング • 国内外の政府・公的機関、企業への専⾨家 • デロイト内専⾨家

5 必要機能のスコープ 本調査では、診断法、治療薬、ワクチンの開発・⽣産において創出したい成果 に対して、必要な機能・機能⽔準を定義し、機能充⾜の取組みを定義する

本調査で扱うモダリティ、プロセス、必要機能 モダリティ 予防⽤ 診断法 治療薬 ワクチン × プロセス 病原体の 流通・ 研究 開発 ⽣産 同定 臨床 × 必要機能構成要素 戦略・ 研究開発 研究開発推進基盤 全体統括 推進 （設備・資材・法制度等）

診断法：本調査で扱う感染症における診断法のスコープ

感染に伴う病態評価のための検査 病原体特定のための検査 （病原体の特定は⾏わない） A：新興感染症の発⽣に伴い 新たな診断法の開発が求められる検査  遺伝⼦検査  ⾎液検査（⼀般的なもの） • PCR法検査等  レントゲン検査  抗原検査  CT検査

• 迅速診断Kit等 B：既存の診断法を置き換える新たな  抗体検査 技術開発が期待されている検査  新たな検査／判読⽅法  顕微鏡検査 • 画像の⾃動読影機、等 • 特殊染⾊法等 • 電⼦顕微鏡検査等  培養検査 • 感染細胞培養等

6 調査アプローチ 調査冒頭で必要機能の仮説を⽴案することで、仮説検証に必要な調査項⽬を特 定。諸外国及び⽇本の取組みを調査し、⽇本の⽬指す姿・取組みを検討した

Step 2. 世界の研究開発動向と諸外国における取組み調査 新型コロナウイルス感染症を取り巻く 世界の研究開発動向 諸外国の取組み Step 2 Step 2 Step 3 世界の診断法、 創出したい成果 世界の研究開発 治療薬、ワクチン （＝政策⽬標） 進捗状況 市場状況

機能要件 国際機関による 必要 機能⽔準 新興感染症への 機能 取組み動向 実施主体

Step 1. 必要機能の検討（仮説） 機能充⾜の打ち⼿ （＝政策） Step 4. 必要機能・⽔準及び打ち⼿の検討 ⽇本が⽬指す姿と取組み Step 4 Step 3. ⽇本の現状把握及び諸外国との⽐較分析 創出したい成果 （＝政策⽬標） ⽇本の現⾏の取組み Step 3 Step 1 現⾏の必要機能 Step 4 機能要件 必要 現⾏の政策 （及び⽬指す姿との 機能⽔準 ギャップ） 機能 実施主体 新型コロナ ウイルス感染症を Step 4 受けて明らかに 機能充⾜の打ち⼿ なった課題 （＝政策）

Step 1：必要機能（仮説）の検討 • 調査の冒頭において、診断法・治療薬・ワクチンの研究開発及び⽣産に関わる必要機能の仮説を⽴案 • 必要機能（仮説）を検証するための調査設計を策定

Step 2：世界の研究開発動向と諸外国における取組調査 • Step 1で策定した調査設定に基づき、諸外国が具備している研究開発及び⽣産機能や政府・アカデミ ア・インダストリーによる平時及び緊急時の取組みを調査・分析

Step 3：⽇本の現状及び諸外国との⽐較分析 • ⽇本における、政府・アカデミア・インダストリーの研究開発及び⽣産に関わる平時及び緊急時の取り 組みの調査や研究開発や⽣産における国内の課題を把握 • Step 2における諸外国及び⽇本の調査結果を踏まえ、政府の取組み（平時における事前準備、緊急時に おける政策・制度等）、産学官の役割分担と相互の連携、ヒト・モノ・資⾦・情報の違い等の観点から ⽐較分析を⾏う

Step 4：必要機能・⽔準及び打ち⼿の検討 • Step 2の諸外国調査にて重要と特定された機能を基に、モダリティ毎の必要機能を定義 • 新型コロナウイルス感染症の研究開発において、成果創出に⾄っている他国の機能⽔準や他国からの学 びを踏まえ、平時・緊急時の機能⽔準を設定 • ⽬指す機能⽔準と現⾏⽔準のギャップを埋めるための打ち⼿（＝政策アイディア）を検討

7 චགྷؽ೵͹સର଀ .2

8 ຌহͲ͹௒ࠬΠϕϫʖο

Ͷɼචགྷͳ͠ΗΖؽ೵ΝخଠࠅͲ۫ඍ͢ͱ͏Ζؽ೵Ώ઒໵Պ΃͹ϐΠϨϱήͶΓΕ॑གྷͳಝఈ͠Ηͪؽ೵Ν ¾ ϠξϨτΡຘͶఈٝͪ͢

൭Ν࣢Ͷ੖ཀྵͪ͢خ֋൅ਬ਒ڂ֋൅ਬ਒ɼC. ݜڂචགྷؽ೵ͺɼA. કྲྀࡨఈʀસର౹ׇɼB. ݜ ¾ Ζ͝ܪ֋൅Νਬ਒͢੔ՎͶڂઝ঳ͶଲͤΖਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹ݜ״ڷA) કྲྀࡨఈʀસର౹ׇʁ৿ ͹ϠωνϨϱήɼકྲࣰྀݳ͹ͪΌͶචགྷ͵ࢊָڱΌ͹ࠅસରͲ͹કྲྀ͹ࡨఈʀ༩ࢋഓ෾Ώકྲࣰྀߨয়ͪ ௒Ν؜΋ڢ͹ଇ਒Ώࠅࡏܠׯ࿊ ਫ਼ࢊ׈ಊ͹ࣰࢬ;ٶ֋൅ڂ֋൅ਬ਒ʁࢊָׯ͹ϕϪʖϢʖͶΓΖݜڂB) ݜ Կ͹ͪΌͶචགྷͳ͵Ζઅඍʀࢬઅɼࣁࡒʤබݬରکਫ਼ࢊ׈ಊ͹ਬ਒ʀ;ٶ֋൅ڂ൭ʁݜخ֋൅ਬ਒ڂC) ݜ ੏Ν؜΋وɼക཈ࡋ๖ɼࣰݩ༽ಊ෼ɼ࣑ྏ༂Ώϭέοϱ͹ݬྋʀݬӹɼ౵ʥɼགྷҽɼ๑ה

࣎ʤʻٺەೖຌͶ͕͜Ζฑ࣎ʀ;ٶ4হͶͱଠࠅ;ٶຌহͲఈٝͪ͢ϠξϨτΡຘ͹චགྷؽ೵ͶԌͮͱɼ3হ ¾ ઝ঳ླྀߨ࣎ʥ͹खૌΊΝ௒ࠬʀ෾ੵΝࣰࢬ͢ɼ5হͶͱؽ೵ຘͶ໪ࢨͤਭ६͹ఈٝΝ״αϫψΤ΢ϩηܗ৿ ߨ͑͞ͳͳͤΖ

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ චགྷؽ೵͹સର଀ʁਏஇ๑ Ͷ֋൅͢ɼචགྷྖ͹ਫ਼ࢊର੏ཱི֮ͤغϏϱυϝρέ࣎Ͷබݬର͹ݗड़ٗढ़Ν૥ ΌΔΗΖٽฯ֮͗غΖͪΌ͹઒໵ਕࡒ͹֮ฯΏබݬରγϱϕϩ͹૥ A. કྲྀࡨఈʀસର౹ׇ ଇ਒ ࣁ֮ۜฯʀഓ෾ܠકྲྀࡨఈ ࢊָׯ࿊ કྲྀࡨఈɼ༑઎ॳҒ෉͜ ‡ චགྷ༩ࢋ͹ׄΕ౲ͱɼ౵ ‡ ༀׄ෾୴͹఑ࣖɼ౵ ‡

௒ڢ͹ϠωνϨϱή ࠅࡏڱࣰߨয় Կک֋൅ର੏͹ڂϠωνϨϱή ‡ ݜ ‡ કྲྀʀ༩ࢋഓ෾͹ݡ௜͢ɼ౵ ‡ ྡজࢾݩ͹ࣰࢬɼ౵ ‡

֋൅ਬ਒ڂB. ݜ εʖθ୵ࡩʛαϱιϕφ݀ఈ ੣඾υδ΢ϱʀ֋൅ʀݗৄ ਫ਼ࢊٗढ़ʀର੏ ؇ཀྵށεʖθ୵ࡩ ‡ ‡ ࢾࡠ඾͹֋൅ ʀਫ਼ࢊʀࡑ ‡ ‡ ɼΫρφԿܯࢾࡠ඾͹ࡠ੔ɼݗৄͳ࠸અ ‡ Τ΢ϩηΰόϞ৚ๅʀ߇ݬʀϐφΤΡϩ ‡ බݬରखѽ๏๑ཱི֮ɼ੓೵ʀ҈ఈ੓֮೟ ਫ਼ࢊٗढ़ཱི֮ ढ़݀ఈ ‡ ୉ྖਫ਼ࢊର੏ٗوη߇ର͹ಝఈɼԢ༽ͤΖ৿ ढ़֋൅ٗ Τ΢ϩηΰόϞʀ߇ݬʀϐφΤ΢ϩη ট೟৻ࠬ ‡ ߇ର͹ݗड़๏๑ཱི֮ ढ़֋൅ٗو৿ ‡

൭ʤઅඍʀࣁࡒʀ๑੏ౕ౵ʥخ֋൅ਬ਒ڂC. ݜ ҈સ੓ʙGxPଲԢࢬઅʀઅඍ ੣ଆ༽ࣁࡒ;ٶ఼ڎ͹ฯ؇ ਫ਼ࢊהබݬରΏ ‡ ఼ڎਫ਼ࢊઅඍʀ ‡ ‡ ‡ ݬӹ੣ଆࢬઅ ͹ݬྋʀࣁࡒحΰόϞ৚ๅմੵઅඍ ਏஇ༂ʀؽ ‡ ֋൅ϕϧρφϓΧʖϞڂබݬରγϱϕϩ ݜ γϱϕϩ ‡ බݬରΰόϞ৚ๅಝఈ༽΢ϱϓϧʙDB༽ڂฑ࣎͹ݜ ‡ Ϗϱυϝρέ൅঳࣎͹බݬରγϱϕϩ ‡ EHR౵͹RWD DB ‡

ઝं͖Δ͹ݗର ྡজࢾݩʀট೟ͶؖΚΖ๑੏ౕ״ ੣඾ݗৄ༽͹ݗର ‡

ਫ਼ࢊགྷҽʀοʖϞ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ‡ ਫ਼ࢊٗढ़֋൅ɼਫ਼ࢊɼ඾࣯؇ཀྵ౵͹ڂݜ ؜΋ གྷҽʀοʖϞ؜΋ܠ؜΋ ‡ ࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ܠࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ ‡ ؜΋ܠࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ ‡

9 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ චགྷؽ೵͹સର଀ʁ࣑ྏ༂ ֋൅͹ͪΌͶͺɼබݬରΝखѽ͓ΖࢬઅʀགྷҽͶՅ͓ɼԿ߻෼ϧغ࣎͹૥ٺە Ζྡজࢾݩࣰࢬࢬઅ͹੖ඍ΍චགྷ͗ܪ֋࢟Ͷغ΢ϔϧϨʖ͹۫ඍΏ࣑ݩ͹૥

A. કྲྀࡨఈʀસର౹ׇ ଇ਒ ࣁ֮ۜฯʀഓ෾ܠકྲྀࡨఈ ࢊָׯ࿊ કྲྀࡨఈɼ༑઎ॳҒ෉͜ ‡ චགྷ༩ࢋ͹ׄΕ౲ͱɼ౵ ‡ ༀׄ෾୴͹఑ࣖɼ౵ ‡

௒ڢ͹ϠωνϨϱή ࠅࡏڱࣰߨয় Կک֋൅ର੏͹ڂϠωνϨϱή ‡ ݜ ‡ કྲྀʀ༩ࢋഓ෾͹ݡ௜͢ɼ౵ ‡ ྡজࢾݩ͹ࣰࢬɼ౵ ‡

֋൅ਬ਒ڂB. ݜ ਫ਼ࢊٗढ़ʀର੏ εʖθ୵ࡩʛඉྡজ ྡজࢾݩ ‡ ࣑ݩ༂͹֋൅ʀਫ਼ࢊ ʀਫ਼ࢊٗढ़ཱི֮ ‡ εʖθ୵ࡩ ʀ ඉྡজ͹ࣰࢬ ‡ ඾࣯؇ཀྵର੏ཱི֮ ʀ୉ྖਫ਼ࢊର੏ ‡ ؇ཀྵށϨʖχԿ߻෼͹࠹నԿ ‡ ਫ਼ࢊʀࡑ ট೟৻ࠬ

൭ʤઅඍʀࣁࡒʀ๑੏ౕ౵ʥخ֋൅ਬ਒ڂC. ݜ ҈સ੓ʙGxPଲԢࢬઅʀઅඍ ੣ଆ༽ࣁࡒ;ٶ఼ڎ͹ฯ؇ ਫ਼ࢊהබݬରΏ ‡ ఼ڎজࢾݩࣰࢬࢬઅʀඅݩं ‡ ਫ਼ࢊྡ ‡ ‡ ݬӹ੣ଆࢬઅ ΰόϞ৚ๅմੵઅඍ ࣑ྏ༂ݬྋɼใૹࣁࡒ౵ ‡ ֋൅ϕϧρφϓΧʖϞڂබݬରγϱϕϩ ݜ γϱϕϩ ‡ බݬରΰόϞ৚ๅಝఈ༽΢ϱϓϧʙDB༽ڂฑ࣎͹ݜ ‡ Ϗϱυϝρέ൅঳࣎͹බݬରγϱϕϩ ‡ EHR౵͹RWD DB ‡ Կ߻෼ࣁݱʀඉྡজ༽ಊ෼ Կ߻෼ࣁݱʙԿ߻෼ϧ΢ϔϧϨʖ ྡজࢾݩʀট೟ͶؖΚΖ๑੏ౕ ‡ ‡ ക཈ࡋ๖ ‡ ඉྡজ༽ಊ෼ ਫ਼ࢊགྷҽʀοʖϞ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ‡ ਫ਼ࢊٗढ़֋൅ɼਫ਼ࢊɼ඾࣯؇ཀྵ౵͹ڂݜ ؜΋ གྷҽʀοʖϞ؜΋ܠ؜΋ ‡ ࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ܠࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ ‡ ؜΋ܠࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ ‡

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ චགྷؽ೵͹સର଀ʁϭέοϱ ͹ͪΌͶͺɼබݬରΝखѽ͓ΖࢬઅʀགྷҽͶڇڛϭέοϱ֋൅ʀغ࣎͹૥ٺە ΌΔΗΖٽՅ͓ɼϭέοϱ͹ηίʖϩΠρϕՆ೵͵ਫ਼ࢊઅඍ͹۫ඍ΍

A. કྲྀࡨఈʀસର౹ׇ ଇ਒ ࣁ֮ۜฯʀഓ෾ܠકྲྀࡨఈ ࢊָׯ࿊ કྲྀࡨఈɼ༑઎ॳҒ෉͜ ‡ චགྷ༩ࢋ͹ׄΕ౲ͱɼ౵ ‡ ༀׄ෾୴͹఑ࣖɼ౵ ‡

௒ڢ͹ϠωνϨϱή ࠅࡏڱࣰߨয় Կک֋൅ର੏͹ڂϠωνϨϱή ‡ ݜ ‡ કྲྀʀ༩ࢋഓ෾͹ݡ௜͢ɼ౵ ‡ ྡজࢾݩ͹ࣰࢬɼ౵ ‡

֋൅ਬ਒ڂB. ݜ ਫ਼ࢊٗढ़ʀର੏ εʖθ୵ࡩʛඉྡজ ྡজࢾݩ ‡ ࣑ݩ༽ϭέοϱ͹֋൅ ʀਫ਼ࢊٗढ़ཱི֮ ‡ εʖθ୵ࡩ ʀ ඉྡজ͹ࣰࢬ ‡ ඾࣯؇ཀྵࢾݩ ʀ୉ྖਫ਼ࢊର੏ ‡ ؇ཀྵށϭέοϱαϱιϕφݗ౾ ‡ ਫ਼ࢊʀࡑ ढ़֋൅ٗ ϭέοϱٗढ़֋൅ ট೟৻ࠬو৿ ‡ ϭέοϱ੣ଆٗढ़ʤ߇ݬ෾཯੠੣౵ʥ ‡

൭ʤઅඍʀࣁࡒʀ๑੏ౕ౵ʥخ֋൅ਬ਒ڂC. ݜ ҈સ੓ʙGxPଲԢࢬઅʀઅඍ ੣ଆ༽ࣁࡒ;ٶ఼ڎ͹ฯ؇ ਫ਼ࢊהබݬରΏ ‡ ఼ڎজࢾݩࣰࢬࢬઅʀඅݩं ‡ ਫ਼ࢊྡ ‡ ‡ ݬӹ੣ଆࢬઅ ౵حΰόϞ৚ๅմੵઅඍ ϭέοϱݬྋɼώ΢Πϩ༲ ‡ ֋൅ϕϧρφϓΧʖϞڂබݬରγϱϕϩ ݜ γϱϕϩ ‡ බݬରΰόϞ৚ๅಝఈ༽΢ϱϓϧʙDB༽ڂฑ࣎͹ݜ ‡ Ϗϱυϝρέ൅঳࣎͹බݬରγϱϕϩ ‡ EHR౵͹RWD DB ‡

ക཈ࡋ๖ʀඉྡজ༽ಊ෼ ྡজࢾݩʀট೟ͶؖΚΖ๑੏ౕ

ਫ਼ࢊགྷҽʀοʖϞ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ‡ ਫ਼ࢊٗढ़֋൅ɼਫ਼ࢊɼ඾࣯؇ཀྵ౵͹ڂݜ ؜΋ གྷҽʀοʖϞ؜΋ܠ؜΋ ‡ ࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ܠࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ ‡ ؜΋ܠࠅ಼֐͹ଠϕϪʖϢʖͳ͹࿊ ‡

10 ઝ঳΃͹״ڷೖຌͶ͕͜Ζ৿;ٶଠࠅ .3 ฑ࣎͹खૌΊ

11 হͲ͹௒ࠬΠϕϫʖο

ઝ঳΃͹खૌΊΝ௒ࠬ͢ɼฑ࣎ΓΕʹ͹״ڷͶΓΖ৿ۂةೖຌͲ͹੕ැʀΠΩυϝΠʀ;ٶຌহͲͺɼଠࠅ ¾ Γ͑͵Ϗϱυϝρέ΃͹ඍ͓Νࣰࢬ͢ͱ͏͖ͪΝ෾ੵͪ͢ ੕ැͶΓΖखૌΊͶ͕͏ͱͺɼචགྷؽ೵ΝैଏͤΖͪΌ͹क͵੕ࡨͳචགྷؽ೵Νਬ਒ͤΖͪΌ͹ࢊָׯ ‡ ͹ༀׄ෾୴Ν௒ࠬ ֋൅ڂ࣎Ͳ͹ݜٺەΏڱ֋൅ਬ਒য়ڂઝ঳ͶؖͤΖݜ״ڷ͹खૌΊͶ͕͏ͱͺɼ৿ۂة;ٶΠΩυϝΠ ‡ ՅଐͶܪ͗ͮͪखૌΊΝ௒ࠬ ֋൅͹੔Վ૓ड़Ͷࢺͮͱ͏ΖϕϪʖϢʖΝ௒ࠬ͹ଲেͳͪ͢ʥڂ࣎Ͷ͕͏ͱଠࠅͶ઎ۨ͜ɼݜٺەʤ

Ͷଠࠅ͖Δ͹ָ;Ν੖ཀྵ͢ͱ͏Ζޛೖຌ͹ฑ࣎͹खૌΊ͹ߡࡱͳ͢ͱɼຌহ͹࠹;ٶଠࠅ ¾

12 ઝ঳΃͹״ڷೖຌͶ͕͜Ζ৿;ٶଠࠅ .3 ฑ࣎͹खૌΊ གྷ֕ .3-1 3-2. ৆ࡋ 3-2-1. ੕ැ ࠅࡏؽؖ .3-2-2 ۂة;ٶΠΩυϝΠ .3-2-3 ;ଠࠅ͖Δ͹ָ .3-3

13 ࣎ٺە ฑ࣎ ࠅ͹ಝ௅ͳࢊׯָ͹खૌΊʁธࠅ֦ ੔͢ͱ͏ΖɽܙΦαεητϞΝ͵ྙکଡ͚͹ࠅ಼֐͹༙ྙϕϪʖϢʖ͗ॄ͏ɼ దۅ֋൅Ͷ੷ڂઝ঳͹ݜ״ڷҘͶΓΕ৿ڶ੕ැͺϏϱυϝρέΏώ΢Ψτϫ͹ ෾ྪ ֕གྷ ઝ঳ؖ࿊༩ࢋ΍5એԱԃΝ௔͓ͱ͕Εɼଡ͚״ಝ௅ ¾ ՁΗ͹ϠξϨτΡͲ΍ธࠅࢤ৖ͺήϫʖώϩࢤ৖͹35~50%ΝઐΌɼ׎ͯ੕ැ͹ ੔͢ͱ͏ΖܙΦαεητϞΝ͵ྙک͹ࠅ಼༙ྙϕϪʖϢʖʤࢊׯָՁΗ΍ʥͶՅ͓ͱք֐ϕϪʖϢʖ͗ॄ͏ɼ Ͳ੊ֆΝڂదͶखૌΞͲ͕Εɼ෱߁͏බݬରͶଲͤΖݜۅઝ঳Ͷ΍੷״ڷҘ΃͹ଲԢͳ͢ͱ৿ڶϏϱυϝρέΏώ΢Ψτϫ͹ ¾ ϭέοϱٗढ़Ͳ΍ࣰ༽Կ͗਒ΞͲ͏ͪوϨʖχͤΖͫ͜Ͳ͵͚ɼ௜ۛະԈͪ͢SARS/MERS࣑ྏ༂ΏmRNA౵͹৿ ¾ ࣰݳ ઝ঳͗ླྀߨͤΖՆ೵੓͹߶͏ࠅͶ͕״ઝ঳ଲࡨͶ஭ྙɽ״ͶɼकͶࠅՊ͹҈સฯ্͹؏఼Ͳฑ࣎ΓΕܢҘΝഐڶ੕ැ ώ΢Ψτϫ͹ Կ͹ࢩԋ΍ࣰࢬک໪ඬ ͜ΖଲԢ೵ྙ ๹ӶકྲྀͶ͕͏ͱώ΢Ψ΢ϱευϱφΏϏϱυϝρέ΃͹खૌΊ͹॑གྷ੓͗ᨵΚΗɼήϫʖώحસฯ্કྲྀΏࠅՊਫ਼෼ฎ҈ 9 ԿΝᨵͮͱ͏Ζکઝ঳ଲࡨ״͵ࠅࡏద;ٶϩϖϩηιΫϣϨτΡકྲྀͶ͕͏ͱͺࠅ಼ͶՅ͓ք֐ ઝ঳Ґ֐Ͷళષ౳Ώ୺״ڷͱ͏Ζ͞ͳ͖ΔଠࠅΓΕ෱߁͏බݬରΝ஭ྙଲেͳ͢ͱ͕ΕɼΦϚϧ౵͹৿͝ܟ஭ྙ ¾ ώ΢Ψτϫଲࡨ΍ ଲে ᙭౵΍஭ྙබݬରͶࢨఈ͢ͱ͏Ζ ʤDARPAʥͶΓΖ༩๹ʀ࣑ྏΝՆ೵ͳͤΖཱࣙదਏஇʤADEPTʥϕϫήϧϞͲͺਏஇ๑͹֋൅ɼ֫ۃժܯڂΉͪɼࠅ๹߶౵ݜ ¾ ઝ঳࣑ྏ༂͹֋൅ΝϏϱυ״ڷढ़͹֋൅౵΃खૌΞͲ͏ΖɽSARS/MERS౵͹৿ٗو࢐ϭέοϱ౵ɼଲԢ൥ҕ͹߁͏ϭέοϱ৿ ઝ঳΃͹ඍ͓Ν߶Όͱ͏Ζ״΍ࣰ֮Ͷਬ਒ͤΖ͞ͳͲɼາஎ͹ޛϝρέ ֦ ϕ ઝ঳ؖ࿊ͺ༁2,000״ڷઝ঳ؖ࿊༩ࢋͺ༁5,300Աԃɼ৿״ॶʤNIAIDʥɼDARPAΝ஦ৼͶɼฑ࣎͹ڂઝ঳ݜ״Ϫ ༩ࢋʀ ¾ ࠅཱིΠϪϩάʖ ΁ٶổ ͨ͹ଠ ԱԃͶ ֋൅ʀ੣ଆࢬઅ͹ࢨఈ౵ɼର੏੖ඍΝࣰࢬڂ࣎Ͷඍ͓ͪྡজࢾݩࢬઅΏݜٺە ¾ Ϣ ಝ௅ద ổ ͵੕ࡨ ֋൅ࢩԋର੏͹ߑ஛͢ɼฑ͖࣎Δ͹ਫ਼ࢊ༲ྖڂ࣎͹ݜٺەʤBARDAʥΝ஦ৼͶۃ֋൅ڂ͹ 9 ฯ݊ෳࢳ঴ࢁԾ͹ਫ਼෼ҫָ઎୼ݜ ख ֮ฯ౵Νࣰࢬ ઝ঳Ͷ͕͜Ζ੊ֆφρϕέϧη͹״ؽؖͶՅ͓ɼڂؽؖΝͺͣΌͳͤΖ੊ֆ਼༙͹ޮదݜڂૌ ¾ ೧ؔ༩ࢋ༁4,000Աԃ͹NIH΢ϱύΤηݜ Ί ΠΩυ ΝϨʖχ͢ͱ͏ڂࣁۜ͗ׯ຿͖Δ౦Ծ͠ΗΖ͞ͳͶΓΕɼ੊ֆ͹ݜڂ୉ָ΍ଡ͚ଚࡑ͢ʤ৏Ғ100୉ָ஦38ߏʥɼͨΗΔ΃ଡֻ͹ݜ ϝΠ ઝ঳࿨ช਼৏Ғ10ϳࠅ͹૱࿨ช਼͹಼ɼ༁4ׄ͗ธࠅʥ״Ζʤ ಋϕϫζΥέφ΍ଡ͚ɼ໪ඬୣ੔Ͷ୉͚߫͘ݛ͢ͱ͏ΖڠΉͪɼΠΩυϝΠୱରͲ͹ࣰ༽Կྙʤ૓༂౵ʥ͗߶͏͓͑Ͷɼׯ຿ͳ͹ ¾ αϝρφϟϱφՁΗ΍ඉ৙Ͷ߶͏;ٶ֋൅ؽ೵ڂઝ঳ݜ״Ν༶͢ɼۂةՁΗ͹ࢤ৖ʤϠξϨτΡʙஏҮʥͲ΍৏ҒεΥΠΝઐΌΖ ¾ ۂة ઝ঳ଲࡨ͹ࠅࡏద͵׈״ڷͲͺɼࣙࠅͲ͹ϭέοϱ֋൅͹Ί͵ΔͥଠࠅͲ൅ਫ਼͢ͱ͏Ζ৿ۂةPfizerΏJohnson & Johnson͹୉घ 9 ಊͶ΍߫ݛɽྈऀͺCEPI͹Ռָࣀ໲җҽճͳ͢ͱࢂժ͢ͱ͕ΕɼPfizerͶ͕͏ͱͺɼCEPIཱིͬ৏͖࣎͝Δ͹ϟϱώʖͲ͍ͮͪ ઝ঳֨୉༩๹ͶࣁͤΖϕϫζΥέφ״ढ़֋൅΍੟ΞͲ͍ΖʤྭʁDARPA͹ٗوͶΓΖ৿ۂةڷԣ͢΍͍Εɼ৿ޛՅ͓ͱɼ੕ැࢩԋ͹ ¾ ͲRNAϭέοϱٗढ़֋൅Ώ߇ର൅ݡϕϧρφϓΧʖϞ͹֋൅ΝmodernaʤธʥɼAbCelleraʤธʥɼCureVacऀʤಢʥࣰ͗ࢬʥ ड़ॶʁUS Executive Office of the President, “National Biodefense Strategy” (2018)ɼ NSC, “Mitigating the Impact of the Pandemic Influenza through Vaccine Innovation”ɼ Whitehouse, “UNITED STATES GOVERNMENT GLOBAL HEALTH SECURITY STRATEGY”(2019)ɼNIHɼNIAIDɼDARPAΤΥϔγ΢φʀࣁྋɼ֦ऀʀ୉ָΤΥϔγ΢φɼ઒໵Պ΢ϱνϑϣʖ౵

࣎ٺە ฑ࣎ ࠅ͹ಝ௅ͳࢊׯָ͹खૌΊʁӵࠅ֦ దͶखૌ΋ɽۅԿͶ੷کۂ੊ֆ਼༙͹ϕϪʖϢʖΝ༙͢ɼ੕ැ΍ҫྏ෾໼͹ࢊ ֋൅Νਬ਒ڂϏϱυϝρέଲԢ͹ൕ঴͖Δ෱߁͏බݬରͶଲ͢ݜڊ੕ැͺգ

෾ྪ ֕གྷ ʤಝͶϭέοϱʀ࣑ྏ༂ʥΝ༶͢ɼ੕ැ΍ಋ྘ҮΝ࠹஭ྙଲেͳఈΌۂةಝ௅ ¾ ธࠅͶ࣏͙ϧ΢ϓγ΢Φϱη྘ҮͲ੊ֆ਼༙͹୉ָΏ ԿΝβʖϩͶݡੀ͓ɼʰ୉͘͵Ϩηέͺ੕ۂదͶखૌΞͲ͏Ζʤࣰ༽ԿͶཻΉΔͥࢊۅԿͶ΍੷کྙۂ֋൅ͫ͜Ͳ͵͚ࢊڂݜ ැʱ͹ࢧ૟͹ԾͲΦαεητϞ੮ओ՗ॶ͹੕ැͶΓΖେ଺ɼք֐Ϩλʖη͹׈༽౵ɼಝ௅ద੕ࡨΝࡀ༽ʥ దͶۅ֋൅Ν੷ڂઝ঳ݜ״ڷઝ঳ʤDisease XʥͶଲͤΖඍ͓΍؜Όͱ৿״͹ϏϱυϝρέଲԢ΃͹ൕ঴͖Δɼາஎ͹ڊգ ¾ Ζࣙࠅ୉ָΝᑑࢢͶࢊׯָҲରͲखૌ΋ގΏ੊ֆ਼༙͹ࣰ੹Νۂةਬ਒ɽήϫʖώϩͲ࣑ྏ༂ʀϭέοϱΝఴ֋ͤΖࣙࠅ Ζ͝ܟઝ঳ͶଲͤΖ༩๹͹ཱི֮Ν໪ඬͳ͢ͱ״ڷࣰݳ ¾ Disease XΝ؜Όͪ৿ ੕ැ Ͷɼਫ਼෼ָద҈સฯ্કޛઝ঳ଲࡨ΃͹఑ݶʤ2016೧ʥ͹״ڷઝ֨୉΃͹ଲԢΝण͜઒໵җҽճͶΓΖ৿״໪ඬ 9 ΦϚϧड़݄೦ ү੔Ν਒ΌΖۂʤ2018೧ʥΝఈΌɼϭέοϱ֋൅ʀࢊྲྀ ઝ঳͗൅ਫ਼͢ಚΖఁ஦ॶಚࠅ΃͹ࢩԋ΍໪ద͹Ҳͯͳ͢ͱ͏Ζ״ڷՅ͓ͱɼ৿ ¾ ֋൅͗क͵ଲেڂDisease XͶଲͤΖϭέοϱ͹ݜ;ٶઝ঳״ڷஎ͹৿ع஭ྙ ¾ ΦϚϧΏMERS౵͹ Կ΃΍ࣁۜʀϨλʖηΝ༑઎ׄΕ౲ͱک֋൅ͫ͜Ͳ͵͚ਫ਼ࢊର੏ڂଲে 9 ଲেබݬର͹ಝఈͳ֚౲ݜ Ζυʖνϗʖηߑ஛ʀ׈༽ʤΰόϞυʖνϗʖηɼྡজࢾݩυʖνϗʖηɼ౵ʥͶ͗ܪ֋൅સൢ͹ՅଐͶڂઝ঳Ν؜Όͪݜ״ ¾ ֦ ϕ ΍઎਒ࠅ͹஦Ͳͺ઎ΞͣͱखૌΞͲ͏Ζ ઝ঳༩ࢋͺɼ283Գԃʤҫྏ෾໼ؖ࿊༩ࢋસର͹༁10%ʥͳ͵ͮͱ͏Ζ״Ϫ ༩ࢋʀ ¾ ӵࠅͶ͕͜Ζฑ࣎͹ ổ ͨ͹ଠ ΏڂϢ ¾ ࢊׯָ͹ϟϱώʖ͖Δߑ੔͠ΗΖUK Vaccine NetworkΝཱིͬ৏͝ɼଡ෾໼Ͷ͕͜Ζ઒໵Պ͹؏఼͖Δ༑઎ͤ΄͘බݬରݜ ֋൅׈ಊΝ໪ࢨ͢ͱ͏Ζڂổ ಝ௅ద ༙๮͵ϭέοϱͳٗढ़΃͹౦ࣁΝݗ౾͢ɼࣰް੓͹߶͏ݜ ͵੕ࡨ ௒کགྷͲ͍Ζ͞ͳΝ॑͗ܠֆ͹࿊ۂ͹ 9 ਫ਼෼ָద҈સฯ্કྲྀͲ΍Ϩηέ͹ཀྵմʀ༩๹ʀ୵எʀଲԢͶͺΠΩυϝΠΏࢊ ख ͶΓͮͱྡজࢾݩυʖνϗʖۂڢૌ ¾ Genomics EnglandΏUK Biobank౵͹खૌΊͶՅ͓ɼࠅ຿ฯ݊γʖϑηʤNHSʥͳIBMऀ͹ ൭ʤNHS DigiTrialʥΝ੖ඍ͢ɼ૓༂֋൅౵΍ࢩخ֋൅ڂໝྡজࢾݩࣰࢬΏΰόϞմੵυʖνϗʖη͹ݜوΊ ηͶΓΖ࣑ྏ༂͹୉ ԋ͢ͱ͏Ζ ࣰै͗ڂઝ঳ݜ״ΠΩυ ¾ University of OxfordɼImperial College LondonɼCambridge University౵ɼ੊ֆφρϕϪϗϩ͹୉ָͶΓΖ ϝΠ 9 University of OxfordͲͺϓΥʖθ1ྡজࢾݩࣰ͗ࢬͲ͘Ζ͹ͺ໬࿨ɼϭέοϱ੣ଆࢬઅΉͲ΍༙ͤΖ ةڷଚࡑͤΖɽҲ๏Ͳ৿͗ۂةઝ঳྘ҮͲϭέοϱΏ࣑ྏ༂Ν༙ͤΖήϫʖώϩ୉घ״Astra Zenecaͳ͏ͮͪ;ٶGlaxo Smith Kline ¾ ۂة ͏͵Ͷؖ͢ͱͺธࠅΆʹ͹੆໼͹߁͠ͺݡΔΗۂ దͶࣰࢬۅಉΝ੷ڢͳ͹ۂةڷͶՅ͓ɼธࠅΝ஦ৼͳͪ͢ଠࠅ͹৿ܠͺࠅ಼༙ྙ୉ָͳ͹࿊ۂةྙ༙ىՎͳ͢ͱɼ৏݃ ¾

ؽؖΤΥϔγ΢φ౵ڂઝ঳કྲྀʤ2019ʥɼGov.UKΤΥϔγ΢φɼNHS DigiTrialsΤΥϔγ΢φɼ઒໵Պ΢ϱνϑϣʖɼ֦ऀʀݜ״ड़ॶʁਫ਼෼ָద҈સฯ্કྲྀʤ2018ʥɼ

14 ࣎ٺە ฑ࣎ ࠅ͹ಝ௅ͳࢊׯָ͹खૌΊʁ஦ࠅ֦ ֋ڂઝ঳ݜ״͹ϏϱυϝρέΝण͜੕ැͳ͢ͱڊΏգི׳ઝ঳ጸ״ࠅ಼͹߶͏ ઝ঳࿨ช਼ͺธࠅͶ࣏͛״֋൅׈ಊྖ΍ଡ͚ɼڂదɽݜۅ൅Ͷଲ͢ͱඉ৙Ͷ੷ ෾ྪ ֕གྷ

ΏɼSARSɼ௙΢ϱϓϩΦϱδ౵͹Ϗϱυϝρέ͗௜ܺͪ͢͞ͳ΍ܢѻౙదͶ߶͖ͮͪྼ࢛దഐི͗׳ઝ঳͹ጸ״Ԏ౵͹،ܗಝ௅ ¾ B ү੔ͶྙΝ೘Ηͱ͏Ζۂಋࢊ;ٶదͶखૌΞͲ͕Εɼ஦Ͳ΍ϭέοϱ֋൅ۅ֋൅Ͷଲ͢ͱඉ৙Ͷ੷ڂઝ঳ݜ״Εɼ੕ැͳ͢ͱ͍ ઝ঳ؖ࿊͗༁28%ΝઐΌΖʥ״֋൅༩ࢋ͹಼ɼڂʤҫྏ෾໼ؖ࿊ݜ ઝ঳࿨ช਼΍ธࠅͶ਼࣏͛݇ΝઐΌΖΉͲͶࢺͮͱ͏Ζ״Վͳ͢ͱ݃ ¾ ઝ঳࣑ྏ༂ࢤ৖෈໎ʥ״ໝʤوໝͺೖຌͳಋوϭέοϱͶ͕͜Ζ஦ࠅࢤ৖;ٶࡃ੔ௗͶ൒͏ࢤ৖੔ௗ΍ஸ͚͢ɼର֐ਏஇ༂ܨΉͪɼ ¾ ઝ঳ླྀߨ࣎͹ࠅ಼ଲࡨͶؖͤΖ๑Ώ੕ࡨΝࡨఈʀࣰࢬ͢ͱ͏Ζ״੕ැ ࣰݳ ¾ SARSҐ߳ɼ ઝ঳ͶଲͤΖ༩๹ʀ࣑ྏકྲྀʤ2016೧ʥɼਫ਼״ڷժʤ2011೧ʥɼ৿ܯεητϞߑ஛ڇڛଲॴ๑ʤ2003೧ʥɼϭέοϱٺە໪ඬ 9 ࠅՊ ෼҈સՌָٗढ़કྲྀʤ2020೧ʥ౵͹ଡ͚͹๑ʀકྲྀΝ੖ඍ ਦ͠Ηͱ͏Ζة୉΍֨ྙڻࠅ΃͹ӪືەΉͪɼʰ஦ࠅϭέοϱʱͶΓΖ ¾ ԿͶฑ࣎ΓΕखૌ΋ک͹ۂϏϱυϝρέΝण͜ɼࠅ಼ϭέοϱࢊڊΏɼգܢѻౙదͶ߶͏ྼ࢛దഐི͗׳ઝ঳͹ጸ״ ¾ ஭ྙ Կ͹खૌΊ͗ᨵکۂઝ঳ͶଲͤΖ༩๹ʀ࣑ྏકྲྀʤ2016೧ʥͲ΍ϭέοϱࢊ״ڷժʤ2011೧ʥɼ৿ܯεητϞߑ஛ڇڛଲে 9 ϭέοϱ ԿͶؖͤΖک֋൅ʀਫ਼ࢊ೵ྙ͹ڂͶΓΖ࣑ྏ༂͹ݜܠઝ঳ͶଲͤΖ༩๹ʀ࣑ྏકྲྀͲͺɼ੕ැࢩԋΏࢊָ࿊״ڷΚΗͱ͏Ζɽ৿ खૌΊ͗ܟ͝ΔΗͱ͏Ζ ֦ ΁ٶઝ঳ؖ࿊༩ࢋͺธࠅͶ࣏͏Ͳ୉͚͘ɼ༁2,600ԱԃͶ״ϕ ༩ࢋʀ ¾ ஦ࠅͶ͕͜Ζฑ࣎͹ ֋൅Ҍ݇౵΃΍ؖ༫ʀղ೘͢ͱ͏Ζڂ͹ݺพݜۂةϪ ͨ͹ଠ ¾ ธӵͳർ͢ͱ஦ԟ੕ැ͹ؖ༫͗޲͚ɼࠅӨ ಝ௅ద ͶΓΖྡজࢾݩ΃͹ࢩԋΏޮదࣁۜ౦ԾͶΓΖ֋൅ՅଐΝߨͮͪۂة࣎Ͷ͕͏ͱͺɼࠅӨٺە ổ 9 Ϣ ͵੕ࡨ ổ ֋൅Ͷڂઅඍʀࢬઅ͗੖ඍ͠Ηɼଠࠅ͹୉ָಋ༹Ͷસͱ͹ϠξϨτΡݜڂઝ঳྘ҮͶ஭ྙͤΖ༙ྙ୉ָͲͺ಼ָ͹ݜ״ΠΩυ ¾ ੕ැ͹ࢩԋΝण͜ɼ ੖ͮͱ͏Ζ͗ڧ؂͹ खૌ΋ ख ϝΠ ૌ 9 ੠՜୉ָͲͺɼ୉ָࢬઅ಼ͶABSL-2͹ࣰݩಊ෼ࢬઅɼBSL-3ࢬઅʤݒઅ஦ʥΏԿ߻෼ηέϨʖωϱήϕϧρφϓΧʖϞ౵Ν۫ඍ͢ͱ͏Ζɽ ઝ঳൅ਫ਼࣎ͶͺݗࠬΫρφ͹֋״αϫψΤ΢ϩηܗ΍ࣰࢬ͠Ηͱ͏Ζɽ৿ڂΊ Ήͪਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹෵਼ϠξϨτΡͶଲͤΖݜ Νࣰࢬ͢ͱ͏Ζڂ൅Ώɼ࣑ྏ༂͹χϧρήϨϛζεϥωϱήɼϭέοϱݜ ͹CanSino౵͹ϕۂةSinopharmΏϗϱοϡʖۂةԿͶΓΕ஦ࠅͲͺࠅ಼ϭέοϱ80%͹εΥΠΝઐΌΖࠅӨکۂ੕ැͶΓΖϭέοϱࢊ ¾ ۂة Ν୴ͮͱ͏ΖڇڛϪʖϢʖ͗ࠅ಼ϭέοϱ ͶଲͤΖखૌΊ΍ߨΚΗͱ͏Ζڇڛࠅ΃͹ϭέοϱ֋൅ʀڷՅ͓ͱɼΠζΠΏΠϓϨΩ͹৿ ¾ 9 ஦ࠅChengdu Institute of Biological Productsऀ͗֋൅ʀ੣ଆͪ͢ೖຌ೶Ԏϭέοϱ͗ɼ஦ࠅ੣ϭέοϱͲॵΌͱWHO͹ࣆ઴೟ఈ ΃͹ট೟Ν֭ಚڎ६*1६خ Ώ஦ࠅ͹ҫྏ઒໵Պ౵Ͷ౦༫͢ͱ͏܋CanSinoऀͺ֋൅஦͹ΦϚϧड़݄೦͹ϭέοϱΝࠅ࿊͹ԾɼΠϓϨΩͶഁݥ͠Ηͪ஦ࠅ͹ฑ࿪ң࣍ 9 ժܯΖଠɼΠϓϨΩͲ͹ྡজࢾݩΝ

ΖͶ౲ͪͮͱɼҫ༂඾͹඾࣯ɼ҈સ੓ɼ༙ް੓౵Νࣆ઴Ͷ֮೟ͤΖͪΌ͹΍͹ͤڇڛ౏৏ࠅ౵΃ҫ༂඾Ν .1* ઝ঳ͶଲͤΖ༩๹ʀ࣑ྏકྲྀʤ2016೧ʥɼ״ڷժʤ2011೧ʥɼ৿ܯεητϞߑ஛ڇڛଲॴ๑ʤ2003೧ʥɼϭέοϱٺەड़ॶʁࠅՊ ؽؖΤΥϔγ΢φ౵ڂਫ਼෼҈સՌָٗढ़કྲྀʤ2020೧ʥɼ֦ऀʀݜ

࣎ٺە ฑ࣎ ࠅ͹ಝ௅ͳࢊׯָ͹खૌΊʁೖຌ֦ ֋൅ڂઝ঳ؖ࿊ݜ״΢ϱϓϩɼ༂ࡐଳ੓͗஦ৼɽܗઝ঳ଲࡨ͹஦ৼͺ৿״ڷ৿ ༩ࢋ΍ธӵ஦ͳർ͢ͱঙ͵͚ɼࢊָ͹׈ಊྖ΍ଠࠅͶർ΄ͱݸఈద ෾ྪ ֕གྷ ΢ϱϓϩΦϱδΏܗ੏͹੖ඍΝਬ਒͢ͱ͏Ζ͗ɼғષ৿و੔ɼઅඍʀࢬઅΏ๑ঁڂಝ௅ ¾ ۛ೧ͺ౏৏ࠅΝ؜΋ଠࠅࢩԋΉͲ֨୉͢ͱݜ ͖ͪͮ͵ઝ঳͹༑઎ౕͺචͥ͢΍߶͚״ڷ༂ࡐଳ੓ʤAMRʥ͗஦ৼͲɼ৿ ઝ঳Ν॑״ໝʀׄ߻ՁΗ΍୉෱Ͷঙ͵͚ɼو֋൅༩ࢋͺҫྏ෾໼સର͹3%௔ͶཻΉΕɼธӵ஦ͳർ͢ͱڂઝ঳ؖ࿊ݜ״Ήͪɼ ¾ ׈ಊྖ͗ଠࠅͶർ΄ͱݸఈద͵ਭ६ͶཻΉΖ;ٶ਼ंڂ΍ঙ͵͏͞ͳ͖ΔɼࢊָՁΗ΍ݜۂة఼྘ҮͳఈΌΖ୉घ ժͶ͕͏ͱܯຌخ֋൅ͺՌָٗढ़ڂઝ঳͹ݜ״ڷʀ࠸ڷժΝࡨఈ͢ɼ৿ܯ΢ϱϓϩΦϱδͶͯ͏ͱͺ2005೧ΓΕ੕ැߨಊܗ੕ැ ࣰݳ ¾ ৿ ໪ඬ ΍॑঳՟ୌୣ੔͹ࢬࡨͳ͢ͱҒ஖෉͜ɽAMRͶͯ͏ͱ΍ݺพࢬࡨΝࡨఈ ࣎Ͷඍ͓ͪฑ࣎͹ࢬࡨΝࡨఈٺەժΏΠέεϥϱϕϧϱΝࡨఈ͢ɼܯ΢ϱϓϩΦϱδɼAMRͺ੕ැߨಊܗ৿ 9 Ҙͳ͵Ζڶ੔Ͷ޴ͪ͜ࢬࡨͳ͢ͱҒ஖෉͜ɼࠅࡏదͶܙ֋൅Ν݊߃ௗथऀճڂઝ঳͹ݜ״ڷʀ࠸ڷժͶͱ৿ܯຌخՌָٗढ़ 9 ԿͶखૌ΋کժͶͱ൅ਫ਼ࠅ΃͹ଲԢܯຌخઝ঳ଲࡨͶؖͤΖ״ ֋൅ͶཻΉΔͥɼ൅ਫ਼ࠅ౵ɼࠅ֐Ͳ͹ଲԢࢩԋ΍໪ࢨͤڂઝ঳΃͹ଲԢͺɼࠅ಼Ͳ͹ର੏੖ඍΏݜ״ ¾ ֋൅ਬ਒ɼ౏৏ڂؽ؇ཀྵର੏੖ඍɼݜثժʤ2016೧ʥͺɼࠅ಼Ͳ͹ܯຌخԿͶؖͤΖکઝ঳ଲࡨ͹״Ҙͳ͵ΖڶࠅࡏదͶ 9 ൭͹੖ඍΏخ֋൅ڂ֋൅ͶཻΉΔͥɼΠζΠͶ͕͜Ζݜڂࠅ͹ࢩԋΝ؜΋ɽ݊߃ʀҫྏકྲྀʤ2020೧ʥͲͺɼࠅ಼Ͳ͹ݜ ੏௒࿪͹ਬ਒Ν໪ࢨͤو ֦ خઝݜʥΏҫ༂״ॶʤڂઝݜ״֋൅ΝࢩԋɽࠅཱིڂͲͺ࣑ྏ༂͹ݜۂ֋൅ؽߑʤAMEDʥ͹૓༂ϔʖηνʖࣆڂϕ ஭ྙ ¾ ೖຌҫྏݜ ֋൅͗਒΋ڂॶʤNIBIOHNʥ౵Ͳͺϭέοϱٗढ़͹ݜڂϪ ଲে ൭ʀ݊߃ʀӭ཈ݜ ổ ¾ ΢ϱϓϩΦϱδϭέοϱ͹ਫ਼ࢊઅඍΏݬ༂ʀݬྋ͹੣ଆࢩԋ΃͹ঁ੔౵ɼ΢ϱϓϧ੖ඍΝਬ਒ܗϢ ࠅ಼Ͳ͹৿ ֋൅༩ࢋͺ74Աԃͳҫྏ෾໼સର͹3%௔ͶཻΉΖڂઝ঳ؖ࿊ݜ״ ¾ ổ ༩ࢋʀ ࣰݩ࣪͹੖ඍɼέϧ΢Ψుࢢݨඏحؽ༙ڠ͹ ͨ͹ଠ ¾ ϭέοϱ͹ਫ਼ࢊઅඍɼݬ༂ʀݬྋ͹੣ଆࢩԋ΃͹ঁ੔ͶՅ͓ɼࣰݩ࣪͹֐෨ཤ༽Ώ ͹಍೘Ν௪ͪ͢ࢬઅʀઅඍ֨ैΝਬ਒ں ख ಝ௅ద ૌ ͵੕ࡨ ੏໚Ͳ͹੖ඍΝࣰࢬو͹ট೟Ͷ޴͜ͱغট೟੏ౕɼಝྭট೟੏ౕ౵ɼҫ༂඾͹૥غΊ ¾ ҫ༂඾ড়݇෉͘૥ దͶࣰࢬۅ΍੷ྙڢɼࠅࡏڂɼք֐Ͳ͹ݜܠͳ͹࿊ۂة֋൅Ν஭ྙ྘Үͳ͢ɼڂઝ঳྘Ү͹ݜ״ؽؖͲͺڂΠΩυ ¾ Ҳ෨͹୉ָݜ Νਬ਒͢ɼڂઝ঳͹ݜ״ڷ΍ਬ਒ɽௗ࡜୉ָͲͺ೦ଵබΏ৿ܠͶ஭ྙ͢ɼք֐ؽؖͳ͹࿊ڂઝ঳͹ϭέοϱ͹ݜ״ϝΠ 9 ୉ࡗ୉ָͲͺɼ ͹ഁݥ౵Νࣰࢬंڂઝ঳ଲࡨਕࡒ͹ү੔Ώݜ״ιϱνʖͶ΍ࢨఈ͠Ηɼྙڢ఼Ͳ͹׈ಊͶΓΕWHOڎڂ౏৏ࠅ͹ݜ ֋൅Νਬ਒ڂͲͺɼ֋൅ࣰ੹ʀஎݡ͹੷Ί৏͝ΏഛफͲٗढ़֭ಚΝߨ͏ɼք֐ఴ֋Ν؜Όͱݜۂةઝ঳Ν఼॑෾໼ͳͤΖҲ෨୉״ ¾ ۂة ͹քحઝ঳͹ਏஇΫρφ౵͹ࣰ༽ԿͶՅ͓ɼસࣙಊݗࠬؽ״֋൅Ώ෱߁͏ڂ෍࢞ϪϑΨͺɼۛ೧͹ζΩ೦ʀSARS͹ݗࠬࢾ༂͹ݜ 9 Ͷࢂ೘ۂઝ঳༽ϭέοϱࣆ״ԿΝ໪ࢨͤɽԚ໼ٝ੣༂ͺUMNϓΟʖϜ͹ഛफͶΓΕک֐ఴ֋ ͺք֐ͳർ΄Ζͳঙ͵͏͗ɼҲ෨Ͳͺࣰ༽ԿͶ੔ޯ͢ɼϭέοϱΏ࣑ྏ༂͹֋൅Νਬ਒ۂةϗϱοϡʖ ¾ AnGesͺҪఽࢢҫ༂Ͷ஭ྙ͢ɼϕϧηϝχDNAΝ࢘ͮͪ੊ֆॵ͹Ҫఽࢢ࣑ྏ༂Ν֋൅ʀࠅ಼ট೟Ν֭ಚɽDNAϭέοϱ΍֋൅஦ 9

ժɼܯຌخժɼ༂ࡐଳ੓ʤAMRʥଲࡨΠέεϥϱϕϧϱɼՌָٗढ़ܯ΢ϱϓϩΦϱδ౵ଲࡨ੕ැߨಊܗड़ॶʁ৿ ؽؖΤΥϔγ΢φ౵ڂຌ๏ਓɼ݊߃ʀҫྏકྲྀɼ޲࿓঴༩ࢋɼ֦ऀʀݜخժʀܯຌخԿͶଲͤΖکઝ঳ଲࡨ͹״Ҙͳ͵ΖڶࠅࡏదͶ 15 ࣎ٺە ฑ࣎ ֋൅Ͷ͕͜Ζ஭ྙබݬରڂࠅࡏؽؖ͹ݜ;ٶࠅ֦ ࠅʀؽؖ͹໪దͶΓΕଲে͗ҡ͵Ζ΍͹͹ɼ஭ྙබݬରΝఈΌͱϨλʖηΝ֦ ֋൅ਬ਒Ν໪ࢨ͢ͱ͏ΖʤೖຌͺາઅఈʥڂΕ౲ͱɼࣰ֮͵ݜׄ

ଠࠅʀࠅࡏؽؖͶ͕͜Ζ஭ྙබݬର*1 ೖຌͶ͕͜Ζ஭ྙබݬର

WHO ஭ྙබݬରͺາઅఈ ¾ ธࠅ ζΩ೦ ϖϱχϧΤ΢ϩη ςϧϪϝΠ SARS έϨϝΠʀαϱβड़݄೦ ళષ౳ ҐԾͺɼAMED͹ Ҍ಼ 2019-2020ʱͶͱۂ՟ ࣆڂઝ঳ݜ״ʰ ଲেͳ͠Ηͱ͏Ζබݬର*2ڂΦϚϧ क͵ݜ ୺᙭ ΨϪϱζช࣊ ࠅࡏؽؖͶͱಝఈ͠Ηͱͤ Ϝʖϔϩή೦ MERS – Ζ஭ྙබݬର͏ ͨ͹ଠ ϧργ೦ ΠϪψΤ΢ϩη ωϏΤ΢ϩη ㍏ Τ΢ϩηܧ ㍏ οέϱήωΠ೦ Ϙηφ ϨϓφώϪʖ೦ Disease X ㍏ ΢ϱϓϩΦϱδ υϱή೦ ㍏ Φ΢θ CEPI ㍏ υϱή೦ ܧύϱνΤ΢ϩη οέϱήωΠ೦ ㍏ ࡋۗ ֫݃ ϚςϨϊη ㍏ ㍏ ༂ࡐଳ੓ۗ Q೦ ӵࠅ ˛ธࠅ˛ӵࠅ˛CEPI˛WHO

ࡎى͹ΩτβϨʖAɼӵࠅͺUK Vaccine Network͹༑઎྘ҮɼCEPIͺPriority DiseaseɼWHOͺPriority DiseaseΝڂธࠅͺNIAID͹ώ΢ΨυΡϓΥϱηݜ .1* ͶోΖͪΌׄѬزଲেͳ͠Ηͱ͏Ζ͗ɼݬҾͳ͵Ζබݬରͺଡڂઝ঳ɼঘࣉ॑঳഑Ԏ΍ݜ״Ծཫ঳ .2* ड़ॶʁUK’s £120m vaccine network ignored Covid-like virus threat - Research Professional News, NIAID Emerging Infectious Diseases/ Pathogens | NIH: National Institute of Allergy and Infectious Diseases, Priority Ҍ಼ʤ2019-2020ʥۂ՟ ࣆڂઝ঳ݜ״diseases – CEPI, UK Vaccine Network - GOV.UK (www.gov.uk), Prioritizing diseases for research and development in emergency contexts (who.int)ɼ

࣎ٺە ฑ࣎ ઝ঳ؖ࿊༩ࢋ״ڷઝ঳ʀ৿״ࠅ͹֦ ֋൅༩ࢋ͹10%Ґ৏͗ڂ༁27ˍ͹஦ࠅΝජಆͶ֦ࠅঙ͵͚ͳ΍ҫྏ෾໼ؖ࿊ݜ ઝ঳ͶैͱΔΗͱ͏Ζʤೖຌͺ3.6%ʥ״

ҫྏ෾໼ؖ࿊ 2,035Աԃ 4஻6,934Աԃ*3 2,912Աԃ*4 9,437Աԃ*7 3,286Աԃ*9 181Աԃ*12 ֋൅ AMEDʀ΢ϱύΤη NIH/DARPA/BARDA UKRI/NIHR Ռָٗढ़෨ ࿊๞੕ැ Bpi Franceڂݜ ؽؖ FY19༩ࢋ FY19ࣰ੹ FY19ࣰ੹ FY2019༩ࢋڂ༩ࢋ૱ֻ ݜ ઝ঳ʀ 10%(UKRI)/ 15.6%*10״ ઝ঳) n/a״ઝ঳ʥ *5 27.6% ʤ״11.3%ʤ 3.6% ઝ঳ʥ DFG͹ϧ΢ϓγ΢Φϱη༩ࢋ״ઝ঳ʥ 9.5%(NIHR) ʤ״ઝ঳ ʤ״ڷ৿ ઝ঳ʥ״ڷ৿) 4.4% ઝ঳ؖ࿊༩ࢋ͹ׄ߻״ઝ঳ʥ ͶઐΌΖ״ؖ࿊༩ࢋ͹ׄ߻ ʤ ୱҒʁԱԃ*1 ઝ঳྘Ү͹༩ࢋʙࣰ੹״ ˛ ઝ঳྘Ү͹༩ࢋ/ࣰ੹״ڷຎྭʁ˛ ৿ 47,500 ઝ঳྘ҮҐ֐΍؜΋༩ࢋ/ࣰ੹״ઝ঳ʀ״ڷ৿ ˛

10,000

ઝ঳ؖ࿊*3״ ઝ঳ؖ࿊*2״ 7,500 5,294Աԃ Աԃ ઝ঳ؖ࿊״ FY20༩ࢋ 74 ઝ঳ؖ࿊״ FY19༩ࢋ 146Աԃ*11 5,000 283Աԃ*6

2,500 ઝ঳ؖ࿊״ ઝ঳ؖ࿊*3״ڷ৿ 2,084Աԃ 2,611Աԃ*8 FY20༩ࢋ 0 ೖຌธࠅ ӵࠅ ஦ࠅ χ΢ς ϓϧϱη ඇ57Աԃɼ΢ϱύΤηܨϕϫζΥέφ༩ࢋʤAMEDଲেޜઝ঳੏״ڷʀ࠸ڷͰ͚৿خժͶܯ֋൅ਬ਒ڂTTBϪʖφΝ࢘༽ *2. ҫྏ෾໼ݜۋUSχϩɼϛϱχɼਕ຿ݫɼϤʖϫ͖Δԃ΃͹׷ࢋϪʖφͺɾMUFG2019೧͹೧ؔฑ .1* ઝ঳͹༩ࢋɼ״ڷઝ঳ؖ࿊ͺNIAID͹ώ΢ΨυΡϓΥϱηˏ৿״ڷ஍ɽ৿ܯઝ঳ؖ࿊ϕϫήϧϞ͹߻״ඇ17Գԃʥ*3. ϧ΢ϓγ΢Φϱη༩ࢋ૱ֻͺɼNIHʤFY2020༩ࢋʥɼBARDAʤFY2020༩ࢋʥɼDARPA͹ܨؽؖڂݜ ໝͺ༁10Աϛϱχʤ2018೧఼࣎ʥΝ*1͹׷ࢋϪʖφͲࢋड़ɽو௒ࠬΓΕUKRI͹ҫྏ྘Ү͹༩ࢋڊ஍ *4. UKRIͶͯ͏ͱͺɼգܯઝ঳ؖ࿊ϕϫήϧϞ͹༩ࢋ͹߻״ઝ঳༩ࢋɼDARPA͹״ઝ঳Ν؜΋״ڷઝ঳ؖ࿊ͺNIAID͹৿״ ֋൅༩ࢋ૱ֻʤ*4ࢂলʥͶଲ͢ͱֽ͜ͱࢋड़ڂઝ͹ݜ״ઝ঳༩ࢋ͹ׄ߻ͺUKRIͺ10%ɼNIHRͺ9.5% *6. *5͹ׄ߻ΝUKRIɼNIHR͹֦ʓ͹ҫྏ෾໼״NIHRͺ1,559ԱԃʤFY18ࣰ੹ʥ *5.༙ࣟंϐΠϨϱήΓΕસର༩ࢋͶઐΌΖ ֻ૱ઝ঳༩๹࣑ྏ઒༽ࣁۜ͹״ͶؖͤΖ૱ֻɽ͵͕ɼ஦ࠅՌָӅ͹༩ࢋͺ༁1.2஻ԃͫ͗ɼҫྏ྘Ү͹༩ࢋͺ෈໎ *8. ࠅՊӶਫ਼݊߃җҽճ͹2019೧॑୉ۂՌָٗढ़෨͹ࢩड़ֻ͹಼ɼҫ༂੣ଆ .7* 2019೧ౕ͹࿊๞੕ැ͹Health Research and Health Industry෾໼Ͷ͕͜ΖR&Dࢩड़ֻ *10. DFG͹ϧ΢ϓγ΢Φϱη༩ࢋͺ2014-2016೧͹DFGͶΓΖϧ΢ϓ΢Φϱη෾໼΃͹3೧ؔ͹ϓΟϱυΡϱή૱ֻΝ೧਼ͲׄΕࢋड़͢ .9* ࡎ͠Ηͱ͏ΖMedtech fundֻۜɽ͵͕ɼANR͹༩ࢋͺ874Աԃʤ2019ى֋൅΃͹ࣁۜ఑ֻ *12. Bpi France annual report 2019Ͷڂઝ঳ؖ࿊ͺ2014-2016೧͹DFGͶΓΖඏਫ਼෼ָʀΤ΢ϩηָʀ໖Ӻָ͹ݜ״ .Ν࢘༽ *11ֻۜͪ ೧ʥͫ͗ɼҫྏ྘Ү͹༩ࢋͺ෈໎ ֋൅ؖ࿊༩ࢋ͹ϛ΢ϱφʱɼNIH, Congressional Justification of the NIH request for the fiscal year (FY) 2021 budget, DOD, FY 2020 Budget Estimates, ASPR FY 2020 Budget-In-Briefɼڂड़ॶʁAMEDʰฑ੔31೧ౕ ҫྏ෾໼͹ݜ ֋൅͹੏ౕʀର੏ʀӣ༽౵ͶؖͤΖ௒ࠬʱɼDFG༩ࢋࣁྋ౵ڂැʰঀ֐ࠅͶ͕͜Ζҫྏݜ಼ֵ

16 ࣎ٺە ฑ࣎ ઝ঳ͶؖͤΖ࿨ช਼״ࠅ͹֦ ׈ಊڂઝ঳ؖ࿊࿨ช਼ͺธࠅ͹1/6ҐԾɼ஦ӵ͹1/2ఖౕͶཻΉΕɼݜ״ೖຌ͹ ୉͚͘ݡ྾ΕͤΖ͗ྖ ΍ಋܑ޴ͳਬࡱ͠ΗΖʥ਼ंڂݜ͏کʤޮదࣁۜͳಋ༹Ͷ࿨ช਼ͳ͹૮ؖ͗

ઝ঳྘Үพ࿨ช਼*3״ ઝ঳ͶؖͤΖ࿨ช਼״कགྷࠅͶ͕͜Ζ ୱҒʁฦ ʥ*1,2 ୱҒʁฦۋʤ2016-2018೧ฑ ֋൅ ೖຌ ӵࠅ ธࠅ ஦ࠅڂWHOࢨఈ͹ݜ ઝݜ NIHR NIH / NIAID / CDC CCDC / CAS״ ઝ঳״ธࠅ 3,934 ༑઎ౕ͹߶͏

஦ࠅ 993 Crimean-Congo hemorrhagic fever 5 8 34 12 ӵࠅ 913 Ebola and Marburg virus disease 11 39 308 151 ϓϧϱη 708 Lassa fever 1 6 23 10 ϔϧζϩ 585 MERS 66 241 339 443 ηϘ΢ϱ 530

߿य 503 SARS 45 127 236 404 Nipah and ೖຌ 493 henipaviral diseases 3 41 9

΢νϨΠ 466 Rift Valley fever 2 3 8 13 χ΢ς 432 Zika 64 20 236 198

ஸ͹৖߻ɼڠέϧϨϗ΢φʀΠψϨτΡέηऀ Web of Science XMLͶͱɼγϔζΥέφΩτβϨ͗”Infectious Disease”Ͳ͍Ζ࿨ชΝ෾਼ΩΤϱφͪ͢΍͹ɽ෾਼ΩΤϱφͳͺɼ1݇͹࿨ช͗ɼೖຌ͹ؽؖAͳธࠅ͹ؽؖB͹ .1* ೖຌΝ1/2ɼธࠅΝ1/2ͳ਼͓Ζ๏๑ ઝ঳͹ชݛʤ2020೧4݆28ೖ఼࣎ʥ͖Δபड़״αϫψΤ΢ϩηܗScopusͶ फ࿧͠Ηͱ͏Ζ৿;ٶઝ঳͹ชݛυʖνʤ2020೧4݆26ೖ఼࣎ʥ״αϫψΤ΢ϩηܗWHO͖Δޮ֋͠Ηͱ͏Ζ৿ .2* ܯઝ঳྘Үพ࿨ช਼Ͷͯ͏ͱͺ௜ۛ5೧Ґ಼Ͷޮන͠Ηͪ࿨ช਼ΝPubmedΓΕॄ״ .3* Ͷͯ͏ͱʱɼPubmedڂΖ ௒ࠬݜܐઝ঳Ͷ״αϫψΤ΢ϩηܗॶ͹ ৿ڂॶʰՌָٗढ़ʀָढ़੕ࡨݜڂॶʰՌָٗढ़ࢨඬ2020ʱɼช෨Ռָ঴Ռָٗढ़ʀָढ़੕ࡨݜڂड़ॶʁช෨Ռָ঴Ռָٗढ़ʀָढ़੕ࡨݜ

࣎ٺە ฑ࣎ ਼ंڂݜ;ٶʤࢂߡʥබݬରพ࿨ช਼ ଠࠅΝྉձ͢ɼೖຌ͹࿨ช਼͗ंڂ΢ϱϓϩΦϱδΏHIVͲͺธࠅ͹࿨ช਼ʀݜ ͏͵ͺѻౙదͶ਼͗ঙ਼ंڂʀݜ਼

΢ϱϓϩΦϱδͶؖͤΖ࿨ช਼ਬҢ HIVͶؖͤΖ࿨ช਼ਬҢ ୱҒʁฦ ୱҒʁฦ

2,000 10,000

1,380 8,000 6,941 1,500 6,000 1,000 ೖຌͺ273ฦʤ2018೧ʥ ೖຌͺ310ฦʤ2018೧ʥ 4,000 ʤธࠅ͹༁5෾͹1ʥ ʤธࠅ͹༁22෾͹1ʥ 500 2,000

0 0 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

United States China France Germany Japan United States China Japan Germany France

ਬҢ਼ंڂਬҢ HIV͹ݜ਼ंڂ΢ϱϓϩΦϱδ͹ݜ ୱҒʁਕ ୱҒʁਕ 1,200 7,000 5,846 793 6,000 5,000 800 4,000 ೖຌͺ ໌ʤ ೧ʥ ೖຌͺ153໌ʤ2016೧ʥ 3,000 168 2016 400 ʤธࠅ͹༁35෾͹1ʥ ʤธࠅ͹༁5෾͹1ʥ 2,000 1,000 0 0 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

United States China Japan Germany France United States China France Germany Japan

࠙෾ੵʀॄܯ͹घॳࠚ ͲPubMedΝݗࡩ͢ɼݗࡩ݃ՎͶ؜ΉΗΖ࿨ชΝபड़ɼᶆᶅͲபड़͠Ηͪ࿨ชΝFirst΍͚͢ͺɼLastؔغ͹Ϋʖϭʖχͳ2002/1/1-2018/12/31͹׳࿨ช਼ͺɼᶅଲে࣮ ‡ ࡎىήϧϓͲͺͨ͹಼ɼຌ௒ࠬͲ͹ηαʖϕͶ؜ΉΗΖࠅΝىɽ৏ܯAuthor͹ॶ଒৚ๅͲࠅพ͹࿨ช਼Ν೧ຘͶॄ ͲPubMedΝݗࡩ͢ɼݗࡩ݃ՎͶ؜ΉΗΖ࿨ชΝபड़ɼᶆ3೧͹಼Ͷ3յҐ৏࿨ช͹ஸंϨηφͶ؜ΉΗؔغ͹Ϋʖϭʖχͳ2002/1/1~2018/12/31͹׳ͺɼᶅଲে਼࣮ंڂݜ ‡ ήϧϓͲىɽ৏ܯΝ೧ຘͶॄ਼ंڂͳఈٝ͢ɼᶅͲபड़͠Ηͪ࿨ช͹સͱ͹ஸंΝ౲֚࿨ช͹First΍͚͢ͺɼLast Author͹ॶ଒৚ๅͲࠅพͶ෾ྪ͢ɼݜंڂΖஸं໌Νݜ ࡎىͺͨ͹಼ɼຌ௒ࠬͲ͹ηαʖϕͶ؜ΉΗΖࠅΝ

֋൅෾ੵʱڂઝ঳྘Үݜ״֋൅ؽߑҗ୙௒ࠬࣁྋʰฑ੔30೧ౕڂड़ॶʁೖຌҫྏݜ

17 ࣎ٺە ฑ࣎ ઝ঳෾໼Ͷ͕͜Ζ࿨ช͹྘Үർֳ*1״ʤࢂߡʥ ൭ɼخઝ঳෾໼͹ϠξϨτΡͺɼΰόϞʀυʖν״͏͵ೖຌ͹࿨ช਼͗ঙ ΔΗΖ͝ڏ൭͗خેخ֋൅ڂݜ

͏͵ઝ঳྘Ү ธԦ஦ͳർ΄ͱ࿨ช਼͗ঙ״ೖຌ͹࿨ช਼͹৵;͗୉͘͏ ઝ঳྘Ү״ϠξϨτΡ ੊ֆͲ࿨ช਼͹৵;͗୉͘͏ ઝ঳྘Ү*4״ 3* 2* ҫ༂඾ ϭέοϱ Φ΢θ×༩๹ϭέοϱ

ఁʀ஦ʀ߶෾ࢢԿ߻෼ Φ΢θ×ఁ෾ࢢ ،Ԏ×ͨ͹ଠҫ༂඾ Φ΢θ×֫࢐ ໖Ӻྏ๑

DDSٗढ़ ઝ঳×࣑ྏΠϕϨ״ ʀυζνϩحʀ ҫྏؽحҫྏؽ ϖϩηίΠ ʤϫϚρφ؜΋ʥ Φ΢θ×࣑ྏΠϕϨ خڂ൭ɼݜخಝͶΰόϞʀυʖν ںࣻતʀ಼ࢻ๎ ͏͵൭Ͳͺ࿨ช਼͗ঙخેخ֋൅ ઝ঳×iPS״ ࠸ਫ਼ҫྏʀ ࠸ਫ਼ҫྏ Ҫఽࢢ࣑ྏ Ҫఽࢢ࣑ྏ

ઝ঳×ϟνϚϫʖϞ״ ઝ঳×φϧϱηέϨϕφʖϞ״ ΰόϞʀ ΰόϞʤҪఽࢢʥʀ Φ΢θ×Ϝ΢έϫώ΢ΨʖϞ ઝ঳×ϕϫτΨʖϞ״ ઝ঳×Ϝ΢έϫώ΢ΨʖϞ״ ઝ঳×Ϝ΢έϫώ΢ΨʖϞ״ ൭ Ψϝέηմੵخυʖν ઝ঳×ΰόϞʀΨϝέηմੵυʖν״ ICTɼDBɼϑρήυʖν ،Ԏ×ҫྏ৚ๅ͹υʖνफॄ ͹ॄ੷ ઝ঳×ҫྏ৚ๅ͹υʖνफॄ״ Ң৪حଃ خ֋൅ڂݜ ൭خે ੏Ռָو×͹ଠ Φ΢θͨ ੏Ռָو×Ԏ، Φ΢θ×ώ΢ΨϜʖΩʖ

PubMedɼInCitesɼJournal Citation ReportΝ࢘͏ɼ࿨ช͹ड़൝೧ͺ2013ʛ2017೧ɼχΫϣϟϱφν΢ϕͺArticleͲ௒ࠬ;ٶWeb of Science Core Collection .1* ੊ֆ͹࿨ช਼͗30ๅҐ৏ʀ੊ֆ͹࿨ช਼͹௜ۛ2೧ׄ߻ʤ2016-17ʥ͗50ˍҐ৏ *3. ੊ֆ͹࿨ช਼͗30ๅҐ৏ ͖ͯೖຌ͹࿨ช਼͗20ๅҐ৏ʀೖຌ͹࿨ช਼͹௜ۛ2೧ׄ߻ʤ2016-17ʥ͗50ˍҐ৏ *4. ธࠅɼԦय͹࿨ช਼͗60 .2* ๅҐ৏ɼ஦ࠅ͹࿨ช਼͗30ๅҐ৏Ͳɼೖຌ͹࿨ช਼͗20ๅາຮ ֋൅ಊ޴௒ࠬʱʤ2019೧ʥڂժրఈݗ౾Ͷ͍ͪͮͱ͹ݜܯ֋൅ڂ߃ʀҫྏકྲྀɼҫྏ෾໼͹ݜ݊غड़ॶʁʰ࣏

࣎ٺە ฑ࣎ Ζஎࡔ਼ܐઝ঳Ͷ״ࠅ͹֦ ৵;କ͜Ζ஦ɼ਼͗ڒઝ঳ؖ࿊͹ಝ״ઝ঳͹ླྀߨ΍͍ΕɼଠࠅͶ͕͏ͱͺ״ڷ৿ ݰঙ਼͗ڒɼಝޛೖຌͶ͕͏ͱͺSARSΏ௙΢ϱϓϩΦϱδླྀߨशଋ ʤ2000-2019೧ʥ *1,2,3,4਼ڒઝ঳ؖ࿊ಝ״ ʤ2000-2019೧ʥ *1,2,3,4਼ڒઝ঳ؖ࿊ಝ״ 500 ʤ݇ʥ 4,000 3,598 ʤ݇ʥ SARS H1N1 H7N9 Zika 400 Ebola 3,000 2,471 300 2,293 200 2,000

100 1,000 316 0 0

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 ஦ࠅ ธࠅ ೖຌ ӵࠅ ஦ࠅ ธࠅ ೖຌ ӵࠅ ʤ2000-2019೧ʥ *1,2,3,5਼ڒʤ2000-2019೧ʥ *1,2,3,5 αϫψΤ΢ϩηؖ࿊ಝ਼ڒαϫψΤ΢ϩηؖ࿊ಝ 200 ʤ݇ʥ 2,000 1,805 ʤ݇ʥ SARS ;ٶઝ঳સൢ״ 1,500 ͶڠαϫψΤ΢ϩη྘Ү 1,165 Ͷ͕͏ͱ੊ֆΝݙӀ਼ڒಝ 100 1,000

500 371 162 0 0

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 ஦ࠅ ธࠅ ೖຌ ӵࠅ ஦ࠅ ธࠅ ೖຌ ӵࠅ

*1. IPC෾ྪʁA61BʤDIAGNOSIS; SURGERY; IDENTIFICATIONʥɼA61KʤPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSESʥɼC07DʤHETEROCYCLIC COMPOUNDSʥɼC07HʤSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDSʥɼC07KʤPEPTIDESʥɼC12NʤMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIAʥɼC12PʤFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTUREʥɼC12QʤMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSESʥɼG01NʤINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING ٽࠅͶԢͣͱ෾ྪɼ෵਼͹ࠅͶ֚౲ͤΖ৖߻ͺͨΗͩΗ͹ΩΤϱφͶ؜ΌΖ *4.ν΢φϩɼঠ࿧ɼ੧ेڋਕ͹بTHEIR CHEMICAL OR PHYSICAL PROPERTIESʥ͹͏ͥΗ͖Ͷ֚౲ *2. ޮๅ൅ߨ೧ʁ2000-2019೧ *3.ࠅͺ੧ෝਕɼड़ ߴʁ coronavirusɼcoronavirusesɼcoronaviridaeɼcoronavirinaeɼorthocoronavirusɼٽߴʁ Infectious diseaseɼ viral infectious diseaseɼcontagious disease͹͏ͥΗ͖Ν؜΋ *5. ν΢φϩɼঠ࿧ɼ੧ orthocoronavirusesɼorthocoronaviridaeɼorthocoronavirinaeɼbetacoronavirusɼbetacoronavirusesɼbetacoronaviridaeɼbetacoronavirinaeɼsarbecovirusɼsarbecovirusesɼsarbecoviridaeɼsarbecovirinaeɼsevere acute respiratory syndromeɼsarsɼ2019 ncovɼcovidɼCOVIDɼCOVID-19ɼSARS-Cov-2͹͏ͥΗ͖Ν؜΋ ड़ॶʁDerwentʤ2021೧3݆3ೖΠέιηʥ

18 ࣎ٺە ฑ࣎ ϕϪʖϢʖ֕གྷ;ٶϠξϨτΡพ͹ࢤ৖ ઝ঳͹ೖຌࢤ৖ͺঘ͚͠ɼήϫʖώϩͶ͕͜Ζ״સͱ͹ϠξϨτΡͶ͕͏ͱ ଚࡑ͢͵͏ʥ͗ۂة͹ࢤ৖εΥΠ΍ঘ͠͏ʤʻ༙ྙ͵ࠅ಼ۂةࠅ಼

ਏஇ๑ࢤ৖ ࣑ྏ༂ࢤ৖ ϭέοϱࢤ৖ ઝ঳޴͜״ஏҮพ ઝ঳࣑ྏ༂ࢤ৖ʤ2021೧ʥ ஏҮพϭέοϱࢤ৖ʤ2019೧ʥ״ஏҮพ ର֐ਏஇ༽ҫ༂඾ࢤ৖ʤ2020೧ʥ ʤ100Աԃʥ ʤ100Աԃʥ ʤ100Աԃʥ 174 62 ௖ , 6 905 469 399 139 ⊂, 9 ⱥ , 5 120 124 14 10 63 32 39 249 32 75

඲ୡ⏺⡿Ḣ᪥୰ࡑࡢ௚ ඲ୡ⏺ ⡿ Ḣ ᪥ ࡑࡢ௚ ඲ୡ⏺⡿Ḣ᪥୰ࡑࡢ௚

ઝ঳࣑ྏ༂ ࢤ৖εΥΠ ʤ2019೧ʥ ϭέοϱ ࢤ৖εΥΠ ʤ2019೧ʥ״ ର֐ਏஇ༽ҫ༂඾ ࢤ৖εΥΠ ʤ2019೧ʥ

Roche 12,873Աԃ (18%) Gilead 21,926Աԃ (26%) GlaxoSmithKline 9,400Աԃ (24%) Abbott 8,332Աԃ (12%) GlaxoSmithKline 17,535Աԃ (21%) Merck 7,455Աԃ (19%) Quest Diagnostics 7,999Աԃ (11%) Merck & Co. 11,642Աԃ (14%) Pfizer 6,267Աԃ (16%) 18% 19% Lab. Corp. of America HD 7,560Աԃ (11%) 26% Pfizer 10,757Աԃ (13%) 24% 24% Sanofi Pasteur 6,159Աԃ (15%) 38% 8% 11% 12% Danaher Corporation 7,092Աԃ (10%) Sanofi 6,931Աԃ (8.2%) 3% CSL 1,189Աԃ (3%) ʀʀʀ ʀʀʀ ʀʀʀ 11% 13% 21% 15% 19% 10% 14% 16% (εηϟρέη 2,907Աԃ (4%) Ԛ໼ٝ 1,405Աԃ (2%) ీวࢀඝ 389Աԃ (1% (H.U.ήϩʖϕHD 388Աԃ (1%) Πητϧη 1,046Աԃ (1%) ඏݜ 390Աԃ (1% (ӭݜԿָ 365Աԃ (1%) ෤ీ༂඾ 750Աԃ (1%) MeijiSeikaϓΟϩϜ 261Աԃ (1%

༽TTBϪʖφΝ࢘ۋUSχϩɼϛϱχ͖Δԃ΃͹׷ࢋϪʖφͺɾMUFG2019೧͹೧ؔฑ .1* ͶׄΕ౲ͱخH.U.ήϩʖϕHDɼӭݜԿָɼీวࢀඝɼඏݜɼ MeijiSeikaϓΟϩϜ͹ࢤ৖εΥΠͶͯ͏ͱͺ݀ࢋ৚ๅΝ .2* ਏஇ๑ࢤ৖Ͷͯ͏ͱͺ֦ࠅIn-Vitro Diagnosticsࢤ৖υʖνͶ2020೧͹GlobalͲ͹Infectious disease IVD͹ઐΌΖׄ߻ʤ23.19%ʥΝ౲ͱͺΌͱࢋड़ .3* ड़ॶʁGlobal In Vitro Diagnostic Market – BIS Research July 2020, Vaccine Development and Production Trends, COVID-19 and Other Vaccines Pipeline - Kalorama Information April 2020, Datamonitor healcare, ֦ऀ݀ࢋ ৚ๅ

19 ઝ঳΃͹״ڷೖຌͶ͕͜Ζ৿;ٶଠࠅ .3 ฑ࣎͹खૌΊ གྷ֕ .3-1 3-2. ৆ࡋ 3-2-1. ੕ැ ࠅࡏؽؖ .3-2-2 ۂة;ٶΠΩυϝΠ .3-2-3 ;ଠࠅ͖Δ͹ָ .3-3

20 ธࠅ

21 ࣎ٺە ฑ࣎ ؽؖ͹ૌ৭ର੏ڂదݜޮ;ٶ੕ැ ઝ঳ͶؖͤΖ੕ࡨ͹ࡨఈɼ״ธࠅͲͺฯ݊ෳࢳ঴ɼࠅ๹૱঴Ν஦ৼͶ ֋൅ΝࢩԋڂॶͲͺݜڂɽΦϋϩάʖ঴ࢁԾ͹ࠅཱིݜڛϓΟϱυΡϱήΝ఑ ֋൅Ͷڂઝ঳ؖ࿊੕ࡨʀݜ״ʷ ຎྭʁ कͶؖ༫ͤΖؽؖ ୉౹྘ැ ୉౹྘ Ռָٗढ़સൢ ੕ࡨસൢ NSTC OSTP OMB PCASTۂࢊ

࿊๞੕ැԥஇͲ͹ ‡ ࿊๞੕ැસର͹ ‡ Ռָٗढ़੕ࡨ৏͹՟ୌ ‡ Ռָٗढ़੕ࡨΝ୴౲ Ռָٗढ़੕ࡨ͹ Ͷͯ͏ͱๅࠄॽΝ൅න ਬ਒क಍ɼঁݶ

݊߃ʀҫྏ੕ࡨʙ ฯ݊ෳࢳ঴ ࠅ๹૱঴ Φϋϩάʖ঴ ʤHHSʥ ʤDODʥ ʤDOEʥ ۃ੏౲و

CDC FDA NIH

࣎Ͷ DARPAٺەઝ঳Ͷ ‡ ฑ࣎ʀ״࣎͹ٺەઝ঳ؖ࿊৚ๅ͹ ASPR ‡ ฑ࣎ʀ״ ‡ ϓΟϱυΡϱήؽؖ ڂઝ঳ؖ࿊͹ݜ״ ੏͹ࡨఈʀࢬߨوؖͤΖ ڛफॄʀ఑ ֋൅Νਬ਒ʤ֐෨ ઝ঳ؖ࿊͹״ฑ࣎ΓΕ ‡ ؜΋ʥܠ࿊ ֋൅Νਬ਒ڂݜ ࣎Ͷͺ֐෨ٺە ‡ ؜΋ʥܠʤ֐෨࿊ ΃ঁ੔ڂBARDA*1 ݜ

࣎ٺەฑ࣎ʀ ‡ ଲԢ͹༩ࢋΝ೩ड़

ॶڂؽؖ DOEࢁԾ͹ࠅཱིݜڂ֋൅ؽؖ NIHࢁԾ͹ݜڂݜ ڂॶ ‡ ϫηΠϧϠηࠅཱིݜڂઝ঳ݜ״ࠅཱིΠϪϩάʖ ‡ ʤNIAIDʥ ॶʤLANLʥ ॶڂࠅཱིਫ਼෼ҫָժ଀ʀਫ਼෼޽ָ ‡ Πϩβϱϊࠅཱིݜ ‡ ॶʤNIBIBʥ ʤANLʥ౵ڂݜ ֋൅Νڂઝ঳ؖ࿊͹ݜ״࣎Ͷٺە֋൅Νਬ਒ ‡ कͶڂઝ঳ؖ࿊͹ݜ״࣎Ͷٺەฑ࣎ʀ ‡ ؜΋ʥ ࢩԋܠʤ֐෨࿊ ʤBiomedical Advanced Research and Development AuthorityʁBARDAʥۃ֋൅ڂਫ਼෼ҫָ઎୼ݜ .1* ֋൅કྲྀʤ2020೧ʥʱɼ੕ැؽؖΤΥϔγ΢φʤWhitehouseɼCDC౵ʥ౵ڂ֋൅͹၈ᛎๅࠄॽ कགྷࠅ͹ݜڂ֋൅͹੏ౕʀର੏ʀӣ༽͵ʹ͹ؖͤΖ௒ࠬʱɼCRDSʰݜڂड़ॶʁ಼ֵׯ๬ʰฑ੔30೧ౕঀ֐ࠅͶ͕͜Ζҫྏݜ

࣎ٺە ฑ࣎ ਫ਼ࢊ͹ؽ೵ैଏ͹ͪΌ͹଩ͬघʁγϜϨ;ٶ֋൅ڂݜ ֋൅ରڂ࣎Ͷඍ͓ͪݜٺە֋൅΃͹ޮదࣁۜ͹౦ԾͶՅ͓ɼޮదؽؖͲ΍ڂݜ ੏͹੖ඍ͗ߨΚΗͱ͏ΖʤNIAIDͶΓΖࢾݩࢬઅϋρφϭʖέཱི֮౵ʥ ؽ೵ैଏ͹ ຎྭʁਏ - ਏஇ๑ ࣑ - ࣑ྏ༂ ϭ - ϭέοϱ ֋൅ ֋൅ ਫ਼ࢊ ਫ਼ࢊ ڂݜ ڂ଩ͬघ ݜ ॽɼήϫʖώϩϖϩηιΫϣϨτΡકྲྀɼ౵ʥְ;ٶ๹Ӷકྲྀحઝ঳ଲࡨͶؖͤΖકྲྀࡨఈʤ҈સฯ্કྲྀɼࠅՊਫ਼෼ฎ״ڷકྲྀࡨఈʀ ਏ ࣑ ϭ ৿ ֋൅ʀਫ਼ࢊ͹ͪΌ͹ࣁ֮ۜฯʤ༁2,084Աԃ͹༩ࢋʥڂઝ঳͹ݜ״ڷસର౹ׇ ਏ ࣑ ϭ ৿ ϭέοϱʀ࣑ྏ༂ʀਏஇ๑ٗढ़΃͹ঁ੔ ਏ ࣑ ϭ ઝ঳༩๹ϕϧρφϓΧʖϞʤP3ʥ౵ʥ״ʤDARPAͶΓΖ༩๹ʀ࣑ྏΝՆ೵ͳͤΖཱࣙదਏஇʤADEPTʥϕϫήϧϞɼ

ઝ঳ଲࡨ͹खૌΊΝࣰࢬ״͵ਏ ࣑ ϭ ธࠅक಍Ͳ੊ֆ݊߃҈સฯ্ΠζΥϱξʤGHSAʥΝ൅ଏ͢ɼήϫʖώϩ

αϱλʖεΠϞʤIDCRCʥ͹ڂઝ঳ྡজݜ״ ࣑ ϭ ࣎Ͷͺྡজࢾݩ͹৖ͳ͢ͱ୉ָ౵͹ࢬઅΝࢨఈʥٺەઅཱིʀӣӨʤ

ઝ঳͹״֋൅ ਏ ࣑ ϭ ք֐Ͷ͕͜Ζڂݜ ܠਬ਒ γʖϗ΢ϧϱη׈ಊʀݳஏࠅ੕ැͳ͹࿊ ֋൅ڂιϱνʖʤVRCʥͶΓΖݜڂϭ ϭέοϱݜ ڂϛ΢ϱφʀΨϔʀίΠٗढ़ݜ ਏ ϋρφϭʖέ͹અཱི ࣎Ͷ޴ͪ͜ࢾݩࢬઅٺە ϭ ϋρφϭʖέʤVTEUʥ͹અཱི

࣎͹ैలʀ࢕৏੣ଆࢬઅ͹ٺە ՆʤEUAʥ͹੖ඍ ϭڒ༽࢘ٺە BSL3ࢬઅ͹੖ඍʀैଏ ਏ ࣑ ϭ-;ٶ֋൅ ਏ ࣑ ϭ BSL-4ڂݜ ϋρφϭʖέʤ ʥߑ஛ ൭ FFMNخਬ਒ ࣎͹ਫ਼ࢊΏैలʀ࢕৏͝ࢬઅͳ͵Ζٺە ಊ෼ࣰݩࣰࢬՆ೵͵ࢬઅ ϭ ʤઅඍʀࣁࡒʀ ਏ ࣑ ϭ ਏ ࣑ ϭ Priority Review Voucher੏ౕ͹಍೘ ఼ CIADMʥڎ఼͹ର੏͹੖ඍʤ॑གྷڎʤABSL-3ʥ͹֮ฯ ॑གྷ ๑੏ౕ౵ʥ ΔͶंۂ༂ࡐΏԿ߻෼͹ϧ΢ϔϧϨʖߑ஛ ਏ ࣑ ϭ ଳ੓ۗͶ༙ް͵߇ۗ༂͹ ଲে͹੣ଆ ࣑ ϭ ͹ԈௗΝ೟ΌΖ੏ౕ಍೘ʤGAIN๑ʥ ໖੻Ν༫͓Ζ๑͹੖ඍʤPREP๑ʥؔغʤNCATSͶΓΖ35ຬҐ৏͹ఁ෾ࢢʥ ࢤ৖ಢઐ

22 ࣎ٺە ฑ࣎ ઝ঳ͶؖͤΖक͵੕ࡨ״ڷ৿ Ҙ͖ΔࠅՊ͹҈સฯ্͹ชຼͲڶธࠅͲͺɼώ΢Ψτϫ౵͹ ઝ঳ͶଲͤΖકྲྀΝࡨఈ͢ɼࠅ಼ʀࠅ֐Ͳ͹ΠΤφϔϪ΢έͶඍ͓ͱ͏Ζ״

2017೧ 2018೧ 2019೧ 12݆ 9݆ ݆̓ 9݆

҈સฯ্કྲྀ ɼธࠅൡӭ͹ਬ਒ɼฑ࿪ ήϫʖώϩϖϩηιΫϣϨτΡકྲྀ ๅࠄॽʰϭέοϱ͹ַ৿Ν௪ͣͪޤธࠅ຿ʀࠅౖ͹ฯ ͹֨୉Ν໪దͳ͢ͱࡨ Ϗϱυϝρέʀ΢ϱϓϩΦϱδ͹ྙڻ͹ң࣍ɼธࠅ͹Ӫ ఁݰʱڻΝ௪͢ɼࠅ಼֐͹ Ӫܠࠅࡏؽؖ౵ͳ͹࿊ ઝ঳͹༩๹ɼݗஎɼଲԢ͹ࣰࢬͶ޴͜ɼ״ ఈ Կɼ ࠅՊ҈સฯ্ճ٠ΓΕགྷ੧ΝکԿࢩԋɼࠅࡏࢩԋکࠅ͹ؽ೵ܠҘΏ ࿊ڶΝ໪దͳͤΖώ΢Ψޤʀธࠅ຿ʀࠅౖฯ ࡃࣀ໲җҽճ͗ܨԿͶ޴ͪ͜ ण͜ɼ୉౹྘کઝ֨୉ ࠅ಼Ͳ͹ϪζϨΦϱη״Ηͱ͕Εɼ͝ܟϏϱυϝρέ͹຀໕͗ ࡎ ࡠ੔ͪ͢ๅࠄॽͲɼ΢ϱϓϩΦىࠅ΃͹ࢩԋͳͳ΍Ͷธ ΠϕϫʖοΝܠյඈͶ޴͜ɼ࿊غ͹૥ ࡃଝࣨ͹؏఼͖ܨઝ঳ؖ࿊಼༲ʁ֚౲෨෾ൊਰγϜϨࠚ ϱδླྀߨͶΓΖ״࠙ ٶԿͶͯ͏ͱݶکଲԢٺەࠅ಼Ͳ͹ Կʁ Δϭέοϱ֋൅΃͹౦ࣁ౵Ͷͯ͏کࠅ಼Ͷ͕͜ΖϪζϨΦϱη ॽ ͱ࿨ͣΖְ;ٶ๹ӶકྲྀحࠅՊਫ਼෼ฎ ࢩԋɼླྀߨͶඍ͓ͪMCM͹ڂઝ঳͹ݜ״ ‡ ҘͶΓΖϨηέఁݰɼͨΗΔ͹ڶɼқਦద͵ਫ਼෼ָదބࣙષɼࣆ ଲԢ࣎͹ ‡ ΢ϱϓϩΦϱδ͹ླྀߨͶඍ͓ٺەজࢾݩ͹ਟଐ͵ࣰࢬ౵ɼྡ ժࡨఈ ͪϭέοϱ֋൅΃͹౦ࣁ͗ܯͶ޴ͪ͜ڂద׎ͯްՎదࣰࢬͶ޴ͪ͜ ݜۅҘ͹յඈʀ६ඍʀଲԢʀյ෰͹੷ڶ खૌΊ͹࿰ૌΊΝ఑ࣖ චགྷͲ͍ΕɼܴཝҐ֐͹ࡋ๖ ‡ ླྀߨ࣎͹Ϗϱυϝρέͳ͵ΖՆ೵੓͹ ઝ঳ؖ࿊಼༲ʁ֚౲෨෾ൊਰγϜϨࠚ ϗʖηΏૌ׷͓ϭέοϱ౵͹״࠙ ɼۂΖබݬର͹ཀྵմ޴৏ͶࣁͤΖࡠ͍ ৿͢͏ٗढ़ͶઞࡑదՆ೵੓͍ ͶଲͤΖϭέ׳ఁݰ͹ͪΌ͹ૌ৭६ඍʁ ླྀߨ͹Ն೵੓͍͗Ζ࣮ڻώ΢Ψ΢ϱευϱφ͹Ӫ ٶΖͳݶ͍͗ ΖखૌΊ οϱ֋൅ɼఁݰࡨ͹ਬ਒ɼਏஇࢾݩʀܐ֋൅Ͷڂ࣎͹ݜٺەॶؽ೵͹ң࣍ɼڂଲԢͶචགྷ͵ݜٺە ‡ ͹ࢩԋڂ͹րવ౵͹ਬ਒ͶࣁͤΖݜح͹༑઎ౕ෉͜ɼ௒੖ϕϫιη͹ཱི֮౵ ؽ ժ͹ࣰࢬɼླྀ௪ ࠅࡏద͵ώ΢ΨιʖϓτΡʀιΫϣϨτΡܯҫָద๹ӶࡨʤMCM*1ʥඍட͹ഓාͶؖͤΖࣆ઴ ‡ ԿʁکଲԢ ͹ٺەγϕϧοΥʖϱ͹҈સ੓ɼιΫϣϨτΡɼ৶བ੓͹֮ฯ౵ɼ Ն೵͵ਏஇࢾݩؽ೵͹ң࣍ɼMCM֋൅ʀཤ༽Ն೵੓͹޴৏౵ ݧ͵බݬର͗࠹ঘݸ͹਼͹ࢬઅͲثಝͶ ‡ ɼ؄ࢻ͹֮೟ɼͨΗΔޤཊ੏͹ͪΌ͹ଲԢʁ ಝఈɼฯ༙ɼฯڻώ΢Ψ΢ϱευϱφӪ Կ౵ɼک͹ࣰࢬͶΓΖ༙๮͵MCM͹඲ ͹ࢬઅͲ͹ϗηφϕϧέτΡη͹ڂ࣎͹ϨΠϩν΢ϞͲ͹ྡজݜٺە ‡ ͹๹ࢯࡨ͹༽ޣՃʀಝఈɼϭέοϱΏ࣑ྏɼਏஇ๑͹ಝఈ౵ බݬର͹۰൅ద͵๎ड़Ώ ࣰࢬ

*1. MCM: Medical Counter Measures ड़ॶʁ US Executive Office of the President, “National Biodefense Strategy” (2018)ɼ NSC, “Mitigating the Impact of the Pandemic Influenza through Vaccine Innovation”ɼ Whitehouse, “UNITED STATES GOVERNMENT GLOBAL HEALTH SECURITY STRATEGY”(2019). White House Economists Warned in 2019 a Pandemic Could Devastate America - The New York Times (nytimes.com)

࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ɼNIBIBͶ͕͜Ζਏஇݗࠬڂઝ঳ͶؖͤΖݜ״NIAIDͲ͹ฑ͖࣎Δ͹ ֋൅Ώ΢ωεΠοϔ͹ેͳ͵Ζڂ࣎͹ݜٺەϋρφϭʖέ͗ڂ͹ݜ ֋൅Νࣰࢬڂ֋൅Νਬ਒ NIBIB: ਏஇ๑ٗढ़ཱི֮͹ݜڂ఼ͳ͢ͱݜڎ͹ڂઝ঳ݜ״ :NIAID

ॶʤNIBIBʥڂॶʤNIAIDʥ ؽؖ໌ ࠅཱིਫ਼෼ҫָժ଀ʀਫ਼෼޽ָݜڂઝ঳ݜ״ؽؖ໌ ࠅཱིΠϪϩάʖ

஭ྙڂɼ ࡋۗ੓ ݜ׳ઝ঳͹஦Ͳ΍ɼಝͶΤ΢ϩη੓࣮״ ஭ྙڂݜ ڂ͹্֒͹ਏஇͳ࣑ྏ͹਒ิͶࣁͤΖݜܧحଃ ਫ਼மබͶ஭ྙ ྘Үرɼ׳ɼਇۗ੓࣮׳྘Ү ࣮

ϋρφϭʖέ͹અཱིڂ֋൅ ϛ΢ϱφʀΨϔʀίΠٗढ़ݜڂιϱνʖʤVRCʥͶΓΖݜڂϭέοϱݜ ͳ͢ͱ1997೧Ͷઅ „ 2007೧ɼϛ΢ϱφʀΨϔʀίΠٗढ़ʤPOCTʥ؂AIDSϭέοϱ͹֋൅͹Ҳ „ ϋρφϭʖέʤPOCTRNʥڂɽNIAIDΝߑ੔ͤΖؽؖͳ͢ͱɼHIV/AIDS ͹ঐ༽ԿͶ޴͜ɼݜཱི ϭέοϱͶՅ͓ɼΦϚϧɼ΢ϱϓϩΦϱδϭ Νઅཱི͢ɼ 5ͯ͹ٗढ़ύϔΝ௪͢ͱPOCT͹֋൅ έοϱ͹֋൅Ν໪దͶ׈ಊΝࣰࢬ Νਬ਒ ͶSARSɼ ¾ ঐ༽Կ͹Ն೵੓͹͍ΖPOCT͹Ϗ΢ϕϧ΢ϱڠVRCͺɼModernaऀ͹Ռָंͳ „ ;ٶ౵ ֋൅ଇ਒ɼ֋൅ϕϫιηͶ͕͜ΖྡজڂMERSΝӀًͤ͘͞αϫψΤ΢ϩη͹ݜ Νࣰࢬ Ϥʖδʖωʖθ͹౹߻͗Ն೵͵࢕ૌΊ͹׈༽ɼ ڛઝ঳͹ ঐ༽Կʀࣰ༽ԿͶ޴ͪ͜ϨλʖηΏஎݡΝ఑״ ઝ঳͹״ ࣎Ͷ޴ͪ͜ࢾݩࢬઅϋρφϭʖέ͹અཱིٺە ఼ڎ֋൅ ¾ ٗढ़ύϔͺҐԾ͹5ڂ֋൅ ݜڂݜ αϱλʖεڂઝ঳ྡজݜ״2019೧12݆஦२ɼ „ ͹खૌΊ ͹खૌΊ ‡ Point-of-Care Technology Research ࣆସ࣎Ͷͺɼ Coordinating CenterٺەΠϞΝઅཱིɽޮ़Ӷਫ਼৏͹ ϭέοϱʀ࣑ྏ඲ՃϤωρφʤVTEUʥͳݼͻ ‡ Atlanta Center for Microsystems Engineered ΗΖࢬઅͲϭέοϱʀ࣑ྏ༂ޫึ͹ྡজࢾݩ Point-of-Care Technologies ΝਟଐͶ֋࢟ͤΖର੏Ν੖ඍ ‡ Center for Innovation in Point of Care VETUͺPhase1͖Δ4ΉͲ͹ࢾݩɼϐφοϡ Technologies for HIV/AIDS at Northwestern ¾ ϪϱζࢾݩΝࣰࢬͤΖ೵ྙΝ༙ͤΖࢬઅ ‡ Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases ϗ΢ϧʖҫՌ୉ָΏΦϠϨʖ୉ָ͵ʹ͹9 ¾ ‡ Center for Advancing Point of Care in ॶΝVTEUͳ͢ͱࢨఈ Heart, Lung, Blood, and Sleep Diseasesڂ͹୉ָΏݜͯ

ड़ॶʁNIAID, “Developing Therapeutics and Vaccines for Coronaviruses”, “Network of VTEU Sites”,” Infectious Diseases Clinical Research Consortium” , NIBIB, “Point-of-Care Technologies Research Network (POCTRN)”౵

23 ࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ໝ͵ঁ੔ΝࣰࢬɽوͶฑ࣎ΓΕ୉ڂDARPAͲͺɼNIHͳർ΄ͱ઎਒ద͵ݜ mRNAϭέοϱٗढ़ΏਟଐϏϱυϝρέԢ౶ϕϧρφϓΧʖϞ౵Ͷ౦ࣁ ઝ঳ؖ࿊ٗढ़Ͷ౦ࣁ״͵DARPA: ઎਒ద

ʤDARPAʥۃժܯڂؽؖ໌ ࠅ๹߶౵ݜ CureVac „ CureVacऀʤಢʥΔͶଲ͢ɼ2011೧Ͷ༁ કྲྀద౦ࣁ͹ଲে෾໼ͳ͢ͱਫ਼෼ָ͹ٗढ़ཤ༽ क ஭ྙ 3,310ຬχϩΝঁ੔ʤ4೧ؔʥɽRNAϭέڂݜ ʤBTOʥΝ ͵ οϱ֋൅ٗढ़͹֋൅Νਬ਒ۃʤ2014೧Ͷͺਫ਼෼ָదٗढ़ڏΝ྽ ྘Ү અཱིʥ ϭ ͳ͢ͱɼ؂έ Moderna „ ADEPTϕϫήϧϞ͹Ҳ ο ModernaऀʤธʥͶଲ͢ɼ2013೧Ͷ࠹୉ ઝ঳͹֨୉༩๹ͶࣁͤΖϕϫζΥέφ౵Ν״ ϱ ༁2,500ຬχϩΝঁ੔ʤ࠹ௗ5೧ؔʥɽ ֋൅Νਬ਒ڂ௪͢ͱݜ ʀ RNAϭέοϱ֋൅ٗढ़͹֋൅Νਬ਒ DARPAͲͺ౲ࣰ࣎ݳ੓͹߶͗ٛ͠໲ࢻ͠Ηɼ ࣑ „ ύ΢ϨηέͲ͍Ζͳ͠Ηͪ֫࢐ϭέοϱ͹ݜ ྏ ͳ͢ͱɼAbCellera Biologicsऀ؂Ν2011೧ΓΕ֋࢟ ༂ AbCellera „ P3͹Ҳڂ „ ADEPTʤ2012೧ࠔʛʥ ɼP3ϕϫήϧϞ ֋ Biologics ʤՅʥͶଲ͢ɼ2018೧Ͷ࠹୉༁3,000ຬ ֋൅Νਬ਒ ൅ χϩΝঁ੔ʤ4೧ؔʥɽ ߇ର൅ݡϕϧρڂʤ2017೧ࠔʛʥ౵Ν௪͢ͱݜ ઝ঳͹ ¾ ༩๹ʀ࣑ྏΝՆ೵ͳͤΖཱࣙదਏஇ ٗ φϓΧʖϞ͹֋൅Νਬ਒״ Ґ઴Ͷ΍ɼ ϕϫىढ़ „ Ͳͺ৏ ʤADEPTʥϕϫήϧϞ AbCellera ADEPT ֋൅ ήϧϞͶ͕͏ͱ΍ঁ੔Νद༫ڂݜ ΏಡોͶΓͮͱӀـ͹खૌΊ ‡ ࣙષ൅ਫ਼ʀਕ޽ద͵බ ҘΝਟଐͶಝఈ͢ͱଲԢͤڶً͘͞͠ΗΖ Ζٗढ़͹֋൅Ν໪దͳͤΖϕϫήϧϞ Ν֋ڂઝ঳༩๹ϕϧρφϓΧʖϞʤP3ʥ ʰ(DARPAͲ2011೧Ͷ֫࢐ϭέοϱ͹ݜ״ ¾ ‡ ADEPTϕϫήϧϞͲ֋൅ͪ͢RNAϭέοϱ ࢟ͪ͢͞ͳͶଲ͢ʥNIHঁ੔ͤΖͶͺϨηέ ढ़ΝᑑͶɼΤ΢ϩη੓බݬର͹෾཯͖Δ ͗୉͙ͤ͘Ζ΍͹Ͳ͍ͮͪɽDARPAͲͺٗढ़ٗ 60ೖҐ಼Ͷɼݳ৖ͲਟଐͶ࢘༽Ն೵͵ҫྏ ͗ؽ೵ͤΖՆ೵੓͍͗Ηͻ౦ࣁͤΖʱ ଲࡨΝ֋൅Ͳ͘Ζݐ࿜͵ٗढ़ϕϧρφ Dr. Amy Jenkin ϓΧʖϞ͹֋൅Ν໪దͳͤΖϕϫζΥέφ ʤDARPA BTOϕϫ ήϧϞϜϋʖζϡʖʥ ड़ॶʁDARPA, “DARPA’s Early Investment in COVID-19 Antibody Identification Producing Timely Results”, “Pandemic Prevention Platform”, “Autonomous Diagnostics to Enable Prevention and Therapeutics (ADEPT)”, Biocentury, “DARPA’s gambles might have created the best hopes for stopping COVID-19”౵

࣎ٺە ฑ࣎ ൭خ֋൅ਬ਒ڂݜ ਫ਼ࢊͶඍ͓ͪࢬઅ;ٶ֋൅ڂࣆସ͹ҫ༂඾͹ݜٺەBARDAΝ஦ৼͶɼ ʤCIADMʥΝઅཱིʀ֮ฯ͢ͱ͏Ζ

ϭέοϱ੣ଆ͹ΫϡϏετΡ֮ฯ

ࣆସͶଲԢͤΖٺەͲܠH1N1ླྀߨΝण͜ɼࢊָׯ࿊ ఼Νઅཱིڎ֋൅ʀ੣ଆΝ୴఼͑॑ڂҫ༂඾͹ݜ

ҘͶࡏ͢ɼҫڶઝ঳͵ʹ͹״BARDAͺ2012೧ΓΕɼ „ ఼ڎ֋൅Ώ੣ଆ͵ʹΝ୴͑॑གྷڂ༂඾͹ਟଐ͵ݜ ʤCIADMʥΝธࠅ಼Ͷઅ஖ ¾ ϟϨʖϧϱχयʤEmergent BioSolutionsऀक಍ʥɼ όʖηΩϫϧψ΢ψयʤόώϩτΡηऀʤϭέοϱ ฑ ෨໵ʥɼτΫγηयʤτΫγηA&M୉ָʥ͗क಍͢ɼ Ώ୉ָ͹ࢬઅΝCIADMͳ͢ͱࢨఈۂة࣎ ຿ؔ „ BARDAͺ2013೧ΓΕɼϏϱυϝρέ࣎Ͷैలʀ࢕৏ ͝੣ଆΝߨ͑ࢬઅ͹ϋρφϭʖέʤFFMNʥΝߑ஛ ¾ ΢ϱυΡΠψयɼόʖηΩϫϧ΢ψयɼωϣʖ ͹ࢬઅΝࢨఈۂةζϡʖζʖयɼϓϫϨξय౵͹

ड़ॶʁBARDA, “Department of Health and Human Services’ Centers for Innovation in Advanced Development and Manufacturing”, GAO, “National Preparedness: HHS Has Funded Flexible Manufacturing Activities for Medical Countermeasures, but It Is Too Soon to Assess Their Effect”౵

24 ࣎ٺە ฑ࣎ ઝ঳ؖ࿊༩ࢋਬҢ״ʤࢂߡʥ ઝ঳ͶׄΕ౲ͱͱ͏ͪ͗ɼ״͹༩ࢋΝޛNIAIDͲͺ2008೧ౕҐ߳ɼ5,000Աԃ઴ ઝ֨୉͗਒΋2016೧ౕ༩ࢋ͖ΔͺଁՅܑ޴Ͷ͍Ζ״ΦϚϧ͹

NIAID͹༩ࢋਬҢ*1 ઝ঳ঈ͚ʥ״ڷઝ঳ʤ৿״ ઝ঳״ڷ৿ ୱҒʁԱԃ ઝ֨୉״MERS ੤ΠϓϨΩͲ͹ΦϚϧ ΦϚϧड़݄೦͹ ઝ঳Ν؜״ڷઝ֨୉ ൔͻΓΕɼ৿״H1N1 ʤशଋઑݶͶࢺΔͥʥ ड़݄೦͹ 6,000 ઝ঳͹༩ࢋ͗ଁՅ״΢ϱϓϩΦϱδ ʤ2016೧݆̑ɼWHO͗शଋΝ൅නʥ ΋

5,000

4,000 3,475 3,310 3,307 3,389 3,353 3,216 3,219 3,048 3,011 3,033 3,000 2,877

2,000

1,000 1,991 2,211 1,731 1,773 1,814 1,799 1,800 1,699 1,744 1,740 1,916

0 ճܯ೧ౕ 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

ࡎى஍ΝܯʤIIDʥ྘Ү͹༩ࢋ͹߻׳ઝ঳ʀ໖Ӻ࣮״;ٶઝ঳ঈ͚ʥͺNIAID͹HIV/AIDs״ڷઝ঳ʤ৿״ઝ঳ʤBioDʥ྘Ү͹༩ࢋɼ״ڷ৿;ٶઝ঳ͺNIAID͹ώ΢ΨυΡϓΥϱη״ڷ৿ .1* ”Fiscal Year 2018 Fact Book|;ٶ”ड़ॶʁNIAID, “Fiscal Year 2017 Fact Book

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱຎྭʁ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ਏஇ๑ʁචགྷؽ೵͹ༀׄ෾୴ ࣎Ͷඍ͓ͪਏஇ๑͹֋ٺەଠϠξϨτΡͳർͤΖͳ੕ැͶΓΖༀׄͺݸఈదɽ ൅ϕϫήϧϞ͹ਬ਒͗੕ැक಍ͲߨΚΗͱ͏Ζ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ࣌વ஄ରɼ ΠΩυϝΠ ࠅࡏؽؖ Όͱ͏Ζਏஇ๑͹೼Ѵʥ ੣඾υδ΢ϱʀ֋൅ ୉ྖਫ਼ࢊର੏͹੖ඍٽεʖθ୵ࡩʤ੕ැʀྡজݳ৖͗ ɼࢾ༂͹ΫρφԿʥ ʤઅඍ੖ඍɼݬྋʀࣁࡒ௒ୣɼགྷҽର੏ɼ౵ʥܯ֋൅ਬ਒ ʤࢾࡠ඾͹ࡠ੔ɼݗৄͳ࠸અڂݜ αϱιϕφ݀ఈʤΤ΢ϩηΰόϞ৚ๅʀ߇ݬʀ ੣඾ݗৄʙඉྡজྡজࢾݩ͹ࣰࢬ ౵͹ਫ਼ࢊحढ़݀ఈʥ ʤබݬରखѽ๏๑ཱི֮ɼਏஇ๑੓೵ʀ҈ఈ੓͹֮೟ʥ ਏஇ༂ʀؽٗوϐφΤ΢ϩη߇ର͹ಝఈɼԢ༽ͤΖ৿ ढ़֋൅ʤΤ΢ϩηΰόϞʀ߇ݬʀϐφΤ΢ϩηٗ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ढ़͹֋൅ʥ ট೟৻ࠬٗو߇ର͹ݗड़๏๑ཱི֮ɼ৿ ੕ැ ͹҈સ੓ʙGLPన߻ࢬઅ ࢾ༂੣ଆʀΫρφԿ͹અඍ GMPన߻ਫ਼ࢊઅඍʀࢬઅڂઝ঳ݜ״ ֋൅ અඍʀڂݜ ݗରण೘ࢬઅɼഓૻର੏ ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ʤ઒༽ࢬઅͲ͹ݗࠬ͗චགྷ͵ਏஇ๑͹৖߻ʥה൭ ࢬઅ බݬରΏخਬ਒ ࢾ༂੣ଆઅඍ ΢ϱξηφϨʖ ढ़ʤAIմੵ౵ʥͶ࢘༽ͤΖٗو৿ ΠϩβϨθϞɼλϓφΤΥΠ౵ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

͹ݬྋʀࣁࡒحࣁࡒ බݬରγϱϕϩ ࢾ༂੣ଆʀΫρφԿ͹ࣁࡒ ਏஇ༂ʀؽ ੕ැ ށ͹ࡑحࢾࡠ඾͹Ϋρφ ਏஇ༂ʀؽ הබݬର ඍடʙࣆ઴༩༁حઝं͖Δ͹ݗࠬࡒྋ ਏஇ༂ʀؽ״ ക཈ࡋ๖ ઝं͖Δ͹ݗࠬࡒྋ״ ढ़ʤAIմੵ౵ʥͶٗو৿ ࢘༽ͤΖָस༽υʖν౵ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

25 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ࣑ྏ༂ʁචགྷؽ೵͹ༀׄ෾୴ ࣎Ν૟ఈͪ͢ྡজࢾݩࢬઅ͹֮ฯٺە൭੖ඍΏخ੕ැͶΓΖ֋൅Յଐ͹ͪΌ͹ ֋൅͗ਬ਒͠Ηͱ͏ΖڂͶΓΖݜܠ౵͗ߨΚΗͱ͏Ζɽฑ͖࣎Δࢊָׯ࿊ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ࣌વ஄ରɼ ΠΩυϝΠ ࠅࡏؽؖ εʖθ୵ࡩʤබݬର͹ಝ੓೼Ѵɼ ਫ਼ࢊٗढ़ʤCMCʥ͹ཱི֮ ୉ྖਫ਼ࢊର੏͹੖ඍ ֋൅ਬ਒ Կ߻෼ηέϨʖωϱή؜΋ʥʥ ʤݬ༂͹੣ଆ๑֋൅ɼ੣ࡒ֋൅ɼ඾࣯඲Ճʥ ʤઅඍ੖ඍɼݬྋ௒ୣɼགྷҽର੏ɼ౵ʥڂݜ ϨʖχԿ߻෼͹࠹నԿ ྡজࢾݩ͹ࣰࢬ ࣑ྏ༂͹ਫ਼ࢊ ʤϨʖχԿ߻෼͹୵ࡩʀ࠹నԿɼAPI੣ଆ๑͹ཱི֮ʥ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ඉྡজࢾݩ͹ࣰࢬ ট೟৻ࠬ ੕ැ ઝ঳࣑ྏ༂઒༽ʥ״ઝ঳࣑ྏ༂઒༽ʥ GMPన߻ਫ਼ࢊઅඍʀࢬઅʤ״͹҈સ੓ʙGLPన߻ࢬઅ ࣑ݩ༂੣ଆઅඍʤڂઝ঳ݜ״ ֋൅ અඍʀڂݜ ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ྡজࢾݩࢬઅʤGCPన߻ࢬઅʥה൭ ࢬઅ බݬରΏخਬ਒ Կ߻෼୵ࡩʀνʖΰρφಝఈ༽અඍ ΢ϱξηφϨʖ ɼηϏαϱɼ౵ʥںɼNMR*2, LS/MS*3ɼέϧ΢ΨుࢢݨඏحʤHTS*1ؽ ࢾ༂੣ଆઅඍ ඉྡজࢾݩ༽͹ಊ෼؇ཀྵࢬઅ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ ࣁࡒ Կ߻෼ࣁݱʙԿ߻෼ϧ΢ϔϧϨʖ ࣑ݩ༂͹ݬྋʤAPIɼశՅࡐʥɼใૹࣁࡒ ࣑ݩ༂͹ݬྋʤAPIɼశՅࡐʥɼใૹࣁࡒ ੕ැ ށ࣑ྏ༂ݬྋ͹ࡑ;ٶΠρι΢ϕϪʖφ ࣑ݩ༂ ࣑ྏ༂ අݩं ࣑ྏ༂ඍடʙࣆ઴༩༁ הබݬର ക཈ࡋ๖ ඉྡজࢾݩ༽͹ಊ෼

གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂགྷҽ ݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

໒ *3. Liquid Chromatography Mass SpectrometryɼӹରέϫϜφήϧϓΡʖ࣯ྖ෾ੵ๑ڠـHigh throughput Screening *2. Nuclear Magnetic Resonanceɼ֫ࣕ .1*

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ϭέοϱʁචགྷؽ೵͹ༀׄ෾୴ ࣎Ͷඍ͓ͪਫ਼ࢊʀैలʀ࢕৏͝ΏྡজࢾݩՆ೵͵અඍΝ੕ැ͗६ඍ͢ͱ͏ٺە Ν௪ͣͱߨΚΗͱ͏Ζܠࢊָׯ࿊͗ڂϭέοϱٗढ़͹ݜوΖɽ৿ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ࣌વ஄ରɼ ΠΩυϝΠ ࠅࡏؽؖ ʤබݬର͹ಝ੓೼ѴɼϠξϨτΡ͹મఈʥ ඾࣯؇ཀྵࢾݩ͹֋൅ ୉ྖਫ਼ࢊର੏͹ཱི֮ εʖθ୵ࡩ ʤϭέοϱ͹९ౕɼްྙɼ҈ఈ੓͹ࢾݩ๑͹ཱི֮ʥ ʤઅඍ੖ඍɼݬྋ௒ୣɼགྷҽର੏ɼ౵ʥ ֋൅ਬ਒ ϭέοϱޫึ͹αϱιϕφݗ౾ ਫ਼ࢊٗढ़͹ཱི֮ʤϭέοϱݬӹ͹ਫ਼ࢊɼڂݜ ʤබݬର͹ക཈๏๑ཱི֮ɼබݬରΰόϞ৚ๅ͹ಝఈʥ ώ΢Πϩ౵΃͹ϭέοϱैలͶΓΖ੣඾Կʥ ϭέοϱ͹ਫ਼ࢊ ϭέοϱ֋൅ٗढ़ཱི֮ ؇ཀྵ ΢ϱξηφϨʖށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ʤ߇ݬ෾཯੠੣ɼΠζϣώϱφʀ҈ఈࡐ௒੖ʥ ྡজࢾݩ͹ࣰࢬ ඉྡজࢾݩ͹ࣰࢬ ট೟৻ࠬ ֋൅ અඍʀ ੕ැڂݜ ͹҈સ੓ʙGLPన߻ࢬઅ ݬӹ੣ଆʀ੣඾Կ͹અඍ GMPన߻ਫ਼ࢊઅඍʀࢬઅڂઝ঳ݜ״ ൭ ࢬઅ ʤݬӹ੣ଆɼക཈ࡋ๖खѽ͏અඍɼ౵ʥخਬ਒ ϭέοϱ͹९ౕɼްྙɼ҈ఈ੓Ν ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ֮೟ͤΖͪΌ͹ࢾݩઅඍ ΠΩυϝΠהබݬରΏ ݬӹ੣ଆઅඍ ྡজࢾݩࢬઅʤGCPన߻ࢬઅʥ༽ڂݜ බݬରΰόϞ৚ๅಝఈ༽͹અඍ ʤ࣏੊େεʖίϱηεητϞɼ౵ʥ ඉྡজࢾݩ༽͹ಊ෼؇ཀྵࢬઅ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ ࣁࡒ ౵حබݬରγϱϕϩ ݬӹ੣ଆʀ੣඾Կ͹ࣁࡒ ϭέοϱ͹ݬྋɼώ΢Πϩ༲ ށϭέοϱݬྋ͹ࡑ;ٶγϱϕϩ ඾࣯؇ཀྵࢾݩ༽ࣁࡒ ϭέοϱ༽ڂݜ ʤVirus poolɼAdjuvant poolʥ ʤϭέοϱ͹९ౕɼްྙɼ҈ఈ੓Ν֮೟ͤΖͪΌ͹ࢾݩࣁࡒʥ ੕ැ ࣑ݩ༽ϭέοϱ ϭέοϱඍடʙࣆ઴༩༁ הබݬର ക཈ࡋ๖ʀಊ෼ʤܴཝ౵ʥ අݩं ඉྡজࢾݩ༽͹ಊ෼ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂགྷҽ ݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

26 ӵࠅ

27 ࣎ٺە ฑ࣎ ؽؖ͹ૌ৭ର੏ڂదݜޮ;ٶ੕ැ Ν஦ৼͶɼNIHRͺ֋൅Ώࣰ༽ԿͶ޴ͪ͜ࢩԋΝ஦ৼͶΠΩυڂݜેخMRCͺ Νߨͮͱ͏Ζڛ΃͹ࣁۜ఑ۂةϝΠΏ ֋൅Ͷڂઝ঳ؖ࿊੕ࡨʀݜ״ʷ ຎྭʁ कͶؖ༫ͤΖؽؖ ಼ֵ Ռָٗढ़સൢ ੕ࡨસൢ BEISۂࢊ ݊߃ʀҫྏ੕ࡨʙ ‡ ੕ࡨࡨఈ ઝ঳؜΋ʥ DHSC״ʤ ۃ੏౲و

OLS ‡ ੕ࡨࡨఈ ઝ঳؜΋ʥ MHRA״NHS ʤ

͹ট೟حઝ঳྘ҮͶଲͤΖ ‡ ҫ༂඾ʀؽ״ ‡ τʖϜ͹ NIHRڂϓΟϱυΡϱήؽؖ UKRI ݜ ঁ੔΍ࣰࢬ

RCs Research Innovate MRC England UK

֋൅ؽؖڂݜ Catapult

ؽؖڂؽؖ NIHRࢁԾ͹ݜڂMRCࢁԾ͹ݜ ‡ MRC Biostatistics Unit at the University of Cambridge (MRC BSU) ‡ NIHR Innovation Observatory (NIHRIO) ‡ MRC Epidemiology Unit at the University of Cambridge (MRC ‡ NIHR Medtech and In vitro diagnostics Co-operatives (MICs) EU) ‡ NIHR Clinical Research Facilities (CRFs) ‡ MRC Centre for Global Infectious Disease Analysis ‡ NIHR Infastructure ‡ MRC-University of Glasgow Centre for Virus Research (MRC CVR) ‡ NIHR Cambridge Biomedical Research Centre ‡ The Francis Crick Institute ‡ NIHR Oxford Biomedical Research Centre ‡ Health Data Research UK (HDR UK) ‡ NIHR Cambridge BioResource ‡ MRC Clinical Trials Unit at UCLɼ౵ ‡ NIHR BioResource ‡ CRUK Cambridge Institute ֋൅Νࣰࢬڂઝ঳ؖ࿊͹ݜ״ؽؖͶͱڂҲ෨ݜ ‡ ‡ Cambridge University Hospitals NHS Foundation Trustɼ౵

֋൅Νࣰࢬڂઝ঳ؖ࿊͹ݜ״ؽؖͶͱڂड़ॶʁBEISΤΥϔγ΢φɼUKRIΤΥϔγ΢φɼMRCΤΥϔγ΢φɼNIHRΤΥϔγ΢φ౵ ‡ Ҳ෨ݜ

࣎ٺە ฑ࣎ ਫ਼ࢊ͹ؽ೵ैଏ͹ͪΌ͹଩ͬघʁγϜϨ;ٶ֋൅ڂݜ ڂ֋൅Νਬ਒ͤΖͪΌ͹αϱλʖεΠϞઅཱིΏݜڂઝ঳༽ϭέοϱ͹ݜ״ڷ৿ ֋൅ϕϧρφϓΧʖϞ͹੖ඍͶ஭ྙ͢ͱ͏Ζڂ֋൅ΝࢩԋͤΖͪΌ͹ݜ ؽ೵ैଏ͹ ຎྭʁਏ - ਏஇ๑ ࣑ - ࣑ྏ༂ ϭ - ϭέοϱ ֋൅ ֋൅ ਫ਼ࢊ ਫ਼ࢊ ڂݜ ڂ଩ͬघ ݜ કྲྀࡨఈʀ સର౹ׇ ਏ ࣑ ϭ ઝ঳કྲྀʥ״ઝ঳ଲࡨͶؖͤΖકྲྀࡨఈʤਫ਼෼ָద҈સฯ্કྲྀɼ״ڷ৿

ਏ ࣑ ϭ ֋൅ʀਫ਼ࢊ͹ͪΌ͹ࣁ֮ۜฯʤ༁283Աԃ͹༩ࢋʥڂઝ঳͹ݜ״ڷ৿

ϭ ֋൅Νਬ਒ͤΖαϱλʖεΠϞઅཱིʤUK Vaccine Networkʥڂઝ঳༽ϭέοϱݜ״ڷ৿

֋൅ ϭڂݜ ֋൅ʀਫ਼ࢊࢩԋڂ΃͹ݜۂةUK Vaccine NetworkͶΓΖΠΩυϝΠΏ ਬ਒ ਏ ࣑ ϭ GenOMICCαϱλʖεΠϞ ΰόϞմੵं׳͹ͪΌ͹ڂઝ঳ݜ״ڷͶΓΖ৿

֋൅ ਏ ࣑ ϭ ࠅ಼Ͷ͕͜ΖBSL4ਭ६͹ ࣑ ߇ۗ༂Νଲেͳͪ͢೧ؔڂݜ ࢬઅ͹׮ඍʤ4ࢬઅʶ1ࢬઅࢬ޽஦ʥ ఈֻ෹͏Ϡυϩ͹ࢾߨϕϫζΥέφࣰࢬ஦ڂ൭ ݜخਬ਒ ਏ ࣑ ϭ ࣑ ୻क़ؔغ͹ڂBSL3ࢬઅ͹੖ඍʀैଏ NHS DigiTrialsͶΓΖྡজݜ;ٶʤઅඍʀࣁࡒʀ BSL-4 ๑੏ౕ౵ʥ ਏ ࣑ ϭ ݄ӹώ΢ΨϜʖΩʖΏ ΰόϞ৚ๅ౵͹ώ΢Ψώϱέ ڛؽؖ΃͹Πέιη఑ڂߑ஛ͳݜ ʤࢂߡʥEUͶ͕͜Ζखૌ ਏ ࣑ ϭ ϭ গཔ͹ϏϱυϝρέΝ૟ఈͪ͢ɼ અඍ΃͹ΨʖϕϱΠέιηʤCERICʥʰϏϱυϝρέ६ඍϭέοϱʱট೟੏ౕʤ΢ϱϓϩΦϱδΝڂݜ ଲেͳͪ͢Pandemic preparedness vaccineʥ͹੖ඍ

28 ࣎ٺە ฑ࣎ ઝ঳ͶؖͤΖक͵੕ࡨ״ڷ৿ ɼޛઝ֨୉΃͹ଲԢ״ӵࠅͲͺΦϚϧड़݄೦͹ ͱ͏Ζͮ͗ܪ࣎͹ଲԢͶؖͤΖ٠࿨͗ՅଐԿ͢ɼકྲྀࡨఈͶٺە

2016೧ 2018೧ 2019೧ 2014ʛ16೧ 4݆ 7݆ 9݆

੤ΠϓϨΩͲ͹ΦϚϧ ઝ֨୉״ड़݄೦͹ ʤ2016೧3݆ɼWHO͗ शଋΝ൅නʥ

ઝ঳કྲྀΝ൅න״ ͳ ਫ਼෼ָద҈સฯ্કྲྀΝ൅න܉گ઒໵җҽճͶΓΖΦϚϧଲԢΝ ੕ැ΃͹఑ݶ͹൅න ਫ਼෼ָదϨηέͶଲ͢ͱɼϨηέ͹ཀྵմɼ 2020ʛ25೧Ͷ࿳Ζɼ΢ϱήϧϱχޮ़Ӷਫ਼ͪ͢ ઝ঳Ͷଲͤ״ઝ֨୉΃͹ଲԢ ༩๹ɼݗஎɼଲԢ͹࿰ૌΊͲखૌΊΝߨ͑ γʖϑηʤPHEʥΝ஦ৼͳͪ͢״ΠϓϨΩͲ͹ΦϚϧड़݄೦ ɼޤ͹ ΖકྲྀΝషΌͱ͕Εɼ༩๹ʀฯܠֆͳ͹࿊ۂͳΝ఑ࣖɽΠΩυϝΠΏࢊ͞ ەΝण͜ɼΠΤφϔϪ΢έ΃͹६ඍɼଲԢɼ ɼ६ඍʀଲԢɼߑ஛ʀనԢɼޜݗஎʀ੏ ٶ࣎͹ΪώψϱηͶؖ͢ͱ఑ݶΝࡠ੔ ॑གྷ੓Ͷ΍ݶٺ ͹ητρϕͶԌͮͱ༙ڠɼ৚ๅܠ఑ݶʀ࿊ ͶଲͤΖϭέοϱ֋ـ࠙क͵఑ݶ಼༲ࠚ ‡ ླྀߨ͹Ն೵੓͍͗Ζබ खૌΊ͹๏޴੓Ν఑ࣖ ؄ࢻυʖν͹֨୉๏๑ɼླྀߨ͹஻͢͹ಝఈɼ ൅΃͹౦ࣁɼਟଐ͵ϭέοϱ֋൅ʀ੣ଆͶࣁ ‡ ͢͵ࡎͺಝͶىઝ঳ͶؖͤΖ״ڷΠϧʖφ͹ࣰࢬ ͤΖٗढ़΃͹౦ࣁɼϭέοϱ֋൅ϕϫιη͹ ‡ ৿ ٶઝ঳કྲྀ͹ࡨఈ Ϝρϕࡠ੔Ͷݶ״ڷ৿ ‡ ‡ ϭέοϱ੣ଆ༲ྖ͹෈ଏ΃͹ଲԢ Ռָࣀ໲җҽճʤSAGEʥ൅ଏϕϫιηΏ ‡ ͹ࡑΕ๏Ͷؖ͢ͱͨ ؽؖΝઅཱིͤΖ৖߻͹ͨ͹ༀׄڂ৿ͪ͵ݜ ‡ ʤࢊָׯ͹Ϗ΢ϕༀʥ ଇ਒͹ͪΌ͹ϕϫڂ༫ͤΖݜرଲԢͶٺە ‡ φαϩઅཱི ࣏͹ࠅՊਫ਼෼ָద҈સฯ্કྲྀͶ͕͜ΖΠ ‡ ΤφϔϪ΢έ࣎Ͷ޴͜ͱӵࠅ͗۫ඍͤ΄͘ ؽ೵ͳΫϡϏετΡ͹ఈٝ

ड़ॶʁGovernment response to the House of Commons Science and Technology Committee “2nd Report of Session 2015-16: Science in Emergencies: UK lessons from Ebola”ɼUK Biological Security StrategyɼPHE Infectious Disease Strategy 2020-2025

࣎ٺە ฑ࣎ ʤࢂߡʥӵࠅ͹݊߃ʀҫྏકྲྀ͹ࡨఈ๏ਓ ֆۂͶɼકྲཱྀིҌ࣎ͺࢊܢΏ߶ྺԿऀճ౵͹ऀճ՟ୌΝഐ״ؽثBrexitͶΓΖ ͘ࠒΊΏ੕ැ͹γ΢ΦϱηͶଲͤΖݸఈద͵ؖ༫౵͗॑ࢻ͠Ηͱ͏Ζת͹

Brexit Four Grand Challenges ੕ࡨ ״ؽث ʤӵࠅ͹ຳྙౕఁԾɼ (AI & Data economy, Future of Mobility, (ਕࡒླྀड़ɼք֐౦ࣁݰঙʥ Clean Growth, Aging Society

કྲྀࡨఈ͹ݬಊྙ Industial Strategy ఼͹ธࠅҢ఺ڎڂݜ White Paper

ຌ๏ਓخકྲྀࡨఈ͹઴఑ʀ

ಉڢֆͳ͹ۂࢊ ໎֮͵੕ැ͹ༀׄ ༽ֆ͹๏͗ྒྷ͚எͮͱ͏Ζɼ ք֐Ϩλʖη͹׈ۂʤࢊ ʤ຿ؔ͗ෝ͓͵͏ϨηέΝෝ͑ɼ ֆ͗αϝρφ͢͵͚ͱͺ ʤք֐౦ࣁɼۂࢊ ෈ଏ՗ॶ͹݂ດΌɼ ҽʥڂؽؖʀݜڂ෼ࣆ͗਒Ή͵͏ɼ ք֐ݜ ͙ʥܪητʖέϙϩξʖؔ͹ ຿ؔ౦ࣁͶΓΖึ׮ɼ౵ʥ

ۂϧ΢ϓγ΢Φϱηࢊ γ΢ΦϱηͶଲͤΖ ֆʥ͹ ΦϱζωΠϨϱήʙ Φϑυϱη͹॑ࢻۂʤಝͶ੣༂ ߨ੕ؖ༫͹ݸఈ ੣ଆ͹॑གྷ੓ ʤકྲྀҌΏϓΟϱυΡϱήଲে ʤγ΢ΦϱηͶؖͤΖқࢧ݀ఈ ॑གྷ੓ ͹૓ड़ʥ ͹ଧ౲੓ݗৄʀ༑઎ॳҒ෉͜ʥ༽ޑ͵దʀ҈ఈదغʤௗ ૬ྙڟͺߨΚ͵͏ʥ ʤ੔ௗ྘ҮͲɼ׎ͯࠅࡏ ʥۂΝ༙ͤΖ਼ঙ͵͏ࢊ

֋൅͹੏ౕʀର੏ʀӣ༽౵ͶؖͤΖ௒ࠬʱๅࠄॽڂड़ॶʁ݊߃ʀҫྏકྲྀ࣪ 2018೧ʰঀ֐ࠅͶ͕͜Ζҫྏݜ

29 ࣎ٺە ฑ࣎ ؖ༫ं;ٶҫྏ෾໼ؖ࿊੕ࡨʁࡨఈϕϫιη ʀ߻қ֭ಚ͗॑ࢻ͠Ηͱ͕Εɼܠֆͳ͹࿊ۂΖͪΌɼࢊ͝ܪԿͶۂӵࠅͲͺࢊ ͘ࠒΊ͗ߨΚΗͱ͏ΖתֆΏΠΩυϝΠ͹ۂదͶࢊۅ੕ࡨࡨఈ࣎΍੷

ϕϫιη ໪దઅఈ ͪͪ͘ୈ͹ࡠ੔ ߻қܙ੔ ࣰߨʙϠωνϨϱή કྲྀ LSIS Committee ߃ʀҫྏ෾໼͹ ࢊׯָ͹઒໵Պ༁25໌ LS Implementation Board݊ ‡ ү੔ ʤࢊָׯ؜΋༁40໌ʥۂLife Science ࢊ ΝϠωνϨϱήɼڱSector Deal ʤӵࠅ͹஦ৼదࢊ ‡ ఑ݶॽʤLSISʥ͹ࡠ੔ ‡ LSIS͹఑Ҍ಼༲Ͷ͕͏ͱ ‡ ಍೘য় ੕ැ͖ͫ ߻қͪ͢΍͹ΝLSSDͶൕ KPIΝઅఈ;ٶΊکͳͤΖʥ ‡ ӵࠅ͹ۂ ʤLSSDʥ Δͨ͞खૌ΋΄͘ͳࢧΚ ӫ ΗΖ྘ҮΝபड़

Industrial ‡ ܨࡃ੔ௗ ʤ෈໎ʥ ʤ෈໎ʥ IS Implementation Board strategy ‡ ޑ༽ң࣍ ΝϠωνϨϱήɼڱ֋൅͹ࠅ֐ླྀ ‡ ࣰߨΝ݀Όͪકྲྀʀࢬࡨ ‡ ಍೘য়ڂWhite paper ‡ ݜ ड़๹ࢯ ͺLSSDͶൕӫ KPIΝઅఈ

ฯ݊঴ ‡ Departmental board + ࠅ຿͹݊߃ʀௗथ ʤ෈໎ʥ Departmental board Departmental ‡ ݊߃͵ࠅ຿ͶΓΖ ࢊָ͹઒໵Պ ΝϠωνϨϱήɼڱ༫ ‡ ༹ʓ͵઒໵஄ର͹΢ϱ ‡ ಍೘য়رࡃ൅ఴ΃͹ܨ Plan ϕρφΝܨͱકྲྀΝܙ੔ KPIΝઅఈ ‡ ʤಋ৏ʥ NIHR Sr Mgmt Team ʤ෈໎ʥ NIHR NIHR ʶࢊָ͹઒໵Պ ͹݊߃՟ୌΝݗ౾ޛAnnual ‡ 30೧ 1೧ؔͲޛplan ͢ɼͨ͹಼ɼࠕ खૌ΋΄͘՟ୌΝபड़ ՁΗ͹੕ࡨͶ͕͏ͱ΍ɼͪͪ͘ୈࡨఈஊ ͘ࠒΊΝࣰࢬת֌͖Δࢊָ͹

΃͹΢ϱνϑϣʖɼ֦੕ැؽؖ͹ΤΥϔγ΢φंܐड़ॶʁ੕ැؖ

࣎ٺە ฑ࣎ ҫྏ෾໼ؖ࿊੕ࡨʤLSSDʥ͹ࡨఈգఖ;ٶҫྏ෾໼ؖ࿊੕ࡨʁ੕ැ΃͹఑ݶॽʤLSISʥ ࢊָׯ͹େනं༁40໌͗ॄΉΕ఑ݶॽ͗ΉͳΌΔΗͪɽ఑ݶॽΝಁΉ͓ͪLife Science Sector DealͲͺɼࢊׯͨΗͩΗ͗ࢬࡨࣰߨͶαϝρφͪ͢

੔ ࣰߨʙϠωνܙકྲྀҌʤ੕ැ΃͹఑ݶॽʥ͹ࡠ੔ ߻қ ࠙Life Science Industrial StrategyʤLSISʥ͹ࡨఈࠚ ࠙Life Science Sector DealʤLSSDʥ͹ࡨఈࠚ Ϩϱή

༁25໌͹઒໵Պ ʤ੕ැʤUKRI౵ʥɼΠ ࢬࡨҌ͹ ࣁۜ෾୴౵Ͷ ΩυϝΠɼοϡϨτΡɼ LSSDࡨఈͶࡏ͢ͱ΍ࢊָ͖Δ઒໵Պ ߞΕࠒΊ ؖͤΖިম ʥ ͗ডᡊ͠Ηͪۂة੣༂ LSSDͲఈٝ͠Ηͪࢬࡨ ΝࣰߨͤΖͪΌ͹Ϩ LS ͳ͹͟غλʖηʤࣁۜɼགྷҽ ࢝ൔ ֆ KPI͹અఈۂͲɼ੕ැʀࢊंڂImplementation Oxford୉ָ͹ݜ ౵ʥ౦ԾͶଲͤΖα ϠωνϨϱή Ϩʖ͏کBoard ͖Δ৶བ͹޲͏Sir John Bell͹ ξʖερϕ͹΍ͳͶૌ৭ ϝρφϟϱφΝࢊׯ͗ ఑ࣖ LSIS Committee ָढ़దʀՌָ खૌ΋ ࢬࡨҌ Ίʙک͵ʤ੕ැʤUKRIɼ ద Innovate UKɼNHS ΄͘྘ҮΝ ʤLong Listʥ Opportunity͹ ɼ பड़ ͹ࡠ੔ۂة౵ʥɼ੣༂ ΠΩυϝΠʥ જ͏ड़͢

࠙ࢂߡࠚLife Science Industrial StrategyʤLSISʥͳͺ Ϩʖξʖερϕ͹΍ͳɼࢊָׯ͹େනं༁͏کֆ͖Δ৶བ͹޲͏Sir John Bell͹ۂͲɼ੕ැʀࢊंڂֆ͗஦ৼͳ͵Εࡨఈͪ͢੕ැ΃͹఑ݶॽͲ͍ΕɼOxford୉ָ͹ݜۂࢊ 9 40໌͗ॄΉΕखΕషΌΔΗͪ ֆۂͶLife Science Sector DealʤLSSDʥΝཱིҌɽLSSDͲखΕషΌΔΗͪखૌΊͶଲ͢ͱɼࢊޛLSISΝण͜ɼӵ੕ැͺOffice for Life ScienceʤOLSʥ*1क಍ͲΚ͖ͥ3ϳ݆ 9 ͖Δ΍Ҳఈ͹౦ࣁʀࢬࡨࣰߨͶଲͤΖαϝρφϟϱφΝಚͱ͏Ζ ֆΝકۂLSISࡨఈ࣎Ͷɼ੕ැ͹ༀׄʤ຿ؔ͗ෝ͓͵͏ϨηέΝෝ͑ɼ෈ଏ՗ॶ͹݂ດΌɼ౵ʥ͗໎֮Ͳ͍ͮͪ͞ͳɼγ΢ΦϱηͶଲͤΖߨ੕ؖ༫Νݸఈ͢ͱ͏ͪ͞ͳɼࢊ 9 ͪͮ͗ܪద͵੕ࡨཱིҌ΃ͳغࠒΊαϝρφϟϱφΝಚͪ͞ͳ͗ժתҌͶཱིྲྀ

કྲྀ঴ʤBEISʥ͹ഓԾͶҒ஖෉͜ΔΗͪɼLSIS͹ͳΕΉͳΌΝߨ͑੕ැؽؖͲ͍Ζۂฯ݊঴ʤDHSCʥͳϑζϋηʀΦϋϩάʖʀࢊ .1* ΃͹΢ϱνϑϣʖɼ֦੕ැؽؖ͹ΤΥϔγ΢φंܐड़ॶʁ੕ැؖ

30 ʤࢂߡʥҫྏ෾໼ؖ࿊੕ࡨʤLSSDʥ͹੕ࡨࣰߨʀϠωνϨϱήର੏ ੕ࡨࣰߨʀϠωνϨϱήΝߨ͑Implementation BoardͳCouncilϟϱώʖͺɼ େනं΍؜ΉΗΖۂةֆ౵͹େනंͲߑ੔͠Ηͱ͕Εɼք֐͹ۂࢊ;ٶ੕ැ

LS Councilϟϱώʖߑ੔ LS Implementation Boardϟϱώʖߑ੔ ಋҗҽௗڠ ಋҗҽௗڠ

‡ DHSC୉਋ BEIS੕ແ࣏ׯ ‡ ‡ BEIS୉਋ ‡ OLS Champion ‡ ੣༂ήϩʖϕճௗ

җҽʤ21໌ʥ җҽʤ25໌ʥ

ֆۂ੕ැ „ οϡϨτΡʖ „ ੕ැ „ ࢊ „ ճڢۂOLS Champion ‡ Wellcome Trust ‡ ฯ݊੕ແ࣏ׯ ‡ ώ΢Ψࢊ ‡ ճڢ໲ ‡ ӵࠅ੣༂ޒBEIS੕ແ࣏ׯ ‡ Ռָٗढ़ ‡ ճʙૌ߻ڢحֆ ‡ OLS ‡ ӵࠅҫྏؽۂฯ݊੕ແ࣏ׯ „ ࢊ ‡ ‡ ‡ ճ NHS UK Biobankڢۂ໲ ‡ ώ΢ΨࢊޒՌָٗढ़ ‡ ۂةϓΟϱυΡϱήؽؖ ‡ ੣༂ ‡ ճڢOLS ‡ ӵࠅ੣༂ ‡ ૌ߻ۂʤ ɼ ɼ ʥ‡ Ռָࢊ ճ UKRI Innovate UK MRCڢۂNHS ‡ ӵࠅҫྏࢊ ‡ ۂةϓΟϱυΡϱήؽؖ ‡ Medtech ‡ ۂةMedtech ‡ ʤUKRIɼBEISɼNIHRʥ ‡ υζνϩʀυʖν઒໵Պ „ οϡϨτΡʖ ճ „ ͨ͹ଠڢҫྏοϡϨτΡʖ ‡ ۂةࠅࡏ௪ঐ঴ ‡ ϧ΢ϓγ΢Φϱηؖ࿊ ‡ ʤӵɼEUɼธɼೖʥ ‡ ౦ࣁαϝϣωτΡʖ LS CouncilϟϱώʖͶͺɼೖຌΝ؜ ͹CEO΍؜ΉΗͱ͏Ζۂة΋ք֐͹

”?΃͹΢ϱνϑϣʖɼ֦੕ැؽؖ͹ΤΥϔγ΢φɼ Response to House of Lords Science and Technology Select Committee report “Life Sciences Industrial Strategy: Who’s driving the busंܐड़ॶʁ੕ැؖ

࣎ٺە ฑ࣎ કྲྀࡨఈʀસର౹ׇʁUK Vaccine Network Ώ༙๮͵ϭέοϱͳٗڂଡ෾໼Ͷ͕͜Ζ઒໵Պ͹؏఼͖Δ༑઎ͤ΄͘බݬରݜ ֋൅׈ಊΝ໪ࢨ͢ͱ͏Ζڂढ़΃͹౦ࣁΝݗ౾͢ɼࣰް੓͹߶͏ݜ

໲ޒ٠ௗͺฯ݊঴क೜Ռָ ‡ ߑ੔ϟϱώʖ ࢊָׯ͖ΔݺਕୱҒͲࢂՅ ‡

અཱི೧ ‡ 2015೧

ઝ঳ͶଲͤΖ༙๮͵ϭέοϱͳͨ͹״ઝ֨୉Νण͜અཱི͢ɼླྀߨ͹Ն೵੓͍͗Ζ״ΦϚϧड़݄೦͹ ‡ ઝ঳͗൅ਫ਼ͤΖఁ஦ॶಚࠅࢩԋΝ໪దͶ׈ಊ״ढ़΃͹౦ࣁɼٗ 4ͯ͹ϭʖΫϱήήϩʖϕͲ׈ಊ ‡ ઝ঳͹ಝఈʀ༑઎෉͜״௪ڠਕॏ;ٶक͵׈ಊ಼༲ 1. ླྀߨ͹Ն೵੓͍͗Ζਕؔ ௒ࠬڻઝ঳ླྀߨԾͶ͕͜Ζϭέοϱ͹Ӫ״ .2 ΉͲ͹ϕϫιηϜρϕ͹ࡠ੔ڇڛϭέοϱ͹୵ࡩʛ .3 4. ϭέοϱ੣ଆͶ͕͜Ζࢬઅʀର੏͹೼Ѵ ‡ οέϱήωΠ೦ ‡ έϨϝΠʀαϱβड़݄೦ ‡ ΦϚϧ ύϱνΤ΢ϩη ‡ 2016೧ͶUK Vaccine Network͗Oxford୉ָ͹ ‡ Ͷଲ͢ͱঁڂϧργ೦ MERS༽Τ΢ϩηϗένʖϭέοϱ͹ݜ ‡ ଲেͳ ‡ Ϝʖϔϩή೦ ੔Νࣰࢬ ͢ͱ͏Ζ ‡ MERS ‡ ౲ϕϫήϧϞͶ͕͏ͱ֋൅͗਒ΌΔΗͱ͏ͪMERS༽ ‡ ωϏΤ΢ϩη බݬର ϭέοϱ͗ɼUniversity of OxfordͳAstraZeneca ‡ Ϙηφ ϭέοϱ֋൅غઝ঳͹૥״αϫψΤ΢ϩηܗͶΓΖ৿ ‡ Q೦ ‡ ϨϓφώϪʖ೦ Ͷܪ͗ͮͪ ‡ ζΩ೦ ‡ Disease X

ड़ॶʁUK Vaccine Network - GOV.UK (www.gov.uk)ɼ|UK COVID-19 vaccines delivery plan” GOV.UK

31 ࣎ٺە ฑ࣎ ֋൅ϕϧρφϓΧʖϞڂ൭ʁݜخ֋൅ਬ਒ڂݜ ͶۂڢGenomics EnglandΏUK Biobank౵͹खૌΊͶՅ͓ɼNHSͳIBMऀ͹ ΓΕߑ஛͠Ηͪྡজࢾݩυʖνϗʖη͗੖ඍ͠Ηɼ૓༂֋൅Νࢩԋ͢ͱ͏Ζ

¾ Genomics EnglandͲͺnThe 100,000 Genomes Project”ͳ͏͑खૌΊΝߨͮͱ͕Εɼ ͹ΰόϞ৚ๅΝफॄ͢ɼ100,000͹ΰόϞഓ྽Ν෾ੵं׳ͺΪϱ͏҅׳ঙ࣮س85,000ਕ͹ The 100,000 ͪ͢ ༽͹ݬҾմ໎Ώਏஇʀ࣑ྏ๑΃͹׈ـGenomes Project ¾ ΰόϞഓ྽ͳҫྏυʖνΝૌΊ߻ΚͦΖ͞ͳͲɼබ ଶ͠ΗΖغ͗ Ν׈੓Կͦ͠Ζ͞ͳ΍౲ϕϫζΥέφ͹໪దͳ͢ͱ͏ͪۂӵࠅͶ͕͜ΖΰόϞࢊ ¾

¾ 500,000ਕ͹ӵࠅࠅ຿ʤ50ʛ80ࡂʥ͹݄ӹώ΢ΨϜʖΩʖɼΰόϞ৚ๅɼҫྏυʖν౵Ν ட੷ ʀ෾ੵΝ໪ࢨ͢ͱ͏Ζڂ੓ΝݜܐUK BioBank Data ¾ ΰόϞ৚ๅͳ൅බϨηέ౵͹ؖ ΠέιηՆ೵ͳ͵ͮͱ͕Εɼࣙࠅ͗ंڂ౲ώ΢Ψώϱέͺ੊ֆ80ϳࠅ͹10,000ਕ͹ౌ࿧ݜ ¾ Ͷ΍߫ݛڂ͜Ͳ͵͚ଠࠅͶ͕͜Ζݜͫ

ͶΓͮͱߑ஛ۂڢNHSɼHealth Data Research UKɼIBMऀ౵ͳ͹ ¾ ͹ҫྏυʖνΝॄ༁ͪ͢υʖνϗʖηʤ2019೧Ͷߑ஛ɼݳࡑ΍ं׳͹ྡজࢾݩ৚ๅΏڊգ ¾ ؽ೵֨୉஦ʥ NHS DigiTrials ¾ ౲υʖνΝ׈༽ͤΖ͞ͳͲɼྡজࢾݩ֋࢟࣎Ͷͺඅݩंޫึ͹ಝఈ͗Ն೵ɽྡজࢾݩࣰࢬ ࢾݩ͹υʖν׈༽ΏɼNHS͗ฯڊͶ͕͏ͱͺɼNHS DigiTrials͗ฯ༙͢ͱ͏Ζգޛ஦ʀࣰࢬ ଶ͠ΗΖغͶΓΖྡজࢾݩ͹ްིԿʀՅଐ͗ܠͱ͏Ζඅݩं͹ҫྏυʖνͳ͹࿊༙͢

ड़ॶʁGenomics englandΤΥϔϘʖζɼUK BioBankΤΥϔϘʖζɼNHS DigiTrialsΤΥϔϘʖζɼNature “How we accelerated clinical trials in the age of coronavirus”

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ਏஇ๑ʁචགྷؽ೵͹ༀׄ෾୴ ֋൅Ͷ͕͜Ζ੕ැղ೘ͺݸఈదͳ͵ͮͱ͕ΕɼΠΩυϝΠͳ΢ϱڂਏஇ๑͹ݜ ξηφϨʖ͗कରͳ͵ͮͱචགྷؽ೵Ν۫ඍ͢ͱ͏Ζ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ࣌વ஄ରɼ ΠΩυϝΠ ࠅࡏؽؖ Όͱ͏Ζਏஇ๑͹೼Ѵʥ ੣඾υδ΢ϱʀ֋൅ ୉ྖਫ਼ࢊର੏͹੖ඍٽʤ੕ැʀྡজݳ৖͗ ɼࢾ༂͹ΫρφԿʥ ʤઅඍ੖ඍɼݬྋʀࣁࡒ௒ୣɼགྷҽର੏ɼ౵ʥܯεʖθ୵ࡩ ʤࢾࡠ඾͹ࡠ੔ɼݗৄͳ࠸અ ֋൅ਬ਒ αϱιϕφ݀ఈʤΤ΢ϩηΰόϞ৚ๅʀ߇ݬʀ ੣඾ݗৄʙඉྡজྡজࢾݩ͹ࣰࢬڂݜ ౵͹ਫ਼ࢊحढ़݀ఈʥ ʤබݬରखѽ๏๑ཱི֮ɼਏஇ๑੓೵ʀ҈ఈ੓͹֮೟ʥ ਏஇ༂ʀؽٗوϐφΤ΢ϩη߇ର͹ಝఈɼԢ༽ͤΖ৿ ढ़֋൅ʤΤ΢ϩηΰόϞʀ߇ݬʀϐφΤ΢ϩηٗ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ढ़͹֋൅ʥ ট೟৻ࠬٗو߇ର͹ݗड़๏๑ཱི֮ɼ৿ ੕ැ ͹҈સ੓ʙGLPన߻ࢬઅ ࢾ༂੣ଆʀΫρφԿ͹અඍ GMPన߻ਫ਼ࢊઅඍʀࢬઅ ΢ϱξηφϨʖڂઝ঳ݜ״ ֋൅ અඍʀڂݜ ݗରण೘ࢬઅɼഓૻର੏ ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ʤ઒༽ࢬઅͲ͹ݗࠬ͗චགྷ͵ਏஇ๑͹৖߻ʥה൭ ࢬઅ බݬରΏخਬ਒ ࢾ༂੣ଆઅඍ ढ़ʤAIմੵ౵ʥͶ࢘༽ͤΖٗو৿ ΠϩβϨθϞɼλϓφΤΥΠ౵ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

͹ݬྋʀࣁࡒحࣁࡒ බݬରγϱϕϩ ࢾ༂੣ଆʀΫρφԿ͹ࣁࡒ ਏஇ༂ʀؽ ށ͹ࡑحࢾࡠ඾͹Ϋρφ ਏஇ༂ʀؽ הබݬର ඍடʙࣆ઴༩༁ ੕ැحઝं͖Δ͹ݗࠬࡒྋ ਏஇ༂ʀؽ״ ക཈ࡋ๖ ઝं͖Δ͹ݗࠬࡒྋ״ ढ़ʤAIմੵ౵ʥͶٗو৿ ࢘༽ͤΖָस༽υʖν౵ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

32 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ࣑ྏ༂ʁචགྷؽ೵͹ༀׄ෾୴ ໝྡو֋൅ΝࢩԋͤΖͪΌ͹ޮద΢ϱϓϧʤ୉ڂͶΓΖ֋൅ਬ਒Ώݜܠࢊָ࿊ জࢾݩࢩԋυʖνϗʖηɼΰόϞυʖνϗʖηɼ౵ʥ͹੖ඍ͗ߨΚΗͱ͏Ζ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ࣌વ஄ରɼ ΠΩυϝΠ ࠅࡏؽؖ εʖθ୵ࡩʤබݬର͹ಝ੓೼Ѵɼ ਫ਼ࢊٗढ़ʤCMCʥ͹ཱི֮ ୉ྖਫ਼ࢊର੏͹੖ඍ Կ߻෼ηέϨʖωϱή؜΋ʥʥ ʤݬ༂͹੣ଆ๑֋൅ɼ੣ࡒ֋൅ɼ඾࣯඲Ճʥ ʤઅඍ੖ඍɼݬྋ௒ୣɼགྷҽର੏ɼ౵ʥ ֋൅ਬ਒ڂݜ ϨʖχԿ߻෼͹࠹నԿ ྡজࢾݩ͹ࣰࢬ ࣑ྏ༂͹ਫ਼ࢊ ʤϨʖχԿ߻෼͹୵ࡩʀ࠹నԿɼAPI੣ଆ๑͹ཱི֮ʥ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ඉྡজࢾݩ͹ࣰࢬ ট೟৻ࠬ ੕ැ ઝ঳࣑ྏ༂઒༽ʥ״ઝ঳࣑ྏ༂઒༽ʥ GMPన߻ਫ਼ࢊઅඍʀࢬઅʤ״͹҈સ੓ʙGLPన߻ࢬઅ ࣑ݩ༂੣ଆઅඍʤڂઝ঳ݜ״ ֋൅ અඍʀڂݜ ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ྡজࢾݩࢬઅʤGCPన߻ࢬઅʥה൭ ࢬઅ බݬରΏخਬ਒ Կ߻෼୵ࡩʀνʖΰρφಝఈ༽અඍ ΢ϱξηφϨʖ ɼηϏαϱɼ౵ʥںɼNMR*2, LS/MS*3ɼέϧ΢ΨుࢢݨඏحʤHTS*1ؽ ࢾ༂੣ଆઅඍ ඉྡজࢾݩ༽͹ಊ෼؇ཀྵࢬઅ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

ࣁࡒ Կ߻෼ࣁݱʙԿ߻෼ϧ΢ϔϧϨʖ ࣑ݩ༂͹ݬྋʤAPIɼశՅࡐʥɼใૹࣁࡒ ࣑ݩ༂͹ݬྋʤAPIɼశՅࡐʥɼใૹࣁࡒ ށ࣑ྏ༂ݬྋ͹ࡑ;ٶΠρι΢ϕϪʖφ ࣑ݩ༂ ࣑ྏ༂ අݩं ࣑ྏ༂ඍடʙࣆ઴༩༁ ੕ැ הබݬର ക཈ࡋ๖ ඉྡজࢾݩ༽͹ಊ෼

གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

໒ *3. Liquid Chromatography Mass SpectrometryɼӹରέϫϜφήϧϓΡʖ࣯ྖ෾ੵ๑ڠـHigh throughput Screening *2. Nuclear Magnetic Resonanceɼ֫ࣕ .1*

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ϭέοϱʁචགྷؽ೵͹ༀׄ෾୴ ਫ਼ࢊઅඍʀࢬوଠϠξϨτΡͳർ͢ͱ੕ැͶΓΖؽ೵۫ඍ͹ༀׄ͗୉͚͘ɼ৿ અ͹ݒઅͶ޴ͪ͜ࣁۜ౦Ծ͗ߨΚΗͱ͏Ζ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ࣌વ஄ରɼ ΠΩυϝΠ ࠅࡏؽؖ ʤබݬର͹ಝ੓೼ѴɼϠξϨτΡ͹મఈʥ ඾࣯؇ཀྵࢾݩ͹֋൅ ୉ྖਫ਼ࢊର੏͹ཱི֮ εʖθ୵ࡩ ʤϭέοϱ͹९ౕɼްྙɼ҈ఈ੓͹ࢾݩ๑͹ཱི֮ʥ ʤઅඍ੖ඍɼݬྋ௒ୣɼགྷҽର੏ɼ౵ʥ ֋൅ਬ਒ ϭέοϱޫึ͹αϱιϕφݗ౾ ਫ਼ࢊٗढ़͹ཱི֮ʤϭέοϱݬӹ͹ਫ਼ࢊɼڂݜ ʤබݬର͹ക཈๏๑ཱི֮ɼබݬରΰόϞ৚ๅ͹ಝఈʥ ώ΢Πϩ౵΃͹ϭέοϱैలͶΓΖ੣඾Կʥ ϭέοϱ͹ਫ਼ࢊ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ϭέοϱ֋൅ٗढ़ཱི֮ ྡজࢾݩ͹ࣰࢬ ʤ߇ݬ෾཯੠੣ɼΠζϣώϱφʀ҈ఈࡐ௒੖ʥ ΢ϱξηφϨʖ ඉྡজࢾݩ͹ࣰࢬ ট೟৻ࠬ ੕ැ ͹҈સ੓ʙ న߻ࢬઅ ݬӹ੣ଆʀ੣඾Կ͹અඍ GMPన߻ਫ਼ࢊઅඍʀࢬઅڂઝ঳ݜ״ ֋൅ અඍʀ GLP ʤݬӹ੣ଆɼക཈ࡋ๖खѽ͏અඍɼ౵ʥڂݜ ϭέοϱ͹९ౕɼްྙɼ҈ఈ੓Ν ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ֮೟ͤΖͪΌ͹ࢾݩઅඍ ΠΩυϝΠה൭ ࢬઅ බݬରΏخਬ਒ ݬӹ੣ଆઅඍ ྡজࢾݩࢬઅʤGCPన߻ࢬઅʥ༽ڂݜ බݬରΰόϞ৚ๅಝఈ༽͹અඍ ʤ࣏੊େεʖίϱηεητϞɼ౵ʥ ඉྡজࢾݩ༽͹ಊ෼؇ཀྵࢬઅ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

౵حࣁࡒ බݬରγϱϕϩ ݬӹ੣ଆʀ੣඾Կ͹ࣁࡒ ϭέοϱ͹ݬྋɼώ΢Πϩ༲ ށϭέοϱݬྋ͹ࡑ;ٶγϱϕϩ ඾࣯؇ཀྵࢾݩ༽ࣁࡒ ϭέοϱ༽ڂݜ ʤVirus poolɼAdjuvant poolʥ ʤϭέοϱ͹९ౕɼްྙɼ҈ఈ੓Ν֮೟ͤΖͪΌ͹ࢾݩࣁࡒʥ ࣑ݩ༽ϭέοϱ ϭέοϱඍடʙࣆ઴༩༁ ੕ැ הබݬର ക཈ࡋ๖ʀಊ෼ʤܴཝ౵ʥ අݩं ඉྡজࢾݩ༽͹ಊ෼ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ ੕ැ ՆڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

33 ࠅ

34 ࣎ٺە ฑ࣎ ؽؖ͹ૌ৭ର੏ڂదݜޮ;ٶ੕ැ ڂՌָٗढ़෨ͶΓΕҫྏؖ࿊੕ࡨࡨఈ͗ߨΚΗɼࢁԾ͹Ҳ෨ݜ;ٶ஦ࠅՌָӅ ߨΚΗͱ͏Ζ͗ڂઝ঳Νଲেͳͪ͢ݜ״ؽߑͲ ֋൅Ͷڂઝ঳ؖ࿊੕ࡨʀݜ״ʷ ຎྭʁ कͶؖ༫ͤΖؽؖ Ռָٗढ़સൢ ࠅແӅ ੕ࡨસൢۂࢊ

֋൅ਬ਒ɼ౵ڂ༩๹ଲࡨɼݜ׳߃ʀҫྏ੕ࡨʙ ‡ ࣮݊ ۃ੏౲و ۃ஦ࠅՌָӅ Ռָٗढ़෨ ࠅՊӶਫ਼݊߃җҽճ ࠅՊ༂඾؄ಞ؇ཀྵ

‡ ੕ࡨࡨఈ ‡ ੕ࡨࡨఈ ͹ট೟حҫ༂඾ʀؽ ‡ ઝ঳؜΋ʥ ஦ࠅ࣮බ༮๹߉੏஦ৼ״ઝ঳؜΋ʥ ʤ״ʤ ۃࠅՊ஦ҫ༂؇ཀྵ ۃҫ੕ҫ؇

֋൅΃͹ঁ੔ΝڂϓΟϱυΡϱήؽؖ ‡ ݜ ઝ঳؜΋ʥ״җҽճ ࣰࢬʤۜخࠅՊࣙષՌָ

֋൅ؽؖڂݜ ؽߑڂؽߑ Ռָٗढ़෨ࢁԾ͹ݜڂ஦ࠅՌָӅࢁԾ͹ݜ ॶ ‡ China National Center for ‡ ࢁԾ͹Ҳ෨ؽؖͲڂࢁԾ͹Ҳ෨ؽؖͲ ‡ ෤׿බಡݜ ‡ ઝ঳ؖ࿊͹״ ઝ঳ؖ࿊͹״ ֋൅Νࣰࢬڂॶ Biotechnology Development ݜڂඏਫ਼෼ݜښ֋൅Νࣰࢬ ‡ ๼ڂݜ ॶڂ༂෼ݜ ‡ ৏քϧ΢ϓγ΢ΦϱηՌָ৚ ‡ ๅιϱνʖɼ౵

ΤΥϔγ΢φۃड़ॶʁ஦ࠅՌָӅΤΥϔγ΢φɼՌָٗढ़෨ΤΥϔγ΢φɼࠅՊӶਫ਼݊߃җҽճΤΥϔγ΢φɼࠅՊ༂඾؄ಞ؇ཀྵ

࣎ٺە ฑ࣎ ਫ਼ࢊ͹ؽ೵ैଏ͹ͪΌ͹଩ͬघʁγϜϨ;ٶ֋൅ڂݜ ͹Ϗϱυϝρέ౵Νण͜ɼଠڊΏգܢѻౙదͶ߶͏ྼ࢛దഐི͗׳ઝ঳͹ጸ״ ԿͶ΍खૌ΋کۂઝ঳ଲেͳͪ͢ࣁۜΝ֮ฯɽϭέοϱࢊ״ࠅΓΕ΍ଡ͚͹ ؽ೵ैଏ͹ ຎྭʁਏ - ਏஇ๑ ࣑ - ࣑ྏ༂ ϭ - ϭέοϱ ֋൅ ֋൅ ਫ਼ࢊ ਫ਼ࢊ ڂݜ ڂ଩ͬघ ݜ

ਏ ࣑ ϭ ժɼ౵ʥܯઝ঳ͶଲͤΖ༩๹ʀ࣑ྏ͹ͪΌ͹୊13࣏5Ω೧״ڷժɼ৿ܯεητϞߑ஛ڇڛઝ঳ଲࡨͶؖͤΖકྲྀࡨఈʤϭέοϱ״ڷકྲྀࡨఈʀ ৿ સର౹ׇ ϭ ਦʥة୉Ν֨ྙڻࠅ΃͹ӪືەͶؖͤΖ੕ࡨʤʰ஦ࠅϭέοϱʱͶΓΖڇڛࠅ΃͹ϭέοϱ֋൅ʀڷΠϓϨΩΏΠζΠ͹৿

ਏ ࣑ ϭ ֋൅ʀਫ਼ࢊ͹ͪΌ͹ࣁ֮ۜฯʤ༁2,611Աԃ͹༩ࢋʥڂઝ঳͹ݜ״ڷ৿

֋൅ڂݜ ਬ਒ ਏ ࣑ ϭ ֋൅ਬ਒ڂઝ঳ͶଲͤΖݜ״ؽߑͶΓΖڂ஦ࠅՌָӅࢁԾΏՌָٗढ़෨ࢂՅ͹ݜ

ਏ ࣑ ϭ ট೟ՅଐͶ޴ͪ͜੏ౕ੖ඍ ;ٶ֋൅ ਏ ࣑ ϭ BSL-4ʤ2ࢬઅʥڂݜ ʤϫʖϨϱήϪϑϣʖɼড়݇෉͘ট೟ɼ BSL3ࢬઅʤ40ࢬઅʶʥ͹੖ඍʀैଏ ൭ ༑઎৻ࠬট೟ɼಝพট೟౵ʥخਬ਒ ʤઅඍʀࣁࡒʀ ࣑ ϭ ࣰݩ༽ಊ෼ʤಝͶྸௗྪʥ͹ ϭ Կک๑੏ౕ౵ʥ ࣄүʀ֮ฯʤଠࠅ΃͹༎ड़΍ࣰࢬʥ ϭέοϱਫ਼ࢊ೵ྙ͹

35 ࣎ٺە ฑ࣎ ઝ঳ͶؖͤΖक͵੕ࡨ״ڷ৿ ઝ঳״Δͺ͖ޛΝ໪ࢨͤࠅՊકྲྀͳญߨ͢ɼSARSڷ͹৾ۂ஦ࠅͲͺώ΢Ψࢊ ଉΝ੏ఈوߨ࣎͹ࠅ಼ଲԢࡨͶؖͤΖ๑Ώླྀ

2002ʛ 2003೧ 2007೧ 2007೧ 2011೧ 2009ʛ10೧ 2012೧ʛ 2012೧ 2016೧ 2020೧ʛ 2020೧ 03೧ 5݆ 8݆ 7݆ 12݆

SARS H1N1 MERS ৿ܗαϫψ ΢ϱϓϩΦϱδ (शଋઑݶͶࢺΔͥ) Τ΢ϩη ݊ ժܯ൅ఴۂՌָٗढ़֋ ਫ਼෼ࢊغ߃ ࠅՊ஦ௗ ժ֕གྷܯʀ ൅ ҫ ʀ2020೧ΉͲͶώ΢ ࡃ͹ܨΝࠅ຿ۂྏ ʀώ΢Ψٗढ़͹ַ৿͹ Ψࢊ ͳ͢ͱɼ༂ࡐΏ࣑ ஬ͳͤΖ͞ͳΝඬᒙ؂෾ Ҳ ໼ ྏ༂֋൅ٗढ़͹॑གྷ੓ ٶસ Ͷݶ ൢ

ઝ঳*1ͶଲͤΖ༩๹ʀ ਫ਼෼҈સՌָٗढ़કྲྀ״ڷεητϞߑ஛ ৿ڇڛϭέοϱ ٺەଲԢ๑ʤ2003ʥɼޮ़Ӷਫ਼ٺەࠅՊ ܯժ ࣑ྏ͹ͪΌ͹୊ ࣏ Ω೧ܯ ੏ʤ2007ʥ 13 5 ‡ ࠅ಼ώ΢ΨιʖϓτΡؽوٺەࣆସ͹ͪΌ͹ ժ ԿΝ໪దͳͪ͢કکઝ঳Ν؜΋ޮ़Ӷਫ਼ࣆ݇Ώࣙષࡄ֒ ‡ 2011ʛ15೧Ͷ࿳Εɼࠅ಼ ೵͹״ ‡ ྲྀ ઝ״ڷεητϞ ‡ 2020೧຦ΉͲ͹৿ڇڛࣆସ൅ਫ਼࣎Ͷ͕͜Ζ੕ැ͹ଲ ͹ϭέοϱٺە౵͹ Ԣ๏๑Ͷͯ͏ͱ੏ఈ ͹ߑ஛Ν໪ࢨͪ͢કྲྀ ঳*1͹༩๹ʀ؇ཀྵεητ ״ Τ΢ϩη͹බҾΏ໖Ӻָ ‡ ઝ Ϟ͹ཱི֮ɼ஦ࠅ͹ήϫʖ ઝ঳͹״ɼڂݜેخ঳ ‡ ਫ਼ࢊ೵ྙͳ඾࣯޴৏Ώ༎ ౵͹ ԿΝ໪کྙڻώϩͲ͹Ӫ 1* ͹ڂԿͶ ༩๹ʀ࣑ྏɼྡজݜکઝ঳ ༩๹કྲྀ ૻʀඍட͹҈સ੓״ڷؖ ৿ ࢨ͢ɼ༩๹ʀ؇ཀྵી஖͹ ଲԢର੏͹ߑٺە࿊ *1 Յ͓ɼք֐ٗढ़͹༎೘ɼ ਬ਒ɼ ࡎىક ໪ඬɼࢬࡨΝغ஦ௗ;ٶԿکઝ঳ ͹༩๹ʀ؇ཀྵ״ڷʀ৿ ࢩԋͶΓΖࠅ ஛౵Ν؜΋ڂժ͹ࡨఈΝ ৿ͪ͵ݜܯଲԢϟΩωθϞʀٺەࡨఈ͢ɼྲྀ ༩๹ʀ؇ཀྵର੏͹੖ඍɼ ‡ ء૬ྙ޴৏౵΍कڟक͵໪దͳ͢ɼ࣑ྏ༂Ώϭέοϱɼਏஇࢾ༂͹ ࡏ ͹ਬ਒ɼࣁࡒඍட৚ๅυʖνʖ බݬରݗஎ೵ྙ͹޴৏ɼڂʀԢ༽ݜેخ ϗʖη͹ߑ஛౵Ν؜΋ ଲԢՆ೵͵ҫྏࢬઅ͹ଁ ౵Ν໪ඬͶ؜΋ک

ໝ͵൅ਫ਼ً͗͞ΕΏͤ͏Ն೵੓͍͗Ζ΍͹Νࣖͤو൅ݡ͗ࠖೋͲ۫ରదʀްՎద͵༩๹ʀங࿛๑͗ܿ೙͢ɼ୉غʀࢰ๤ི͗߶͏ɼ૥ـͲ͹ಧષ͹൅ਫ਼Ώౕ॑͹බؔغͲ͍Εɼ୻ىઝ঳ͳ͹න״੓ٺݬชͲͺಧ൅͹ .1* ࿪ࠅࠅແӅ৿ซ෨ʤSCIOʥΤΥϔγ΢φʤwww.scio.gov.cnʥڠү࢚ΤΥϔγ΢φʤwww.nhc.gov.cnʥɼ஦՜ਕ຿گड़ॶʁ஦ࠅՌָ

࣎ٺە ฑ࣎ ժʤ໪ඬઅఈʥܯεητϞڇڛકྲྀࡨఈʀસର౹ׇʁϭέοϱ ֋൅Ώਫ਼ࢊ೵ྙ͹ڂԿͶखૌΞͲ͕ΕɼݜکۂࠅແӅͺɼฑ࣎ΓΕϭέοϱࢊ ԿΏϭέοϱஹடྖ͹ॉ෾ྖ͹֮ฯ౵ͶखૌΞͲ͏Ζک ଲেϠξϨτΡ खૌΊ ֕གྷ Dx Rx Vx ͱ͏Ζ ᤯͝ܟͶɼҐԾ໪ඬΝୣ੔ͤΖ͞ͳΝ಼ؔغ2015೧~2011 Կکᶅ ৚ๅ؇ཀྵྙ͹ ϪϗϩҫྏؽؖͲ90%Ґ৏ڹϪϗϩҫྏؽؖͲ100%ɼ܌Ψϱϧ΢ϱ௜ંๅࠄིΝ Կک೵ྙ͹ڂᶆ ݜ ԿکΝڂԿ͹ՅଐͶࢊָ͹ݜۂϭέοϱࢊ Կکᶇ ਫ਼ࢊ೵ྙͳ඾࣯͹ ϭέοϱ͹و͹ଁࢊͳ৿ۂة୊Ҳྪϭέοϱ͹ਫ਼ࢊ෈ଏΝմ݀ɽ୊್ྪϭέοϱ͹ਫ਼ࢊ ༎೘Νࢩԋ ᶈ ҈સదંझ͹ࣰݳ ࣉಒɼ೸ଞ෨ɼஏ๏͹ંझིΝ߶ΌΖ Կکϭέοϱ ᶉ ϭέοϱ͹༎ૻʀஹட͹҈સ੓ ੏Νࡨఈ͢ɼαʖϩχοΥʖϱΝߑ஛وର੏ ༎ૻΏ؇ཀྵڇڛ Կکժ ᶊ ϭέοϱஹட͹ةߑ஛ ଈͲ֚ۂةదͶ඲Ճ͢ϭέοϱஹடଲেΝ؇ཀྵɽغ൅ਫ਼͹ϨηέΝఈ׳੕ැ෨໵Ͳ֦࣮ ౲ଲেϭέοϱΝਫ਼ࢊʀஹடͤΖ ଲԢྙ͹޴৏ٺᶋ Ԣ ଲԢࡨΝࡨఈٺەɼ֋൅ɼਫ਼ࢊɼླྀ௪ɼஹட͹ϕϫιη౵͹ڂ࣎͹ݜٺە Կکᶌ ؇ཀྵର੏͹ ६౵Ν໎֮Կخϭέοϱ͹ౌ࿧ট೟ɼ඾࣯඲Ճ ૬ྙ͹޴৏ڟᶍ ࠅࡏ ԿکΝޤք֐ٗढ़͹༎೘౵ΝࢩԋɼαΠٗढ़͹ฯ Կکઝ༩๹ྙ͹״ ᶎ ಊ෼ࣰݩ࣪͹৚ๅΝ੕ැ؇ཀྵԾ͹৚ๅ؇ཀྵεητϞ΃౹߻

ݒ宥妫䎠ద௪எʱ2011೧12݆31ೖܧ⹻ରڛड़ॶʁࠅແӅʰࠅ⊈Ӆ⊅ޮ⍬䎖ဍ当⎸⎸ఴրַҗ౵෨㛯Ӻම

36 ࣎ٺە ฑ࣎ કྲྀࡨఈʀસର౹ׇʁϭέοϱஹட؇ཀྵର੏ ;ٶઝ঳͹ླྀߨΝण͜ɼ੕ැͺॉ෾͵ϭέοϱਫ਼ࢊྖ״αϫψΤ΢ϩηܗ৿ ஹடྖΝ໪ࢨͤܯժΝཱིͱͱ͏Ζ ଲেϠξϨτΡ खૌΊ ֕གྷ Dx Rx Vx ϭέοϱஹடકྲྀͶͯ͏ͱҐԾ͹๏ਓ಼༲Νݗ౾ʁ ᤯ ᶅ ϭέοϱඍட؇ཀྵ͹઒໵ૌ৭અཱི ࠅՊϪϗϩ͹ϭέοϱඍட؇ཀྵ͹ૌ৭Νઅ஖͢ɼഓԾϟϱώʖͶࠅՊӶਫ਼෨໵ɼ࣮බ؇ ֋൅ʀਫ਼ࢊڂඍ෨໵ɼٗढ़ʀࡔ੕ࢩԋ෨໵ɼϭέοϱݜܱٺەཀྵ෨໵ɼ༂඾؄ಞ෨໵ɼ Ν؜΋ۂة͹ࠅӨڇڛ ֋൅ϕϧρφϓΧʖϞ͹ߑ஛ڂઝ঳ϭέοϱݜ״ڷᶆ ৿ کΝڂढ़ݜٗેخ֋൅ιϱνʖΝઅཱིɽබݬָͳ໖Ӻָ͹ڂઝ঳ϭέοϱݜ״ٺەࠅՊ οϡ΢ωʖθύϞηνʖཝ૧ʤCHOʥࡋ๖/ࠝம๰য়ࡋ๖Ҫఽࢢ޽/܊ϭέοϱ Կ͢ɼ߮฾/୉ௐۗ ֋൅ϕϧρφϓΧʖϞΝߑ஛ͤΖڂஹட؇ཀྵର੏ ָ͹ϭέοϱ͹ݜ ժϭέοϱ͹ඍடϟΩωθϞ͹ߑ஛ͳրવܯʤݳࡑݗ౾஦ʥ ᶇ ࠅՊ໖Ӻ ͶଲͤΖϭέοϱ੣඾͹೧ؔऩགྷΝඍடͤΖ׳ߨ࣮ླྀ Կکᶈ ϭέοϱਫ਼ࢊ೵ྙ༩ඍྙ͹ Ήͪͺ2ͯಢཱི͹ਫ਼ࢊϧ΢ϱͲਫ਼ࢊ֮ฯ͢ɼਫ਼ࢊྙΝ೧ۂةࠅ಼ਫ਼ࢊ͹֦ϭέοϱΝ2ऀ ࢤ৖ऩགྷ150ˍͶଁՅؔ ᶉ ϭέοϱ͹඾࣯րવ ɼϕϫιηրવɼ࢕༹րવɼ҈༙ڠϭέοϱϟʖΩʖ͹WHOࣆ઴೟ৄखಚΝࢩԋɽٗढ़ ६Ν৏͝Ζخఈ੓րવ౵Νࣰࢬ͢ɼϭέοϱ඾࣯ 2020೧6఼݆࣎αϫψؖ࿊͹ࡔແࢩड़ͺ༁2஻7,000Աԃ ᤯ ҫྏ෼ࣁͶؖ͢ͱͺʁ ҫ༂඾ɼ གྷ͵ҫ༂඾ͺ஦ԟ੕ැ͖ΔҲׇ߬೘͢ͱ؇ཀྵ॑ ‡ ҫྏ෼ࣁ͹ ͹ਫ਼ࢊͶحଈ͹ҫ༂඾Ώҫྏ༽඾ʀؽۂةઝ঳͗शଋͤΖΉͲͺɼ״αϫψΤ΢ϩηܗ৿ ‡ ඍட චགྷ͹ݬࡒྋͺͤ΄ͱ੕ැ͖ΔҲׇ߬೘͢ͱฯ؇ ͹੣ଆ඾࣯޴৏ɼਫ਼ࢊଁࢊ౵Ν఑঑حͶଲ͢ͱɼҫ༂඾Ώҫྏ༽඾ʀؽۂةҫ༂඾ ‡

ʱ2020೧5݆25ೖܧड़ॶ:ʰਕ୉େන檅๗ᣨʁݒ宕Յ㖚桝Ⱙ宥守ɾݒཱིࠅՊӺම₏⣮ର

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ਏஇ๑ʁචགྷؽ೵͹ༀׄ෾୴ ݗࠬର੏Ν۫ඍͤΖͪΌ͹ҫྏؽؖ౵Ͳ͹ݗࠬ࣪͗෈ଏ͢ͱ͕Εɼ੕ැͶΓΖ Կ͹खૌΊ͗ߨΚΗͱ͏Ζکݗࠬର੏ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ࣌વ஄ରɼ ΠΩυϝΠ ࠅࡏؽؖ Όͱ͏Ζਏஇ๑͹೼Ѵʥ ੣඾υδ΢ϱʀ֋൅ ୉ྖਫ਼ࢊର੏͹੖ඍٽʤ੕ැʀྡজݳ৖͗ ɼࢾ༂͹ΫρφԿʥ ʤઅඍ੖ඍɼݬྋʀࣁࡒ௒ୣɼགྷҽର੏ɼ౵ʥܯεʖθ୵ࡩ ʤࢾࡠ඾͹ࡠ੔ɼݗৄͳ࠸અ ֋൅ਬ਒ αϱιϕφ݀ఈʤΤ΢ϩηΰόϞ৚ๅʀ߇ݬʀ ੣඾ݗৄʙඉྡজྡজࢾݩ͹ࣰࢬڂݜ ౵͹ਫ਼ࢊحढ़݀ఈʥ ʤබݬରखѽ๏๑ཱི֮ɼਏஇ๑੓೵ʀ҈ఈ੓͹֮೟ʥ ਏஇ༂ʀؽٗوϐφΤ΢ϩη߇ର͹ಝఈɼԢ༽ͤΖ৿ ढ़֋൅ʤΤ΢ϩηΰόϞʀ߇ݬʀϐφΤ΢ϩηٗ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ढ़͹֋൅ʥ ট೟৻ࠬٗو߇ର͹ݗड़๏๑ཱི֮ɼ৿ ੕ැ ͹҈સ੓ʙGLPన߻ࢬઅ ࢾ༂੣ଆʀΫρφԿ͹અඍ GMPన߻ਫ਼ࢊઅඍʀࢬઅڂઝ঳ݜ״ ֋൅ અඍʀڂݜ ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ݗରण೘ࢬઅɼഓૻର੏ה൭ ࢬઅ බݬରΏخਬ਒ ʤ઒༽ࢬઅͲ͹ݗࠬ͗චགྷ͵ਏஇ๑͹৖߻ʥ ΢ϱξηφϨʖ ࢾ༂੣ଆઅඍ ढ़ʤAIմੵ౵ʥͶ࢘༽ͤΖٗو৿ ΠϩβϨθϞɼλϓφΤΥΠ౵ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

͹ݬྋʀࣁࡒحࣁࡒ බݬରγϱϕϩ ࢾ༂੣ଆʀΫρφԿ͹ࣁࡒ ਏஇ༂ʀؽ ށ͹ࡑحࢾࡠ඾͹Ϋρφ ਏஇ༂ʀؽ הබݬର ඍடʙࣆ઴༩༁ ੕ැحઝं͖Δ͹ݗࠬࡒྋ ਏஇ༂ʀؽ״ ക཈ࡋ๖ ઝं͖Δ͹ݗࠬࡒྋ״ ढ़ʤAIմੵ౵ʥͶٗو৿ ࢘༽ͤΖָस༽υʖν౵ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

37 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ࣑ྏ༂ʁචགྷؽ೵͹ༀׄ෾୴ Կ߻෼͹ηέϨʖωϱή౵͹ޮద΢ϱϓϧ੖ඍ͗ߨΚΗͱ͏ΖɽΉͪɼট೟৻ ࠬՅଐ͹ͪΌ͹๑੖ඍ΍ߨΚΗͱ͏Ζ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ࣌વ஄ରɼ ΠΩυϝΠ ࠅࡏؽؖ εʖθ୵ࡩʤබݬର͹ಝ੓೼Ѵɼ ਫ਼ࢊٗढ़ʤCMCʥ͹ཱི֮ ୉ྖਫ਼ࢊର੏͹੖ඍ Կ߻෼ηέϨʖωϱή؜΋ʥʥ ʤݬ༂͹੣ଆ๑֋൅ɼ੣ࡒ֋൅ɼ඾࣯඲Ճʥ ʤઅඍ੖ඍɼݬྋ௒ୣɼགྷҽର੏ɼ౵ʥ ֋൅ਬ਒ڂݜ ϨʖχԿ߻෼͹࠹నԿ ྡজࢾݩ͹ࣰࢬ ࣑ྏ༂͹ਫ਼ࢊ ʤϨʖχԿ߻෼͹୵ࡩʀ࠹నԿɼAPI੣ଆ๑͹ཱི֮ʥ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ඉྡজࢾݩ͹ࣰࢬ ট೟৻ࠬ ੕ැ ઝ঳࣑ྏ༂઒༽ʥ״ઝ঳࣑ྏ༂઒༽ʥ GMPన߻ਫ਼ࢊઅඍʀࢬઅʤ״͹҈સ੓ʙGLPన߻ࢬઅ ࣑ݩ༂੣ଆઅඍʤڂઝ঳ݜ״ ֋൅ અඍʀڂݜ ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ྡজࢾݩࢬઅʤGCPన߻ࢬઅʥה൭ ࢬઅ බݬରΏخਬ਒ Կ߻෼୵ࡩʀνʖΰρφಝఈ༽અඍ ΢ϱξηφϨʖ ɼηϏαϱɼ౵ʥںɼNMR*2, LS/MS*3ɼέϧ΢ΨుࢢݨඏحʤHTS*1ؽ ࢾ༂੣ଆઅඍ ඉྡজࢾݩ༽͹ಊ෼؇ཀྵࢬઅ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ ࣁࡒ Կ߻෼ࣁݱʙԿ߻෼ϧ΢ϔϧϨʖ ࣑ݩ༂͹ݬྋʤAPIɼశՅࡐʥɼใૹࣁࡒ ࣑ݩ༂͹ݬྋʤAPIɼశՅࡐʥɼใૹࣁࡒ ށ࣑ྏ༂ݬྋ͹ࡑ;ٶΠρι΢ϕϪʖφ ࣑ݩ༂ ࣑ྏ༂ අݩं ࣑ྏ༂ඍடʙࣆ઴༩༁ ੕ැ הබݬର ക཈ࡋ๖ ඉྡজࢾݩ༽͹ಊ෼

གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂགྷҽ ݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

໒ *3. Liquid Chromatography Mass SpectrometryɼӹରέϫϜφήϧϓΡʖ࣯ྖ෾ੵ๑ڠـHigh throughput Screening *2. Nuclear Magnetic Resonanceɼ֫ࣕ .1*

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ϭέοϱʁචགྷؽ೵͹ༀׄ෾୴ ౵ɼکಋͲ͹ϭέοϱ֋൅͗෵਼ߨΚΗͱ͏ͪΕɼ੣ଆઅඍ͹ଁڠฑ࣎ΓΕׯ຿ ֋൅ਬ਒΃͹஭ྙౕ͗߶͏ڂଠϠξϨτΡͳർ͢ͱ੕ැͶΓΖݜ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ VCɼ࣌વ஄ରɼ༽ڂݜ ΠΩυϝΠ ࠅࡏؽؖ ʤබݬର͹ಝ੓೼ѴɼϠξϨτΡ͹મఈʥ ඾࣯؇ཀྵࢾݩ͹֋൅ ୉ྖਫ਼ࢊର੏͹ཱི֮ εʖθ୵ࡩ ʤϭέοϱ͹९ౕɼްྙɼ҈ఈ੓͹ࢾݩ๑͹ཱི֮ʥ ʤઅඍ੖ඍɼݬྋ௒ୣɼགྷҽର੏ɼ౵ʥ ֋൅ਬ਒ ϭέοϱޫึ͹αϱιϕφݗ౾ ਫ਼ࢊٗढ़͹ཱི֮ʤϭέοϱݬӹ͹ਫ਼ࢊɼڂݜ ʤබݬର͹ക཈๏๑ཱི֮ɼබݬରΰόϞ৚ๅ͹ಝఈʥ ώ΢Πϩ౵΃͹ϭέοϱैలͶΓΖ੣඾Կʥ ϭέοϱ͹ਫ਼ࢊ ϭέοϱ֋൅ٗढ़ཱི֮ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ʤ߇ݬ෾཯੠੣ɼΠζϣώϱφʀ҈ఈࡐ௒੖ʥ ྡজࢾݩ͹ࣰࢬ ඉྡজࢾݩ͹ࣰࢬ ট೟৻ࠬ ੕ැ ͹҈સ੓ʙGLPన߻ࢬઅ ݬӹ੣ଆʀ੣඾Կ͹અඍ GMPన߻ਫ਼ࢊઅඍʀࢬઅڂઝ঳ݜ״ ֋൅ અඍʀ ʤݬӹ੣ଆɼക཈ࡋ๖खѽ͏અඍɼ౵ʥڂݜ ϭέοϱ͹९ౕɼްྙɼ҈ఈ੓Ν ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ֮೟ͤΖͪΌ͹ࢾݩઅඍ ΢ϱξηφϨʖה൭ ࢬઅ බݬରΏخਬ਒ ݬӹ੣ଆઅඍ ྡজࢾݩࢬઅʤGCPన߻ࢬઅʥ༽ڂݜ බݬରΰόϞ৚ๅಝఈ༽͹અඍ ʤ࣏੊େεʖίϱηεητϞɼ౵ʥ ඉྡজࢾݩ༽͹ಊ෼؇ཀྵࢬઅ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

౵حࣁࡒ බݬରγϱϕϩ ݬӹ੣ଆʀ੣඾Կ͹ࣁࡒ ϭέοϱ͹ݬྋɼώ΢Πϩ༲ ށϭέοϱݬྋ͹ࡑ;ٶγϱϕϩ ඾࣯؇ཀྵࢾݩ༽ࣁࡒ ϭέοϱ༽ڂݜ ʤVirus poolɼAdjuvant poolʥ ʤϭέοϱ͹९ౕɼްྙɼ҈ఈ੓Ν֮೟ͤΖͪΌ͹ࢾݩࣁࡒʥ ࣑ݩ༽ϭέοϱ ϭέοϱඍடʙࣆ઴༩༁ ੕ැ הබݬର ക཈ࡋ๖ʀಊ෼ʤܴཝ౵ʥ අݩं ඉྡজࢾݩ༽͹ಊ෼ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

38 ೖຌ

39 ࣎ٺە ฑ࣎ ؽؖ͹ૌ৭ର੏ڂదݜޮ;ٶ੕ැ ઝ঳ͶؖͤΖ੕ࡨ͗ࡨఈ͠Ηɼ״ೖຌͲͺɼ಼ֵׯ๬Ώ޲ਫ਼࿓ಉ঴Ν஦ৼͶ ॶΝ஦ৼͶࣰࢬڂ֋൅ͺ޲࿓঴ʀಋ঴ॶ؇͹ݜڂϓΟϱυΡϱήͺAMEDɼݜ ઝ঳ؖ࿊੕ࡨʀ״ʷ ֋൅Ͷڂड૮ׯఝ ຎྭʁ ݜ I. ੕ࡨʀકྲྀ कͶؖ༫ͤΖؽؖ ׯ๬ ಼ֵැ಼ֵ Ռָٗढ़સൢ Ռָ .1 ࡃࡔ੕ ‡ ੔ௗકྲྀճ٠ʁ੔ௗકྲྀ͹۫ରԿਬ਒ܨ ੕ࡨસൢ IT૱߻કྲྀຌ෨ۂࢊ ࡃࡔ੕੕ࡨ͹๏ਓܨ :ࡃࡔ੕ࣀ໲ճ٠ܨ ‡ ΢όϗʖεϥϱ ੔ௗકྲྀճ٠ ࡨఈ ʙકྲྀ࣪ ࣀ໲ճ٠ ΢όϗʖεϥ :Ռָ΢όϗʖεϥϱճ٠ ‡ ճ٠ ϱ૱߻કྲྀ͹ࡨఈ

2. ϧ΢ϓγ΢Φϱηʙ ޲࿓঴ ܨࢊ঴ ชՌ঴ ૱ແ঴ ݊߃ʀҫྏ ઝ঳ؖ࿊੕ࡨ͹ࡨఈʀ״ ‡ ༩ࢋ͹ഓා

PMDA NISTEP ݊߃ʀҫྏકྲྀ ઝ঳Ͷ״࣎͹ٺەਬ਒ຌ෨/ કྲྀ࣪ ‡ ฑ࣎ʀ ੏͹ࡨఈʀࢬߨوؖͤΖ ϓΟϱυΡϱή ‡ ݊߃ʀҫྏકྲྀ͹ཱིҌ II. ‡ ਬ਒ܯժ͹ཱིҌɼ݀ఈ ΃͹༩ࢋۂAMED͹֦ࣆ ‡ ժ ഓ෾ݗ౾ةϓΟϱυΡϱή .1

AMED JST

֋൅ʀڂઝ঳ؖ࿊͹ݜ״ ‡ ժ͹ࣰߨܯϓΟϱυΡϱήࣰࢬ ‡ ਬ਒ .2 ਬ਒ڂಋݜڠ ϕϫζΥέφ಼ڂʙݜۂࣆ ‡ ༩ࢋ͹ഓ෾ɼϓΟϱυΡϱ ժةή

֋൅ NCGM NIBIOHN NIHSڂIII. ݜ ઝ঳ؖ࿊͹״࣎Ͷٺە൭ʀ݊߃ʀ ʤࠅཱིҫ༂඾ RIKEN ‡ ฑ࣎ʀخNIID ʤࠅཱིࠅࡏҫྏ ʤҫ༂ ॶʥڂॶʥ ʤཀྵԿָݜڂઝ঳ݜ״ʤࠅཱི ֋൅Νਬ਒ڂॶʥ ݜڂॶʥ ৱ඾Ӷਫ਼ݜڂιϱνʖʥ ӭ཈ݜڂݜ ֋൅Νਬ਒ڂઝ঳ؖ࿊͹ݜ״࣎Ͷٺەฑ࣎ʀ ‡

ड़ॶʁ಼ֵׯ๬ΤΥϔγ΢φɼ݊߃ʀҫྏકྲྀਬ਒ຌ෨ΤΥϔγ΢φɼ޲࿓঴ΤΥϔγ΢φɼชՌ঴ΤΥϔγ΢φ౵

࣎ٺە ฑ࣎ ਫ਼ࢊ͹ؽ೵ैଏ͹ͪΌ͹଩ͬघʁγϜϨ;ٶ֋൅ڂݜ ֋൅ਬ਒ΏڂؽؖͶΓΖฑ͖࣎Δ͹ϭέοϱʀ࣑ྏ༂ʀਏஇ๑͹ݜڂదݜޮ Ν੖ඍͤΖͪΌ͹અඍʀࣁࡒ͹੖ඍ΍ߨΚΗͱ͏Ζڧ؂֋൅ڂݜ ؽ೵ैଏ͹ ຎྭʁਏ - ਏஇ๑ ࣑ - ࣑ྏ༂ ϭ - ϭέοϱ ֋൅ ֋൅ ਫ਼ࢊ ਫ਼ࢊ ڂݜ ڂ଩ͬघ ݜ

કྲྀࡨఈʀ ਏ ࣑ ϭ સର౹ׇ ϭέοϱʀ࣑ྏ༂ʀਏஇ๑ٗढ़΃͹ঁ੔ʤ70Աԃʥ ϭ ΢ϱϓϩΦϱδϭέοϱ͹ٗढ़֋൅΃͹ঁ੔ʤ޲࿓঴ʥܗ৿

ਏ ࣑ ϭ ֋൅Νࢩԋڂઝ঳͹ݜ״ڷͳ͢ͱCEPI͹׈ಊͶࢂժ͢ɼ৿؂௒͹Ҳڢࠅࡏ

࣑ ϭ ݬ༂ʀݬྋ͹ࠅ಼ ੣ଆࢩԋ΃͹ঁ੔ʤ޲࿓঴ʥ

΢ϱϓϩΦϱδϭέοϱ͹ਫ਼ࢊࢬઅܗϭ ৿ ેخઝ঳ͶؖΚΖ״ ֋൅ ਏ ࣑ ϭڂݜ චགྷྖ͹֮ฯʤ޲࿓঴ʥ;ٶઝݜʥ ͹ߑ஛ࢩԋ״͹ਬ਒ʤڂਬ਒ ʀԢ༽ݜ Ζ߇ݬʀܐઝ঳Ͷ״ ϭ ࣑ ϭ ֋൅͹ਬ਒ʤNIBIOHNʥڂઝ঳͹ϠρέΠρϕϭέοϱ͹ݜ״ ઝݜʥ״߇݄ੜ͹੣ଆ͹ࣰࢬʤ ࣑ ϭ ઝ঳͹߇ରҫ༂඾ɼϭέοϱ֋൅͹ਬ਒ʤNIBIOHNʥ״

֋൅ ࣑ ϭ ώ΢Ψώϱέ͹ ࣑ ϭ ࣰݩ༽γϩ͹ڂݜ ʤNIBIOHNʥ༙ڠ൭ ߑ஛ʀ؇ཀྵʤNIBIOHNʥ ฯ༙ʀخਬ਒ ਏ ࣑ ϭ ࣰݩ࣪͹ฯ༙ʤNIBIOHNʥحؽ༙ڠ ʤઅඍʀࣁࡒʀ ๑੏ౕ౵ʥ ਏ ࣑ ϭ ઝ঳ࣰݩࢬઅ͹ฯ༙ʤNIBIOHNʥ״3͹;ٶBSL2

ਏ ࣑ ϭ ઝݜʥ״4ࢬઅ͹ฯ༙ʤ;ٶBSL3

ট೟੏ౕ͹غ࣑ ϭ έϧ΢Ψ ਏ ࣑ ϭ ૥ ͹಍೘ʤชՌ঴ʥ ಍೘ʤPMDAʥںుࢢݨඏ ਏ ࣑ ϭ ઝݜʥ״ઝ঳઒໵Պ͹཈੔ʤ״

40 ࣎ٺە ฑ࣎ ઝ঳ͶؖͤΖक͵੕ࡨ״ڷકྲྀࡨఈʀસର౹ׇʁ৿ ઝ״ڷժΝࡨఈɽΉͪɼҫྏ෾໼͹કྲྀͶͱ৿ܯ΢ϱϓϩʀAMRͲͺߨಊܗ৿ ֋൅ͶՅ͓ɼࠅ֐Ͳ͹ଲԢࢩԋ΍໪ࢨͤڂ঳Ͷଲ͢ࠅ಼Ͳ͹ର੏੖ඍΏݜ

2005೧ 2011೧ 2014೧ 2016೧ 2018೧ 2020೧

ʥغઝ঳ଲ ݊߃ʀҫྏકྲྀʤ୊್״Ҙͳ͵Ζڶʥ ࠅࡏదͶغ΢ϱϓϩΦϱδ౵ଲࡨߨ ݊߃ʀҫྏકྲྀʤ୊Ҳܗ৿ ֋൅ͶՅ͓ɼΠζΠͲ͹ڂժ ࠅ಼ݜܯຌخԿͶؖͤΖک໪ඬΝઅఈ ࡨ͹ڂઝ঳ͶଲͤΖݜ״ժ ಝఈ͹ܯಊ ੏௒࿪͹و൭͹੖ඍΏخ֋൅ڂݜ ڂؽ؇ཀྵର੏੖ඍɼݜثຌ๏ ʀ2020೧ΉͲ͹໪ඬͳ͢ͱɼ΢ϱϓ ࠅ಼͹خ΢ϱϓϩ౵͹ଲࡨ͹ܗ৿ ઝ঳ʀAMR͹સ ֋൅ਬ਒ɼ౏৏ࠅ͹ࢩԋΝ؜΋ ਬ਒Ν໪ࢨͤ״ਓʀી஖౵Νࣖͤ੕ࡨɽ 2005 ϩʀυϱήʀԾཫ঳ Τ΢ϩη౵Ν؜΋ܗ֋ ʀࠅ಼Ͳͺ৿ڂͶͪ͢ɼ༂ ʀࠅ಼ͲͺAMEDͶΓΖݜخժͶ६ͣͱ ΰόϞυʖνϗʖη౵Νܯ೧ͶWHO͹ଲࡨ ઝ঳ͶଲͤΖਏஇ༂ʀ࣑ྏ༂ʀ״ ੔౵ɼքܙ఼͹ڎڂࡨఈҐཔɼ਼յ͹րఈΝࣰࢬ ࡐνʖΰρφ෨Ғ͹ಝఈɼ৿ͪ͵ਟଐ ൅ਬ਒ɼݜ ֋൅ΏBSLࢬઅڂ΢ϱϓϩ͹൅ਫ਼࣎͹Ϗϱ ਏஇ๑౵͹֋൅ʀࣰ༽Կ౵Νઅఈ ֐Ͳήϫʖώϩ͵࿰ૌͲ͹߫ݛɼ ϭέοϱ౵͹ݜܗʀ৿ ࢩԋ౵Ν؜΋ڂΖׯ຿ ౵΃͹ݜܐઝ঳ଲࡨͶ״υϝρέϭέοϱ֮ฯ͹ͪΌ͹ ʀ2030೧ΉͲ͹໪ඬͶ৿ͪ͵ϭέο ౏৏ࠅ͹ ࢩԋ౵Ν؜΋ܠ֋൅ΏϭέοϱඍடͶؖ͢ ϱʀ߇Τ΢ϩη༂౵͹֋൅Νઅఈ ࿊ڂݜ ٶͱ΍ݶ

ժʤ2011ʛ2020೧ౕʥܯຌخՌָٗढ़ ઝ঳ΝήϫʖώϩͲ͹॑གྷ՟ୌ AMRଲࡨΠέεϥϱϕϧϱ າཔ౦ࣁકྲྀ״ڷʀ࠸ڷ2011೧ౕΓΕ৿ ઝ঳ଲࡨͳ͢ͱݜ״Ҙͳ͵Ζڶؽؖ౵ ࠅࡏదͶܐժΝಁΉ͓ɼؖܯ֋൅ WHO͹ߨಊڂͳଌ͓ɼ଩ͬघͳ͢ͱϭέοϱɼ࣑ྏɼਏஇ๑͹ݜ Կ౵͹ک೵ྙʀؽ೵ڂ੔Ώݜܙ఼͹ڎڂ ಉ͢ͱखૌ΋ଲࡨΝઅఈɽ6෾໼Ͷڢ͗ ٶਬ਒Ͷݶ ͵ؖͤΖ໪ඬΝઅఈ͢ɼકྲྀͳ۫ରద Ζ͝ܟ֋൅ʀࠅ಼֐ ਬ਒ɼήϫʖώϩͲ͹ࢩԋΝڂʤ11ʛ15೧ౕʥͲͺϭέοϱ͹ݜغʀ୊࢝ खૌΊΝࡨఈ ఼ڎڂઝ঳ͶؖͤΖබݬର͹೼Ѵʀ ʀࠅ಼Ͳͺௗ࡜୉Ν஦ৼͳͪ͢ݜ״ڷʀ࠸ڷਬ਒ɼ৿ٶ΃͹෕ Կ౵ɼکؽ೵ڂ੔Ώਕࡒү੔Ν؜΋ݜܙɼ༂ࡐଳ੓ ͹ڂʀ6෾໼Ͷͺ༂ࡐଳ੓͹ݜ ٶ֋൅ਬ਒Ͷݶڂ༩๹ʀਏஇʀ࣑ྏͶؖͤΖݜ ඏਫ਼෼ͶଲͤΖ༩๹ʀਏஇʀ࣑ྏघஊ ֋൅ ήϫʖώϩͲͺࠅࡏฯ݊ؽؖΏCEPI౵΃ڂઝ঳͹ݜ״ڷʀ࠸ڷʤ16ࠥ20೧ౕʥͲͺ৿غޔʀ୊ Ν؜΋ྙڢ֋൅͹ਬ਒Ώɼࠅࡏڂ͹ݜ ઝ঳ଲԢਕࡒ͹ү੔౵Ν״੔Ͷ޴ͪ͜ࢬࡨͳ͢ͱҒ஖Ͱ͜ɼAMED ͹ࢩԋɼࠅࡏܙΝ݊߃ௗथऀճ ؜΋ ٶ֋൅ਬ਒Ͷݶڂઝ঳ݜ״Ν஦ৼͳͪͨ͢ΗΔ͹

ժɼາཔ౦ࣁકྲྀ౵ܯຌخԿͶؖͤΖکઝ঳ଲࡨ͹״Ҙͳ͵ΖڶʥɼAMRଲࡨΠέεϥϱϕϧϱɼ݊߃ʀҫྏકྲྀɼࠅࡏదͶغޔʀغժʤ୊࢝ܯຌخժɼՌָٗढ़ܯ΢ϱϓϩΦϱδ౵ଲࡨߨಊܗड़ॶʁ৿

࣎ٺە ฑ࣎ કྲྀࡨఈʀસର౹ׇ ઝ঳ͶؖͤΖਏஇ๑ʀ࣑ྏ๑ʀ༩๹๑ͶؖͤΖࣰ༽ԿࢩԋͶ״ڷAMEDͲͺ৿

ԿͶ΍खΕૌΞͲ͏Ζ ଲেϠξک൭خڂՅ͓ɼBSL-4ࢬઅ͹੖ඍ౵͹ݜ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ௪ڠ ઝ঳ͶؖͤΖਏஇ๑ʀ࣑ྏ๑ʀ༩๹๑͹ࣰ༽Կࢩԋ ‡ AMED״ڷ৿ ʥۂࣆڂઝ঳ͶଲͤΖַ৿దҫ༂඾౵֋൅ਬ਒ݜ״ڷʀ࠸ڷʤ৿ ‡ ౲खૌΊͺɼ6ͯ͹౹߻ϕϫζΥέφ͹಼ɼҫ༂඾ϕϫζΥέφ಼Ͳܯժ͠ ʱۂࣆڂઝ঳ͶଲͤΖַ৿దҫ༂඾౵֋൅ਬ਒ݜ״ڷʀ࠸ڷΗͱ͏Ζʰ৿ Ͷ౲ͪΖ ൭ٗढ़͹֋൅ɼਏஇ๑ʀ࣑ྏ๑ʀ༩๹๑͹خ;ٶڂݜેخઝ঳͹״કྲྀࡨఈʀ ‡ ࠅ಼֐ ֋൅Ν઀Η໪͵͚ਬ਒ͤΖ͞ͳΝ໪ࢨͤڂΉͲ͹ݜڂ֋൅౵͹ࣰ༽Կݜ ͹ਬ਒Ώௗ࡜୉ָBSL4ࢬઅΝ஦֫ͳڂ఼Ͷ͕͜Ζݜڎڂઝ঳ླྀߨஏ͹ݜ״ ‡ સର౹ׇ Կک൭Νخڂઝ঳ݜ״൭͹੖ඍͶΓΕɼࠅ಼֐͹خڂݜͪ͢ ܠΏଡ༹͵෾໼͗࿊ڂ఼ͲಚΔΗΖݗରʀ৚ๅ౵Ν׈༽ͪ͢ݜڎڂք֐ݜ ‡ Νਬ਒ڂదݜેخઝ঳͹༩๹ʀਏஇʀ࣑ྏͶࣁͤΖ״Νਬ਒͢ɼڂݜͪ͢ ৿΢ωεַڂઝ঳ݜ״ࠅࡏఴ֋કྲྀϕϫήϧϞʤJ-GRIDʥͳڂઝ঳ݜ״ʤ ‡ ΠτΡϔʤJ-PRIDEʥ͗౹߻ʥ

ड़ॶʁAMEDΤΥϔγ΢φ౵

41 ࣎ٺە ฑ࣎ ઝ঳ؖ࿊༩ࢋ״͹Ϗϱυϝρέ࣎͹ڊʤࢂߡʥգ ड़ͪ͗͢ɼϏϱυϝρέڎ֋൅༩ࢋΝڂH1N1ླྀߨ࣎Ͷͺ1,400Աԃओ͹ݜ ઝ঳ؖ࿊༩ࢋͺ74ԱԃͶཻΉΕɼଠࠅͳർ͢ͱఁ͏ਭ६Ͷ͍Ζ״͹ޛशଋ

ઝ঳ଲࡨ༩ࢋ*1״ϏϱυϝρέͶ͕͜Ζڊգ;ٶฑ࣎ ຎྭ*2 ֋൅ؖ࿊༩ࢋڂୱҒʁԱԃ*4 ˛ϏϱυϝρέଲԢ͹ݜ ֋൅Ґ֐͹ؖ࿊༩ࢋڂϏϱυϝρέଲԢ͹ݜ˛ ֻ૱ 3,005Աԃ ʤਫ਼ࢊʀͨ͹ଠʥ ֋൅ؖ࿊༩ࢋڂઝ঳͹ݜ״΢ϱϓϩҐ֐༩ࢋ ˛ϏϱυϝρέଲԢҐ֐͹ܗ৿ 3,000 ֋൅Ґ֐ڂઝ঳͹ݜ״֋൅ 64Աԃ ˛ϏϱυϝρέଲԢҐ֐͹ڂݜ 1‡ 2 ‡ ਫ਼ࢊؖ࿊ 0Աԃ ؖ࿊༩ࢋʤਫ਼ࢊʀͨ͹ଠʥ 1 2‡ ͨ͹ଠ 319Աԃ

2,500 5

2010೧ౕͲͺ 2,000 ༩ࢋܻ͗ݰ 4

SARSҐ֐༩ࢋ 1,500 1‡ ֋൅Ґ֐͹ڂ΢ϱϓϩҐ֐༩ࢋ ݜܗ֋൅ 105Աԃ ৿ڂݜ ਫ਼ࢊؖ࿊ 0Աԃ ‡ ֋൅ 0Աԃ ༩ࢋͶͯ͏ͱͺڂݜ ‡ ͹ଠ 525Աԃͨ 2‡ ֻ૱ ͏͵ਫ਼ࢊؖ࿊ 0Աԃ ֮೟Ͳ͘ͱ͏ ‡ 1,000 781Աԃ ৿ܗ΢ϱϓϩ༩ࢋ*5 1‡ ͨ͹ଠ 186Աԃ ֋൅ 1,305Աԃڂݜ 3‡ ઝ঳״ ਫ਼ࢊؖ࿊ 950Աԃ 3 4‡ ֻ૱ SARS༩ࢋ ֋൅ؖ࿊༩ࢋڂ΢ϱϓϩ༩ࢋ ݜܗ͹ଠ 367Աԃ ৿ͨ 5‡ 2 ֋൅ 17Աԃ 310Աԃڂݜ 3‡ 500 ֋൅ 0Աԃڂݜ ‡ ਫ਼ࢊؖ࿊ 0Աԃ 74Աԃ*3 ‡ ਫ਼ࢊؖ࿊ 0Աԃ ‡ 1 4‡ ͨ͹ଠ 134Աԃ 1 3 2‡ ͨ͹ଠ 124Աԃ 0 4 2 ճܯ೧ౕ 2004 ʀʀʀʀ 2009 2010 ʀʀʀʀ 2019 SARSླྀߨ ৿ܗ΢ϱϓϩΦϱδླྀߨ ฑ࣎ ֻ૱ ʤ2003೧ʥ ʤ2009ʛ2010೧ʥ 310Աԃ

ઝ঳͹ਫ਼ࢊʤઅඍ؜״֋൅Ґ֐ʤਫ਼ࢊʥͺଲেڂʀ֋൅Ͷؖ࿊ͤΖ༩ࢋɼݜڂઝ঳͹ݜ״֋൅༩ࢋͺɼଲেڂʥ΢ϱϓϩΦϱδͶؖͤΖ༩ࢋΝଲেͳͤΖ *2. ݜܗ2010೧ౕͺH1N1ʤ৿;ٶ2004೧ౕͺSARSؖ࿊༩ࢋɼ2009 .1* ઝ঳༩ࢋ *4. USχϩɼϛϱχɼਕ຿ݫɼϤʖϫ͖Δԃ΃͹׷״ؽؖ͹ڂਫ਼ࢊҐ֐Ν؜΋ *3. 2019೧ౕ͹AMEDʀ΢ϱύΤηݜ;ٶʀ֋൅ڂઝ঳͹ݜ״֋൅Ґ֐ʤͨ͹ଠʥͺҫྏର੏੖ඍΏඍட౵͹ଲেڂ΋ʥͶؖͤΖ༩ࢋɼݜ ड़ͪ͢ͳਬࡱڎਫ਼ࢊؖ࿊༩ࢋ͖Δ;ٶ֋൅ڂ͹༩ࢋͺ2009೧ౕ͹ݜۂTTBϪʖφΝ࢘༽ *5 ࡋ๖ക཈๑ϭέοϱࣰਫ਼ࢊࢬઅ੖ඍ౵ਬ਒ࣆۋࢋϪʖφͺɾMUFG2019೧͹೧ؔฑ ֋൅ؖ࿊༩ࢋ͹ϛ΢ϱφʱڂड़ॶʁ޲ਫ਼࿓ಉ঴ɼ༩ࢋҌ͹कགྷࣆߴʀึਜ਼༩ࢋҌ͹֕གྷʤฑ੔16೧ౕɼฑ੔21೧ౕɼฑ੔22೧ౕʥɼ AMEDʰฑ੔31೧ౕ ҫྏ෾໼͹ݜ

࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ֋൅Ͷ޴ͪ͜ϠρέΠρϕϭέοϱغ͹ϏϱυϝρέΝण͜ɼϭέοϱ૥ڊգ ਬ਒͠Ηͱ͏Ζ ଲেϠξ͗ڂढ़͹ݜٗو֋൅Ώϭέοϱ͹৿ڂ͹ݜ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ Vx ڂ֋൅͹ਬ਒ ‡ ޲ਫ਼࿓ಉ঴ʤࠅཱིݜڂઝ঳ϠρέΠρϕϭέοϱ͹ݜ״ ֋൅ڂݜ ൭ʀخͳ͢ͱɼϠρέΠρϕϭέο ֋൅๑ਕ ҫ༂؂ઝ঳ଲࡨ͹Ҳ״ڷਬ਒ ‡ 2019೧ౕ༩ࢋҌͶͱɼ৿ ॶʥڂ֋൅Νࣰࢬ ݊߃ʀӭ཈ݜڂϱ͹ࡠ੣Ͷ޴ͪ͜ݜ ϠρέΠρϕʤໝ٘ʥϭέοϱͳͺɼࣆ઴ͶϠυϩබݬର߇ݬΝ༽͏ͱ 9 ੣ଆ๏๑Νཱི֮ͪ͢ϭέοϱ ؽؖͳ͹࿊ܐ৚ๅ౵Ν׈༽ͪ͢ɼؖं׳ͺೋබ͹ۂ੔ֻʁ37Աԃʤຌࣆঁ ‡ ͹ਬ਒Ώ৿༂૓ड़ଇ਒͹AI͹֋൅౵΍؜ΉΗΖʥڂͶΓΖݜܠ ֋൅๑ਕ Vx, Rxڂઝ঳͹߇ରҫ༂඾ɼϭέοϱ֋൅͹ਬ਒ ‡ ࠅཱིݜ״ ൭ʀ݊߃ʀӭ཈خઝ঳͹࣑ྏ߇ରɼ༎೘݄ӹݬྋ༟པಝच໖ӺήϫϔϨϱ੣ࡐ͹େ଺ͳ͵ ҫ༂״ ‡ ॶڂΖૌ׷͓߇ର͹֋൅ͶՅ͓ɼබݬର͵ʹ͹νϱϏέ࣯ΝૌΊ߻Κͦͪɼα ݜ ϱϛʖϋϱφϭέοϱ͹֋൅Νਬ਒

ॶ Vx, Rxڂઝ঳ݜ״Ζ߇ݬʀ߇݄ੜ͹੣ଆࣰࢬ ‡ ࠅཱིܐઝ঳Ͷ״ ઝ঳౵͹৚ๅ״ιϱνʖͲͺɼڂؽ؇ཀྵݜثઝ঳״2020೧4݆Ͷ৿અͪ͢ ‡ ઝ঳൓พ͹ͪΌ͹ݗࠬɼ͞ΗͶؖͤ״౵ͶՅ͓ɼڛफॄΏ෾ੵʀ݃Վ͹఑ ౵ΝࣰࢬڂΖ߇ݬʀ߇݄ੜ͹੣ଆɼ͞ΗΔͶචགྷ͵Ռָద͵௒ࠬʀݜ

௪ڠ ॶڂઝ঳ݜ״͹ਬ਒ ‡ ࠅཱིڂʀԢ༽ݜેخઝ঳ͶؖΚΖ״ པΓΕଚࡑͤڈ;ٶ׳ઝ঳ͳ͢ͱҒ஖Ͱ͜ΔΗͱ͏Ζ࣮״ڷʀ࠸ڷಝͶ৿ ‡ ϭέ;ٶබݬର͹෾ࢢਫ਼෼ָմੵͶՅ͓ɼͨΗΔ͹ਟଐਏஇ๑׳Ζ॑གྷ࣮ ͹Ԣ༽ΝकͪΖ՟ୌͳɼҪఽࢢૌ׷͓ϭέοϱ͹ڂοϱ౵͹֋൅ʀԢ༽ݜ Ώɼ৿͢͏൅૟͹ϭέοϱ֋൅ʤ೬ຜϭέοϱɼDNA ϭέοϱڂ֋൅ݜ ΍ਬ਒ڂ౵ʥ͹ݜ

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

42 ࣎ٺە ฑ࣎ ൭ʁϨλʖη֮ฯخ֋൅ਬ਒ڂݜ ͜Ͳ͵͚ɼώ΢ͫڛ֋൅΃͹ঁ੔ۜ఑ڂઝ঳͹ݜ״ڷ੕ැʀޮదؽؖͶΓΖ৿ ౵͹Ϩλʖη੖ඍͶ΍खΕૌΞͲ͏Ζ ଲেϠξڇڛΨώϱέ͹ߑ஛Ώࣰݩ༽ಊ෼͹ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ΢ϱϓϩΦϱδϭέοϱ͹ٗढ़֋൅ࢩԋ ‡ ޲ਫ਼࿓ಉ঴ Vxܗ֋൅ ৿ڂݜ ΢ܗઝ঳൅ਫ਼Ͷඍ͓ɼ৿״΢ϱϓϩΦϱδ౵͹ܗ൭ ‡ 2020೧ౕ༩ࢋҌͶͱɼ৿خਬ਒ Ζࡋ๖ക཈๑ͶΓΖٗढ़֋൅ΝࢩԋܐϱϓϩΦϱδϭέοϱͶ Ͷͺ߇΢ϱϓϩΦϱδΤ΢ϩη༂͹ඍடΏਭࡏଲۂ੔ֻʁ197Աԃʤຌࣆঁ ‡ ֋൅Ͷ௜ંదͶؖ࿊͢͵͏׈ಊ΍؜ΉΗΖʥڂࡨ౵ɼݜ ݬ༂ʀݬྋ͹ࠅ಼੣ଆࢩԋ ‡ ޲ਫ਼࿓ಉ঴ Vx, Rx ୊3࣏ึਜ਼༩ࢋҌͶͱɼք֐ғଚౕ͹߶͏ݬ༂ʀݬྋ;ٶ2020೧ౕึਜ਼༩ࢋ ‡ Ν໪దͳ͢ͱɼࠅ಼Ͳ͞ΗΔ͹੣ଆΝࣰࢬ͢Γ͑ͳͤΖ੣ڇڛ͹ࠅ಼҈ఈ ౵Ͷଲ͢ɼ੣ଆॶ͹৿અ຤ͺઅඍߍ৿Ͷචགྷ͵ඇ༽ΝҲ෨ึঁۂة༂ ੔ֻʁ30Աԃʤึਜ਼༩ࢋʥɼ30Աԃʤ୊3࣏ʥ*1ঁ ‡ ֋൅๑ਕ Vx, Rxڂώ΢Ψώϱέ͹ߑ஛ʀ؇ཀྵ ‡ ࠅཱིݜ ൭ʀ݊߃ʀӭ཈خʀDNAώϱέɼϐφૌ৭ώϱέΝฯ༙ ҫ༂הJCRBࡋ๖ώϱέɼೖຌਕ༟པBࡋ๖ ‡ ॶڂΞࡋ๖ɼ൅ޭ͗Ξࡋ๖౵)Ν3,400झҐ৏ฯ ݜ͗)הJCRࡋ๖ώϱέʁക཈ࡋ๖ 9 ༙ ʀDNAΝ༁הʀDNAώϱέʁೖຌਕ༟པ෈ࢰԿBࡋ๖הೖຌਕ༟པBࡋ๖ 9 2,200ਕ෾ฯ༙ ϐφૌ৭ώϱέʁघढ़࢔༪ૌ৭౵͖Δ౜݃ૌ৭131ݗରɼݽఈૌ৭37ݗ 9 ϨϱϏૌ৭ঘฤ;ٶځରɼ،ϝέϫλʖϞͨ͹ଠ6ݗରɼ޳֘Ἱ౩ϨϱϏ 15ݗରɼ౜݃ࢹ๳઴ۨࡋ๖26ݗରɼ౜݃׊ຜࡋ๖25ݗରɼ౜݃ൿේથң լࡋ๖14ݗରɼ౜݃ൿේֱԿࡋ๖8ݗରɼ౜݃ൿේϟϧόγ΢φ6ݗରɼ ౜݃ࠐૌ৭༟པࡋ๖5ݗରΝฯ༙ ֋൅๑ਕ Vx, Rxڂࠅཱིݜ ‡ ڇڛࣰݩ༽γϩ͹ฯ༙ʀ ൭ʀ݊߃ʀӭ཈خໝ ҫ༂وιϱνʖͲͺΩωέ΢δϩΝ஦ৼͶࣰݩ༽γϩ͹୉ڂௗྪҫՌָݜྸ ‡ ॶڂΝࣰࢬ ݜڇڛൡ৫αϫωʖΝฯ༙͢ɼࣰݩ༽γϩྪ͹඾࣯؇ཀྵɼ

ࡎىઝ঳ͶಝԿͪ͢ଲԢͲͺ͵͏ͪΌฑ࣎͹खΕૌΊͳ͢ͱ״༲ͺಋ಼ۂઝ঳ͶଲԢͤΖखΕૌΊ͗ߨΚΗͱ͏Ζ͗ɼࣆ״αϫψΤ΢ϩηܗͺ৿غ͹༩ࢋҌฦ੔࣎ۂຌࣆ .1* ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

࣎ٺە ฑ࣎ ൭ʁϨλʖη֮ฯخ֋൅ਬ਒ڂݜ ઝ঳઒໵Պү੔͹खૌΊ״ઝݜͲͺ״Ν׈੓ԿͤΖͪΌɼڂઝ঳ݜ״ࠅ಼Ͳ͹ Ν2021೧ΓΕࣰࢬ༩ఈͲ͍Ζ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ௪ڠ ॶڂઝ঳ݜ״ઝ঳઒໵Պ͹཈੔ ‡ ࠅཱི״ ֋൅ڂݜ ઝ঳઒໵Պ཈੔Νߨࣰ͑ஏӺָιϱ״ΝଁՅͦ͠ɼ਼ंڂ൭ ‡ 2021೧ΓΕݜخਬ਒ νʖΝ৿અ༩ఈ ҽ༁300໌ɼߨ੕৮༁50ڂॶ͹ఈҽͺݳয়͹361໌ʤݜڂઝ঳ݜ״ࠅཱི 9 ໌ʥ͖Δ716໌ʤ಼༃෈໎ʥͶଁҽ༩ఈ

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

43 ࣎ٺە ฑ࣎ ൭ʁઅඍʀࢬઅ͹੖ඍخ֋൅ਬ਒ڂݜ Ώح֋൅๑ਕͲͺฯ༙͢ͱ͏Ζࣰݩؽڂ֋൅Νਬ਒ͤΖͪΌɼࠅཱིݜڂࠅ಼ݜ

3͹ࣰݩࢬઅΝ֐෨ཤ༽Ն೵ͳ͢ͱ͏Ζ ଲেϠξ;ٶBSL-2 གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ௪ڠ ֋൅๑ਕڂʀࣰݩ࣪͹֐෨ཤ༽ ‡ ࠅཱིݜح֋൅ ؽڂݜ ൭ʀ݊߃ʀӭ཈خΝ໪దͳͤ ҫ༂ڂ౵ͶΓΖ૓༂ݜۂة౵͹ଇ਒͹ͪΌɼ֐෨͹ڂ൭ ‡ ҫ༂඾֋൅ݜخਬ਒ ॶڂుࢢ ݜܗ໒ʤNMRʥઅඍ͹֐෨ཤ༽͕Γ;ಃգڠـΖ଎ఈΝण͜೘Ηɼ֫ࣕ Ν࢘༽ͪ͢ण୙ࢾݩΝࣰࢬںݨඏ

௪ڠ ֋൅๑ਕڂઝ঳ࣰݩࢬઅ͹ฯ༙ ‡ ࠅཱིݜ״3͹;ٶBSL2 ൭ʀ݊߃ʀӭ཈خઝ঳ࣰݩࢬઅ ҫ༂״ಋཤ༽ࢬઅͳ͢ͱڠιϱνʖͲͺɼڂௗྪҫՌָݜྸ ‡ ॶڂ3ʥΝฯ༙ ݜ;ٶʤBSL2

௪ڠ ॶڂઝ঳ݜ״4ࢬઅ͹ฯ༙ ‡ ࠅཱི;ٶBSL3 ‡ ଞࢃுࣹͲͺɼೖຌͲ༏Ҳ͹BSL4ࢬઅΝฯ༙ Ͱ͚ࢬઅͳ͢ͱࢨఈ͠ΗɼҲझබݬର͹ॶ࣍͹টخઝ঳๑Ͷ״2015೧Ͷ 9 ೟Νखಚɽ2019೧Ͷͺ޲ਫ਼࿓ಉ୉਋ΓΕҲझබݬର͹෾༫Νण͜Ζ͞ͳ ͹ࢨఈΝण͜ɼք֐ΓΕΦϚϧड़݄೦౵͹ಝఈҲझබݬରΝ༎೘ ‡ ރࢃுࣹͲͺɼBSL3ࢬઅΝฯ༙

৿ܗ΢ϱϓϩΦϱδϭέοϱ͹ਫ਼ࢊࢬઅߑ஛ࢩԋ ‡ ޲ਫ਼࿓ಉ঴ Vx ΢ϱϓϩΦϱδϭέοϱ֋൅ʀਫ਼ࢊର੏੖ඍྡ࣎ಝྭި෉ۜͶΓΖࡋܗ৿ ‡ ܗͶͱɼࡋ๖ക཈๑ͶΓΖ৿ۂ๖ക཈๑ϭέοϱࣰਫ਼ࢊࢬઅ੖ඍ౵ਬ਒ࣆ ΢ϱϓϩΦϱδϭέοϱ͹ਫ਼ࢊࢬઅ੖ඍࢩԋ Ͷͯ͏ͱɼܴཝക཈ؔغ΢ϱϓϩΦϱδϭέοϱ͹ਫ਼ࢊܗસࠅ຿෾͹৿ 9 ΝགྷͤΖͳ͞ΘΝൔ೧Ͷ୻क़ͤΖ͞ͳؔغ๑Ͳͺ̏೧ൔ͖Δ̐೧ఖౕ͹ Νඬᒙ ۂώ΢Ψτρέ͹3ऀ͗ࣆڠɼ୊ҲࢀۂKMώ΢Ψϫζέηɼ෤ీ༂඾޽ 9 Νࣰࢬ

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

࣎ٺە ฑ࣎ ๑੖ඍ;ٶ൭ʁઅඍʀࢬઅخ֋൅ਬ਒ڂݜ ট೟੏ౕ͹಍೘Ώྡজࢾݩ͹૮஌૯޳֋અ౵ͶΓΕɼغPMDAͲͺড়݇෉͘૥ ֋൅ਬ਒ΝࢩԋͤΖखΕૌΊΝߨͮͱ͏Ζ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ͹಍೘ ‡ ช෨Ռָ঴ Vx, Rxں֋൅ έϧ΢Ψుࢢݨඏڂݜ ͹ࣙಉԿʀԗֶԿΝں൭ ‡ 2020೧ึਜ਼༩ࢋʤ୊3࣏ʥͶͱɼέϧ΢Ψుࢢݨඏخਬ਒ ໪దͳͪ͢֋൅༽ͳ͢ͱɼ300ΫϫుࢢϚϩφ͹ຌ଎ఈ༽ύ΢Φϱχؽ1ୈ ఼ͶͨΗͩڎͳ300ΫϫుࢢϚϩφ͹༩ඍ଎ఈ༽ηέϨʖωϱήؽ1ୈΝ2 Կͳ͢ͱ300ΫϫుࢢϚϩφɼک͹੖ඍں4ୈʥɽΉͪɼݨඏܯΗ੖ඍʤ 200ΫϫుࢢϚϩφΝ1ୈͥͯ੖ඍʤܯ2ୈʥ*1 ੔ֻʁ32Աԃঁ ‡ ট೟੏ౕ͹಍೘ ‡ PMDA Rx,Vxغҫ༂඾ড়݇෉͘૥ ౵ΝଲেͶҫ༂඾׳ঙ͵͏਼࣮͗ं׳Ͳ༙ް͵࣑ྏ๑͗๣͚͢׳ಠ͵࣮॑ ‡ ট೟੏ౕΝ಍೘غড়݇෉͘૥ Ͷ༙ްޛસ੓Ν֮೟ͪ͢৏Ͳɼ੣൤҈;ٶট೟ਅ੧࣎ͶҲఈఖౕ͹༙ް੓ ‡ Ͷ͕͜Ζ֋൅༩ۂة੓ʀ҈સ੓͹௒ࠬ౵ΝࣰࢬͤΖ͞ͳ౵Νট೟ড়݇Ͳɼ ͹ࣰ༽ԿΝଇ਒ͤΖغݡ੓Ν߶Όɼ૥ ௪ڠ জࢾݩ͹૮஌૯޳֋અ ‡ PMDAྡ ૮஌Ͳ͘Ζ૯޳Ν֋અ͗ۂةজࢾݩͶͯ͏ͱPMDA৮ҽͳྡ ‡

ࡎىઝ঳ͶಝԿͪ͢ଲԢͲͺ͵͏ͪΌฑ࣎͹खΕૌΊͳ͢ͱ״༲ͺಋ಼ۂઝ঳ͶଲԢͤΖखΕૌΊ͗ߨΚΗͱ͏Ζ͗ɼࣆ״αϫψΤ΢ϩηܗͺ৿غ͹༩ࢋҌฦ੔࣎ۂຌࣆ .1* ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

44 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ਏஇ๑ʁචགྷؽ೵͹ༀׄ෾୴ ֋൅Νਬ਒͢ɼ੕ැͺࣁࡒ͹໚ͲҲ෨͹ؽ೵Ν۫ඍɽڂฑ࣎ΓΕࢊָ֦ʓͲݜ ֋൅ʀਫ਼ࢊͶ͕͜Ζ੕ැ͹ؖ༫ͺଠϠξϨτΡͳർͤΖͳݸఈదڂݜ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ ΠΩυϝΠ ࠅࡏؽؖ Όͱ͏Ζਏஇ๑͹೼Ѵʥ ੣඾υδ΢ϱʀ֋൅ ୉ྖਫ਼ࢊର੏͹੖ඍٽεʖθ୵ࡩʤ੕ැʀྡজݳ৖͗ ɼࢾ༂͹ΫρφԿʥ ʤઅඍ੖ඍɼݬྋʀࣁࡒ௒ୣɼགྷҽର੏ɼ౵ʥܯ֋൅ਬ਒ ʤࢾࡠ඾͹ࡠ੔ɼݗৄͳ࠸અڂݜ αϱιϕφ݀ఈʤΤ΢ϩηΰόϞ৚ๅʀ߇ݬʀ ੣඾ݗৄʙඉྡজྡজࢾݩ͹ࣰࢬ ౵͹ਫ਼ࢊحढ़݀ఈʥ ʤබݬରखѽ๏๑ཱི֮ɼਏஇ๑੓೵ʀ҈ఈ੓͹֮೟ʥ ਏஇ༂ʀؽٗوϐφΤ΢ϩη߇ର͹ಝఈɼԢ༽ͤΖ৿ ढ़֋൅ʤΤ΢ϩηΰόϞʀ߇ݬʀϐφΤ΢ϩηٗ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ढ़͹֋൅ʥ ট೟৻ࠬٗو߇ର͹ݗड़๏๑ཱི֮ɼ৿ ੕ැ ͹҈સ੓ʙGLPన߻ࢬઅ ࢾ༂੣ଆʀΫρφԿ͹અඍ GMPన߻ਫ਼ࢊઅඍʀࢬઅڂઝ঳ݜ״ ֋൅ અඍʀڂݜ ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ݗରण೘ࢬઅɼഓૻର੏ה൭ ࢬઅ බݬରΏخਬ਒ ʤ઒༽ࢬઅͲ͹ݗࠬ͗චགྷ͵ਏஇ๑͹৖߻ʥ ΢ϱξηφϨʖ ࢾ༂੣ଆઅඍ ढ़ʤAIմੵ౵ʥͶ࢘༽ͤΖٗو৿ ΠϩβϨθϞɼλϓφΤΥΠ౵ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

͹ݬྋʀࣁࡒحࣁࡒ බݬରγϱϕϩ ࢾ༂੣ଆʀΫρφԿ͹ࣁࡒ ਏஇ༂ʀؽ ށ͹ࡑحࢾࡠ඾͹Ϋρφ ਏஇ༂ʀؽ הබݬର ඍடʙࣆ઴༩༁حઝं͖Δ͹ݗࠬࡒྋ ਏஇ༂ʀؽ״ ക཈ࡋ๖ ઝं͖Δ͹ݗࠬࡒྋ״ ढ़ʤAIմੵ౵ʥͶٗو৿ ࢘༽ͤΖָस༽υʖν౵ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ࣑ྏ༂ʁචགྷؽ೵͹ༀׄ෾୴ ֋൅͹ਬ਒ʀࢊָ΃͹ࢩԋͶՅ͓ɼබݬରฯ؇ࢬઅΏηϏαϱɼڂ੕ැͶΓΖݜ ౵͹અඍɼώ΢Ψώϱέ౵͹ϧ΢ϔϧϨΝ੕ැʀޮదؽؖͶͱ੖ඍںుࢢݨඏ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ ΠΩυϝΠ ࠅࡏؽؖ εʖθ୵ࡩʤබݬର͹ಝ੓೼Ѵɼ ਫ਼ࢊٗढ़ʤCMCʥ͹ཱི֮ ୉ྖਫ਼ࢊର੏͹੖ඍ Կ߻෼ηέϨʖωϱή؜΋ʥʥ ʤݬ༂͹੣ଆ๑֋൅ɼ੣ࡒ֋൅ɼ඾࣯඲Ճʥ ʤઅඍ੖ඍɼݬྋ௒ୣɼགྷҽର੏ɼ౵ʥ ֋൅ਬ਒ڂݜ ϨʖχԿ߻෼͹࠹నԿ ྡজࢾݩ͹ࣰࢬ ࣑ྏ༂͹ਫ਼ࢊ ʤϨʖχԿ߻෼͹୵ࡩʀ࠹నԿɼAPI੣ଆ๑͹ཱི֮ʥ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ඉྡজࢾݩ͹ࣰࢬ ট೟৻ࠬ ੕ැ ઝ঳࣑ྏ༂઒༽ʥ ΢ϱξηφϨʖ״ઝ঳࣑ྏ༂઒༽ʥ GMPన߻ਫ਼ࢊઅඍʀࢬઅʤ״͹҈સ੓ʙGLPన߻ࢬઅ ࣑ݩ༂੣ଆઅඍʤڂઝ঳ݜ״ ֋൅ અඍʀڂݜ ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ྡজࢾݩࢬઅʤGCPన߻ࢬઅʥה൭ ࢬઅ බݬରΏخਬ਒ Կ߻෼୵ࡩʀνʖΰρφಝఈ༽અඍ ɼηϏαϱɼ౵ʥںɼNMR*2, LS/MS*3ɼέϧ΢ΨుࢢݨඏحʤHTS*1ؽ ࢾ༂੣ଆઅඍ ඉྡজࢾݩ༽͹ಊ෼؇ཀྵࢬઅ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

ࣁࡒ Կ߻෼ࣁݱʙԿ߻෼ϧ΢ϔϧϨʖ ࣑ݩ༂͹ݬྋʤAPIɼశՅࡐʥɼใૹࣁࡒ ࣑ݩ༂͹ݬྋʤAPIɼశՅࡐʥɼใૹࣁࡒ ށ࣑ྏ༂ݬྋ͹ࡑ;ٶΠρι΢ϕϪʖφ ࣑ݩ༂ ࣑ྏ༂ අݩं ࣑ྏ༂ඍடʙࣆ઴༩༁ ੕ැ הබݬର ക཈ࡋ๖ ඉྡজࢾݩ༽͹ಊ෼

གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

໒ *3. Liquid Chromatography Mass SpectrometryɼӹରέϫϜφήϧϓΡʖ࣯ྖ෾ੵ๑ڠـHigh throughput Screening *2. Nuclear Magnetic Resonanceɼ֫ࣕ .1*

45 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱ ຎྭʁ – ΢ϱξηφϨʖ – ੕ැٺە ฑ࣎ ؽؖ –VCɼ࣌વ஄ରɼࠅࡏؽؖڂ୉ָʀޮదݜ – ϭέοϱʁචགྷؽ೵͹ༀׄ෾୴ Ͷɼࢬઅʀڠ֋൅ࢩԋΝߨ͑ͳڂɼࢊָ΃͹ݜڂ࣑ྏ༂ͳಋ༹ɼ΢ϱύΤηݜ અඍɼࣁࡒͶ͕͏ͱ΍ਫ਼ࢊΝ؜Όͱ੕ැ͗ؽ೵ैଏͶखૌΞͲ͏Ζ ֋൅ ਫ਼ࢊ ڂݜ

௒ʤྡজࢾݩɼট೟৻ࠬɼ౵ʥɼචགྷؽ೵͹घഓʤྡজࢾݩର੏ʀਫ਼ࢊର੏͹੖ඍ౵ʥ ੕ැڢଇ਒ɼࠅࡏܠ֋൅કྲྀࡨఈɼࢊׯָ࿊ڂકྲྀࡨఈʀસର౹ׇ ݜ ࣁۜ ֋൅༽ࣁۜ ਫ਼ࢊ༽ࣁۜ༽ڂݜ VCɼ ΠΩυϝΠ ࠅࡏؽؖ ʤබݬର͹ಝ੓೼ѴɼϠξϨτΡ͹મఈʥ ඾࣯؇ཀྵࢾݩ͹֋൅ ୉ྖਫ਼ࢊର੏͹ཱི֮ εʖθ୵ࡩ ʤϭέοϱ͹९ౕɼްྙɼ҈ఈ੓͹ࢾݩ๑͹ཱི֮ʥ ʤઅඍ੖ඍɼݬྋ௒ୣɼགྷҽର੏ɼ౵ʥ ֋൅ਬ਒ ϭέοϱޫึ͹αϱιϕφݗ౾ ਫ਼ࢊٗढ़͹ཱི֮ʤϭέοϱݬӹ͹ਫ਼ࢊɼڂݜ ʤබݬର͹ക཈๏๑ཱི֮ɼබݬରΰόϞ৚ๅ͹ಝఈʥ ώ΢Πϩ౵΃͹ϭέοϱैలͶΓΖ੣඾Կʥ ϭέοϱ͹ਫ਼ࢊ ϭέοϱ֋൅ٗढ़ཱི֮ ؇ཀྵށઝ༩଎ΝՅັͪ͢ਫ਼ࢊྖʀࡑ״ ʤ߇ݬ෾཯੠੣ɼΠζϣώϱφʀ҈ఈࡐ௒੖ʥ ྡজࢾݩ͹ࣰࢬ ඉྡজࢾݩ͹ࣰࢬ ট೟৻ࠬ ੕ැ ͹҈સ੓ʙGLPన߻ࢬઅ ݬӹ੣ଆʀ੣඾Կ͹અඍ GMPన߻ਫ਼ࢊઅඍʀࢬઅڂઝ঳ݜ״ ֋൅ અඍʀ ʤݬӹ੣ଆɼക཈ࡋ๖खѽ͏અඍɼ౵ʥڂݜ ϭέοϱ͹९ౕɼްྙɼ҈ఈ੓Ν ͹ฯ؇ɼക཈ࡋ๖खѽ͏અඍ ֮೟ͤΖͪΌ͹ࢾݩઅඍ ΢ϱξηφϨʖה൭ ࢬઅ බݬରΏخਬ਒ ݬӹ੣ଆઅඍ ྡজࢾݩࢬઅʤGCPన߻ࢬઅʥ༽ڂݜ බݬରΰόϞ৚ๅಝఈ༽͹અඍ ʤ࣏੊େεʖίϱηεητϞɼ౵ʥ ඉྡজࢾݩ༽͹ಊ෼؇ཀྵࢬઅ ઝ๹ࢯଲࡨ͹ͪΌ͹અඍʀࣁࡒ״གྷҽ

֋൅ϕϧρφϓΧʖϞʤEHRΏΰόϞմੵ౵͹υʖνϗʖη౵ʥڂݜ

౵حࣁࡒ බݬରγϱϕϩ ݬӹ੣ଆʀ੣඾Կ͹ࣁࡒ ϭέοϱ͹ݬྋɼώ΢Πϩ༲ ށϭέοϱݬྋ͹ࡑ;ٶγϱϕϩ ඾࣯؇ཀྵࢾݩ༽ࣁࡒ ϭέοϱ༽ڂݜ ʤVirus poolɼAdjuvant poolʥ ʤϭέοϱ͹९ౕɼްྙɼ҈ఈ੓Ν֮೟ͤΖͪΌ͹ࢾݩࣁࡒʥ ੕ැ ࣑ݩ༽ϭέοϱ ϭέοϱඍடʙࣆ઴༩༁ הබݬର ക཈ࡋ๖ʀಊ෼ʤܴཝ౵ʥ අݩं ඉྡজࢾݩ༽͹ಊ෼ གྷҽʀοʖϞ ֋൅གྷҽʀοʖϞ ਫ਼ࢊགྷҽʀοʖϞڂݜ ؜΋ʥܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠ؜΋ʥ ʤࠅ಼֐͹ଠؽؖͳ͹࿊ܠགྷҽ ʤࠅ಼֐͹ଠؽؖͳ͹࿊

Ն ੕ැڒՆ GDPɼҫ༂඾ট೟੏ౕ GMPɼҫ༂඾੣ଆڒۂ๑੏ౕ GLPɼҫ༂඾੣ଆ൤ജ

46 ͨ͹ଠʤಢࠅʥ

47 ࣎ٺە ฑ࣎ ಢࠅ੕ැͶΓΖք֐Ϩλʖη׈༽͹खૌΊ ͵ઝ঳ͶಝԿͪ͢खૌΊͲͺ͵͏͗ɼธࠅΆʹΦαεητϞ͗߶ౕԿ͢ͱ͏״ ͹൅ఴΝ໪ࢨ͢ͱ͏ΖۂదͶݼ;ࠒΊɼࣙࠅࢊۅಢࠅͲͺք֐ϨλʖηΝ੷͏

ࡃΦϋϩάʖ঴ʤBMWiʥ͗ܨࠅ಼֐͹ϗϱοϡʖΫϡϒνϩΝݼ;ࠒ΋ͪΌɼ࿊๞ ‡ ੭੏༑۲ΝࣰࢬͤΖϕϫήϧϞ;ٶࣁۜ͹֭ಚ ϗϱοϡʖΫϡϒνϩͶଲ͢ͱࣁۜࢩԋ ʰINVEST – Subsidy for Venture Capital programmeʱΝࣰࢬ ΃͹౦ࣁֻۂةͺɼϗϱοϡʖΫϡϒνϩͶΓΖstart upֻڛ౲ϕϫήϧϞ͹ࣁۜ఑ ‡ ͶԢͣͱ݀ΌΔΗΖ

‡ Կ͹ͪΌɼέϧηνʖΝঁ੔ͤΖϕϫήک૬ྙڟࠅࡏ;ٶଚέϧηνʖ͹ࠅࡏԿع ϕϪʖϢʖ͹ ϧϞʰέϧηνʖࠅࡏϋρφϭʖέʱΝࣰࢬ ݼ;ࠒΊ ‡ 2016೧ΓΕ֋࢟ͪ͢ϕϫήϧϞͲɼ5೧ؔͲ࠹߶€4ඨຬʤ༁4.8ԳԃʥΝݺพέϧη νʖ΃ঁ੔ͤΖݡࠒΊͲ͍Ζ ઎͹ۂڢ౲ϕϫήϧϞͲͺɼޮదࣁۜΝࢩԋͤΖͫ͜Ͳ͵͚ɼ੕ැʤBMBFʥ͗ࠅࡏ ‡ ؽؖΝಢࠅ͹έϧηνʖͶݼ;ࠒ΋͞ͳΝ໪ࢨ͢ͱ͏ΖڂࠅΝ୵ࡩ͢ɼଠࠅݜܠ఑

ΔΗͱ͏Ζ͝ڏժʱ͗ܯύ΢τέકྲྀ2020͹ࢬࡨ͹ҲͯͶʰ઒໵৮ү੔ ‡ ͵ࡃͳΦϋϩάʖʱɼʰַ৿దܨ͵ࡃͳऀճʱɼʰ࣍କՆ೵ܨ઒໵ਕࡒ͹ ± ύ΢τέકྲྀͳͺɼʰυζνϩ ʱɼʰ݊߃ద͵ਫ਼׈ʱɼʰηϜʖφϠϑϨτΡʱɼʰࠅ຿ਫ਼׈ͳιΫϣϨτΡʱ͹༑ڧ؂ү੔ ࿓ಉ ঴ʤBMBFʥͶΓΖ΢όϗʖεϥϱ੕ࡨڂүݜگ઎՟ୌ͹մ݀Ν໪దͳͪ͢࿊๞ ద͵ౌ༽Ώ༙ࣁ֪֐ࠅਕ͹ಢࠅҢेࢩԋ౵Νࣰࢬ͢ɼۅժͲͺɼࡑಢ֐ࠅਕ͹੷ܯ౲ ‡ ք֐͹઒໵৮ਕࡒ͹खૌΊΝ໪ࢨ͢ͱ͏Ζ

֋൅કྲྀʱʤ2018೧ʥɼBMBF ”The new High-Tech Strategy - Innovations for Germany”ʤ2014ʥɼ|INVEST – Venture capitalڂड़ॶʁ CRDSʰՌָٗढ़ʀ΢όϗʖεϥϱಊ޴ๅࠄ~χ΢ς~ʱʤ2015ʥɼCRDSʰकགྷࠅ͹ݜ grant” BMWi

࣎ٺە ฑ࣎ ͹खૌΊʁώ΢Ψέϧηνʖܠࢊָׯ࿊ χ΢ς͹ϧ΢ϕςΡϐͲͺɼयʀࢤ੕ැ͹ԋঁΝण͜ɼ੕ැʀΠΩυϝΠɼ ੔ܙΉΕɼώ΢ΨέϧηνʖΝॄ͗ۂةώ΢Ψτέόϫζʖ͹

ώ΢ΨετΡ ΫϡϱϏη ۂةؽؖʀڂώ΢ΨετΡ ΫϡϱϏη಼ͶॶࡑͤΖݜ ϧ΢ϕςΡϐ

Ϝρέηʀϕϧϱέ ϓϧΤϱϙʖϓΟʖ χ΢ς౹߻ਫ਼෼ଡ༹੓ ιϱνʖʤiDivʥڂॶ IZI ݜڂ਒Կਕྪָݜ ϧ΢ϕςΡϐ ιϱνʖ͹̏ڂਕྪָ͹ྼ࢛͹௒ࠬΝ ‡ GMPέϨʖϱϩʖϞ ‡ DFG͹ݜ ‡ ࣰࢬ͢ɼߡݻҪఽָɼ ࢬઅΝ۫ඍ͢ɼϐφ͹ ͯͲ͍Εɼਫ਼෼ଡ༹੓͹ Νࣰࢬڂࡋ๖࣑ྏ ݜܙ਒ԿҪఽָ౵͹෵਼͹ ࣙՊʀಋझҡ ෨໵Νฯ༙ ༂͹੣ଆϕϫιη͹ࣰૹ ͶಝԿ͢ɼࡋ๖ʀҪఽࢢ ࣑ྏ༂͹و࣑ྏ༂౵ɼ৿ ੣ଆ͗Ն೵ གྷ֕

BioCity Leipzig ‡ 2003೧Ͷδέιϱयϧ΢ϕςΡϐࢤ ؽؖͺڂΏݜۂةΖͤڋͶઅཱིͪ͢ώ΢Ψέϧηνʖ ‡ ΨϓΡηͳࣰݩ࣪Ν׮ඍ͢ͱ͕Εɼ೘ ͳ͢ɼݒઅ࣎Ͷ ༁40஄ରۂΝ൅ఴࢊۂώ΢Ψࢊ ‡ ͺδέιϱय੕ැͺ ԱϤʖϫɼϧ΢ Νߨ͑SpinplantऀɼਏஇΫρφΝ֋൅ͤΖڂ࠸ਫ਼ҫྏ͹ݜ 9 1 ϕςΡϐࢤ੕ැͺ ԱϤʖϫͳౖஏΝ 1 Selfdiagnosticsऀ౵͹ଠɼύ΢ηϩʖϕρφηέϨʖωϱήʀ ֋൅Νߨ͑ϧ΢ϕςΡϐ୉ָڂ߻ཀྵద૓༂ςʖϩʀٗढ़͹ݜ;ٶͲώ΢ΨέϧηνʖΝߑ஛ ਏஇ๑ܙΖͤڛ఑ ‡ ΫϡϱϏη಼Ͷͺ੕ැʀΠΩυϝΠ͹ ͹ώ΢Ψτέόϫζʖʀώ΢ΨҫྏιϱνʖʤBBZʥ΍ଚࡑ ɼ͢ڋ೘͗ۂةࢬઅͶՅ͓ɼڂؖ࿊ݜ ઝ঳͹״αϫψΤ΢ϩηܗAdversis PharmaऀͲͺ৿ۂةBBZͳώ΢Ψ 9 ΢ϱΫϣϗʖνʖ͹ༀׄΝՎͪͤ ߇ରݗࠬΫρφΝ֋൅ BioCity Leipzig΍ଚࡑ

ࣆ౵ىड़ॶʁBioCity Campus LeipzigΤΥϔγ΢φɼϧ΢ϕςΡϐ୉ָʀBBZΤΥϔγ΢φɼ֦झωϣʖη

48 ઝ঳΃͹״ڷೖຌͶ͕͜Ζ৿;ٶଠࠅ .3 ฑ࣎͹खૌΊ གྷ֕ .3-1 3-2. ৆ࡋ 3-2-1. ੕ැ ࠅࡏؽؖ .3-2-2 ۂة;ٶΠΩυϝΠ .3-2-3 ;ଠࠅ͖Δ͹ָ .3-3

49 ֋൅ΝࢩԋͤΖࠅࡏؽؖڂઝ঳ͶؖͤΖݜ״ڷ৿ ਫ਼ࢊΝࢩԋͤΖ;ٶ֋൅ڂઝ঳ͶଲͤΖਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹ݜ״ ΔΗΖ͝ڏक͵ࠅࡏؽؖΏ࣌વ஄ରͳ͢ͱɼWHOɼCEPIɼΰ΢ςࡔ஄͗

ϑϩ&ϟϨϱξʀ WHO CEPI ΰ΢ςࡔ஄ ઝ঳ͶଲͤΖϭέοϱ͹֋൅ “ALL LIVES HAVE EQUAL VALUE”͹Ծɼ״ڷ৿ ͤ΄ͱ͹ਕʓ͗Ն೵͵࠹߶͹݊߃ ϝρεϥϱ ΝՅଐͦ͠ɼླྀߨ࣎Ͷϭέοϱ΃͹ સͱ͹ਕͶ݊߃Ͳਫ਼ࢊద͵ਫ਼׈Νૻ ਭ६Ͷ౺ୣͤΖ͞ͳ ΠέιηΝՆ೵ͶͤΖ͞ͳ ΖͪΌࢩԋΝߨ͑͞ͳ

2019೧4݆ݳࡑ194ϳࠅʀஏҮͳ ࢂՅ 2६Յ໏ஏҮʤธࠅͺ2021೧7݆ 2020೧12݆ݳࡑ31͹ࠅͳ஄ର͗ࢩԋ ʷ ϟϱώʖ ͹୦ୂΝ௪ࠄʥ

ઝ঳ͶଲͤΖϭέοϱ֋൅״ڷ৿ „ ઝ঳ؖ࿊ͲͺϛϨΨɼNTDsɼ״ „ ͹ࢩԋ ઝ঳͹Ϊ΢χϧ΢ϱࡠ੔Ώ HIVɼϜϧϨΠΝଲেͳ͢ɼ״ „ ฑ࣎͹׈ಊ „ າஎ͹බݬରͶଲͤΖϭέοϱ ͳ຀໕ޜઝະԈ͹੏״౏৏ࠅͲ͹ ڛघજ͏౵͹φϪʖωϱή͹఑ ֋൅͹ϕϧρφϓΧʖϞٗढ़΃͹ ͶࣁͤΖ׈ಊΝఴ֋ ౦ࣁ

ઝ঳͹࠹״αϫψΤ΢ϩηܗ৿ „ ઝ঳Ͷଲͤ״αϫψΤ΢ϩηܗ৿͹எݡΝॄ༁ͪ͢Ϊ΢χϧ΢ „ ৿ ϱ͹ࡠ੔ɼชݛ͹υʖνϗʖη Ζϭέοϱ֋൅Ͷ޴͜9ͯ͹ϭέο ઝ঳Ͷଲͤ״αϫψΤ΢ϩηܗ͹ߑ஛ ϱޫึΝಝఈ „ ৿ Ζ੊ֆద͵ଲԢ͹ࢩԋͶ༁17Ա ڛ࣎͹ „ γϕϧ΢οΥʖϱʀνηέ „ ϭέοϱ֋൅΃͹क͵ࣁۜ఑ٺە ׈ಊ ϓΧʖηΝ௪ͪ͢චགྷ͵ҫྏ༽ ¾ Novavaxʤ࠹୉$3Ա8,800ຬʥ 5,000ຬχϩΝ ڛOxford / AstraZeneca ఑ ¾ ڛ඾͹఑ „ ACT AcceleratorΝ௪ͣͪɼϭ ʤ࠹୉$3Ա8,410ຬʥ ର੏͹ߑ஛ͳ ¾ Modernaʤ࠹୉$100ຬʥྙڢέοϱ֋൅͹ ϭέοϱ͹ޮฑ͵ഓා

ड़ॶʁWHOΤΥϔγ΢φɼCEPIΤΥϔγ΢φɼBill & Melinda Gates FoundationΤΥϔγ΢φ

࣎ٺە ฑ࣎ ֋൅ࢩԋʤฑ࣎ʥڂCEPIͶΓΖݜ ೖຌͺཱིͬ৏࣎͝ΓΕCEPIͶؖ༫͢ͱ͕Εɼ୊ࢀ͹ड़ࣁർིΝ࣍ͬɼϚʖχϟ ϱώʖͳ͢ͱ౦ࣁ൓இ͹ࢩԋͶ΍ؖ༫͢ͱ͏Ζ

Ҥ ׈ಊ಼༲ܨ൅ଏ͹ ڛCoalition for Epidemic Preparedness InnovationʤCEPIʥͺΦϚϧ „ ϭέοϱ֋൅ϕϫιηͶଲ͢ͱϓΟεϨτʖεϥϱͳࣁۜΝ఑ „ ड़݄೦͹ླྀߨΝण͜ͱ൅ଏ գͪ͢ ౦ࣁंͳ͢ͱؖ༫ܨΗͪ͹ͺླྀߨ͖Δ1೧͗͠ڛΦϚϧड़݄೦Ͷଲ͢ͱϭέοϱ͗఑ ‡ Ηͱͪ͘ϭέοϱ͍͗ͮͪͶ΍ؖ͠ڂ࣎ͳଲԢ͗ஙΗɼ10೧Ͷోͮͱݜ ઝ঳͹ླྀߨͶඍ͓ɼ ϓΟεϨτʖνʖͳ͢ͱؖ༫״எ͹عΚΔͥ11,000 ਕҐ৏͹ࢰंΝड़ͪ͢͞ͳͲɼ ϭέοϱ͹֋൅ΝՅଐͤΖ࢕ૌΊ͹චགྷ੓͗໎Δ͖ͳ͵ͮͪ Ϗʖφψʖερϕܠ2017೧1݆ͶξϚηճ٠͕͏ͱਜ਼ࣞ൅ଏͪ͢ׯ຿࿊ „ ླྀ௪ ൅ݡ ֋൅ ੣ଆ ౦༫ ‡ ೖຌʤ޲ਫ਼࿓ಉ঴ʥɼχ΢ςɼόϩΤΥʖɼϑϩˏϟϨϱξΰ΢ςࡔ஄ɼ ஹ଄ ड़ڎࡃϓΧʖϧϞ͗ܨΤΥϩΩϞφϧηφɼ੊ֆ

ڛϝρεϥϱ ‡ ༙๮͵ޫึं΃͹ϕϫζΥέφͳ͢ͱ͹ࣁۜ఑ ڛઝ঳޴ٗ͜ढ़ࢩԋϕϧρφϓΧʖϞ͹఑״ڷ৿ ‡ ڛઝ঳ླྀߨ࣎͹ϭέοϱ͹֋൅ଇ਒ͳޮฑ͵Πέιη͹఑״ڷ৿ „ ɼ౵Ν؜΋ڛ઒໵Պࢩԋ͹఑ ‡ ‡ ʰCreating a world in which epidemics are no longer a threat to humanityʱΝηϫʖΪϱͳ͢ͱܟ͝Ζ ઝ঳ླྀߨͶඍ͓ɼϏϱυϝρέ͹Ն೵੓͍͗ΖͶ΍ؖΚΔͥࢤ৖੓Ͷ ׈ಊ͹੔Վ״ ‡ Ͷɼ „ 2019೧Ͷͺϭέοϱ͹֋൅Ͷ500Աԃʤ$4.6ԱʥΝ౦ࣁ͢ɼ5ͯ͹༑઎ڠͲଇ਒ͤΖͳܠઝ঳ΝଲেͳͤΖϭέοϱ͹֋൅Ν੊ֆ࿊״๣͢͏ ֋൅ɼ੣ଆɼྡজ඲ՃΝଇ਒ͤΖٗढ़ڂઝ঳ླྀߨ൅ਫ਼࣎͹ϭέοϱݜ״ 19͹ϭέοϱޫึΝϛʖφϓΧϨΨͳ͢ͱฯ࣍ܯබݬରͶଲ͢ͱ߻ దʀ੏ౕద͵ϕϧρφϓΧʖϞΝߑ஛ ༑઎බݬରʁϧργ೦ɼ್ϏɼMERSɼϨϓφώϪʖ೦ɼοέϱήωΠ ‡ ࠅ͹ؖ༫ „ ਟଐ͵ϭέοϱ͹֋൅ΝՆ೵ͳͤΖͪΌ͹3ͯ͹ਟଐ͵ϭέοϱ֋൅ϕ֦ ϧρφϓΧʖϞΝฯ࣍ અཱི͖Δ5೧ؔͲ1,081Աԃʤ$10Գʥ͹ࣁ֮ۜฯΝ໪ࢨͤCEPIͶଲ͢ɼ „ 810Աԃʤ$7.5Աʥ͹׈ಊࣁۜ͗ॄΉΖ ‡ ϭέοϱ֋൅ϕϧρφϓΧʖϞʁϭέοϱϕϨϱνʖɼ෾ࢢέϧϱϕϕܯ2019೧3఼݆࣎Ͳ ෱RNAϭέοϱϕϧρφϓΧʖϞଁހࣙ;ٶϧρφϓΧʖϞɼ कགྷ͵ड़ࣁंͳྩ੷ड़ࣁֻۜ*1,2 Ӻָ௒ࠬ;ٶઝ঳ླྀߨஏҮͲ͹઒໵Պ͹ডॄ״ͶΓΖۂڢࠅ੕ැͳ͹֦ „ [ ] ΤΥϩΩϞφ ड़ࣁं Ԧयҗҽճ όϩΤΥʖ ೖຌ ΰ΢ςࡔ஄ χ΢ς ϧηφ ͹ࣰࢬ ड़ࣁֻۜ ‡ ϗωϱɼάωΠɼϨϗϨΠɼψ΢ζΥϨΠɼεΦϧϪΨϋͲ͹ϧργ೦ 241 194 135 108 108 109 ʤԱԃʥ Ͷؖ࿊ͤΖӺָ௒ࠬ͹ࣰࢬ ड़͢ɼ౦ࣁϕϫζΥέφ͹൓இΝࢩԋ ‡ ϧργ೦Ͷͯ͏ͱͺψ΢ζΥϨΠͶɼ್ϏΤ΢ϩηͶͯ͏ͱͺεϱΪڎϚʖχϟϱώʖΝ „ 2໌͗౦ධݘΝ࣍ͯϚʖ ϛʖϩ΃͹੊ֆద͵઒໵Պ͹ডॄܯॶɼ෤ీ༂඾͹ਕҽڂઝ঳ݜ״ೖຌ͖Δͺࠅཱི ‡ χϟϱώʖͳ͢ͱࢂժ

TTBϪʖφΝ࢘༽͢׷ࢋۋ2019೧3఼݆࣎Ͳ͹ྩ੷ड़ࣁֻۜ *2. MUFG2019೧͹೧ؔฑ .1* ड़ॶʁCEPIΤΥϔγ΢φ

50 ઝ঳΃͹״ڷೖຌͶ͕͜Ζ৿;ٶଠࠅ .3 ฑ࣎͹खૌΊ གྷ֕ .3-1 3-2. ৆ࡋ 3-2-1. ੕ැ ࠅࡏؽؖ .3-2-2 ۂة;ٶΠΩυϝΠ .3-2-3 ;ଠࠅ͖Δ͹ָ .3-3

51 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ͹कགྷ͵खૌΊʁਏஇʤ1/2ʥۂة Abbottͺݗࠬ๏๑ʀՃ֪ଵ౵͹؏఼Ͳଡ༹͵੣඾ఴ֋Νߨͮͱ͏ΖɽInnovita ΊکͺࠅՊϕϫζΥέφ΃͹ࢂժࣰ੹Ν࣍ͬɼٗढ़ྙʀਫ਼ࢊ೵ྙ͹߶͗͠

Abbottʤธࠅʥ Innovitaʤ஦ࠅʥ

֋൅કྲྀڂ֋൅કྲྀ ݜڂݜ ͳ͢ɼ෵਼͹ࠅՊɼ঴ʤࢤʥۂϏϱυϝρέ࣎͹༹ʓ͵ωʖθͶԢ͓ΔΗΖଡ༹͵੣ ¾ ݗࠬΫρφΝक࣢͹ࣆ ¾ ඾ఴ֋Ν໪ࢨ͢ͱ͏Ζʤଡ͚͹ਕΝଲেͶݗࠬͲ͘Ζ क಍͹Ռָٗढ़ϕϫζΥέφ΃ࢂժ ۂةժʥΏ஦ঘܯժʤࠅՊ863ܯ൅ఴڂΓ͑҈Ճ͵Ճ֪અఈɼݗࠬ͹৖ॶΝમͻͥݗࠬՆ೵ɼ 9 ࠅՊύ΢τέݜ ͹खૌΊɼ঴ʤࢤʥͶΓΖकགྷ͵ݜۜخਟଐͶ݃ՎΝड़ͤɼ౵ʥ ΢όϗʖεϥϱ ౵Ͷؖ༫ڂ

֋൅ਬ਒ڂݜ ֋൅ਬ਒ڂݜ ઝ঳͹ਏஇ๑Ν֋״Ҫఽࢢʀ߇ରʀ߇ݬݗࠬͶ͕͏ͱ ¾ ߶͏ٗढ़ྙʀਫ਼ࢊ඾࣯͹ैଏ ¾ ൅ʀ৏ࢤʤ੊ֆॵ͹HIV߇ରݗࠬ؜΋ʥ ϕϫζΥέφۂࢊڷࠅՊ֋൅րַҗҽճͶΓΖકྲྀద৿ 9 ੊ֆॵ͹HIV߇ରݗࠬ͹֋൅ʀ৏ࢤΝ࢟Όɼ෵਼බݬର Ͷ೟ఈ͠ΗΖ 9 ʤ ɼ ౵ʥΏਏஇٗढ़ʤҪఽࢢʀ߇ରʀ߇ݬݗࠬʥ ͶΓΖਫ਼ࢊϧ΢ιϱηট೟ΝखۃHIV HBV 9 ஦ࠅࠅՊ༂඾؄ಞ؇ཀྵ ΃͹எݡΝฯ༙ ಚ

൭خ֋൅ਬ਒ڂ൭ ݜخ֋൅ਬ਒ڂݜ බݬରγʖϗ΢ϧϱηؽ೵ʀର੏͹۫ඍ ¾ ਫ਼ࢊ೵ྙ͹ң࣍ʀ֨୉ ¾ ήϫʖώϩͲ͹HIVΏHBV͹γʖϗ΢ϧϱηͶΓΖรҡझ 9 ໖ӺൕԢΏ֫࢐౵͹෵਼झྪ͹ਏஇ༂͹ਫ਼ࢊϧ΢ϱΝฯ༙ 9 Ν͏ͬ૥͚ࡱஎͤΖͪΌ͹ର੏Ν۫ඍ ͢ɼ೧ؔ2,000ຬ͹ਏஇࢾ༂Νਫ਼ࢊ Өࣁݱ͹ฯ༙ 9 ๼ธͳΠζΠΝ؜΋20ϳࠅҐ৏Ͷਏஇࢾ༂Ν༎ड़ܨ͵๝෍ ¾ ಋ͢ͱ3.5Աݫ͹౦ࣁΝߨ͏৿ͪ͵੠ືؽڠ஦ࠅՌָӅͳ 9 ήϫʖώϩ͹ର֐ਏஇ༂ࢤ৖ͲͺεΥΠ୊ Ғɽଠऀͳർ 9 ఼౵Νઅཱིڎ͹֋൅ح 2 ֋൅ʀਫ਼ࢊର੏ʤઅඍɼڂӨࣁݱʤࣁۜɼݜܨ͵ͱ๝෍ֳ͢ Կک֋൅གྷҽ͹ү੔ڂགྷҽʥΝ؜΋ʥΝฯ༙ ¾ ݜ ಋର੏Νཱི֮ڠ஦ࠅՌָӅΏ๼஦ࠅ޽Ռ୉ָ౵ͳ 9 ढ़ं͹φϪʖωϱήࣰࢬ͹ͪΌͶ਼ඨຬݫΝ౦ࣁٗ 9

࿪ࠅՌָٗढ़෨ΤΥϔγ΢φʤwww.most.gov.cnʥ౵ڠड़ॶʁAbbottΤΥϔγ΢φɼChicago Business “Abbott went all in on COVID tests and it‘s just getting started”ɼInnovitaΤΥϔγ΢φɼ஦՜ਕ຿

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ͹कགྷ͵खૌΊʁਏஇʤ2/2ʥۂة ઝ঳͹ਏஇΫρφʀࢾ༂Ν֋൅͢ɼࠅ಼͹ର֐ਏஇ༂͹εΥΠͺ2Ғɽ״෱߁͏ Νࣰࢬܠͳ͹Πϧ΢Πϱη఑ۂةԿͶ΍஭ྙ͢ͱ͕Ε஦ࠅکΉͪɼք֐ఴ֋͹ ෍࢞ϪϑΨʤೖຌʥ

֋൅કྲྀڂݜ ʥ͹ࠅ಼ۂʤϩϝϏϩη*1ࣆحસࣙಊݗࠬؽ ¾ ԿͶ஭ྙکεΥΠ֨୉ʀք֐ఴ֋͹ ժʰTransform!2020ʱʤ19ࠥ20ܯӨܨغ஦ 9 ೧ʥͶͱඬᒙ

֋൅ਬ਒ڂݜ ઝ঳͹ਏஇΫρφʀࢾ༂౵͹֋൅ࣰ੹״෱߁͏ ¾ 1966೧ɼ੊ֆॵ͹ഗಡݗࠬࢾ༂Ν੣඾ԿɽζΩ 9 ֋൅Νࣰࢬڂ೦ɼSARS൅ਫ਼࣎Ͷͺݗࠬࢾ༂͹ݜ 9 ਟଐਏஇΫρφͲͺ΢ϱϓϩΦϱδΤ΢ϩηɼ HBVɼHIVɼΠυόΤ΢ϩηɼRSΤ΢ϩη౵ɼݗ ʀࢾ༂Ͳͺ΢ϱϓϩΦϱδΤ΢ϩηɼحࠬؽ HBVɼHCVɼHTLVΝఴ֋

൭خ֋൅ਬ਒ڂݜ ֆφρϕ͹๝෍͵ࣁݱۂࠅ಼ ¾ 9 ήϫʖώϩࢤ৖Ͳ͹εΥΠͺࠅ಼੐ͲͺH.U.ή ϩʖϕͺ୊2Ғ ¾ ࢢճऀԥஇܗ͹࿊ܠର੏͹ߑ஛ 9 2019೧ͶͺH.U.ήϩʖϕ಼ͲήϩʖϕԥஇܗͲ͹ ढ़ʀ੣඾඲ՃοʖϞΝઅཱིٗ Νघֽ͜ΖۂH.U.ήϩʖϕ಼Ͷͺण୙ྡজݗࠬࣆ 9 ΦηΠʖϩΦϩ΍ଚࡑ ܠͳ͹Πϧ΢Πϱη఑ۂة஦ࠅ ¾ ஦ࠅ͹୉घۜ༧ήϩʖϕฑ࿪ฯݧήϩʖϕͳ͹߻ 9 อճऀΝ௪ͣɼݗࠬϧϚΝ஦ࠅࠅ಼֦ஏͶఴ֋

ड़ॶʁH.U.ήϩʖϕΤΥϔγ΢φɼ෍࢞ϪϑΨΤΥϔγ΢φ

52 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ΠΩυϝΠ͹खૌΊʁਏஇ Ͷखૌ΋ɽௗ࡜୉ָͲͺɼڂઝ঳ݜ״ιϱνʖΝ۫ඍ͢ڂ੠՜୉ָͺ਼ʓ͹ݜ Νฑ࣎ΓΕਬ਒͢ͱ͏Ζڂઝ঳͹ݜ״ڷॶͲ෵਼͹৿ڂ೦ଵҫָݜ ੠՜୉ָʤ஦ࠅʥ ௗ࡜୉ָʤೖຌʥ

֋൅ਬ਒ڂ֋൅કྲྀ ݜڂݜ αϱλʖεΠϞ͹ڂઝ঳ݜ״τʖϜͳ͢ͱ໖ӺָָՌɼఽઝබָɼޮ ¾ BSL-4ࢬઅΝ஦֫ͳͪ͢ڂҫָӅ͹ݜ ¾ ੔ܙ ɼιϱνʖΝ࣏ʓͶઅཱི͝ܟ߃ָΝ݊ڠ ҫՌࣅՌ୉ָɼښ୉ָɼ౨ښιϱνʖʤ2008ʥɼ 9 ๼քಕ୉ָɼ౨๼୉ָɼ౨ڂʁੜ՜୉ָΦ΢θ૱߻ݜڂઝ঳ݜ״ 9 ጱٝग़୉ܜ୉ָɼ۟य୉ָɼௗ࡜୉ָɼރιϱνʖʤ2013ʥɼ໖Ӻָݜ ୉ࡗ୉ָɼਈڂઝ঳ݜ״ੜ՜୉ָҫָ෨ ͹9୉ָ͗ࢂՅָ ڠ߃ָʁޮ݊ڠॶʤ2014ʥɼޮڂʁੜ՜୉ָ໖Ӻָݜڂ ઝ঳෾໼Ͳ͹੊ֆΝ״;ٶ੔ܙ఼ڎ͹ڂιϱνʖʤ2010ʥ 9 Ҳझබݬରݜڂ߃ݜ݊ ֋൅ਬ਒ ϨʖχͤΖਕࡒ͹ү੔Ν໪ࢨ͢ͱ͏Ζڂݜ ਬ਒ڂॶͶΓΖݜڂಋ΢ό ¾ ೦ଵҫָݜڠͶΓΖΤ΢ϩη໖Ӻָ͹ܠࠅʀ঴ʀ୉ָ͹࿊ ¾ ఼ʤίωΠɼϗφψϞʥΝ༙͢ͱ͕ΕɼϜϧڎڂք֐ݜ 9 ڂϗʖεϥϱιϱνʖΝઅཱི͢ɼΤ΢ϩη໖Ӻָ͹ݜ ம঳ɼφϨϏόμʖϜ঳ɼαϪϧɼυϱήٷΝ޴৏ ϨΠɼे݄ྙ ڂઝ঳ΏԾཫ঳ΝଲেͶݜ״حٷ೦ɼԭ೦ɼঘࣉ͹ݼ 2014೧10݆ΓΕ෤׿୉ָक࠷Ͳ஦ࠅՌָӅ͹෤׿Τ΢ϩ 9 LAMP༽ࢾ༂͹֋൅ޭܮ͵ॶɼ ¾ ৙ԻͲ͹ฯଚʀ༎ૻ͗Ն೵ڂॶɼਫ਼෼෼ཀྵָݜڂॶɼ৏քϏηςʖϩݜڂηָݜ ಋͲɼΦϚϧΤ΢ϩڠ࣎Ͷ޴ͪ͜ඍ͓Ν໪ඬͶ׈ಊ 9 ΫϢόϱϟυΡΩϩεητϞθͳٺەɼ͢ܠ՜஦Ռٗ୉ָ࿊ LAMP༽৙Իޭܮ͵൭ η઒༽͹৙ԻͲ͹ฯଚΏ༎ૻ͗Ն೵خ֋൅ਬ਒ڂݜ ฯଚࢾ༂Ν֋൅ ժܯࢬઅ͹୉෱͵֨୉Νڂ5೧ؔͲ͹ݜ ¾ ઝ঳౵Νଲেͳͪ͢Կ߻෼ηέϨʖωϱή״ ¾ ॶΝ5೧ؔͲ12ࢬઅ͖Δ20ࢬઅͶଁΏͤखૌڂ໖Ӻָݜ 9 ʰԿ߻෼ϧ΢ϔϧϨʖΝۂ൭ࣆخڂΊΝ֋࢟͢ɼBSL-3ࣰݩ࣪અ஖Ͷ޴ͪ͜׈ಊΝָௗࣰ͗ࢬ 9 ช෨Ռָ঴࠹઎୼ݜ ״൭͹੖ඍʱ͹ݫɼخүگʀڂΝऔͯ͘͜ΖҟͶ॑ࢻʥ ׈༽ͪ͢૓༂౵࠹઎୼ݜंڂਬ਒Ώ༑ऴ͵ݜڂʤݜ ઝ঳౵ΝଲেͶԿ߻෼ηέϨʖωϱήΝࣰࢬ ͶΓΕҪఽࢢഓۂڢͳ͹ۂة੕ැɼࠅ࿊ɼࡔ஄Ώ຿ؔ ¾ ൭خ֋൅ਬ਒ڂΝ੖ඍ ݜڧ؂ڂ྽݀ఈٗढ़౵Ν؜΋ݜ ॶͶΓΖਕࡒү੔ڂॶΏΰ΢ς ¾ ೦ଵҫָݜڂͶΓΖҫྏεητϞਫ਼෼ָݜۂڢࠅ࿊ͳ͹ 9 ྙڢڂͶؖͤΖWHOݜڂઝ঳ݜ״Τ΢ϩηڷͶΓΖGHDDI*1Νઅཱི 9 ʰ೦ଵʀ৿ۂڢࡔ஄ͳ͹ ιϱνʖʱͳ͢ͱWHO͹ࢨఈΝण͜ͱ͏Ζɽ౨ೈΠζΠ ΋౏৏ࠅ͖Δݜ͢ۦઝ঳Ͷ״ڷΏΠϓϨΩ͹೦ଵබʀ৿ ״ઝ঳ଲࡨਕࡒ͹ү੔ΏɼWHOक಍͹״ਫ਼Νण͜೘Ηڂ ॶ͹ਕࡒΝഁݥڂઝ঳ଲࡨΏࠅࡏճ٠Ͷ઒໵Պͳ͢ͱݜ

ݒઅ͠ΗͪGlobal Health Drug Discovery Institute;ٶಋͲઅཱིڠࢤ੕ැͶΓͮͱښΰ΢ςࡔ஄ɼੜ՜୉ָɼ๼ .1* |ઝ঳͹ࠂෲΝ໪ࢨ͢ͱʛ״ڷιϱνʖๅࠄ |ௗ࡜୉ָҫָ෨ʛ೦ଵබʀ৿ྙڢड़ॶʁੜ՜୉ָΤΥϔγ΢φɼௗ࡜୉ָΤΥϔγ΢φɼWHO

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ͹कགྷ͵खૌΊʁ࣑ྏ༂ۂة ֋൅ΝڂGileadͺWHO΍஭ྙଲেͳ͢ͱ͏ΖබݬରΝଲেͶϪϞυεϑϩ͹ݜ ࣰࢬɽ෍࢞ϓ΢ϩϞͺ΢ϱϓϩ༽ඍட༂֮ฯ͹ͪΌΠϑΪϱਫ਼ࢊର੏Ν੖ඍ

Gilead੠՜୉ָʤ஦ࠅʥ Sciencesʤธࠅʥ ෍࢞ϓ΢ϩϞʤೖຌʥ

֋൅કྲྀڂ֋൅કྲྀ ݜڂݜ ઝ঳Ν஭ྙ྘Үͳ͢ͱखૌ΋״ ¾ ֋൅Νࣰࢬڂઝ঳྘ҮΝ஭ྙ྘Үͳ͢ͱݜ״Τ΢ϩη ¾ ઝ঳΍৿༂֋൅͹஭ྙ྘Ү״ͳด;ɼ׳࣮ܨҐ֐Ͷఁʀ஦ॶಚ 9 ͗ΞΏ஦਽ਈىHIVɼHCV͗कྙ੣඾Ͳ͍Ζ͗ɼ৏ 9 ֋൅Νࣰࢬڂઝ঳ʤΦϚϧɼMERSɼSARSɼ ͳ͢ͱݜ״ڷࠅͲ൅ਫ਼͢ͱ͏Ζ৿ ֋൅Ͷ΍खૌ΋ 9 ৏ࢤ඾ɼ֋൅඾ͶͺҐԾΝ؜΋ڂυϱή೦ʥͶଲͤΖݜ ֋൅ਬ਒ ‡ ߇ਇۗ͹ϝαψμʖϩͳ߇Τ΢ϩη༂͹ϓΟϑϒϧϑڂݜ ઝ঳ͶଲͤΖ਼ଡ͚͹੣඾Ν֋൅ ϩʤΠϑΪϱʥΝ൤ജ״Τ΢ϩη ¾ HCV7ݺɼ΢ϱϓϩΦϱδ1ݺ͹੣඾ ‡ ߇ۗ༂͹λϨηϫϜ΢εϱΝPhase 3Ͳ֋൅஦;ٶHIV11ݺɼHBV 9 HDVͲ4݇͹ྡজࢾݩΝࣰࢬ ¾ Կָɼώ΢Ψɼժ଀ɼAI౵ଡ෾໼͹ٗढ़ΝૌΊ߻Κͦɼ;ٶ৏ࢤɼHIV9݇ɼHBV Ζ͝ܟΝࣰߨ ʰਏஇʱͳʰ࣑ྏʱΝҲରԿͤΖΠϕϫʖοΝڂಋݜڠ2015೧ΦϚϧླྀߨ࣎ͶͺUSAMRIID*1ͳ 9 ֋൅ਬ਒ڂ2Νଲেͳͪ͢ ݜ*׳MERSɼSARSɼΦϚϧΝ؜΋෵਼࣮ ¾ ϪϞυεϑϩ͹ඉྡজʀྡজࢾݩΝࣰࢬ ¾ ߇΢ϱϓϩΦϱδΤ΢ϩη༂ͳ͢ͱ2014೧Ͷ 9 ΦϚϧɼSARSͲPhase 3ɼMERSɼϜʖήϔϩέɼ್Ϗ ΠϑΪϱΝ৏ࢤ Τ΢ϩηͲ ྡজࢾݩΝࣰࢬ஦ Phase 1 9 2015೧Ͷͺୈ࿹੕ැؽؖ͗ɼ2017೧Ͷͺೖຌ੕ැ͗΢ϱ Νࣰࢬ͢ͱ͏ΖUAB*3͗NIH͖Δ2019೧3݆Ͷݜ ϓϩΦϱδ͹ླྀߨͶඍ͓ඍடΝ݀ఈڂಋݜڠ 9 ੔ۜͳ͢ͱ$37.5 millionΝ֭ಚ ¾ ༂ࡐଳ੓Νݡੀ͓࣑ͪྏ༂͹֋൅Νਬ਒ঁڂ దؽؖʤNIHɼNIAIDɼCDC౵ʥΏWHOɼΠΩυϝΠޮ 9 ಡ੓Τ΢ϩη͹࣑ྏ༂ͶՅ͓ɼਟଐ੓ʀ؈ک஗ࢰི͹߶͏ 9 ֋൅Νࣰࢬͪ͢ΕɼϪϞυεϑϩ͹in-vitroυʖڂ౵ͳݜ ΊΝ࣍ͯର֐ਏஇ༂Ν༽͏ͪۗʀΤ΢ϩη͹ඬదکҝ੓͹ ڛν౵Ν఑ ࣑ྏΝࣰݳ͢ɼ༂ࡐଳ੓ۗΝݡੀ͓ͪۗझಝҡద߇ۗ༂͹ ൭ ֋൅Νਬ਒خ֋൅ਬ਒ڂݜ ൭خ֋൅ਬ਒ڂઝ ݜ״ڷͳ৿ۂةธ੕ැʀޮదؽؖɼΠΩυϝΠɼଠ ¾ Ν௪ͣͪϨϪʖεϥϱߑ஛ ¾ ฑ͖࣎Δ͹ΠϑΪϱਫ਼ࢊઅඍ͹੖ඍۂڢͲ͹ڂ঳ݜ ߇΢ϱϓϩΦϱδ༂ͳ͢ͱɼೖຌΏୈ࿹੕ැ͖Δ͹ඍடགྷ 9 ڛఁʀ஦ॶಚࠅ΃͹ҫ༂඾ΠέιηΝ఑ ¾ ઝ঳͹༩๹౵Ν஦ৼͶҫ༂඾ ੧ͶଲԢ͢ಚΖਫ਼ࢊର੏Ν੖ඍ״઎਒ࠅͶཻΉΔͥɼ HIV 9 ΠέιηΝཱི֮ ʤͤҲ๏Ͳɼ੊ֆద͵ϏϱυϝρέླྀߨΝ૟ఈͪ͢ਫ਼ࢊ ࣎ٺە໤ͺ۫ඍ͢ͱ͏͵͖ͮͪͪΌɼڇڛΫϡϏετΡʀ චགྷͳ͵ͮͪʥ͗ܠ͹఑ۂةͶͺࠅ֐

ड़ॶʁGilead Annual Report (2018)ɼͨ͹ଠGileadΤΥϔγ΢φɼ෍࢞ϓ΢ϩϞΤΥϔγ΢φ

53 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ʀΠΩυϝΠ͹कགྷ͵खૌΊʁϭέοϱʤ1/2ʥۂة Νਬ਒ɽڂઝ঳͹ϭέοϱݜ״ڷ৿͢ۂڢͳۂةModernaͺ੕ැؽؖΏ୉घ੣༂ ݽ͵֋൅ʀਫ਼ࢊର੏Νཱི֮کSinopharmͺ஦ࠅࠅ಼ϭέοϱεΥΠ80%ΝઐΌ Modernaʤธࠅʥ Sinopharmʤ஦ࠅʥ

֋൅કྲྀڂ֋൅કྲྀ ݜڂݜ ֋൅Νਬ਒ ¾ ώ΢Ψҫ༂඾ɼԿָҫ༂඾ɼݳେ׿๏༂Ͷ஭ྙͪ͢ܠͳ࿊ۂة੕ැؽؖʀ୉घ੣༂ ¾ Νฯ࣍ڒBARDAΏDARPA͖Δ͹ζΩ೦ɼοέϱήωΠ೦౵΃͹ϭ 9 ήϩʖϕસରͲ༁2,340݇͹ಝ 9 ֋൅ɼ੣ଆͶ΍खૌ΋ڂέοϱ֋൅΃͹ঁ੔Ν֭ಚ ¾ ϭέοϱ͹ݜ ઝ঳͹༩๹ʀ࣑ྏͶࣁͤΖ״2015೧ɼRSΤ΢ϩηΝ؜΋ 9 ֋൅ʀࣰ༽ԿͶ޴͜ɼϟϩέͳકྲྀڂmRNAҫ༂඾͹ݜ ֋൅ਬ਒ڂదΠϧ΢ΠϱηΝగ݃ ݜ ͳ͢ͱۂة஦ԟ੕ැ؇׍͹ࠅӨήϩʖϕ ¾ ໝ͗୉͚͘ɼ୉ൔ͹ࢤ৖ΝઐΌΖو֋൅ਬ਒ ਫ਼ࢊڂݜ ֋൅Ͷ஭ྙ 9 ήϩʖϕસରͲ͹ϭέοϱ੣ଆ೵ྙͺ೧ؔ7Աຌڂઝ঳ͶଲͤΖϭέοϱ͹ݜ״ ¾ ࢢճऀ͹஦ࠅਫ਼෼ٗढ़ʤCNBGʥ ͺɼ஦ࠅ࠹୉͹ϐφϭ 9 9 ζΩ೦ɼοέϱήωΠ೦ɼRSV͹ϭέοϱͺPhase1೘Εɽ Ͳ͍Εɼ೧ؔ50झྪ͹ϭέοϱΝਫ਼ࢊۂةέοϱ͹֋൅ NIHͳͺSARSɼMERSΝӀًͤ͘͞αϫψΤ΢ϩη͹ݜ ͢ɼࠅ಼ࢤ৖εΥΠͺ ˍ ౵Νਬ਒ 80ڂ Νਬ਒ڂಋݜڠΝ॑གྷϛζεϥϱͲౌ༽͢ɼ ¾ ෵਼͹୉ָͳंڂड़ਐ͹ݜۃ੏౲و੕ැ ¾ ϭέοϱ͹ࣰ༽ԿͶ޴͜ͱՅଐԿ 9 ৏քި௪୉ҫָӅͳ͹ҫ༂Ӷਫ਼੕ࡨ྘ҮͶ͕͜Ζ5೧ؔ͹ ڛࣁۜΝ఑ڂͶݜۂڢ 9 2018೧ɼFDAͲϭέοϱਅ੧͹ট೟౵ɼCDCͲυϱή೦ ͶSinopharmۂڢɼྡজ྘ҮͲ͹ڂݩΝ༙ͤΖWellington Sunദ࢞Νϭέοϱક 9 ߁౨ҫՌ୉ָͳ͹ݜܨڂ౵͹ݜ ڛ੏ؖ࿊͹੻೜ंͶࡀ༽ ͖Δٗढ़ࢩԋΝ఑وʀྲྀ

൭خ֋൅ਬ਒ڂ൭ ݜخ֋൅ਬ਒ڂݜ ֋൅Ͷ஭ྙڂ੣ଆʛ࢕৏͝ ¾ ϭέοϱ͹ݜ;ٶڂຌऀͳಋय಼Ͷͱྡজݜ ¾ ؽؖʤ13ϴॶʥͶ͕͜ΖϭέοڂΉͲ͹ؽ೵Ν׮ඍͤΖ੣ଆࢬઅΝฯ༙ 9 ࢁԾ͹ࠅՊϪϗϩ͹ݜ ຬਕҐ৏ ܯҽ਼ͺڂϱʀ࣑ྏ༂྘Ү͹ݜ mRNAϭέοϱޫึ 1;ٶ2018೧ɼธࠅPhase1ʀ2͹ࣰࢬ 9 Ն೵ͳ͵Ζ޽৖Νݒ 9 2019೧ɼࢢճऀ͹୉घϭέοϱϟʖΩʖ஦ࠅਫ਼෼ٗढ़*1͗ۂ͹੣ଆΏࢾݩɼैలʀ࢕৏͝ࡠ ֋൅ֻͺ14Ա8,400ຬݫʤജ৏߶͹ڂઅ ʤCNBGʥ ͹ݜ 12.3%ʥ

஦ࠅਫ਼෼ٗढ़ʤChina National Biotech Group CompanyʥͺSinopharm͹ࢢճऀͲ୉घϭέοϱϟʖΩʖ .1* ࿪ࠅ஦ԟਕ຿੕ැΤΥϔγ΢φʤwww.gov.cn/ʥ౵ڠड़ॶʁModerna Corporate PresentationsɼଠModernaΤΥϔγ΢φɼSinopharmΤΥϔγ΢φɼ஦՜ਕ຿

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ʀΠΩυϝΠ͹कགྷ͵खૌΊʁϭέοϱʤ2/2ʥۂة ֋൅Ͷ੔ޯ͢ͱ͏ΖOxford୉ָɼغઝ঳༽ϭέοϱ͹૥״αϫψΤ΢ϩηܗ৿ Νࣰࢬڂઝ঳͹ݜ״ڷAnGesͲͺฑ࣎ΓΕϭέοϱٗढ़͹֋൅Ώ৿ Oxford୉ָʤӵࠅʥ AnGes/୉ࡗ୉ָʤೖຌʥ ֋൅કྲྀڂ֋൅ਬ਒ ݜڂݜ Τ΢ϩηϗένʖϭέοϱٗढ़͹ཱི֮ ¾AnGes Ҫఽࢢҫ༂͹ήϫʖώϩϨʖξʖΝ໪ࢨ͢ɼ ¾ ֋൅Νਬ਒ڂͶ330 ໌Ͷ ϭέοϱʀ࣑ྏ༂͹ݜعઝ঳*1Ͳ͹ྡজࢾݩͲ״ଠ͹ 9 ֋ڂ֋൅ݜڂઝ঳Ν஭ྙ෾໼͹1ͯͳ͢ͱݜ״ ChAdOx1 based-vaccines͹౦༫ࣰ੹͍͗ͮͪ ¾ࡗ୉ Ν͢ͱ͕ΕɼMERS޴͜͹ChAdOx1ϭ ൅ਬ਒ڂMERS͹ݜ 9 έοϱΝ֋൅ࡃΊͫͮͪ ֋൅ਬ਒ڂݜ ͹ࣰ੹ڂઝ঳ݜ״;ٶ൭ ¾AnGes ϭέοϱخ֋൅ਬ਒ڂݜ ֋൅ࢬઅʀઅඍ ¾ Ҫఽࢢ࣑ྏ༽੣඾͹੣඾ԿͶΓΕϕϧηϝχ*1͹;ٶڂ༁͠Ηͪ࠹઎୼͹ݜॄ ¾ ɼϭέοϱ੣ଆɼྡজࢾݩΉͲΝOxford୉͹ όΤύΤΝฯ༙ɽ߶݄ѻDNAϭέοϱ΍֋൅஦ڂݜ 9 ઝ঳ͶଲͤΖ״Ν௪͢ɼܠΫϡϱϏη಼ͲࣰࢬՆ೵͵ର੏ͳ͵ͮͱ͏Ζ ¾ ธώ΢Ωϩऀͳ͹࿊ 2008೧ͶWellcome Trust͖Δ͹ˌ3.4m͹ࣁۜ DNAϭέοϱ͹֋൅όΤύΤΝட੷ ‡ Νण͜ɼϭέοϱߑ੔གྷોʤΠζϣώϱφɼ 9 ώ΢Ωϩऀͺ௙΢ϱϓϩΦϱδΤ΢ϩη౵͹ڛ఑ ϗένʖʥ͹֮ฯɼϭέοϱ֋൅ٗढ़޴৏ͳච DNAϭέοϱΝ֋൅ ઝ঳Ͷ͕͜Ζஎݡʀࣰ੹״ໝ͵ྡজࢾݩͲ͹ϭέο ¾ ࡗ୉ ෱߁͏وགྷ͵અඍ͹۫ඍɼঘ ϱ֋൅Ν໪దͳ͢ͱݒઅ ɼοέϱήωΠڂݜેخHIVΏυϱήΤ΢ϩη౵͹ ¾ ֋൅༽ʤPhase2ΉͲʥ͹ϭέοϱ੣ ౵͹ྡজ֋൅Νࣰࢬ;ٶڂݜ ‡ ଆࢬઅ͹۫ඍ ͵ϭέοϱ͹Phase1ΉͲ͹ྡজࢾݩࣰࢬՆ೵ ‡ ൭خ֋൅ਬ਒ڂҫྏؽؖΝΫϡϱϏη಼Ͷ۫ඍ ݜ ͶΓΖ֋൅ʀ੣඾Կܠͳ͹఑ۂة੷ ¾AnGes ଠॄ͗ंڂ༑ऴ͵ݜ ¾ Ν௪͢ͱ࣑ྏ༂Ώϭέܠͳ͹఑ۂةΏք֐ۂةΝ઒໵ͳ͢ͱ͏ ¾ ࠅ಼୉घڂΤ΢ϩηϗένʖϭέοϱ͹ݜ 9 οϱ͹֋൅Νਬ਒ ڂΝߨͮͱ͏ΖݜڂΏMERSΏEbloa͹ݜंڂΖݜ ֋൅Ͷචགྷͳ͵ΖࢬઅΏઅඍ͹ฯ༙ڂɼΤ΢ϩηϗένʖ૓ଆ͹எࣟʀٗढ़Ν༙ͪ͢ ¾ ࡗ୉ ݜं ֋൅Ͷචགྷ͵ࢬઅʀઅඍΝฯڂઝಊ෼ࣰݩࢬઅ౵ɼݜ״ ¾ Ήͮͱ͏ॄ͗ंڂ౵ɼ੊ֆ஦͖Δ༑ऴ͵ݜंڂݜ Ζ ༙ɽҫָ෨෡଒͹බӅ΍ฯ༙ ܐ͖࣎Δ͹ືં͵ؖۂAnGes/¾ ࡗ୉ ૓ दگ෉ߪ࠴رदͺ୉ࡗ୉ָ୉ָӅگ͹ਁԾंۂAnGes૓ ¾

*1. flu, Zika virus, and prostate cancer to the tropical disease chikungunya, ౵ ड़ॶʁJenner InstituteΤΥϔγ΢φ, BBC “Oxford vaccine: How did they make it so quickly?”ɼΠϱζΥηΤΥϔγ΢φɼ୉ࡗ୉ָΤΥϔγ΢φ

54 ઝ঳΃͹״ڷೖຌͶ͕͜Ζ৿;ٶଠࠅ .3 ฑ࣎͹खૌΊ གྷ֕ .3-1 3-2. ৆ࡋ 3-2-1. ੕ැ ࠅࡏؽؖ .3-2-2 ۂة;ٶΠΩυϝΠ .3-2-3 ;ଠࠅ͖Δ͹ָ .3-3

55 ࣎ٺە ฑ࣎ ଠࠅ͖Δ͹ָ;ʁฑ࣎ خαϫψଲԢͶͱ੔Վ૓ड़Ͷࢺͮͱ͏Ζธӵ஦ͺՁΗ΍ʰฑ࣎͹ඍ͓ʱͶܗ৿ Ͱ͏ͱ੔Վࣰ͗ݳ͠Ηͱ͕Εɼฑ͖࣎Δ͹खૌΊ͹୉ࣆ͗͠րΌͱ֮೟͠Ηͪ

Ҙ౵͖ڶฑ࣎Ͷ͕͜Ζ SARS/ MERS͹ླྀߨΏɼώ΢Ψτϫ͹ 01 ͳ໎֮͵ Δɼʰ৿ͪ͵Ϗϱυϝρέʱ΃͹ଲԢΝ໪ඬͶ״ؽث߶͏ ໪ඬઅఈ ܟ͝ͱͪ͘ ԿΝඬᒙکઝ঳ଲࡨ״ήϫʖώϩϖϩηιΫϣϨτΡકྲྀ౵Ͷͱࠅ಼֐Ͳ͹ ଲেͳ͢ͱ13ݺ͹஭ྙබݬରΝఈٝ͢ͱ͏ΖڂNIAID͹ώ΢ΨυΡϓΥϱηݜ ઝ঳΃͹ଲԢΝ҈સฯ্ΏݺพકྲྀͲ॑གྷࢻ״ؽͳ͢ͱܘΦϚϧΝ ͏͵ΔΗͱ͏͝ܟ΢ϱϓϩͳ༂ࡐଳ੓ۗҐ֐͹Ϗϱυϝρέ΃͹ଲԢͺ໎֮Ͷܗ৿ ଲেͳͤΖබݬର͹ಝఈͺ͠Ηͱ͕Δͥڂઝ঳ଲࡨͳ͢ͱ஭ྙݜ״ڷ৿

Ͷ৏ࢤ͢ͱ͏Ζ΍͹عฑ͖࣎Δ͹෱߁ʀ ϭέοϱʀ࣑ྏ༂ՁΗ΍ 02 ֋൅ਬ਒ͳ ͺɼฑ͖࣎Δۛ͢͏ٗढ़ʀΤ΢ϩηͲྡজࢾݩڂ஥ࣰ͵ݜ ੕ැͶΓΖ೼Ѵ ஊ֌ΉͲ਒ΞͲ͏ͪ

΃͹ϓΟϱυΡϱήΝ༑઎దͶׄΕ౲ͱڂUK Vaccine NetworksͶΓΖ஭ྙබݬର͹ಝఈͳ֚౲ݜ ΝࣰࢬڂModernaͲͺฑ࣎ΓΕmRNAٗढ़͹ݜ ൭Νߑ஛خDARPA͹ࢩԋΝण͜AbCelleraͺϏϱυϝρέ࣎͹֋൅Յଐ͹ͪΌ͹ٗढ़ ઝ঳Ͷଲ͢ͱ΍ธࠅ͹1/6ҐԾɼ஦ӵ͹1/2ఖౕ͹࿨ช਼ͶཻΉΖ״ڷࣙର͗ݰঙܑ޴Ͳɼ৿ڂΤ΢ϩηݜ

౹Ώࣁࡒʀઅඍ֮ฯɼܧྫໍض࣎͹ࢨٺە ࣎Νݡੀ͓ͪٺە 03 ੏౵͹੖ඍ͗ߨΚΗͱ͕Εɼਪ௜ཱིͬ৏͝و๑ ൭੖ඍ ͹६ඍ͗੖ͮͱ͏ͪخਬ਒

֋൅ࢩԋର੏Νߑ஛͢ɼฑ͖࣎Δ͹ਫ਼ࢊ༲ྖ֮ฯ౵Νࣰࢬڂ࣎͹ݜٺەBARDAΝ஦ৼͶͪ͢ ઝ঳ΉͲͺ૟ఈ͠Ηͱ͕Δͥɼ״ڷժʤ2005೧ʥΏ༂ࡐଳ੓ʤAMRʥ͗஦ৼͲɼଠ͹৿ܯ΢ϱϓϩΦϱδͶଲͤΖ੕ැߨಊܗ৿ າ੖ඍ

56 ೖຌͶ͕͜Ζ;ٶଠࠅ .4 ࣎͹खૌΊٺەઝ঳΃͹״αϫψΤ΢ϩηܗ৿

57 হͲ͹௒ࠬΠϕϫʖο

֋ڂ࣎ଲԢʤ੕ැ಼ର੏੖ඍɼݜٺەઝ঳ͶଲͤΖ੕ැ͹״αϫψΤ΢ϩηܗೖຌ͹৿;ٶຌহͲͺɼଠࠅ ¾ ֋൅੔Վʤ࿨ช਼ɼஎࡔ਼ɼ֋൅ʀট೟੣඾਼ɼڂ൅ਬ਒׈ಊɼࣁۜʀ΢ϱϓϧʀϨλʖη౦Ծɼ౵ʥΏݜ ࣎Ͷ੔Վ૓ٺەೖຌ͹੔ՎΝർֳɽΉͪɼ;ٶҲఈ੔ՎΝ૓ड़͢ͱ͏ΖϕϪʖϢʖ਼ɼ౵ʥΝ௒ࠬ͢ɼଠࠅ Νಝఈͪ͢ۂةड़Ͷࢺͮͱ͏ΖࠅΏΠΩυϝΠʀ

࣎͹खૌΊ͹௒ࠬΝࣰٺەʥ͹ۂةͲಝఈͪ͢੔Վ૓ड़Ͷࢺͮͱ͏ΖϕϪʖϢʖʤ੕ැɼΠΩυϝΠɼى৏ ¾ ࢬͪ͢ ਫ਼ࢊΝՅଐͤΖͪΌ͹क͵੕ࡨΝ௒ࠬ;ٶ֋൅ڂ੕ැͶΓΖखૌΊͶ͕͏ͱͺචགྷؽ೵Νैଏ͢ɼݜ ‡ ࣎͹ଲԢٺە͹खૌΊͶ͕͏ͱͺɼݺพϕϪʖϢʖ͹ࣆྭͳ͢ͱฑ͖࣎Δ͹ඍ͓ͳۂة;ٶΠΩυϝΠ ‡ ͗ʹ͹Γ͑Ͷ੔Վ૓ड़Ͷܪ͖͗ͮͪΝ௒ࠬ

Ͷଠࠅ͖Δ͹ָ;Ν੖ཀྵ͢ͱ͏Ζޛ࣎͹खૌΊ͹ߡࡱͳ͢ͱɼຌহ͹࠹ٺەೖຌ͹;ٶଠࠅ ¾

58 ೖຌͶ͕͜Ζ;ٶଠࠅ .4 ࣎͹खૌΊٺەઝ঳΃͹״αϫψΤ΢ϩηܗ৿ ֋൅੔Վڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿;ٶགྷ֕ .4-1 4-2. ৆ࡋ 4-2-1. ੕ැ ࠅࡏؽؖ .4-2-2 ۂة;ٶΠΩυϝΠ .4-2-3 ;ଠࠅ͖Δ͹ָ .4-3

59 ࣎ٺە ฑ࣎ ઝ঳ͶؖͤΖक͵੕ࡨ״αϫψΤ΢ϩηܗࠅͶ͕͜Ζ৿֦ ೖຌ͹௧Յ༩ࢋฦ੔ʤ700Աԃ௔ʥ͗4݆Ͳ͍ͮͪ͹Ͷଲ͢ɼଠࠅͺ3݆஦Ͷ਼ ඨԱʛ਼એԱԃ͹༩ࢋΝׄΕ౲ͱͱ͕Εɼ੕ැͳ͢ͱ͹ॵಊ͗૥͖ͮͪ 2019೧12݆ 2020೧1݆ 2݆ 3݆ 4݆ 5݆ 6݆

෤׿ࢤͲݬҾ෈໎͹ ର੏ ࣁۜ R&Dਬ਒ ର੏ ഑Ԏ൅ਫ਼Ν൅නʤWHOʥ WHνηέϓΧʖη͹અཱི 9,530 ԱԃʤCARES Act౵ʥ ࢊָׯͲ͹ϭέοϱʀ SPHERESαϱλʖ ֋ʤACTIVʥɼ εΠϞ͹અཱིڂ࣑ྏ༂ݜ R&Dਬ਒ R&Dਬ਒ ର੏ ਏஇΫρφ͹֋൅ଇ਒ ʤࢊָׯʥ ΢ϱϓϧ ͹ϭέοϱޫึʀ࣑ྏ༂ʀ COVID-19 HPCઅཱིʤࢊָׯʥʤRADxʥۂة mRNAϭέοϱޫึ͹ഓ྽ Ν࠹शԿʤNIH/Moderna) ϭέοϱ੣ଆ ֋൅΃ঁ੔ ༲ྖ͹֮ฯڂธࠅ ਏஇ๑͹ݜ ๑੖ඍ౵ ΢ϱϓϧ R&Dਬ਒ R&Dਬ਒ (BARDA) ʤCIADMʥ Ͱ͚ઑݶ ࣑ྏ༂ট೟ϕϫιη͹ Operation WarpخPREP๑Ͷ ΃ۂةਏஇ๑֋൅Ͷ޴͜ ౵ ՅଐԿʤCTAPʥ Speed൅නंۂʤϭέοϱ੣ଆ ݼ;͖͜ (BARDA) ΃͹໖੻ʥ ֋൅Ώ ࣁۜ ର੏ R&Dਬ਒ ର੏ R&Dਬ਒ڂଚٗढ़ΝᑑͶͪ͢ݜع Աԃ ໝ CPPCઅཱིʤࢊׯʥ ਏஇ๑͹඲ՃوCOG-UK ࣑ྏ๑ͶؖͤΖ୉ 528 ޛ΃͹ݼ;͖͜ͺธࠅͶ྾ۂة ʤBudget 2020ʥઅཱིʤࢊׯʥϧϱξϞԿࢾݩ֋࢟ ϕϫήϧϞ֋ ࢟ ӵࠅ R&Dਬ਒ R&Dਬ਒ (ACTT-EU/UK) (CONDOR) ର੏ ΢ϱϓϧ αϫψΤ΢ϩܗUKRI/NIHRͶΓΖαϫ ࣑ྏ๑ͶؖͤΖ ৿ UK Vaccine ઝ঳ςʖϩ״ໝϧϱξϞԿࢾݩ ηو୉ ูޮڂψݜ Taskforceઅཱི ֋࢟(RECOVERY) Ϋρφ֋൅ ࣁۜ ࣁۜ ๑੖ඍ౵ ΢ϱϓϧ ࣁۜ 14Աԃ(1ʛ6݆) 222.9Աԃ ༂ࡐౌ࿧ਅ੧ՅଐԿɼ ݗରݗࠬ࣪͹੖ඍ 49.5Աԃ ༂඾ౌ࿧घ਼ྋ͹ ஦ࠅ ର੏ R&Dਬ਒ ໖ঈ౵ࣰࢬ ઴೧ౕ͹௒੖ඇɼ༩ඍඇҐ֐Ͳ͹ Ռݜߊ䎖享͹અཱི ϭέοϱ͹R&D஭ྙ ֋൅༩ࢋͺ4݆Ґ߳ͳଠࠅΓΕங͏ڂ྘Ү݀ఈɼԿ߻෼ ݜ ηέϨʖωϱή͹ࣰࢬ ର੏ ࣁۜ ࣁۜ ࣁۜ ๑੖ඍ౵ ࣁۜ ৿ܗαϫψΤ΢ϩη 20.3Աԃʤ2019೧ౕࣧߨ࢔ʥ 31.1Աԃʤ2019೧ౕ ܯ783.5Աԃ ಝྭট೟੏ౕ͹ 609Աԃ ઝ঳ଲࡨຌ෨અ஖ ௒੖ඇɼ༩ඍඇʥ 32.5Աԃɼ751Աԃ న༽ʤ࣑ྏ༂ʥ״ R&Dਬ਒ ڛR&Dਬ਒ ͹ յͶ෾͜ͱ఑ 2 Ϩλʖη ൭خܠೖຌ Ϩλʖη υʖν࿊ ΢ϱϓϧ ϭέοϱؖ࿊੣඾ ڂਏஇ๑ʀ࣑ྏ๑ʀϭέοϱ͹ݜ ͹ߑ஛ɼ ֋൅ AI ڛαϫψΤ΢ϩη͹ ֋൅͹ਬ਒ અඍ֨ैʀ༑઎ཤ༽֋࢟ ֮ฯ΃ࣁۜ఑ܗ৿ ֋࢟ ਬ਒ڛࡋ๖఑ ֋൅ͶՅ͓ɼڂธӵͲͺ6݆ΉͲ͹ؔͶɼݺʓ͹ݜ ֋൅΢ωεΠοϔཱི͗ͬ৏͗ΕɼࢊָׯͲ͹खૌΊ͗׈൅Կڂ੕ැक಍Ͳ͹ݜ ઝݜ౵ʥ౵״ड़ॶʁ੕ැؽؖΤΥϔγ΢φʀࣁྋʤ BARDAɼNIHɼWhite HouseɼNIHRɼUKRIɼFDAɼ޲࿓঴ɼAMEDɼ

࣎ٺە ฑ࣎ ֋൅Ͷ౦Ծ͠Ηͪޮదࣁۜڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿ ֋൅༩ࢋͳ͢ͱೖຌͺ૱ֻ1,930Աԃɼӵࠅͺ1,929Աԃɼڂαϫψؖ࿊͹ݜ ֋൅΃͹౦ࣁֻͺ79Աԃڂธࠅͺ9,530ԱԃΝ೩ड़ɽ஦ࠅͺ೼ѴՆ೵͵ݜ

ʤԱԃʥ 6,000 9,530Աԃ*3

5,000

4,000

3,000

1,930Աԃ*1 Աԃ*2 2,000 1,929 1,236Աԃ*5 982Աԃ*6 1,000 79Աԃ*4 0 ೖຌ ӵࠅ ธࠅ ஦ࠅ χ΢ς ϓϧϱη

ֻ૱ࡎ͍Ζ੕ැ͹༩ࢋىͶͯ͏ͱʱʤ2021೧2݆26ೖʥͶڱ֋൅͹਒ṁয়ڂઝ঳Ͷؖ࿊ͤΖAMED͹ݜ״αϫψΤ΢ϩηܗAMEDʰ৿ .1* ֻڛɼCEPI΃͹ࣁۜ఑;ٶʀ΢όϗʖεϥϱࢩԋ͹༩ࢋֻɼڂؽ೵ଁՅ΃͹༩ࢋֻɼ 2021೧ౕ͹UKRIͶଲͤΖݜ;ٶNHSͶଲͤΖࢾݩ͹ΫϡϏετΡ;ٶ༩ࢋֻڂBudget 2020ʤ2020೧3݆൅නʥͶ͕͜ΖNIHR΃͹ݜ .2* ʤ2020೧3݆൅නʥ͹߻ܯ 2020೧3݆Ͷࢬߨ͠ΗͪCoronavirus Aid Relief, and Economic Security ActͶ͕͜ΖɼCDCɼNIHɼFDAɼBARDA΃͹༩ࢋֻ .3* ɼCOVAX΃͹αϝρφֻڛ΃͹ࣁۜ఑ڂݜۂڢαϫψ͹࣑ྏ༂ɼݗࠬΫρφɼϭέοϱ྘ҮͲ͹ࠅࡏ;ٶϕϫζΥέφͲ͹ঁ੔ڂݜٺەϕϫζΥέφ΃͹ঁ੔ɼՌָٗढ़෨ͶΓΖڂҗҽճͶΓΖαϫψݜۜخࠅՊࣙષՌָ .4* ܯॶʀϕϫιη΢όϗʖεϥϱιϱνʖʀϭέοϱ੣ଆˏ΢όϗȄεϥϱιϱνʖ౵͹ࢩԋֻɼϐφοϡϪϱζࢾݩࢩԋֻ͹߻ڂϟϱφ࠹୉ֻɼΩνϏϩφݜ ֻܯɼBMBFͶΓΖϭέοϱ֋൅ϕϫήϧϞ͹ঁ੔ֻɼBMBFͶΓΖҫ༂඾֋൅Ͷ޴ͪ͜ঁ੔ֻ͹߻ֻڛ͹CEPI΃͹ࣁۜ఑ޛઝ঳൅ਫ਼״αϫψΤ΢ϩηܗ৿ .5* ֻܯɼANRͶΓΖঁ੔ֻ͹߻ֻڛ੣ଆͶଲͤΖ੦༁ʤ2020೧6݆൅නʥɼACT-Accelerator΃͹఑;ٶڂ༩ࢋ͹ଁՅֻʤ2020೧3݆൅නʥɼ୉౹྘ͶΓΖҫ༂඾ݜڂ10೧ؔͶ͕͜Ζຘ೧͹Ռָٗढ़ݜޛ୉౹྘ͶΓΖࠕ .6* ֋ࣁྋɼAmerican Society for Microbiologyޮ;ٶड़ॶʁ֦झ঴ு

60 ࣎ٺە ฑ࣎ ઝ঳͹࿨ช਼״αϫψΤ΢ϩηܗࠅͶ͕͜Ζ৿֦ ઝ঳ͶؖͤΖೖຌ͹࿨ช਼ͺ஦ࠅʀธࠅ͹༁1/10ɼ״αϫψΤ΢ϩηܗ৿ ϕϪϕϨϱφγʖώ਼ͺธࠅ͹1/20ҐԾͶཻΉΖ

ϕϪϕϨϱφγʖώͶ͕͜Ζ ઝ঳͹࿨ช਼*1״αϫψΤ΢ϩηܗ৿ ઝ঳ͶؖͤΖ౦ߚ਼*2,3״αϫψΤ΢ϩηܗ৿ ʤ2020೧4݆຦఼࣎ʥ ʤ2020೧9݆຦఼࣎ʥ ୱҒʁฦ ୱҒʁ݇ 1,500 5,000

4,000 1,000 3,000

2,000 500 1,000

0 0 ธࠅ ஦ࠅ ӵࠅ ߿य ೖຌ ؘࠅ ෈໎ ߵߕ ߿य ஦ࠅ ธࠅ ӵࠅ ୈ࿹ ೖຌ ΢ϱχ χ΢ς Ωψξ η΢η ΢ϱχ Ωψξ χ΢ς ΢ϧϱ η΢η ΢νϨΠ ϓϧϱη ϔϧζϩ ηϘ΢ϱ Ψϧϱξ ϗϩάʖ ΢νϨΠ ϓϧϱη ηϘ΢ϱ ୉ؘ຿ࠅ ϔϧζϩ Ψϧϱξ ΢ηϧΦϩ ηΤΥʖυϱ εϱΪϛʖϩ ηΤΥʖυϱ

࠙5݆ΉͲ͹౦ߚ਼ͳ͹ർֳࠚ ώϱήϧυεϣ ఺͢ͱ͏Ζɽธࠅٱ5݆ΉͲ͹౦ߚ਼ͺ஦ࠅ͗Ϩʖχ͢ͱ͏ͪ͗ɼ9݆ΉͲ͹౦ߚ਼Ͳͺธࠅ͗ ಋ༹ɼӵࠅ͹౦ߚ਼΍ଁՅܑ޴Ͷ͍Ζɽ Ӷਫ਼Ͷ़ޮ;ٶઝ֨୉ɼ״͹බয়Ͷؖ࿊ͤΖ౦ߚ͗࠹΍ଡ͚ʤ25.4%ʥɼธࠅͲͺं׳஦ࠅͺ ؖͤΖ౦ߚ͗ଡ͚ʤ23.6%ʥɼೖຌͲͺࠅพർֳͶؖ࿊ͤΖ౦ߚ͗ଡ͏ܑ޴ʤ19.4%ʥͶ͍Ζ ͏͵қࣆߴʁસ਼16,066 ݇͹಼ɼસର͹༁ 2 ׄͲ͍Ζ3,141 ݇Ͷͯ͏ͱࠅʀஏҮ͗ׄΕ౲ͱΔΗͱ͏ཻ .2* WHO ͖Δޮ֋͠Ηͱ͏Ζชݛʀ࿨ชυʖνʤWHO COVID-19 Databaseʥ ͳϕϪϕϨϱφγʖώ .3* ಋͲޮ֋͢ͱ͏Ζ COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxivڠmedRxiv͗ ;ٶ bioRxiv ࣆͶଲ͢ͱࠅʀஏҮΝׄΕ౲ىScopusͶ ͗ଲেɽ୊Ҳஸं͹ॶ଒ؽؖ΍͚͢ͺ࠹ॵͶड़ݳͤΖϟʖϩΠχϪη͖Δ֦;ٶઝ঳͹ชݛυʖνʤ2020೧4݆26ೖ఼࣎ʥ״αϫψΤ΢ϩηܗWHO͖Δޮ֋͠Ηͱ͏Ζ৿ .1* ઝ঳͹ชݛʤ2020೧4݆28ೖ఼࣎ʥ͖Δபड़ ͱͱ෾ੵɽ 9 ݆ 27 ೖΉͲ͹υʖνΝफॄ״αϫψΤ΢ϩηܗफ࿧͠Ηͱ͏Ζ৿ ಊڂॶʰCOVID-19 / SARS-CoV-2 ؖ࿊͹ϕϪϕϨϱφΝ༽͏ͪݜڂॶ ड़ॶʁช෨Ռָ঴Ռָٗढ़ʀָढ़੕ࡨݜڂॶʰՌָٗढ़ࢨඬ2020ʱɼช෨Ռָ঴Ռָٗढ़ʀָढ़੕ࡨݜڂड़ॶʁช෨Ռָ঴Ռָٗढ़ʀָढ़੕ࡨݜ Ͷͯ͏ͱʱ ޴͹ࢾߨద෾ੵ ʤึҪʥʱڂΖ ௒ࠬݜܐઝ঳Ͷ״αϫψΤ΢ϩηܗॶ͹ ৿ڂʰՌָٗढ़ʀָढ़੕ࡨݜ

࣎ٺە ฑ࣎ Ζஎࡔ਼ܐઝ঳Ͷ״αϫψΤ΢ϩηܗ৿ ڒ͹ಝޛαϫψΤ΢ϩηླྀߨܗ֋൅ྙΝஸ͚͢߶Όͱ͏ͪ஦ࠅ͗৿ڂ೧ݜۛ ͪ͝ڏखಚͶ͕͏ͱଠࠅΝѻౙͤΖ੔ՎΝ ʤ2000-2021೧ʥ *1,3,5਼ڒʤ2000-2020೧ʥ *1,2,3,4 αϫψΤ΢ϩηؖ࿊ಝ਼ڒαϫψΤ΢ϩηؖ࿊ಝ ʤ݇ʥ ʤ݇ʥ 1,600 3,500

1,400 3,000

1,200 2,500 1,000 2,000 1,753 536 800 1,500 600 1,000 400 1,805 1,165 200 500 24 39 371 0 0 162 ஦ࠅ ธࠅ ೖຌ ӵࠅ 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

2020-2021೧ 2000-2019೧ ஦ࠅ ธࠅ ೖຌ ӵࠅ

*1. IPC෾ྪʁA61BʤDIAGNOSIS; SURGERY; IDENTIFICATIONʥɼA61KʤPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSESʥɼC07DʤHETEROCYCLIC COMPOUNDSʥɼC07HʤSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDSʥɼC07KʤPEPTIDESʥɼC12NʤMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIAʥɼC12PʤFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTUREʥɼC12QʤMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSESʥɼG01NʤINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING ࠅͶԢͣͱ෾ྪɼ෵਼͹ࠅͶ֚౲ͤΖ৖߻ͺͨΗͩΗ͹ΩΤϱφͶ؜ΌΖ *4. ν΢φϩɼঠ࿧ɼ੧ेڋਕ͹بTHEIR CHEMICAL OR PHYSICAL PROPERTIESʥ͹͏ͥΗ͖Ͷ֚౲ *2. ޮๅ൅ߨ೧ʁ2000-2020೧ *3. ࠅͺ੧ෝਕɼड़ ߴʁ coronavirusɼcoronavirusesɼcoronaviridaeɼcoronavirinaeɼorthocoronavirusɼorthocoronavirusesɼorthocoronaviridaeɼorthocoronavirinaeɼbetacoronavirusɼbetacoronavirusesɼbetacoronaviridaeɼٽ betacoronavirinaeɼsarbecovirusɼsarbecovirusesɼsarbecoviridaeɼsarbecovirinaeɼsevere acute respiratory syndromeɼsarsɼ2019 ncovɼcovidɼCOVIDɼCOVID-19ɼSARS-Cov-2͹͏ͥΗ͖Ν؜΋ *5. ޮๅ൅ߨ೧ʁ 2020-2021೧ ड़ॶʁDerwentʤ2021೧3݆3ೖΠέιηʥ

61 ࣎ٺە ฑ࣎ ֋൅੔Վʁਏஇ๑ڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿ ֋൅ڂͲݜۂةͶଡ͏ɽࠅพͲͺɼ୉ָʀڠਏஇ๑ͺϏ΢ϕϧ΢ϱ਼ʀট೟਼ ͏͵֋൅Νߨͮͱ͏ΖϕϪʖϢʖ͗ঙڂ਒΋ธӵ஦Ͷർ΄ɼೖຌͺݜ͗

ϕϪ΢Ϣʖ਼ʤҲఈ੔ՎΝ૓ड़͢ͱ͏ΖϕϪʖϢʖ͹Ίʥ ڱ֋൅ʀট೟য়

Phase1 Phase2 Phase3 ট೟*1 ਏஇٗढ़ Ҫఽࢢݗࠬ ߇ରݗࠬ ߇ݬݗࠬ ธࠅ ୉ָ*4 13 2 0 *1 *2 ʤColumbia Universityɼ ʤEmory Universityɼ ~780 336 ଠʥ ଠʥ 5*ۂة Նڒ༽࢘ٺەʤ EUA؜΋ʥ 7 11 3 ʤAbbott “ID Now” ɼ ʤBio-Rad “ϕϧτϨΠ ʤAbbott “BinaxNOW”ɼ ଠʥ SARS-CoV-2 Total Ab ଠʥ ࢾ༂ʥ”ɼଠʥ༽ڂݜ) ӵࠅ ୉ָ*4 1 1 1 ট೟੣඾ྭ ʤUniversity of ʤUniversity of ʤUniversity of གྷ Cambridgeʥ Southamptonʥ Oxfordʥ֕ ʥ໌ۂةʤΩρα಼ͺ֋൅ 5*ۂة ‡ ෵਼ࠅʀஏҮͲট೟Νखಚ͢ͱ͏ 0 2 0 BINAXNOW ʤAbingdon Health ธࠅ Ζ੣඾͗ଡ਼ଚࡑ (Abbott) “AbC-19™ Rapid Test”ɼ దͶ੣඾Ν৏ࢤ ଠʥۅਏஇٗढ़Ͳ੷֦ ‡ ୉ָ*4 ‡ ෵਼ࠅʀஏҮͲট೟Νखಚ͢ͱ AbC-19™ ஦ࠅ 0 1 0 Rapid Test ʤSunYat-Sen Ζ੣඾ͺݸఈదͲɼ߇ରʀ߇͏ ӵࠅ (Abingdon Universityʥ 0 4 0 5*ۂة (ݬݗࠬ͗஦ৼ Health ‡ ෵਼ࠅʀஏҮͲট೟Νखಚ͢ͱ ӵ寡ಝ2019-৿ܗ ʤInnovita “2019-nCoV য়බಡIgM/IgG Ab Test”ɼଠʥץ ६Ͷͺຮͪ͵͏͗ɼخ ஦ࠅ ͏Ζ੣඾ͺݸఈదͲɼ߇ରݗࠬ 倻߻㢧㴲宼∩ᚭ *4 ஦ৼ*3 ʤ囹ରۜ๑ʥ(Innovita) ೖຌ ୉ָ 000εηϟρέη౵΍ଚࡑ͗ Φηϕϧ΢ϱ ‡ ෵਼ࠅʀஏҮͲট೟Νखಚ͢ͱ *5 001 ۂة ೖຌ SARS-CoV-2 Ζ੣඾ͺඉ৙Ͷݸఈద (෍࢞ϪϑΨ) ʤ෍࢞ϪϑΨ “Φηϕϧ͏ ΢ϱSARS-CoV-2”ʥ ͳ͢ͱɼ஦ࠅͲͺ஦ࠅͺ೘ࠅ઴ɼ݄ੜIgM͹ӆ੓ৄ໎ॽ͹఑ܢClinicalTrials.gov͹ʰCOVID-19 diagnosisʱݗࡩ݃Վ *2. FDA EUAγ΢φ৏ʰIn Vitro Diagnostic Productsʱʤ2021೧2݆22ೖΠέιηʥ *3. ߇ରݗࠬ͗ଡ͏ഐ .1* ͱ͏ΖՆ೵੓͗ߡ͓ΔΗΖɽ͢ٶࣖΝٝແԿ͢ͱ͕ΕɼPCRΏ߇ݬݗࠬͳญߨ͢ͱɼ߇ରݗࠬΝࣰࢬɽΉͪɼؽࡒ͹࢘༽౵͹໚ͲͺPCRΓΕ߇ରݗࠬ͹๏͗ೋౕ͗ఁ͏͞ͳͶՅ͓ɼ෱߁͏ஏҮͲ͹ݗࠬͶ޴͜ͱ߇ରݗࠬ͗෕ αϫψΤ΢ܗࡎɽӵࠅʀ஦ࠅͺUS News͹Best Global Universities for Infectious DiseasesͶϧϱέ΢ϱͤΖ୉ָ͹಼ɼ৿ىࡎ͍Ζ୉ָ͹಼ɼຌ௒ࠬηαʖϕ಼͹ࠅͶॶࡑͤΖ୉ָΝىBiocentury COVID-19 DiagnosticsͶ .4* ࡎɽՅ͓ͱɼUK Rapid Test ConsortiumՅ໏ىΝۂة͹಼ɼট೟਼͗3ஏҮʙࠅҐ৏ͲຌPJηαʖϕ಼͹ࠅͶॶࡑͤΖۂةࡎ͍Ζى֋൅ΝࣰࢬͤΖ୉ָΝ௧Յ *5. Biocentury COVID-19 DiagnosticsͶڂઝ঳͹ਏஇ๑͹ݜ״ϩη ࡎىΝۂةࡎ͍Ζىɼࢤ৖ϪϛʖφͶͱ2ͯҐ৏Ͷۂة ड़ॶʁBiocentury COVID-19 Diagnostics (2020೧11݆20ೖ఼࣎)ɼUS News, ”Best Global Universities for Infectious Diseases”, ֦ؽؖΤΥϔγ΢φɼFDAΤΥϔγ΢φ౵

࣎ٺە ฑ࣎ ֋൅੔Վʁ࣑ྏ༂ڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿ ࣑ྏ༂Ͷͯ͏ͱͺɼྡজࢾݩ஦͹ޫึͺଡ͏΍͹͹ɼট೟ͶࢺΖ੣඾਼ͺ ଚ༂͹నԢ֨୉Ώ৿༂֋൅Νਬ਒ع΍ۂةܧͶɼೖڠͳۂةݸఈదɽԦธ

ϕϪʖϢʖ਼ʤҲఈ੔ՎΝ૓ड़͢ͱ͏ΖϕϪʖϢʖ͹Ίʥ 1*ڱ֋൅ʀট೟য়

Phase1 Phase2 Phase3 ট೟

420ʶ *1 9 *2 ธࠅ ୉ָ*4 19 Ն ʤCornell Universityɼଠʥڒ༽࢘ٺەʤ EUA8݇؜΋ʥ 8 5*ۂة ʤGilead Science ”ϪϞυεϑϩ”ɼଠʥ

གྷ ট೟੣඾ྭ ӵࠅ ୉ָ*4 4֕ ʤΩρα಼ͺೖຌ͹੣඾໌ʥ ʤKing’s College Londonɼଠʥ ͹Ϩϛζεϥωϱήχϧρή ϪϞυεϑϩۂةธࠅ ‡ 1 5*ۂة ࣑ྏ༂ʤώϞ ʤϗέϩϨʖʥوธࠅ ʤϪϞυεϑϩ౵ʥɼ৿ ϧωϑϜϔ౵ʥՁΗ΍ট೟ࡃΊ ʤGlaxoSmithKline ”LY-CoV555ͳ VIR-7831͹ญ༽ྏ๑ʤ࣑ݩ஦ʥ”ʥ ஦ࠅ ୉ָ*4 0 ͹Ϩϛζεϥωϱήχϧρή ϪϞυεϑϩۂةӵࠅ ‡ ଠࠅ ͹Ίট೟ࡃΊ ʤϗέϩϨʖʥ 0 5*ۂة ‡ ଠࠅͲͺາট೟͹ϓΟϑϒϧϑϩ*3Ν ஦ࠅ ট೟ʤ੕ැ͹࣑ྏ๏ਓͶͺͨΗҐ֐͹ ϓΟϑϒϧϑϩ ଠࠅາট೟༂4झΝ؜΋ʥ ʤΠϑΪϱʥ ೖຌ ୉ָ*4 0 ६Ͷͺຮͪ͵͏͗ɼخ ෍࢞ϓ΢ϩϞ෍ࢃԿָɼ ͹Ϩϛζεϥωϱήχϧρή υΫγϟνμϱۂةଠࠅ ‡ ஦֐੣༂౵͗ଚࡑ 5*ۂة ͹࣑ྏ༂ʤΠ ʤϪψυρέηʥ 0ۂةೖຌ ͹Ίট೟ࡃΊʤࣙࠅ ϑΪϱʥͺາট೟ʥ ͗༽ઝ঳޴͜͹࢘״αϫψΤ΢ϩηܗ࢘༽͗ট೟͠Η࣑ͪྏ๑ͳ৿ٺەժ಩ʥͶ਒ΞͲ΍҈સͳ൓இ͠Η਼ͪʤϭέοϱঈ͚ʥ *2. CTAP DashboardͶͱܯFDA͹CTAP Dashboard ͶͱFDAͶΓΖ৻ࠬ͗ߨΚΗɼINDʤ࣑ݩ .1* 㟪ފۂΝ༽͏ͱ߇΢ϱϓϩΦϱδΤ΢ϩη༂͹֋൅ʀ੣ଆʀ൤ജΝ஦ࠅͲߨ͑ݘཤΝᔵߒքਜ਼༂ڒ஍ *3. ஦ࠅͲ͹ϓΟϑϒϧϑϩͺɼ2016೧Ͷ෍࢞ϓ΢ϩϞ͗஦ࠅͶ͕͜ΖʰϓΟϑϒϧϑϩʱ͹ؖ࿊ಝܯট೟͠Η࣑ͪྏ๑͹߻ ࡎ *5. Biocentury COVID-19 therapies and vaccines: Clinical͹ىࡎ͍Ζ୉ָ͹಼ɼຌ௒ࠬηαʖϕ಼͹ࠅͶॶࡑͤΖ୉ָΝىଡ଼ *4. Biocentury COVID-19 therapies and vaccines: Clinical͹TherapyͶڒݸޮ࢚ऀͶଲ͢ͱ༙ ࡎʤʰINFECTIOUS DISEASE DRUGS MARKET - GROWTH, TRENDS, AND FORECASTS (2020 - 2025)ʱɼىΝۂةࡎ͹͍Ζىࢤ৖ϪϛʖφͶͱ2ऀҐ৏;ٶۂة͹಼ɼຌ௒ࠬηαʖϕ಼͹ࠅͶॶࡑͤΖۂةࡎ͍ΖىTherapyͶ ʰInfectious Disease Therapeutics Market Analysis By Disease Type (HIV infection, Influenza, Malaria, Tuberculosis, Hepatitis, and HPV infection), By Region, And Segment Forecasts, 2018 - 2025ʱɼʰGlobal Infectious Disease Drug Market 2020 Edition Report with Impact of COVID-19 ʱʥ ड़ॶʁFDA CTAP DashboardɾBiocentury COVID-19 therapies and vaccines: Clinicalʤ2020೧12݆4ೖ఼࣎ʥɼࢤ৖Ϫϛʖφʤ INFECTIOUS DISEASE DRUGS MARKET - GROWTH, TRENDS, AND FORECASTS (2020 - 2025 ʥ 㟪༙ݸޮ࢚ͳగ݃ : ωϣʖηϨϨʖη | ෍࢞ϓ΢ϩϞ (fujifilm.co.jp)ɼ֦ऀʀ୉ָΤΥϔγ΢φ౵ފۂ༁Ν஦ࠅ୉घ੣༂ճऀ ᔵߒքਜ਼༂ܘϧ΢ιϱηڒ౵ʥɼ߇΢ϱϓϩΦϱδΤ΢ϩη༂ʰΠϑΪϱ৥ʱͶؖͤΖಝ

62 ࣎ٺە ฑ࣎ ֋൅੔Վʁϭέοϱڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿ ͺາͫۂةܧ͹੣඾Νট೟ࡃΊͫ͗ɼೖۂةͲͺࣙࠅۂةϭέοϱͺɼธӵ஦ ͺ෱߁͏ϭέοϱٗढ़Ͳ͹֋൅͗਒΋ۂةট೟खಚͶࢺΔͥɽธ஦

ϕϪʖϢʖ਼ʤҲఈ੔ՎΝ૓ड़͢ͱ͏ΖϕϪʖϢʖ͹Ίʥ 1*ڱ֋൅ʀট೟য়

Phase1 Phase2 Phase3 ট೟ ϭέοϱझพ ࢐ Τ΢ϩη γϔϤωρ ෈׈Կ Τ΢ϩη֫ ϗένʖ φ ཽ༹ࢢ 19 24 22 9 ธ ୉ 00000 ࠅ ָ*2 00 3 1 4 ة *2 ʤModerna ” mRNA - ʤJannsen ʤNovavax “NVX- ɼଠʥ Pharmaceutical CoV2373”ɼଠʥ”1273 ۂ “Ad26.COV2.S”ʥ གྷ ট೟੣඾ྭ ӵ ୉ 0 1 000֕ ʥ ࠅ ָ*2 ʤUniversity of໌ۂةʤΩρα಼ͺ֋൅ / ֋൅ Oxford ” AZD1222ۂة2020೧12݆ɼࣙࠅ ‡ Covishield”ʥ Comirnaty ธࠅ ʤBioNtech/PfizerɼModernaʥ͹ 00 1 1 0 ة ՆΝ൅නɽ ʤBioNTech/Pfizerʥڒ༽࢘ٺەϭέοϱͶ *2 ʤAstraZeneca ʤGSK ”SCB-2019”ʥ / AZD1222“ ۂ ੊ֆ֦ࠅͲট೟ʀ౦༫͗਒΋ ֋൅ Covishield”ʥۂة2020೧12݆ɼࣙࠅ ‡ ʤOxford/ AstraZenecaʥ͹ϭέο AZD1222 ஦ ୉ 0 3 1 00 ӵࠅ ʤOxford/AstraZenecaʥ *2 ʤUniversity of Hong ʤSichuan University Նɽ ࠅ ָ Kong ”DelNS1-2019- “Recombinant Sf9ڒ༽ϱΝ࢘ ੊ֆ֦ࠅͲট೟ʀ౦༫͗਒΋ nCoV-RBD-OPT1”ɼ cell”ʥ ଠʥ ֋൅ۂة2020೧12݆ɼࣙࠅ ‡ 0 3 3 1 1 ة BBIBP-CorV ஦ࠅ ʤSinopharmʥ͹ϭέοϱΝট೟ɽ *2 ʤAdvaccine ʤCanSino Biological ʤAnhui Zhifei ʤSinovac BioPharmaceutical “Convidecia”ʥ Longcom “ZF2001”ɼ “CoronaVac”ɼଠʥ ۂ ʤSinopharmʥ ஦ࠅҐ֐͹෵਼ϴࠅͲ΍౦༫͗਒΋ “INO-4800”ʥ ଠʥ ೖ ୉ 1 0000 ‡ 2021೧2݆ɼBioNtech/Pfizer͹ϭ Comirnaty ຌ ָ*2 ʤ୉ࡗ୉ָ|AG0301- ֋ ʤBioNTech/Pfizerʥ COVID19|ʥۂةೖຌ έοϱΝট೟ɽҲ๏ɼࣙࠅ 0000 1 ة ൅͹ϭέοϱͺ֋൅ஊ֌Ͷ͍Ζ ६Ͷͺຮͪ͵͏͗ɼKMώ΢ΨϫζέηɼIDϓΟʖϜɼخ ʤAnGes/Takara 2* Bio |AG0301- ۂ COVID19|ʥ Ԛ໼ٝ౵͗ଚࡑ Ͷɼ֦PhaseͶ͕͜Ζ਼݇Νࢋड़ʤPhase1/2ͺPhase 2ɼPhase2/3ͺPhase3Ͷ؜΋ʥɽট೟ࡃΊ͹ϭέοϱͶͯ͏ͱخWHOͶΓΖDraft landscape and tracker of COVID-19 candidate vaccines (2021೧1݆29ೖߍ৿൝ʥΝ .1* ࡎىʀ୉ָΝۂةͶɼPhase2Ґ߳͹ϭέοϱ͹֋൅خࡎ *2. WHOͶΓΖDraft landscape and tracker of COVID-19 candidate vaccines (2021೧1݆29ೖߍ৿൝ʥΝىͶخ͹൅නࣁྋΝۂةͺɼ֦ࠅޮదؽؖ͹ট೟৚ๅ຤ͺ֋൅ ड़ॶʁWHO, Draft landscape and tracker of COVID-19 candidate vaccines (2021೧1݆29ೖߍ৿൝ʥ౵

࣎ٺە ฑ࣎ ট೟ν΢Ϟϧ΢ϱ;ٶ֋൅੔Վʁ֋൅ڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿ ໝͫ͜Ͳ͵͚ɼฑ͖࣎Δಋझ͹Τ΢ϩηͲ͹֋൅Ώɼو࣎͹ॵಊ͹ଐ͠ʀٺە ԣ͢ޛ൭͹ߑ஛͗੔Վ૓ड़Νخ֋൅ڂढ़ʀݜٗوາஎ͹බݬରͶଲԢ͑͢Ζ৿ 20೧ 21೧ 1݆ 2݆ 3݆ 4݆ 5݆ 66݆ 77݆ 88݆ 99݆ 1010݆ 1111݆ 1212݆ 11݆݆ 2݆ 3݆ ຎྭʁ - ྡজࢾݩ֋࢟ೖ Thermo Fisher PCRݗࠬ ٺەਏஇ๑ ଡ༹͵බݬରͶଲͤΖਏஇ๑͹֋ ธࠅ - ট೟ೖ ൅ࣰ੹ɼࣙऀϨλʖη͹ॄ஦౦Ծ ࢘༽ট೟ ࡎนܟAbbott PCRݗࠬ ࣆྭ - Εɼ͗ܪ֋൅ͶغΏ൓இ͹ଐ͗͠૥ Edinburgh Abingdon CEϜʖέखಚ ੊ֆ஦͹෱߁͏ωʖθͶો૥͚ଲ PCRݗࠬ Genetics ߇ରݗࠬ Health ট೟ٺBioGerm ஦ࠅԢ ԢͲͪ͘ PCRݗࠬ ট೟ٺInnovita ஦ࠅԢ ߇ରݗࠬ ೖຌড়݇෉͘ εηϟρέη ෍࢞ϪϑΨ ੣ଆ൤ജ PCRݗࠬ ߇ݬݗࠬ Gilead ࣑ྏ༂ ಋझ͹බݬରͲ͹֋൅ࣰ੹ΏϏϱ ϪϞυεϑϩ Նڒ༽࢘ٺەυϝρέͶ͕͜Ζ૓༂ϕϫιηՅ P3 ธࠅ Eli Lilly/ AbCellera Նڒ༽࢘ٺەಋͲ੖ඍʥ P1, P2/3 ώϞϧωϑϜϔ ธࠅڠ൭ʤࢊׯخଐର੏ʀ ͹ฑ͖࣎Δ͹ߑ஛*1͗ɼ࣑ྏ༂͹ Eli Lilly/ Incyte Նڒ༽࢘ٺەͱ͏Ζ P3 ώϨεοωϔ ธࠅͮ͗ܪ֋൅Ͷغ૥ ෍࢞ϓ΢ϩϞ P3 ϓΟϑϒϧϑϩ ট೟ਅ੧

ٗو෱߁͏බݬରͶଲԢ͢ಚΖ৿ ϭέ ֫࢐ϭέοϱ BioNTech/Pfizer Նڒ༽࢘ٺەࣰ੹Ν P1/2 P3 ธࠅڂοϱ ढ़Ώಋझ͹බݬରͲ͹ݜ ໝώ΢Ψ ModernaوΖΠΩυϝΠʙঘ༙ͤ ࢐ϭέοϱ֫ Նڒ༽࢘ٺەϭέοϱ֋ P1 P3 ธࠅغɼ૥͗ۂڢͳ͹ۂة ൅Ͷܪ͗ͮͱ͏Ζ Oxford/ Τ΢ϩηϗένʖϭέοϱ AstraZeneca P1/2 P2/3 ӵࠅ࢓ఈద࢘༽ট೟ Sinopharm ෈׈Կϭέοϱ P1/2 P3 ஦ࠅਜ਼ࣞট೟

P1/2 ֫࢐ϭέοϱ P2/3 AnGes/୉ࡗ୉ָ

෾཯͖Δ60ೖҐ಼Ͳ͹ҫྏଲࡨʙ࣑ྏ༂֋൅Ν໪దͳ͢ͱ͏ΖDARPAͶΓΖPandemic Prevention Platform (P3) program. γϔϤωρφהබݬର .1* Ͷ੔ޯ ϭέοϱ P1/2 Ԛ໼ٝڂઝ঳࣑ྏ༂͹ݜ״αϫψΤ΢ϩηܗAbCellera͗2018೧ΓΕ౲ϕϫήϧϞͶࢂժ͢ͱ͕Εɼ৿

63 ೖຌͶ͕͜Ζ;ٶଠࠅ .4 ࣎͹खૌΊٺەઝ঳΃͹״αϫψΤ΢ϩηܗ৿ ֋൅੔Վڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿;ٶགྷ֕ .4-1 4-2. ৆ࡋ 4-2-1. ੕ැ ࠅࡏؽؖ .4-2-2 ۂة;ٶΠΩυϝΠ .4-2-3 ;ଠࠅ͖Δ͹ָ .4-3

64 ธࠅ

65 ࣎ٺە ฑ࣎ ਫ਼ࢊ͹ؽ೵ैଏ͹ͪΌ͹଩ͬघʁγϜϨ;ٶ֋൅ڂݜ ۂة֋൅Ώڂଚٗढ़ΝᑑͶͪ͢ݜع1݆Ͷͺ੕ැ಼νηέϓΧʖη͗અཱི͠Ηɼ ʤ2020೧1݆ʥͶ֋࢟͠Ηͱ͏ͪغ֋൅ਬ਒͗૥ڂ΃͹ݼ;͖͜ͶΓΖݜ ؽ೵ैଏ͹ ຎྭʁਏ - ਏஇ๑ ࣑ - ࣑ྏ༂ ϭ - ϭέοϱ ֋൅ ֋൅ ਫ਼ࢊ ਫ਼ࢊ ڂݜ ڂ଩ͬघ ݜ ଲԢ͹ର੏੖ඍʤ੕ැ಼Ͳ͹νηέϓΧʖηઅཱིʥٺە કྲྀࡨఈʀ ਏ ࣑ ϭ સର౹ׇ ֋൅Ͷ͕͜Ζ༑઎ద྘Ү͹ಝఈڂ࣑ ϭ ϭέοϱʀ࣑ྏ༂͹ݜ

֋൅ਬ਒ࢩԋʤOperation Warp SpeedɼRADx΢ωεΠοϔɼ౵ʥڂਏ ࣑ ϭ ϭέοϱʀ࣑ྏ༂ʀਏஇ๑֋൅΢ωεΠοϔΝ௪ͪ͢ঁ੔ʀݜ

֋൅ʀਫ਼ࢊ͹ͪΌ͹ࣁ֮ۜฯʤ༁9,530Աԃ͹༩ࢋʥڂઝ঳͹ݜ״αϫψΤ΢ϩηܗਏ ࣑ ϭ ৿

ਏ ࣑ ϭ ηϏαϱ׈༽͹ࢊָׯ ϭέοϱʀ࣑ྏ༂ʀ ֋൅ ਏ ࣑ ϭڂݜ ෾֮ฯڇڛαϱλʖεΠϞઅཱིʤCovid-19 HPC Consortiumʥ ਏஇΫρφ͹ ༙ڠਬ਒ ΰόϝέη෾ੵ͹ਬ਒ʀ ࣎͹ϭέοϱ੣ଆ༲ྖ͹֮ฯٺە ਏ ࣑ ϭ ଇ਒͹αϱλʖεΠϞઅཱི ϭ

֋൅ࢩԋڂ࣑ ϭ ߶ౕઅඍΝཤ༽ͪ͢ϭέοϱʀ࣑ྏ༂͹ݜ

ਏ ࣑ ϭ ࢾ༂ɼςʖϩɼ৚ๅΝ ϭέοϱʀؖ࿊༽඾͹༽ڂNIAID͹ଲেබݬର͹ݜ ֋൅ ࣑ ࣑ྏ༂͹֋൅ଇ਒ηΫʖϞ͹੖ඍʤCTAPʥ ϭڂݜ ฯ֮ڇڛԿࢩԋɼکαϝϣωτΡΏਏஇ༂֋൅ं΃֋ࣖ ੣ଆڂ൭ ॄ༁͢ݜخਬ਒ ΔͶ໖੻Ν༫͓Ζ๑͹ंۂ࣎͹ྡজࢾݩͶؖͤΖ ଲে੣ଆٺە ;ٶదؽؖͶΓΖࢾ༂͹֋൅ޮ ʤઅඍʀࣁࡒʀ ਏ ਏ ࣑ ϭ ϭ ઑݶʤPREP๑ʥ;ٶؽؖ΃͹ഓා Ϊ΢χϧ΢ϱ൅ߨ ੖ඍڂࠅ಼ݜ ๑੏ౕ౵ʥ Նʤ ʥڒ༽࢘ٺە ਏ ࣑ ϭ EUA ͶΓΖট೟෉༫

࣎ٺە ฑ࣎ ʤ1/2ʥܠકྲྀࡨఈʀસର౹ׇʁࢊָׯ࿊ OSTPͳDOEͲͺࢊָׯ͹ηϏαϱΝཤ༽ͪ͢ΰόϞմੵ͹ଇ਒ɼ Νߨ͑αϱλʖεΠϞΝઅཱི༙ڠCDCͲͺΰόϞഓ྽৚ๅ͹ COVID-19 HPCαϱλʖεΠϞ SPHERESαϱλʖεΠϞ Ͷ༙ڠαϫψΤ΢ϩη͹ΰόϞഓ྽৚ๅ͹ܗαϫψΤ΢ϩη ৿ܗ੊ֆ͹ηϏαϱΝ׈༽ͪ͢৿ ໪ద ໪ద ઝ֨୉͹૏ࢯࢩԋ״ࢩԋ ΓΖڂ͹ݜ

2020೧11఼݆࣎Ͳ43͹ϟϱώʖ͗Յ໏ ʤक͵ϟϱώʖʥ ʤक͵ϟϱώʖʥ ੕ැؖ࿊ؽؖ „ ॶɼNIAIDɼNIST౵ڂ੕ැؖ࿊ؽؖ ¾ CDCɼΠϩβϱϊࠅཱིݜ „ ֆۂؽؖʤҲ෨ʥɼ „ ࢊڂΦϋϩάʖ঴ࢁԾ͹ࠅཱིݜ ¾ ࢂՅ ࠅཱིՌָࡔ஄ ౵ ࢂՅ ϟϱώʖ ϟϱώʖ ¾ AbbottɼbioMérieuxɼQiagen ౵ ֆ „ ָढ़ؽؖۂࢊ „ IBMɼϜ΢έϫλϓφ ౵ ¾ ϗ΢ϧʖ୉ָɼαʖϋϩ୉ָ ౵ ¾ ढ़ؽؖ „ ඉӨཤ஄ରָ „ Ϝγοϣʖιρς޽Ռ୉ָɼϪϱιϧʖ ¾ ϑϩˏϟϨϱξʀΰ΢ςࡔ஄ ౵ ¾ ޽Ռ୉ָ ౵

„ 2020೧3݆ɼϙϭ΢φύΤηΓΕઅཱི͗൅න ΗͪOSTPɼDOEɼIBM͗क಍ͤΖࢊָׯ࿊͠ ܠαϱλʖεΠϞ ఑Ҍڂϛʖνϩγ΢φΝ௪ͣͱ఑ड़͠Ηͪݜ „ ͹৻ࠬޛɼϟϱώʖ͹ϨλʖηͳϜροϱή „ 2020೧5݆ɼCDC͗અཱིΝ൅නͪ͢αϱλʖ གྷ ֕གྷ֕ ༙ڠΝࣰࢬ εΠϞͲɼϟϱώʖͺഓ྽৚ๅΝڂɼηϏαϱΝ׈༽ͪ͢ݜ͢ ¾ 2020೧11఼݆࣎Ͳ͹αϱϒϣʖτΡϱή೵ྙ ϕϫζΥέφΝڂͺ600PFLOPSͲ90Ґ৏͹ݜ ࢩԋ ͹఺ؾրવͶࣁͤΖՆ೵ं׳2020೧11݆Ͷͺ ¾ ੓͹͍ΖϕϫζΥέφ΃͹஭ྙΝ൅න

ड़ॶʁCOVID-19 HPC ConsortiumΤΥϔγ΢φɼIBM, “COVID-19 High Performance Computing Consortium Enters New Phase Focused on Helping Researchers to Identify Potential Therapies for Patients”, Global Biodefense, “CDC Launches National Viral Genomics Consortium to Better Map SARS-CoV-2 Transmission”

66 ࣎ٺە ฑ࣎ ʤ2/2ʥܠકྲྀࡨఈʀસର౹ׇʁࢊָׯ࿊ ͱ༑઎దͶࢾݩΝ਒ΌΖ෾໼Νಝఈ͢ܠACTIV΢ωεΠοϔͲͺɼࢊָׯͲ࿊ ͢ɼ༙๮͵ϭέοϱʀ࣑ྏ༂͹֋൅Νଇ਒ ACTIVʤAccelerating COVID-19 Therapeutic Interventions and Vaccinesʥ

2020೧4݆Ͷ൅න͠Ηͪׯ຿Ϗʖφψʖερ „ ৿ܗαϫψΤ΢ϩηͶଲͤΖ࠹΍༙๮͵ ੏ϕϫιηو໪ద ϕͲɼࢾݩυδ΢ϱ͹߻ཀྵԿɼ ΏࢂंڂͶɼࢾݩͤΖ༂ࡐʀݜڠϭέοϱΏ࣑ྏ༂͹֋൅ଇ਒ ͳ͹௒੖ͳ ଚ͹ྡজࢾݩϋρφعՅंʀҫྏॊࣆंɼ ༽ϭʖέ͵ʹ͹ϨλʖηΝ׈ 4ͯ͹஭ྙ྘ҮΝઅఈ͢ɼ֦྘ҮͲϭʖΫϱή „ ήϩʖϕ͗׈ಊΝࣰࢬ ੕ැؖ࿊ؽؖ „ ௒దͲڢ྘Үᶅ ઴ྡজ࣑ྏ͹ಝఈ͹ͪΌ͹ɼ ¾ ¾ BARDAɼCDCɼDODɼୂༀ܋ਕ঴ʤVAʥɼ ߻ཀྵద͵ϓΧʖϧϞ͹֋൅ʤ઴ྡজWG) EMAɼNIHɼFDAɼOperation Warp Speed ¾ ྘Үᶆ ࠹΍༙๮͵ϭέοϱͳ࣑ྏ๑͹ྡজࢾ ֆۂࢊ „ ݩ͹ՅଐԿʤ࣑ྏʀྡজWGʥ AbbVieɼAmgenɼAstraZenecaɼBristol ¾ ྘Үᶇ ྡজࢾݩ͹೵ྙͳ༙ް੓͹޴৏ʤྡজ ¾ ɼ ɼ ɼ ֕གྷ Myers Squibb Eisai Eli Lilly and Company ࢾݩΫϡϏετΡWGʥ EvotecɼGileadɼGlaxoSmithKlineɼJohnson ¾ ྘Үᶈ ϭέοϱޫึ͹඲Ճ͹ՅଐԿʀਟଐ͵ & JohnsonɼMerck & Co., Inc. ɼModernaɼ ࢂՅ ট೟ʤϭέοϱWGʥ ϟϱώʖ NovartisɼNovavaxɼPfizerɼRhythm TherapeuticsɼRoche-GenentechɼSanofiɼ „ ෵਼͹෾໼Ͳϭέοϱʀ࣑ྏ༂͹ྡজࢾݩΝ TakedaɼVir Biotechnology ༑઎దͶਬ਒ „ ඉӨཤ஄ର ¾ ϭέοϱʁᶅSanofi/GSKɼᶆModerna/NIAIDɼ ¾ Bill & Melinda Gates Foundationɼ ᶇUniversity of OxfordɼᶈJanssen Fred Hutchinson Cancer Research Centerɼ Pharmaceuticals͹ࢾݩΝࢩԋ ͹Ϡόέं׳Foundation for the National Institutes of ¾ ࣑ྏ༂ʁᶅ໖Ӻ௒੖ༀɼᶆ֐པ ͹Ϡόέϫʖं׳Healthɼ ϫʖψϩ߇ରྏ๑ଠɼᶇ೘Ӆ ݽ༂ɼᶉBig EffectڿRTI International ψϩ߇ରྏ๑ଠɼᶈ߇ ઝ࣑ྏ༂౵ʥ͹ࢾݩΝࣰࢬ״Trialʤਚ৙੓

ड़ॶʁNIH, “ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES (ACTIV)”ɼҫ༂ܨࡃONLINE, “COVID-19 Watchոʰ͓࢘Ζʱ࣑ྏ༂Ν߻ཀྵదͶ୵ͤACTIV΢ωεΠοϔ|౵

࣎ٺە ฑ࣎ ֋൅ਬ਒ʁOperation Warp Speedڂݜ ࠕյ͹αϫψԾͶ͕͏ͱͺɼϭέοϱΝ஦ৼͶࠅΝ໲Κࣰͥݳ੓͹߶͏ٗढ़΃ ʛਫ਼ࢊΉͲΝࢩԋڂໝͶ౦ࣁ͢ɼଡ਼͹ϭέοϱ͹ݜو୉

Operation Warp Speed ໪ඬʰ2021೧1݆ΉͲͶ3Այ෾ʱ͹ࣰݳͶ޴͜ɼ֋൅ʀਫ਼ࢊΝ஦ৼͶଡ਼͹ϭέοϱͶ౦ࣁ͢ɼͨ͹੣ଆͶච ֋൅఼͖࣎Δࢩԋڂ໤΍֮ฯɽୢ͢ɼmRNAٗढ़Ͷͯ͏ͱͺݜڇڛགྷ͵੣඾͹

ઝ঳͹ϭέοϱɼ࣑ྏ๑ɼ״αϫψΤ΢ϩηܗ৿ „ ਏஇ๑͹֋൅ʀਫ਼ࢊʀླྀ௪͹ଇ਒ ໪ద ෾ڇڛ;ٶڛ΃͹ࣁۜ఑ڇڛ2021೧1݆ΉͲͶ࠹ॵ͹3Այ෾͹҈સ׎ͯްՎద „ ϭέοϱ֋൅ʀ੣ଆʙ „ ϭέοϱ͹ਫ਼ࢊʀླྀ௪ ֮ฯ͵ ੔઎ „ ϭέοϱ੣ଆ೵ྙ͹֮ฯঁ ʙ֕གྷ „ ϭέοϱؖ࿊੣඾͹֮ฯ ୉౹྘ͶΓΖޮࣞ൅නͺ2020೧5݆15ೖ „ ࣑ྏ༂͹֮ฯ „ ୢ͢ɼखૌΊࣙରͺ3݆ͶϭέοϱޫึͶଲͤΖ ¾ غ֋࢟࣎ ঁ੔ΝͤΖ౵ɼޮࣞ൅නҐ઴ΓΕࣰࢬ

„ DOD „ FDA Նڒ༽࢘ٺەؖ࿊ͤΖ „ ߇ର༂΃͹ „ HHS „ NIH ੕ැؽؖ ¾ 2020೧11݆ɼ΢ʖϧ΢ϨϨʖ͗֋൅ͤΖϠόέ „ „ ڒ༽࢘ٺەCDC BARDA ϫʖψϩ߇ର࣑ྏ༽ώϞϧωϑϜϔ͹ ՆʤEUAʥΝট೟ ՆɼธࠅͶ͕͜Ζڒ༽࢘ٺە;ٶ੔Վ „ ϭέοϱ͹֋൅ ϭέοϱͶͺ༁180ԱχϩɼϭέοϱҐ֐Ͳͺ༁ ౦༫͹֋࢟ „ 15.7Աχϩʤ2020೧10఼݆࣎ʥ Moderna;ٶ੔ֻ ¾ 2020೧12݆ɼPfizerͳBioNTechɼঁ ՆʤEUAʥڒ༽࢘ٺەୢ͢ɼखૌΊࣙରͺ3݆ͶϭέοϱޫึͶଲͤΖ ͗֋൅ͤΖϭέοϱޫึ͹ ¾ ঁ੔ΝͤΖ౵ɼޮࣞ൅නҐ઴ΓΕࣰࢬ Νট೟

ड़ॶʁDepartment of Defense,”Coronavirus: Operation Warp Speed”ΤΥϔγ΢φɼBloomberg, “Inside Operation Warp Speed’s $18 Billion Sprint for a Vaccine”౵

67 ࣎ٺە ฑ࣎ ʤࢂߡʥModernaʤธʥͳธࠅ੕ැͶΓΖϭέοϱ֋൅ν΢Ϟϧ΢ϱ ธࠅ੕ැ͗ҲๅΝण͜2ुؔҐ಼ͶmodernaͳNIHͺmRNAϭέοϱ͹ ഓ྽Ν࠹शԿɼ2݆Ծ२Ͷͺࢾݩ༽ϭέοϱΝ༽қ

ର ੏ ઝ ୉౹྘ැͺCOVID-19঴ுؔνηέϓΧʖη NIHͺαϫψଲԢοʖϞΝઅཱིɽNIHड״ߑ ੕ැ಼Ͳ஦ࠅͲ͹ ௗ͗ݙӀۃௗ΍ࢂժ ੰ࣏ௗɼϜϋζϟϱφ୴౲ۃͶؖ͢ͱ೟ࣟ Νઅ஖ɽHHSௗׯɼNIAIDڱ஛ য় Ͷ ޴ ͜ ͪ NIH಼ͲαϫψΤ΢ϩη ಊ ͶؖͤΖ٠࿨Νࣰࢬ ޴

2019೧ 2020೧ 12/31 1/3 1/10 1/13 1/23 1/27 1/29 1/30 2/4 2/7 2/11 2/13 2/18 2/24 3/6 3/11 3/13

Ϗϱυϝρέ ඉ৙ࣆସ ٺە͵WHOࣆແॶ ੊ֆద (΃͹ๅࠄ(஦ࠅ) ࣆସઑݶ(WHO) ઑݶ(WHO) ઑݶ(ธࠅ Janssenऀ͹ ʤ஦ࠅଈ͗ʥΤ΢ϩη ϭέοϱ͹ ͹ΰόϞഓ྽Νޮ֋ ྡজ඲ՃࢩԋΝ Sanofiऀͳ͹ϭέοϱ Modernaऀ͗NIAIDͶࢾ (Ν൅න ݩϭέοϱΝ༎ૻ(NIHܠ൅න(BARDA) ֋൅͹࿊ (ݜ NIHͳModernaऀͺ (BARDA mRNAϭέοϱޫึ͹ Ϡόέϫψʖϩ߇ର͹ ڂ ֋ ഓ྽Ν࠹शԿɽNIHͺ ֋൅Ͷ͕͜ΖRegeneron 3/16Ͷྡজࢾݩ Phase 1͗֋࢟ ൅ Phase1ࣰࢬΝࣖࠨ Pharmaceuticalsऀͳ͹ ϪϞυεϑϩ͹઴ྡজ Ν൅න(BARDA) ࢾݩͶؖͤΖ൅ݡΝܠಊ (NIH) ࿊ ޴ ൅න(NIAID) ৿ܗαϫψΤ΢ϩη͹ਏஇʀ Modernaऀ͹mRNAϭέο ϱޫึ͹࠹ॵ͹ྡজώρο ۂة࣑ྏ๑֋൅Ͷؖৼ͹͍Ζ (Δ͹఑ҌΝགྷ੧(FDA) ͗׮྅͢ɼ෾ੵࢾݩ΃(NIH͖

ड़ॶʁModerna, “Moderna‘s Work on a COVID-19 Vaccine Candidate” ౵

࣎ٺە ฑ࣎ ֋൅ਬ਒ʁRADx΢ωεΠοϔڂݜ ਏஇ๑Ͷ͕͏ͱ΍ɼݗࠬΫρφ֋൅Ν໪ࢨͤ΢ωεΠοϔΝཱིͬ৏͝ɼ ֋൅ࢩԋΝࣰࢬڂ͹ݜܗ൒ૺ

RADx΢ωεΠοϔ ͹՟ୌͲ͍Εɼࠅ຿͹ݗࠬ͗ՆەΏฯݧ੏ౕΓΕɼPOCTʙՊఋ༽ਏஇΫρφ͹֋൅ͺ٦ڱઝ֨୉য়״ธࠅͲ͹ ೵͵༙๮ٗढ़͹֋൅Νࢩԋ

„ 2020೧12݆ΉͲͶ1ೖ౲ͪΕธࠅ຿͹༁2%ʤ600 „ 4ͯ͹ϕϫήϧϞͲߑ੔͠Ηͱ͕ΕɼਏஇΫρφ͹֋ ໪ద ຬਕͶ૮౲ʥΝݗࠬՆ೵ͳͤΖΫϡϏετΡ͹ ൅ͺͨ͹಼͹ᶅRADx TechɼᶆRADx- ATPϕϫήϧ ߑ஛ ϞͲࣰࢬ ଲেͳ͵ͮͪϕϫζΥέφͶͺ઒໵ՊοʖϞΝׄΕ „ ϕϫήϧϞ ౲ͱɼϕϫζΥέφ͹ϨηέΏϜ΢ϩηφʖϱɼϨ གྷ λʖηΝಝఈ͢ɼPhase1΃͹Go/No Go൓இΝࣰࢬɽ֕ „ 2020೧4݆29ೖͶNIH͗൅න Phase1ͲͺϜ΢ϩηφʖϱ͹ୣ੔ɼPhase2Ͳͺࣰ Paycheck Protection Program and Health Care ૹͶ޴ͪ͜खૌΊΝࣰࢬ ¾ غ֋࢟࣎ Enhancement Act͹੔ཱི͖Δ1ुؔҐ಼Ͷ֋࢟ „ Phase2Ͳͺ11ऀ͗ঁ੔͠Ηͱ͕ΕɼҪఽࢢʀ߇ݬݗ ࠬɼPOCͳϧϚݗࠬ͹૔๏౵ɼ෱߁͏ٗढ़Ͷঁ੔

„ NIH/NIBIB „ DARPA ؖ࿊ͤΖ „ BARDA „ FDA ੕ැؽؖ „ CDC „ 2020೧12݆15ೖɼRADx΢ωεΠοϔͶͱࢩԋͤ ״αϫψΤ΢ϩηܗΖ ऀ͗֋൅ͪ͢৿ ੔Վ Ellume USA ͵ઝ঳͹߇ݬݗࠬΝFDA͗ট೟ɽవಆͲ߬೘Ն೵ Պఋ༽͹ݗࠬ ੣඾ʥͳ͢ͱͺॵ͹ ট೟ ੔ֻ „ 15Աχϩ (OTC FDAঁ

ड़ॶʁNIH “RAPID ACCELERATION OF DIAGNOSTICS (RADX)”ΤΥϔγ΢φɼThe New England Journal of Medicine “Rapid Scaling Up of Covid-19 Diagnostic Testing in the United States — The NIH RADx Initiative”ɼNIH ΤΥϔγ΢φ౵

68 ࣎ٺە ฑ࣎ ॶ͹खૌΊڂ֋൅ਬ਒ʁࠅཱིݜڂݜ ॶͲͺɼXતϑʖϞΏηϏαϱ౵͹߶ౕ͵અඍΝڂΦϋϩάʖ঴ࢁԾ͹ࠅཱིݜ ཤ༽͢ͱ༂ࡐޫึ͹ηέϨʖωϱήΏ૏֒ࡐ͹୵ࡩ౵Νࣰࢬ

ॶڂॶ ϫηΠϧϠηࠅཱིݜڂॶ ΨʖέϨρζࠅཱིݜڂΠϩβϱϊࠅཱིݜ

ࢋϠυϩΝܯઝ঳͹਼ָదϠυϩͳ״ „ αϫψΤܗॶ͹઎୼๎ࣻޭࢬ „ ਕ޽எ೵ٗढ़Ν׈༽͢ɼ৿ڂΠϩβϱϊࠅཱིݜ „ અʤAPSʥͲͺXતϑʖϞΝ׈༽͢ͱ ΢ϩη͹εητϞਫ਼෼ָͳ෾ࢢϟΩω ֋൅ Ͷͺɼళષ౳ɼ୺᙭ۗɼHIVɼڊգ ¾ ڂ߶෾ࢢ͹Xત݃ধߑଆմੵΝࣰࢬ͢ɼ θϞΝݜ αϫψΤ΢ϩηͶଲͤΖ࣑ྏ๑ͳ ΦϚϧड़݄೦ɼ΢ϱϓϩΦϱδ౵͹ܗ૏֒ࡐ͹୵ࡩͶ߫ݛ „ ৿ ͳ͢ͱɼ֫ഃࡇ஦੓ ӺָదϠυϩΝ֋൅؂͹Ҳڂઝ֨୉Νε ਏஇ͹ݜ״αϫψΤ΢ϩη͹ܗ৿ „ ઝ֨୉ɼͨ͹״αϫψΤ΢ϩη͹ܗݬࢢ࿏ʤHFIRʥ „ ৿༽ڂϝϣϪʖεϥϱͤΖͪΌ͹ӺָϠυϩ ࢢݱʤSNSʥͳݜ ࡏ͹ਕʓ͹ߨಊͶͯ͏ͱ͹ϠυϩԿΝ ڛͶ఑ंڂ͹ߑ஛Νࣰࢬ ΃͹ϨϠʖφΠέιηΝݜ ͺ఑ҌΝ఑ड़ ࣰࢬंڂ๮ͤΖݜسࡃ׈ಊΝߨͮͪ৖߻͹ϗʖ ¾ ཤ༽Νܨ௪৙͹ ¾ ηϧ΢ϱ͹εϝϣϪʖεϥϱΝࣰࢬ ͤΖචགྷ͍Ε ஦ „ COVID-19 HPCαϱλʖεΠϞͶࢂՅ COVID-19 HPCαϱλʖεΠϞͶࢂՅ ͢ɼηϏαϱΝ׈༽͢ͱঘ෾ࢢ༂෼Կ „ ɼηϏαϱΝ׈༽͢ͱઞࡑద͵༂ࡐ ߻෼͹ಝఈ౵ɼઞࡑద͵༂ࡐޫึ͹η͢ ͹ηέϨʖωϱήͶ߫ݛ έϨʖωϱήͶ߫ݛึޫ ॶ͹ηϏαϱڂ࠸ཤ༽͗Ն೵׎ͯΓΕްՎద͵N95Ϝ ¾ ΨʖέϨρζࠅཱིݜ „ ࢋܯ͹֋൅ ʰγϝρφʱͺ200PFLOPS͹حٷਕ޽ݼ;ٶηέ ೵ྙΝୣ੔ „ ࠸ཤ༽Ն೵͵ϜηέΏϓΥ΢ηεʖϩ Νࣰࢬڂχ͹৿͢͏υδ΢ϱ͹ݜ

ड़ॶʁDepartment of EnergyΤΥϔγ΢φ౵

࣎ٺە ฑ࣎ ൭ʁϭέοϱਫ਼ࢊର੏͹੖ඍخ֋൅ਬ਒ڂݜ ΫϡϏε;ٶࣆସ͹ϭέοϱ੣ଆͶඍ͓ͪࢬઅ͹અཱིٺەBARDAΝ஦ৼͶɼ τΡΝ֮ฯɽϭέοϱؖ࿊༽඾͹੣ଆ༲ྖ΍֮ฯ͢ɼใׇద͵੣ଆର੏Ν੖ඍ

ର੏͹੖ඍڇڛϭέοϱ੣ଆ͹ΫϡϏετΡ֮ฯ ϭέοϱؖ࿊༽඾͹ࠅ಼੣ଆʀ

ΏΠρι΢ɼحࣆସͶଲԢͤΖ BARDAΏDODɼHHSͲͺώ΢Πϩ༲ٺەͲܠH1N1ླྀߨΝण͜ɼࢊָׯ࿊ ෾Ν֮ฯڇڛ౵͹ؖ࿊༽඾͹ࠅ಼੣ଆ͹֨୉ʀحϭέοϱ੣ଆʀैలʀ࢕৏͝ࢬઅΝઅཱི ஭ࣻ

ҘͶࡏ͢ɼҫ༂ڶઝ঳౵͹״BARDAͺ2012೧ΓΕɼ „ ͳ͢؂఼ „ BARDAͺαϫψϭέοϱʀ࣑ྏ༂֋൅ࢩԋ͹Ҳڎ֋൅Ώ੣ଆ౵Ν୴͑॑གྷڂ඾͹ਟଐ͵ݜ ෾Ν֮ฯڇڛ͹ࠅ಼੣ଆʀحʤCIADMʥΝธࠅ಼Ͷઅ஖ ͱɼώ΢Πϩ༲ ͹ࠅ಼Ͳ͹حϟϨʖϧϱχयʤEmergent BioSolutionsऀक಍ʥɼ ¾ 2020೧7݆ɼCorningऀ͹ώ΢Πϩ༲ ¾ ɽ͞ΗڛόʖηΩϫϧψ΢ψयʤόώϩτΡηऀʤϭέοϱ ੣ଆΫϡϏετΡ֨୉Ͷ2Ա400ຬχϩΝ఑ ฑ ͺBARDA͹ࢨఈͤΖϭέοϱΏ࣑ྏ༂֋൅ح෨໵ʥɼτΫγηयʤτΫγηA&M୉ָʥ͗क಍͢ɼ Δ͹༲ ڛΏ୉ָ͹ࢬઅΝCIADMͳ͢ͱࢨఈ Νߨ͑ϏʖφψʖͶଲ͢ͱ༑઎దͶ఑ۂة࣎ ຿ؔ „ BARDAͺ2013೧ΓΕɼϏϱυϝρέ࣎Ͷैలʀ࢕৏ „ DODΏHHSͶ͕͏ͱ΍ϭέοϱɼਏஇΫρφͶචགྷ͵ ੣ଆΝߨ͑ࢬઅ͹ϋρφϭʖέʤFFMNʥΝߑ஛ ෼ࣁΝ֮ฯ͝ 2020೧7݆ɼDODͳHHSͺɼBecton, Dickinson ¾ ە ΢ϱυΡΠψयɼόʖηΩϫϧ΢ψयɼωϣʖ ¾ and CompanyͶଲ͢ɼαϫψݗࠬ୼຦ʰBD ٺ ͹ࢬઅΝࢨఈۂةζϡʖζʖयɼϓϫϨξय౵͹ ୉Ͷ༁֨;ٶ࣎ Veritorʱ޴͜Πρι΢͹ਫ਼ࢊઅཱི ڛ2,430ຬχϩΝ఑ ¾ 2020೧8݆ɼDODͺGoldbelt SecurityͶଲ͢ɼαϫ ʀਓ͹௒ୣͶ1Աحψϭέοϱ͹౦༫Ͷ޴ͪ͜஭ࣻ ڛธ੕ැͺCIADMͲ͹αϫψϭέοϱ͹੣ଆ೵ྙΝ֮ฯ 2,500ຬχϩΝ఑ „ ͹ԾɼTeelܠธ੕ැͺEmergent BioSolutionsऀͶ6Ա2,800ຬχ ¾ 2020೧10݆ɼDODͺHHSͳ͹࿊ ¾ ە ઝ঳͹ݗࠬ״αϫψΤ΢ϩηܗϩʤ2020೧6݆ʥɼτΫγηA&M୉ָ͹CIADMͶ2 PlasticsͶଲ͢ɼ৿ ٺ ࣎ Ա6,500ຬχϩʤಋ೧7݆ʥ͹νηέΨʖξʖΝ൅ߨ Ͳ࢘༽ͤΖηϭϔητΡρέ͹ࠅ಼ਫ਼ࢊΫϡϏε ڛɼϭέοϱ͹ਫ਼ࢊ೵ྙΝ֮ฯ τΡ֨୉Ͷ༁698ຬχϩΝ఑͢

ड़ॶʁड़ॶʁBARDA, “Department of Health and Human Services’ Centers for Innovation in Advanced Development and Manufacturing”, GAO, “National Preparedness: HHS Has Funded Flexible Manufacturing Activities for Medical Countermeasures, but It Is Too Soon to Assess Their Effect”ɼDOD, “Coronavirus: DOD Response Timeline”౵

69 ࣎ٺە ฑ࣎ ൭ʁ๑੏ౕ౵੖ඍخ֋൅ਬ਒ڂݜ ౵΃͹໖੻Ν൅ྫͪ͢ଠɼྡজࢾݩࣰࢬ͹ंۂͰ͚ϭέοϱ੣ଆخPREP๑Ͷ Ϊ΢χϧ΢ϱΝ൅නɽ࣑ྏ๑͹ট೟ϕϫιηՅଐԿϕϫήϧϞ΍৿ͪͶ֋࢟

PREP๑ʤPublic Readiness and Emergency ৿ܗαϫψΤ΢ϩη࣑ྏ๑ՅଐԿϕϫήϧϞ(CTAPʥ Preparedness Actʥ Ͱ͚ ৿͢͏࣑ྏ๑͹֋൅ଇ਒͹ͪΌɼخHHSௗׯͺ2020೧3݆ɼPREP๑ʤ2005೧੔ཱིʥͶ „ αϫψΤ΢ϩη࣑ྏ๑ՅଐԿϕϫήϧϞ(CTAPʥΝ֋࢟ܗઑݶΝ൅න ৿ қ͹ҩ๑ߨҟ͗͵͏ݸΕɼ༂෼ɼਫ਼෼੣ࡐɼބಋ๑Ͳͺɼ ¾ ɼφϨΠʖζޛ͹֋൅ʀݗࠬʀ੣ଆʀླྀ௪ʀ௒ࡐͶؖ༫ͤΖݺਕ „ ϟʖϩ૯޳Ͳ໲͏߻ΚͦΝण྘حؽ ͹ࠠཛྷɼΉͪͺ෼దଝ֒͹ οʖϞ͗24࣎ؔҐ಼Ͷण྘͹ࢭΝ௪எۂΉͪͺૌ৭Ͷਕਐউ֒ɼࣆ ఑ҌͶؖͤΖචགྷ͵໲͏߻Κͦ౵Ν௪͢ɼυΡ „ ͶଲͤΖ໖੻Ν༫͓ΖݘݸΝHHSௗׯͶ෉༫ ໲͏߻Κͦٽ੧ ηΩρεϥϱ͹֋࢟Ͷ͍ͪΕॉ෾͵৚ๅ͹ΏΕ ઝ঳ϭέοϱ״αϫψΤ΢ϩηܗΏ ౵͹৿ ‡ Pfizer Moderna ͳΕΝࣰࢬ ͺ੻೜͖ۂةͶқਦͦͥͶ໲ୌ͗൅ਫ਼ͪ͢৖߻ɼ͞ΗΔ͹ Δ໖ঈ „ FDA͹֚౲Ϥωρφ΃఑Ҍ಼༲Νૻ৶͢ɼ৻ࠬ ಋ๑͹ઑݶͺ2020೧2݆ͶḬͮͱ༙ްͳ͵Εɼ2024೧10݆ ‡ 1ೖΉͲ༙ް

ڛPre-IND „ ఑ҌͶଲͤΖΠχώ΢ηΝ఑ FDAͶΓΖྡজࢾݩΪ΢χϧ΢ϱ ϝʖτΡϱή ઝ঳ؖ࿊ҫ༂඾״αϫψΤ΢ϩηܗFDAͲͺ2020೧3݆ɼ৿ „ ͹ྡজࢾݩ͹ࣰࢬͶؖͤΖΪ΢χϧ΢ϱʰConduct of ଲে͗෈౲͵ϨηέͶڂਅ੧͠Η࣑ͪྏ๑͹ݜ „ Clinical Trials of Medical Products During the COVID-19 INDs Public Health Emergency Guidance for Industry, ࡿ͠Η͵͏͖͹඲Ճ౵Νࣰࢬ Investigators, and Institutional Review BoardsʱΝ൅නɽ Ґޛɼ෵਼յߍ৿ ͏͵2020೧10݆͹ߍ৿࣎Ͷͺɼϭέοϱ͹EUAট೟Ͷ޴͜ͱ „ న઀׎ͯট೟͠Ηͪཤ༽Ն೵͵େ଺ྏ๑͗ ¾ ࢘ٺەࡎ EUAs ৖߻౵ɼಝఈ͹གྷ݇͗ຮͪ͠ΗΖ৖߻ɼىਅ੧ं͗චགྷ͵υʖνΏ৚ๅ͹ਬওࣆߴͶͯ͏ͱ ՆʤEUAʥΝ൅ߨڒ͹ͪΌ͹༽

ड़ॶʁHHS “Public Readiness and Emergency Preparedness Act”ɼnDeclaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19”ɼFDAΤΥϔγ΢φ౵

࣎ٺە ฑ࣎ ઝ঳΃͹ଲԢકྲྀ״αϫψΤ΢ϩηܗʤࢂߡʥธࠅώ΢υϱ੕ݘͶ͕͜Ζ৿ ԿͶࣁͤΖࢬࡨΝ؜΋ࠅՊકྲྀک֋൅Ώ੣ଆ೵ྙڂώ΢υϱ੕ݘ൅ଏཎೖͶݜ Ν൅නɽ੕ࡨ͹༑઎ࣆߴͶ΍ϭέοϱ͹৻ࠬϕϫιη౵͹ࢬࡨΝ؜΋ ֋൅ؖ࿊͹क͵ࢬࡨᶅ ࿊๞੕ැ಼͹ର੏੖ඍڂCOVID-19ଲԢʀϏϱυϝρέ६ඍ͹ࠅՊકྲྀ ݜ ઝ঳ଲࡨΝ଍͸ͱ౹ׇؽ೵Ν୴͑״αϫψΤ΢ϩηܗ࿊๞੕ැ͹৿ „ 2021೧1݆ɼώ΢υϱ୉౹྘ͺम೜ཎೖͶ৿ܗαϫψΤ΢ϩη ϪηϛϱηοʖϞʤCOVID-19 Response OfficeʥΝฦ੔ɽΨώϜ੕ ઝ঳ͶଲͤΖકྲྀΝ൅න״ ݘ͗ࠅՊ҈સฯ্ճ٠ʤNSCʥ͹ԾͶ૓અͪ͢ήϫʖώϩϖϩηι Ν࠸ߑ஛ۃώ΢ΨυΡϓΥϱη;ٶΫϣϨτΡ ࠅՊકྲྀͶ͕͜Ζ7ͯ͹໪ඬ ઝ঳ଲԢ௒੖ׯ͹અ஖ͳͨ״αϫψΤ΢ϩηܗ୉౹྘ࢨྫ*2Ͷͱɼ৿ ¾ ఈɽ௒੖ׯ͹ༀׄͶͺϭέοϱ౵͹ਫ਼وธࠅ຿͹৶བյ෰ ͹ༀׄ౵͹ର੏Ͷͯ͏ͱ .1 ΖखૌΊ͹௒੖౵Ν؜΋ܐʀഓාΏਏஇτηφ͹֨୉Ͷڇڛસ͖ͯްՎదɼใׇద͵ϭέοϱʀΫϡϱϘʖϱ͹ఴ֋ ࢊʀ҈ .2 Τ΢ϩη֨ࢆ͹ܲݰʤϜηέ஥༽Ώݗࠬɼ෾ੵɼ࣑ྏɼυʖνɼ .3 ֋൅ਬ਒ڂ֋൅ؖ࿊͹क͵ࢬࡨᶆ ࣑ྏ๑͹ݜڂҫྏਕࡒɼ໎֮͵ޮ़Ӷਫ਼ਭ६͹֨ैʥ ݜ ઝ঳͹࣑ྏ๑֋൅ʀ඲ՃͶ޴͜ɼଡ༹͵ྡজࢾ״αϫψΤ΢ϩηܗࠅ๹ਫ਼ࢊ๑͹׈༽ „ ৿;ٶࢩԋ͹֨୉ٺە͵ਟଐ .4 ɼྃߨ͹࠸֋͹ྈཱི ݩΝࣰࢬͤΖͳͳ΍Ͷɼ઴ྡজ͹ޫึ୵ࡩʀ֋൅ϕϫήϧϞΝઅཱིۂͳָߏΏࣆޤ࿓ಉं͹ฯ .5 ͵ฑ౵͹ਬ਒ʤਕझʀஏ๏֪ࠫʥ „ αϫψ଒͹Τ΢ϩηΝඬదͳͪ͢৿͢͏߇Τ΢ϩη༂͹֋൅Ͷචགྷ;ٶޤ߶Ϩηέਕ޳͹ฯ .6 Ҙ΃͹ଲԢྙրવ ઴ྡজςʖϩΝ֋൅ڶগཔ͹;ٶࠅࡏద͵ธࠅࢨ಍ྙ͹յ෰ .7 Կک֋൅͹֦ϓΥʖθͶ͕͜Ζࢩԋڂݜ „ Ν௪͢ɼ࠹న͵࣑ྏνʖΰρφ͹ಝܠֆ౵ͳ͹࿊ۂΠΩυϝΠɼࢊ ¾ COVID-19ͳଲ߇ͤΖͪΌ͹ώ΢υϱ-ύϨηܯժ ఈʀ༑઎෉͜ɼύ΢ηϩʖϕρφʀηέϨʖωϱή͹Πρι΢અܯ౵ ժΝ ΍؜΋ܯઝ঳ͶଲͤΖ״αϫψΤ΢ϩηܗ༑઎ࣆߴͳ͢ͱɼ৿ ୉౹྘ࢨྫ*3Ͷͱɼ৿͢͏࣑ྏ๑֋൅͹ଇ਒Ͷ޴͜ɼHHSௗׯͶଲ͢ɼ ¾ ɼ͢ܠͶɼචགྷͲ͍Ηͻ੕ැؽؖҐ֐͹Ϗʖφψʖͳ࿊ڠϙϭ΢φύΤηΤΥϔγ΢φ৏Ͳޮ֋ɽ NIHॶௗͳ ΝࢩԋͤΖͪΌ͹કྲྀ͹ࡨఈ͹ࣰࢬΝࢨࣖڂ֋൅ؖ࿊͹ࢬࡨͺकͶҐԾΝ؜΋ ݜڂݜ Կک֋൅ؖ࿊͹क͵ࢬࡨᶇ ࠅ๹ਫ਼ࢊ๑͹׈༽ͶΓΖ੣ଆ೵ྙڂસธࠅ຿ͶໃྋͲϭέοϱ͗಩͚͞ͳΝฯৄͤΖͪΌͶɼ ݜ „ ϭέοϱ͹੣ଆʀླྀ௪͹ܯժͶ250ԱχϩΝ೩ड़ ඾ɼڇڛΖܐΝ༫͓͵͏Γ͑Ͷ „ ࠅ๹ਫ਼ࢊ๑ʤDPAʥ͹൅ಊͶΓΖϭέοϱંझʀਏஇͶڻϭέοϱ͹҈સ੓ʀ༙ް੓͹݀ఈͶ੕࣑͗Ӫ „ ʤPPEʥ෈ଏ΃ଲԢ۫ޤΖͤ΄ͱ͹݀ఈͶͺՌָं͗ؖ༫ɼ ݺਕ๹ܐΖͪΌɼᶅ҈સ੓ʀ༙ް੓Ͷͤ ଲেͶͺࢾݩࢾ༂ɼ ݗࠬ͹ͪΌ͹෾ੵؽփɼਟଐݗࠬΫρφɼ ¾ ᶆFDA͗ট೟ͤΖϭέοϱ͹ྡজυʖνΝޮනɼᶇϏϔϨρέʀϪ PCR ״αϫψΤ΢ϩηܗɼεϨϱζɼ৿حυρχηϘʖη͹ঙ͵͏஭ࣻ ϑϣʖ͹ͪΌ͹ๅࠄॽࡠ੔ʀ٠ճ΃͹఑ड़ʀໃݗԀͲ͹൅න ʀࡒྋ౵Ν؜΋حઝ঳͹ϭέοϱ͹੣ଆʀླྀ௪ଇ਒Ͷචགྷ͵ؽ ͹࠸ߑ஛ۃώ΢ΨυΡϓΥϱη;ٶήϫʖώϩϖϩηιΫϣϨτΡ „ ୉౹྘ࢨྫ*4Ͷͱɼ঴ுͶଲ͢ɼDPAΝ؜΋ͤ΄ͱ͹న઀͵ݘݸΝ׈ ¾ Կکธࠅࠅࡏ֋൅ு͹බݬର௧੽ϕϫήϧϞʰ ʱ͹࠸࢟ಊʀ „ ඾෈ଏ΃ଲԢͤΖΓ͑ࢨࣖڇڛPREDICT ༽͢ɼ ΨϓΡη͹࠸ݒښCDC͹Disease Detective*1͹ଁҽɼ๼ „

ࣆସ΃͹ଲԢΝߨ͑ༀ৮ *2. Executive Order on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19ٺەɼڂ͹௧੽ɼΠΤφϔϪ΢έ͹ݜ׳࣮ .1* and to Provide United States Leadership on Global Health and Security *3. Executive Order on Improving and Expanding Access to Care and Treatments for COVID-19 *4. Executive Order on a Sustainable Public Health Supply Chain ड़ॶʁWhitehouse, “Priorities COVID-19 The Biden-Harris plan to beat COVID-19”, “National Strategy For the COVID-19 Response and Pandemic Preparedness”

70 ࣎ٺە ฑ࣎ ʤࢂߡʥธࠅ͹Ռָٗढ़੕ࡨͶ͕͜ΖΫʖϏʖλϱ ૱ݩ͹͍Ζਕ෼͹ౌ༽ɼࠅ๹ܨͲ͹ۂة઴੕ݘͲͺαϫψͶ͕͏ͱ΍୉घ੣༂ ঴͹ؖ༫͗߶͖ͮͪ͗ɼ৿੕ݘͲͺ॑གྷϛηφͲ͹Ռָं͹ౌ༽͗໪ཱིͯ φϧϱϕ੕ݘʤ2017- 2021/1ʥ ώ΢υϱ੕ݘʤ2021/1-ʥ Alex Azarࢱ Xavier Becerraࢱ HHSௗׯʤ2018-2021/1ʥ HHSௗׯ ͱɼ ʀΩϨϓΧϩωΠय࢚๑ௗׯܨ໲ɼ෯ௗׯΏEli Lilly USA͹ऀௗΝޒʀHHS͹๑ཱ HHSௗׯΝແΌͪ ͳ͢ͱΨώϜίΠʤACAʥ͹ ୉Ͷ஭ྙ֨ ʀ༂Ճ͹Ӏ͘Ծ͝ΏΨϒΨ΢χ໲ୌ΃͹ଲԢ౵Ͷ஭ྙɽ Eric Landerࢱ ͺɼϙϭ΢φύΤηޛઝ঳൅ਫ਼״αϫψΤ΢ϩηܗ৿ ໲ޒOSTPௗׯʀՌָ Frances H. Arnoldࢱɼ ڂ͹νηέϓΧʖη͹ϟϱώʖͳ͢ͱࢂՅͤΖ౵ɼݜ ʀ ͹ϔϫʖχ ֋൅Ͷؖ༫ MIT/Harvard Maria Zuberࢱ ಋ٠ௗڠॶݫॶௗɼҪఽָंɼ PCASTڂݜ ෾ࢢਫ਼෼ָंɼ਼ָ Moncef Slaouiࢱ ʀArnoldࢱͺόʖϗϩԿָৈ ʀφϧϱϕ੕ݘͲͺ༁2೧ ໲ʤ2020-2021/1ʥ णৈ͹ՌָंɼZuberࢱͺMITޒOperation Warp Speed͹कੰ ௗׯ ͪͮͫੰۯ͚ۛ दگΚͮͱ͕Εɼ OSTP ͹ஏཀྵ෼ཀྵָܠͶௗΔ͚ڂʀϭέοϱݜ ɼώ΢υϱ੕ݘͲͺ಼͗ͫ ޛ֋൅੻೜ंͳ͢ͱΦϚϧ ʀφϧϱϕ੕ݘͲͺम೜ڂGlaxoSmithKlineͶͱݜ ϟϱώʖͶ֪৏ֵ͝ ͱɼ 33ϳ݆࢟ಊ͢͵͖ͮͪPCASTܨΝ؜΋ϭέοϱ֋൅Ν؄ಞɽModerna͹ༀҽΝ ໲ΝແΌͪ ͫ͗ɼώ΢υϱ੕ݘͲͺ૥ଐޒOperation Warp Speed͹डੰ ׈ಊ֋࢟

Operation Warp Speed͹ਬ਒ର੏ Francis Collinsࢱ ࣧߨ੻೜ं ୴౲੻೜ं NIHॶௗ Jeff Zientsࢱ ʀ2009೧ʤΨώϜ੕ݘʥ Coordinator of the ؖ࿊੕ැؽؖ ΓΕNIHॶௗ͹ྡজҪఽָं܋ ҫྏ੕ࡨؖ࿊ ੕ැؽؖ COVID-19ଲԢ௒੖ׯ݋୉ ‡ ϭέοϱʁMatt Hepburn ౹྘ޒ໲ Anthony Fauciࢱ Moucel Slaouiࢱ ‡ ϭέοϱʁ ࣑ྏ๑ʁSean Biggerstaff ʀΨώϜ੕ݘͲͺNECௗׯ NIAIDॶௗ ɼCOVID-19 ‡ Peter Marks ‡ ਏஇ๑ʁ ౵ΝແΌɼ कੰҫྏޒ໲ ‡ ࣑ྏ๑ʁ HealthCare.gov Major General Lee Payne ͹ϫʖϩΠΤφͶଲԢɽ຿ ʀ1984೧ΓΕNIAIDॶௗΝແ Janet Woodcock ‡ ੣ଆʀླྀ௪ʁ ઝ঳͹઒໵Պɽώ΢υ״ݩ΍༙ͤΖ ΌΖܨStacy Cummings ؔιένͲ͹ Gustave F. ‡ ਏஇ๑ʁ ‡ ιΫϣϨτΡʀࢩԋʁ ޒʀώ΢υϱ੕ݘͲͺϏϱυ ϱ੕ݘͲͺCOVID-19͹ҫྏ Perna཰܋୉গ Bruce Tromberg Andrew Kilianski ϝρέ͹ଲԢસରΝ౹ׇ ໲Ͷ΍म೜

ड़ॶʁHHSΤΥϔγ΢φɼNPR, “Biden Administration: Here Are His Cabinet Members And Key Advisers”ɼICAS, “Top Announced Biden Administration Personnel in Diplomacy & Foreign Policy”౵

71 ӵࠅ

72 ࣎ٺە ฑ࣎ ਫ਼ࢊ͹ؽ೵ैଏ͹ͪΌ͹଩ͬघʁγϜϨ;ٶ֋൅ڂݜ ͵࢘༽Ն೵͗ंڂ֋൅ਬ਒Ώࠅ಼֐͹ݜڂؽؖ౵ͶΓΖݜڂMRCࢁԾ͹ޮదݜ ֋൅ςʖϩΏϕϧρφϓΧʖϞΝ֋൅ʀ੖ඍ͢ͱ͏Ζڂݜ ؽ೵ैଏ͹ ຎྭʁਏ - ਏஇ๑ ࣑ - ࣑ྏ༂ ϭ - ϭέοϱ ֋൅ ֋൅ ਫ਼ࢊ ਫ਼ࢊ ڂݜ ڂ଩ͬघ ݜ

કྲྀࡨఈʀ ϭ ଲԢ͹ର੏੖ඍʤ੕ැ಼Ͳ͹νηέϓΧʖηʤUK Vaccine Taskforce౵ʥઅཱིʥٺە સର౹ׇ ਏ ࣑ ϭ ֋൅ਬ਒ࢩԋڂਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ֋൅͹ঁ੔ʀݜ

ਏ ࣑ ϭ ֋൅ʀਫ਼ࢊ͹ͪΌ͹ࣁ֮ۜฯʤ༁528Աԃ͹༩ࢋʥڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿

֋൅ڂݜ ਬ਒ ਏ ࣑ ϭ ੕ැक಍Ͳ͹αϱλʖ ࣑ NHS DigiTrialsΝཤ༽ͪ͢ Ͳ͹ྡজࢾݩࣰࢬʤRECOVERY trialʥؔغʤΰόϞ౵ʥ ୻ڂݜેخεΠϞͶΓΖ ࣑ ϭ ׯ຿ηϏαϱؖ࿊αϱλʖ ڛεΠϞ΃͹ࢂՅɼηϏαϱ఑ Τ΢ϩη͹ࡠ੔ܗਏ ࣑ ϭ ໝ٘ ʤMRC-LMBʥ ਏ ࣑ ϭ Τ΢ϩη͹ࡋ๖৷೘ʀ ଁ෱ͤΖ๏๑͹ಝఈʤMRC-LMBʥ

ਏ ࣑ ϭ ک͹ ϭ ϭέοϱ੣ଆઅඍ͹ଁڂઝ঳ؖ࿊ݜ״αϫψΤ΢ϩηܗ֋൅ ਏ ࣑ ϭ Τ΢ϩη஁പɼDNAɼ ৿ڂݜ ൭ ߇ର౵͹ਫ਼ࢊʤCoronavirus Toolkit) ঁ੔Ͳ͹༑઎Ϫϑϣʖϕϫιη͹੖ඍʀࣰࢬ ʤΩνϏϩφɼVMICɼ౵ʥخਬ਒ ͹݄ӹ৚ๅΏҪఽࢢ৚ๅ͹ ࣑ ϭ ྡজࢾݩ͹ਅ੧घକ͘Ͷ͕͜Ζं׳ ʤઅඍʀࣁࡒʀ ਏ ࣑ ϭ ઝ঳ؖ࿊֋൅͹༑઎״αϫψΤ΢ϩηܗ๑੏ౕ౵ʥ υʖνϗʖηߑ஛ʤCO-CONNECTʥ ৿ ઝ঳͹ਏஇΫρφ͹״αϫψΤ΢ϩηܗਏ ৿ ਅ੧ϓϫʖ͹੖ඍ ਏ ࣑ ϭ ࢬઅॊࣆं޴͜Ϊ΢χϧ΢ϱ͹੖ඍڂϧϚʀݜ ʤࢂߡʥEUͶ͕͜Ζखૌ અඍ΃͹Ψʖϕϱ ϭ ໃ೟Ն͹ϭέοϱ΃ڂਏ ࣑ ϭ ݜ ੏รߍوՆΝ෉༫ͤΖͪΌ͹ڒΠέιη͹ਅ੧घକ͘ΝՅଐʤCERICʥ Ҳ࣎ద

࣎ٺە ฑ࣎ કྲྀࡨఈʀસର౹ׇʁUK Vaccine TaskforceʤVTFʥ Ν໪దͳ͢ͱڛઝ঳༽ϭέοϱ͹ࠅ຿΃͹఑״αϫψΤ΢ϩηܗదͶͺ৿غ୻ ԿΝ໪ࢨͤک͹ۂదͶͺগཔ͹Ϗϱυϝρέ΃ඍ͓ͪϭέοϱࢊغΖ͗ɼௗ͏

͹߻қڇڛͳ͹༑઎ۂةαϫψΤ΢ϩη „ ϭέοϱ֮ฯͶ޴͜ɼܗӵࠅࠅ຿ͶଲͤΖ༙๮͵৿ .1 ۂةઝ঳ϭέοϱ΃͹ਟଐ͵Πέιη͹֮ฯ ¾ ҡ͵ΖϭέοϱϠξϨτΡΝ֋൅͢ͱ͏Ζ״ Νࣰݳ 7ऀͳ߻қڇڛ͵ϭέοϱ͹ࠅࡏద ໪ద 2. ʀླྀ௪ΝࢩԋͤΖखૌΊڇڛࠅ΃͹ϭέοϱڷద͵ „ ৿غগཔ͹ϏϱυϝρέͶඍ͓ΖͪΌ͹ௗ .3 ൅ ʰCOVAXʱ΃͹ࢂՅۂϭέοϱકྲྀΝཱི֮͢ɼϧ΢ϓγ΢Φϱηࢊ Ζ ¾ ӵ੕ැͶΓΖ༁741Աԃ͹ࣁۜ౦Ծ͝ܪఴͶ ΍Ͳ͘Ζڇڛࣙࠅͫ͜Ͳ͵͚ଠࠅ΃͹ϭέοϱ ¾ ԿکΓ͑੣ଆΫϡϏετΡΝ Կکνηέ „ ϭέοϱ੣ଆʀླྀ௪ΫϡϏετΡ͹ ϓΧʖη ¾ ෵਼ϭέοϱϠξϨτΡ͹ਫ਼ࢊͶଲԢͤΖͪΌɼ „ 2020೧5݆ Ͷ޴ͪ͜ࣁۜ౦Ծک఼͹ଁڎʤVTFʥ ੣ଆ ԿͶखૌΞͲکಝͶmRNA͹੣ଆΫϡϏετΡ ¾ غ৏ཱི࣎͝ क͵ ͕Εɼ༁12ԳԃΝCPI΃ঁ੔ ఼ڎखૌΊ ¾ ࣙࠅ޴͜ϭέοϱਫ਼ࢊ༽Ͷ੕ැ͗Ҳ෨੣ଆ ੕ැؖ࿊ؽؖʁ ͹੣ଆΫϡϏετΡΝ֮ฯ „ ¾ BEISɼ DHSCɼ NIHRɼUK Government ¾ ϭέοϱ੣ଆགྷҽ͹ү੔ʀφϪʖωϱή΍ࢩԋ ର੏ʙ InvestmentsɼNIHR ʤ6ԱԃΝCGT catapult΃ঁ੔ɼCGTͶͱφ ϪʖωϱήΝࣰࢬʥ ֆۂؖ࿊ؽؖ „ ࢊ জࢾݩ͹ਬ਒ʀՅଐࢩԋྡ „ ۂةBioIndustry AssociationʤBIAʥɼݫ੣༂ ¾ ड़ਐं ¾ ࠅ຿ϪζηφϨʖ͹ߑ஛ࢩԋͶΓΖྡজࢾݩ͹ Ϩέϩʖφϟϱφ͹Յଐं׳ ෵਼͹ϭέοϱࢾݩͶΓΖϭέοϱ͹੓೵ʀ༙ ¾ VTF͹ਜ਼ࣞϟϱώʖͲͺ͵͏͗ɼLife Science ް੓͹඲ՃΝಋਭ६ͲࣰࢬͤΖͪΌɼඬ६Կ Industry Strategyʤ੕ැ΃͹఑ݶॽʥࡨఈͶ΍ Πρι΢Ν֋൅ ʀ६ඍܯؖ༫͢ͱ͏ͪSir John Bell΍VTFͶଲ͢ͱঁݶ ¾ ϐφοϡϪϱζࢾݩ͹અ ෨໵ΏܐVTF͗क಍ͳ͵Εɼଡ਼͹੕ැؖ ‡ ٠Νਬ਒ڢWellcome Trustͳ͹ ड़ॶʁBEIS ”UK Vaccine Taskforce 2020 Achievements and Future Strategy”, BEIS “Inside the Race to Develop a COVID-19 Vaccine”, Gov.UK “Government launches Vaccine Taskforce to combat coronavirus”ɼ| UK scientists worry vaccines may not protect against S.African coronavirus variant’” Reuters

73 ࣎ٺە ฑ࣎ ܠકྲྀࡨఈʀસର౹ׇʁࢊָׯ࿊ ֋൅Νଇ਒ͤΖͪΌɼ෵਼͹αϱλʖεΠϞڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿ ཱི͗ͬ৏͗ͮͪ

खૌΊ໌স ࢂժʀϏʖφψʖ஄ର ֕གྷ

Ϗʖφψʖͳ͢ͱҐԾ஄ର͗ࢂՅ ‡ UKRIɼฯ݊঴ɼWellcomeTrust͖Δ͹ܯ2,000ຬϛϱχ͹ ઝ঳͹εʖίϱ״αϫψΤ΢ϩηܗCOVID-19 ‡ ୉ָؽؖʁΨρέηϓΧʖχ୉ָɼ΢ϱϘϨ ࢩԋΝण͜ͱઅཱིɽ৿ ઝ͹௧੽ɼΤ΢ϩηรҡ͹ಝఈɼ݊߃״Genomics UK ΠϩΩϪρζϫϱχϱ౵ଡ਼ εϱήΝߨ͏ɼ αϫψΤܗCOG-UK) ‡ ੕ැؖ࿊ؽؖʁNHSɼӵࠅޮ़Ӷਫ਼ு౵ υʖνͳ͹౹߻ͶΓΕɼΤ΢ϩη͹ΰόϞͳ৿) ࡠ༽͹඲ՃΝ໪దͳͪ͢ޕՎͳ͹૮݃;ٶॶɼΤΥϩΩϞγϱ ΢ϩη͹ึҾࢢڂConsortium ‡ ຿ؔʁέΠχϧϞݜ ॶ౵ ׈ಊΝఴ֋ڂΪʖݜ

COVID-19 ‡ ੕ැؖ࿊ؽؖʁUKRIɼMRCɼξ΢ϢϠϱχϧ ͱઅཱི͠Ηͪ͢ڛUKRIɼWellcomeTrust͗क͵ࣁۜΝ఑ ‡ Protein ΢φλʖη౵ αϫψΤ΢ϩܗαϱλʖεΠϞͲɼӵࠅ͹ՌָंؔͲ͹৿ Production ‡ ຿ؔʁWellcomeTrust౵ Ν໪దͳ͢ͱ׈༙ڠઝ঳Ͷؖ࿊ͤΖνϱϏέ࣯ࢾ༂͹״η Consortium ‡ ୉ָؽؖʁϔϨηφϩ୉ָɼήϧηβʖ୉ָ ಊ ॶ౵ڂCPPC) Τ΢ϩηݜ) ݸ෉͘Ͳ༁ ຬ͹ࣁۜ఑غɼ ͶΓΖ ϳ݆͹ ‡ UK Ϗʖφψʖͳ͢ͱҐԾ஄ର͗ࢂՅ UKRI NIHR 12 650 Νण͜અཱིڛ coronavirus ୉ָؽؖʁώʖϝϱΪϞ୉ָɼίϱϔϨρζ ‡ ΝࣰࢬڂτʖϜΝઅఈ͢ɼݜڂimmunology ୉ָ౵ଡ਼ ‡ 5ͯ͹ݜ ໖Ӻɼᶇ໖ӺබཀྵָɼᶈިࠫൕԢ੓αϫψޜconsortium ᶅҲ࣏໖Ӻɼᶆ๹ ຿ؔʁӵࠅ໖ӺָճɼISARIC4C౵ ‡ (UK-CIC) Τ΢ϩη໖Ӻɼᶉ໖Ӻյඈ

ड़ॶʁMRC response to COVID-19ɼଠMRCΤΥϔγ΢φɼCOG-UKΤΥϔγ΢φɼ౵

࣎ٺە ฑ࣎ ֋൅ਬਬ਒ڂݜ ڠؽؖͺ୉ָͳڂ֋൅͹ͪΌɼޮదݜڂઝ঳ͶଲͤΖݜ״αϫψΤ΢ϩηܗ৿ ໝྡজࢾݩ౵ΉͲ෱߁͚׈ಊ͢ͱ͏ΖوΔ୉͖ڂݜેخಋͲ ଲেϠξϨτΡ ࣁۜ ؖ༫ं Dx Rx Vxڛࢬࡨʙࢾݩ ֕གྷ ఑ αϫψΤ΢ϩη ‡ MRCܗΝߨ͏ɼ৿ڂಋݜڠMRCͳΠΩυϝΠͺ ‡ ઝ঳͹ςʖϩΫρφΝ֋൅״ Coronavirus ‡ The University of ‡ 120Ґ৏͹DNAέϫʖϱɼ70Ґ৏͹νϱϏέ࣯ɼ42Ґ৏͹ Dundee Toolkit ߇ରΝਫ਼੔͢ཤ༽Ն೵ Ͷ޴͜ΤΥϔ৏Ͳޮ֋ंڂ੊ֆ஦͹ݜ ‡ ‡ MRC-Laboratory for Molecular BiologyʤLMBʥͺॶ༙ͤ ‡ MRC-LMB ͳߑଆਫ਼෼ָ͹઒໵੓Ν׈͖͢Τ΢ϩηںStudy of Virus Ζ߶մ଀ౕݨඏ ϠξϨτΡ ڂreplicates ͗ࡋ๖಼Ͷ৷೘͢෵੣ͤΖ๏๑Νݜ ڂ௪ݜڠ Τ΢ϩη͹ࡠ੔Νࣰࢬܗٛࣇ ‡ ڂݜ MRC ‡ ״αϫψΤ΢ϩηܗΝߨ͏৿ڂಋݜڠMRCͳΠΩυϝΠͺ ‡ Study of Spike Νࣰࢬ ‡ The Francis Crickڂઝ঳͹ηϏ΢ένϱϏέ࣯ߑଆ͹ݜ Protein Institute ‡ MRC – University of Glasgow Centre for Virus Research ‡ ˌ50ຬ ‡ MRC 㾐 ઝ঳ ‡ CVR״αϫψΤ΢ϩηܗಋ͢৿ڠʤCVRʥͳΠΩυϝΠ͗ ΝࣰڂCRUSH ͶଲͤΖ༂෼ηέϨʖωϱήΏଳ੓Τ΢ϩηԿ͹ݜ ࢬ 210ຬ ‡ MRC 㾐ˌ ‡ ׳ઝ঳͹ࠅཱིබӅ͹೘Ӆ״αϫψΤ΢ϩηܗMRCक಍Ͳ৿ ‡ ໝ͵ϧϱξϞԿࢾݩΝوΝଲেͳ࣑ͪ͢ྏ๑ͶؖͤΖ୉ं RECOVERY ࣰࢬ ੏͹ট೟͗9ೖؔͲ׮྅و;ٶtrial ‡ ඬ६30-60ೖ͹ྛཀྵద ౌं׳NHS DigiTrialsΝ׈༽͢3ϳ݆Ͳ176ࢬઅ12,000ਕ͹ ‡

֋൅ ࿧Νࣰݳ MRCक಍ͲϪϞυϞεϑϩ͹ϧϱξϞԿࢾݩΝࣰࢬ ‡ MRC 㾐 ‡ ΝॄΌͱ͕ΕɼӵࠅͳάϨεϡं׳ACTT-EU/UK ‡ ੊ֆ஦Ͳ1,000ਕҐ৏͹ ͲMRC-Clinical Trials Unit͗ࢾݩΝ୴౲

ड़ॶʁMRC response to COVID-19ɼଠMRCΤΥϔγ΢φɼNature 584, 326 (2020) ɼNHS DigitalΤΥϔγ΢φɼ౵

74 ࣎ٺە ฑ࣎ ൭ʁࢬઅʀઅඍخ֋൅ਬ਒ڂݜ ର੏͹੖ඍͶଡֻ͹ࣁۜ౦ԾΝߨ͑͞ͳͲਫ਼ڇڛ੕ැ͗ϭέοϱ͹੣ଆઅඍΏ Կ͗ਦΔΗͱ͏Ζکࢊର੏͹ߑ஛ʀ

ଲেϠξϨτΡ ࣁۜ ؖ༫ं Dx Rx Vxڛࢬઅʀઅඍ ֕གྷ ఑ ‡ ӵ੕ැͺCell and Gene Therapy Catapult ˌ1Ա ‡ Cell and Gene Therapy ᤯ Catapult Manufacturing Innovation Centre ͶϭέοϱΏ ʤӵ੕ැʥ Catapult ΢όϗʖ ઎਒ҫ༂඾͹੣ଆઅඍͶड़ࣁɼຘ਼݆ඨຬਕ෾ Manufacturing εϥϱ ͹ϭέοϱ੣ଆ͗Ն೵ Innovation Centre ੣ଆ ‡ 2021೧12݆Ͷࢬઅસର͗׮੔༩ఈ ιϱνʖ ‡ 2020೧ՈͶ෨෾దͶ׮੔ͤΖϭέοϱഓඍࢬઅ ڛͶͺӵ੕ැ͗พ౏ࣁۜΝ఑ ‡ Vaccines Manufacturing Innovation Centre ˌ6.6એຬ ‡ University of Oxford ᤯ ʤUKRIʥ ‡ Imperial College and ۂةʤVMICʥͺӵ੕ැक಍͹΍ͳΠΩυϝΠͳ ϭέοϱ ͳ࿊ܠ͢ͱઅཱི the London ੣ଆͶଲ ‡ LSHTM;ٶ੣ଆࢬઅʁ ‡ ෵਼͹ϭέοϱϠξϨτΡ͹֋൅ VMIC Ԣͪ͢ࢬઅΝ੖ඍ ‡ Pharmaceutical K.K. ‡ MSD ‡ Cytiva ‡ ӵࠅ੕ැ͗CDMOʤCP Pharmʥͳިম͢ɼ ‡ CP Pharm ᤯ ϭέοϱ OxfordͳAstraZeneca͹ϭέοϱ੣ଆΫϡϏε ੣ଆ τΡΝ֮ฯ͢ͱ͏Ζ ΫϡϏε τΡ֮ฯ

ड़ॶʁ GOV.UK ,GEN, Science Business Reporting , GOV.UK “Industrial strategy delivers new vaccines manufacturing centre to lead the fight against deadly disease”

࣎ٺە ฑ࣎ ൭ʁυʖνϗʖηʀϕϧρφϓΧʖϞخ֋൅ਬ਒ڂݜ ͹৚ๅʤΰόϞɼ݄ӹ౵ʥΝ༽͏ͱɼ༹ʓ͵υʖνϗʖηΝߑ஛͢ɼं׳ࠅ຿Ώ Ώඅݩं͹ਟଐ͵ϨέϩʖτΡϱή౵΃͹खૌΊ͗ߨΚΗͱ͏Ζڂබݬରݜ υʖν ଲেϠξϨτΡ ࣁۜ ؖ༫ं Dx Rx Vxڛϗʖη ֕གྷ ఑ ໝ ෈໎ ‡ NHS ᤯᤯وઝ঳ͶଲͤΖ࣑ྏ༂͹୉״αϫψΤ΢ϩηܗ৿ ‡ জࢾݩͶNHS DigiTrialsΝ׈༽ͪ͢͞ͳͲɼ3ϳ݆ ‡ IBMྡ NHS ؔͲ12,000ਕ͹අݩंΝ176ؽؖͲϨέϩʖτΡϱ ‡ HDR-UK ઝ঳Ͷؖ״αϫψΤ΢ϩηܗDigiTrials ήͤΖ͞ͳͶ੔ޯɽ৿ ΖྡজࢾݩͲͺɼNHS DigiTrials͹ฑ࣎͹ؽ೵Ν֨ͤ ௃ͪ͢

400ຬ ‡ The Universities ofˌ ‡ ״αϫψΤ΢ϩηܗಋͲɼ৿ڠ੕ැͳΠΩυϝΠ͗ ‡ ͶυʖνϗʖηΝߑ஛ ϠξϨτΡخӹγϱϕϩΝ݄ं׳ઝ঳͹ ڂ௪ݜڠ ,ʤUKRIɼNIHRʥ Nottingham Ͳ͹Τ΢ϩηఽ೽΃͹֨ࢆ๹ࢯΏ࠹ ‡ University of Dundeeڠ໖ӺͶΓΖޮ ‡ CO- ৿͹࣑ྏ๑Ͷͯ͏ͱ͹৚ๅΝ౹ׇͪ͢υʖνϗʖη ‡ The Universities of ڛͶ఑ंڂCONNECT Νߑ஛͢ɼݜ Edinburgh ༽ंڂ͹৚ๅλʖη͖Δ߇ର৚ๅ౵Νफॄ͢ɼݜ ‡ 44 ‡ ͹ޮ֋ϕϧρφϓΧʖϞΝ੖ඍ HDR-UK ‡ PHE ‡ MRCΏNIHRͶՅ͓NHS EnglandɼWellcome Trustɼ ‡ ˌ300ຬ ‡ MRC Genomics Νण͜ɼGenomics Englandͺ ʤUKRIɼNRCʥ ‡ NIHRڛCRUK͗ࣁۜ఑ sequence ઝ঳ ‡ NHS England״αϫψΤ΢ϩηܗಋ͢ͱ৿ڠGenoOMICCͳ of Covid- Ν ‡ Wellcome Trustڂण੓Ͷͯ͏ͱ͹ݜ״ΰόϞ͖ΔΤ΢ϩηं׳͹ 19 ࣰࢬ ‡ CRUK Patients ‡ GenoMICC ‡ NIHRΏUKRIɼAsthma UKɼBritish Lung ෈໎ ‡ NIHR ᤯ Νण͜ɼබӅΏਏྏॶɼղ ‡ UKRIڛFoundation͖Δࣁۜ఑ ޤࢬઅͲ͹ਏஇ๑͗ʹ͹Γ͑Ͷࣰߨ͠Η͖ͪ඲Ճͤ ‡ CONDOR Asthma UK ಋϕϫήϧϞʤCOVID-19 National ‡ British LungڠΖଡࢬઅ DiagnOstic Research and Evaluation Foundation ʤCONDORʥʥΝࣰࢬ

ड़ॶʁ NIHRΤΥϔγ΢φɼMRC response to COVID-19ɼ౵ 75 ࣎ٺە ฑ࣎ ൭ʁ๑੖ඍخ֋൅ਬ਒ڂݜ ઝ঳ؖ࿊͹״αϫψΤ΢ϩηܗ৏ࢤʀླྀ௪Ͷ޴͜ɼ৿غ࣑ྏ༂Ώϭέοϱ͹૥ Ն౵͗ߨΚΗͱ͏Ζڒʀྡজࢾݩघକ͘͹༑઎Ώໃ೟Նϭέοϱ͹Ҳ࣎ڂݜ

ϭέοϱ ࣑ྏ༂ ਏஇ๑

ࢬઅॊࣆं޴͜҈સΪ΢χϧ΢ϱ͹ޮනʤనٕߍ৿ʥڂઝ঳ԾͲ͹ϧϚʀݜ״αϫψΤ΢ϩηܗ৿ ‡

ਏ;ٶઝ঳ਏஇ״αϫψΤ΢ϩηܗ६Ν ‡ ৿خ͹඲Ճڂ੓͹߶͏ݜٺە͹৻ࠬϕϫιηɼڂઝ঳ؖ࿊ݜ״αϫψΤ΢ϩηܗ৿ ‡ ޴͜͹Ϊ΢ξϱηंۂ఑ࣖ இΫρφ͹੣ଆ ઝ঳ؖ࿊͹ྡজࢾݩͶؖͤΖΪ΢ξϱηΝࡠ੔ʀޮනʤనٕߍ Ν൅නʤనٕߍ৿ʥ״αϫψΤ΢ϩηܗ৿ ‡

ʀ֋൅ ৿ʥ 9 ਅ੧๏๑ʀ඲Ճϕϫιη͹఑ࣖڂݜ ఈͳ͵Ζ৖߻͹఑ࣖوઝ঳ؖ࿊͹ྡজࢾݩ͹ਅ੧Ϫϑϣʖ͹ਟଐԿ 9 ಝྭ״αϫψΤ΢ϩηܗ৿ 9 ઒໵૮஌ϟʖϩ૯޳͹અ஖ɼࢾݩͶؖͤΖ૮஌͹ࣰࢬ 9 জࢾݩ͹ਅ੧๏๑͹఑ࣖྡ 9 ਫ਼ࢊ

‡ ࠅ಼Ͳ͹ϭέοϱླྀ௪ࢩԋΝ໪దͳ͢ɼ ଉΝรߍ͢ɼϧ΢ιϱη͗෉༫وݳߨ ͠Ηͱ͏͵͏ໃ೟Ն͹ҫ༂඾ͳϭέοϱ ΝҲ࣎దͶ೟Նʤ2020೧10݆ࢬߨʥ Նͳڒڇڛ͵ໃ೟Նҫ༂඾͹Ҳ࣎ద 9 Ζ৖߻Ͷͯ͏ͱ໎֮Կ͵ Ζ৖߻͹ͤڛ௪ 9 ໃ೟Նҫ༂඾Ν఑ླྀ ຿ࣆ੻೜໖ঈ͹న༽൥ҕΝ֨୉ ϭέοϱ౦༫Ն೵͵ं͹֨୉ 9 Նʤಝఈড়݇ʥڒໃ೟Նҫ༂඾͹ઑఽ 9 ͹ϧ΢ιϱη͹໖ঈंۂԹജ 9

ड़ॶʁDepartment of Health & Social CareΤΥϔγ΢φɼMHRA, “Guidance Clinical trials applications for Coronavirus (COVID-19)”౵

76 ࠅ

77 ࣎ٺە ฑ࣎ ਫ਼ࢊ͹ؽ೵ैଏ͹ͪΌ͹଩ͬघʁγϜϨ;ٶ֋൅ڂݜ ֋൅͹਒ṁ؇ཀྵ͹బఊͶՅ͓ɼԿ߻෼ϧ΢ڂݜ;ٶՌݜߊ䎖䶂ͶΓΖકྲཱྀིҌ ൭΍੖ඍخϔϧϨʖΏಊ෼Ϡυϩώϱέ౵͹ ؽ೵ैଏ͹ ຎྭʁਏ - ਏஇ๑ ࣑ - ࣑ྏ༂ ϭ - ϭέοϱ ֋൅ ֋൅ ਫ਼ࢊ ਫ਼ࢊ ڂݜ ڂ଩ͬघ ݜ ਏ ࣑ ϭ ֋൅οʖϞʥઅཱིʥڂଲԢ͹ର੏੖ඍʤՌݜߊ䎖享ʤ੕ැͶΓΖݜٺە કྲྀࡨఈʀ

֋൅Ͷ͕͜Ζڂસର౹ׇ ਏ ࣑ ϭ ਏஇ๑ʀϭέοϱʀ࣑ྏ༂͹ݜ τʖϜʥ͹ಝఈڂݜٺە༑઎ద྘Үʤ ਏ ࣑ ϭ ֋൅ਬ਒ࢩԋڂਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ֋൅͹ঁ੔ʀݜ

ਏ ࣑ ϭ ໝ෈໎ʥو֋൅ʀਫ਼ࢊ͹ͪΌ͹ࣁ֮ۜฯʤ໤དద͵༩ࢋڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿ Ռݜߊ䎖 ͶΓΕɼ ਏ ࣑ ϭ 享 জࢾݩ͹਒ṁʀ੔ՎͶ߻Κͦྡ ౦ԾϨλʖη͹௒੖౵ղ೘Νࣰࢬ

֋൅ ࣑ ࣑ڂݜ ਬ਒ Կ߻෼ηέϨʖωϱή͹ࣰࢬ ੕ැͶΓΖྡজࢬઅ͹મఈࢩԋ ࣑ ྡজࢾݩυʖν͹Ҳݫ؇ཀྵͳ ಝͶ༙ް͵ࢾݩ݃Վ͹ಝఈ

֋൅ ਏ ࣑ ϭ ಊ෼Ϡυϩ ਏ સࠅ͹ҫྏؽؖͶଲ͢ͱڂݜ ६Νຮͪͪ͢ݗରݗࠬ࣪͹અ஖Νགྷ੧خ൭ Ϩλʖηώϱέ͹ߑ஛ BSL-2Ґ৏͹خਬ਒ ਏ ࣑ ϭ ͹ౌ࿧ྋ໖ঈحʤઅඍʀࣁࡒʀ ҫ༂඾ʀҫྏؽ ๑੏ౕ౵ʥ ਏ ࣑ ϭ ༂ࡐౌ࿧ਅ੧ॽ͹৻ࠬͳট೟ΝՅଐԿ

࣎ٺە ฑ࣎ ֋൅οʖϞʥ͹खૌΊ಼༲ڂՌݜߊ䎖䶂ʤݜ ϕϫζΥέφ͹ޮูɼڂ֋൅કྲྀɼݜڂ֋൅οʖϞʥͺݜڂՌݜߊ䎖䶂ʤݜ Ͷࣰݳͪ͢غಋ֋൅͹ର੏౵Ν૥ڠ

ͶҐԾ4ͯ͹खૌΊΝ֋࢟ͪ͢ʁٺɼ૥ޛ֋൅οʖϞʥઅཱིڂ2020೧1݆ͶՌݜߊ䎖䶂ʤݜ

τʖϜͳ͢ͱಝఈڂݜٺەҐԾ͹τʖϜΝ ¾ ֋൅Ͷؖ͢ͱɼ஭ྙڂ֋൅྘Ү 2݆ɼՌݜߊ䎖享ͺϭέοϱݜڂ஭ྙͤΖݜ .1 τʖϜʥ͹ಝఈ ᶅ ྡজࢾݩ๏๑ͳ༂඾ηέϨʖωϱήڂݜٺەʤ ᶆ ݗࠬٗढ़ͳ੣඾͹֋൅ ͤΖ5ͯ͹ٗढ़࿑તΝఈΌͪʁ ෈׈Կϭέοϱ „ ڂઝ঳බָ͹ݜ״ᶇ Τ΢ϩηබݬָͳ ҪఽࢢૌΊ׷͓ϭέοϱ „ ֋൅ „ ΠυόΤ΢ϩηϗένʖϭέοϱڂᶈ ϭέοϱݜ ᶉ ಊ෼Ϡυϩߑ஛ „ ֫࢐ϭέοϱ „ ओಡԿ΢ϱϓϩΦϱδΤ΢ϩηϭέοϱ*1

τʖϜΝ ݇ট೟ࡃΊڂݜٺەՌָٗढ़͹ ¾ τʖϜ͹ 20ڂݜٺەى৏ .2 ¾ ֋൅͹ޮูΝ֋࢟ɽڂɼݗࠬΫρφݜ͢ܠ࿊͗ۃࣰࢬ Ռָٗढ़෨ΝࠅՊ༂඾؄ಞ؇ཀྵغ૥ ޮู֋࢟ޛ327݇ਅ੧ࡃΊ ϕϫζΥέφΝઅͪ͜ڂτʖϜ͹ޮูΝ֋࢟͢ɼ20঴ࢤͶݜڂݜٺە஦ࠅՌָӅ͖Δ ¾

͹મఈ౵͹৚ๅΝؖ࿊הɼΤ΢ϩηڂࡋ๖࣑ྏٗढ़͹ݜײ֋൅οʖϞ͖Δࡀ݄ɼڂݜ ¾ ʤͤؖ࿊෨໵͹৆ࡋ֮೟खΗͥʥ༙ڠಋਬ਒ର੏͹ཱི֮ ෨໵ؔͶڢ .3 ༙ڠՎΝྡজҫྏؽؖ΃ਟଐ݃ڂ֋൅οʖϞ͖Δݜڂݜ ¾ ڂτʖϜΝϕϫζΥέφԿɽݜڂಋ֋൅Ν఑঑͢ɼݜڠ͹ۂةؽؖʀڂҫྏؽؖʀݜ ¾ τʖϜ͹ࢂՅଲেͳ੻೜ंΝ໎֮Ͷ͢ɼϕϫζΥέφຘͶՌݜߊ䎖享͖Δ઒೜Νમఈ ֋൅Νࢩԋڂɼݜ͢

ࣰݩ࣪͹҈સ੓Ώ ֋൅Ͷన༽Ͳ͘ΖΓ͑Ͷ؇ཀྵର੏Ν੖͓ΖڂԿ͢ɼݜکࣰݩ࣪͹҈સ੓Νڂݜ ¾ .4 Կک؇ཀྵର੏͹

ઝͳ΢ϱϓϩΦϱδ͹ྈ๏Ν๹͛͞ͳ͗Ն೵״൤ജট೟͹ओಡԿ΢ϱϓϩΦϱδ͹Τ΢ϩηϭέοϱͶ৿αϫψΤ΢ϩηνϱϏέ࣯Ν௧Յɽ੔ޯͤΖͳɼ৿αϫψΤ΢ϩη .1* Ӻමݜ⎸࿑亦ɾ֦༙䬡ࠥỿ᠏఼ʃ|ɼ౵ץ䝇৿ޔҲช寢㣝ʁ| އ୉कߊ๏޴๏໚खಚ昝ஊ੓忂ఴ|ɼૠޔड़ॶʁChina news “Ռٗ෨ʁӺමݜ⎸౵

78 ࣎ٺە ฑ࣎ ֋൅οʖϞʥ͹ର੏ڂʤࢂߡʥՌݜߊ䎖䶂ʤݜ ֋൅Յଐ͹ͪΌɼҫແӅ͹ࢁԾͶՌݜߊڂઝ঳ଲԢ͹ݜ״αϫψΤ΢ϩηܗ৿ ର੏Νߑ஛ܠ֋൅οʖϞʥ͗ૌ੔͠Ηɼ੕ැؖ࿊෨໵ͶΓΖ࿊ڂ䎖䶂ʤݜ

Ռָٗढ़સൢ ࠅແӅ ֋൅οʖϞ͹ϟϱώʖૌ৭ڂ੕ࡨસൢ ˛ ݜۂࢊ

Ռݜߊ䎖䶂*1 ֋൅οʖϞʥڂʤݜ ݊߃ʀҫྏ੕ࡨʙ ۃ੏౲و ۃ஦ࠅՌָӅ Ռָٗढ़෨ ࠅՊӶਫ਼݊߃җҽճ ࠅՊ༂඾؄ಞ؇ཀྵ

஦ࠅ࣮බ༮๹߉੏஦ৼ ۃࠅՊ஦ҫ༂؇ཀྵ ۃҫ੕ҫ؇

ϓΟϱυΡϱήؽؖ җҽճۜخࠅՊࣙષՌָ

֋൅ؽؖڂݜ ؽߑڂؽߑ Ռָٗढ़෨ࢁԾ͹ݜڂ஦ࠅՌָӅࢁԾ͹ݜ ॶ ‡ China National Center forڂ෤׿බಡݜ ‡ ॶ Biotechnology Developmentڂඏਫ਼෼ݜښ๼ ‡ ॶڂ༂෼ݜ ‡ ৏քϧ΢ϓγ΢ΦϱηՌָ৚ ‡ ๅιϱνʖɼ౵

֋൅׈ಊΝ୴౲ͤΖɽڂ֋൅οʖϞʥͳͺɼ2020/01αϫψ൅ਫ਼࣎Ͷઅཱིͪ͢ྡ࣎ૌ৭Ͳ͍Ζɽ࣑ྏ༂ɼϭέοϱɼਏஇ౵͹ݜڂαϫψՌݜߊ䎖享ʤݜ .1* ֋൅ڂ12͹੕ැૌ৭͗੔ҽͳ͵ΖɽΉͪɼݜܯɼLogistic Support Department of the Central Military Commission౵ɼ߻ۃ೸ଞ෨ɼքؖ૱ॼɼྜྷ૴ۂү෨ɼࡔ੕෨ɼ೸گ׈ಊͶؖΚΖૌ৭Ͷͺɼ൅ఴրַҗҽճɼڂݜى৏ ઝं௧੽/஦ҫ༂౵͹9෾Ռճ͗ଚࡑ״/οʖϞ͹Ծɼҫ༂඾/ϭέοϱ/ݗࠬ

࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ֋൅οʖϞʥͺ࣑ྏ༂͹ྡজࢾݩ݃Վ͹ڂ֋൅ްིԿ͹ͪΌɼՌݜߊ䎖䶂ʤݜ ৚ๅΝҲݫ؇ཀྵ͢ͱ͏Ζ ଲেϠξϨτΡ खૌΊ ֕གྷ ؖ༫ं Dx Rx Vx ֋൅οʖϞʥͺ࣑ྏ༂͹ ‡ ҫແӅ ᤯ڂ֋൅ϕϫιηްིԿ͹ͪΌɼՌݜߊ䎖享ʤݜ জࢾݩ݃Վ͹৚ๅΝҲݫ؇ཀྵ͢ͱ͏Ζྡ ͹ϕϫιηͶͯ͏ͱʁ༙ڠಝͶɼ৚ๅ ֋൅෾Ռճʤ஦ࠅਫ਼෼ٗ㜖⎸ఴ஦ৼʥ͹ڂ֋൅οʖϞ͹ҫ༂඾ݜڂݜ ‡ ઒໵ՊͲ֦༂඾͹ྡজࢾݩࣰࢬՆ൳Ν٠࿨͢ͱқݡॽΝ఑ड़ɽ ྡজ ֋൅οʖϞ͖ΔࠅՊ⍒ਫ਼݊߃җʤCCDCʥڂࢾݩ΃਒ΌΖ༂඾ͺɼݜ জࢾݩ͹ Ͷ఑ड़ྡ ɼྡজ͢ܠͳ࿊ۃү෨ͺɼҫ੕ҫ؇گ৚ๅҲݫԿ ‡ ࠅՊ⍒ਫ਼݊߃җʤCCDC)͹Ռָ ͹ଲেҫྏؽؖΝમఈڂݜ Ώྡজࢾݩ͹੔ՎΝஏҮ঴ڱCCDC෨໵ͺྡজࢾݩ͹਒ṁয়څஏҮ঴ ‡ ɽ༙ڠ֋൅οʖϞ)Ͷڂ͹Ռָٗढ़෨໵Ͷ఑ड़͢ɼࠅՊՌָٗढ़෨(ݜڅ ֋൅οʖϞͺͨΗΔ৚ๅΝण͜ͱɼ઒໵ՊΝॄΌͱݗ౾ͪ͢৏Ͳɼڂݜ ήϩʖޤٻɼ෯ࡠ༽౵ʥΝҫྏصےՎ͹͍Ζ༂඾৚ๅʤਬও༽ྖɼް ϕͶ௪எ

ద௪எʱ2020೧3݆29ೖڂয়බಡ഑Ԏ卖෼࣑䕾ḛজݜץܗ哬䇘ఴ৿طड़ॶʁࠅແӅʰ䎖ဍ妫ᣄҫ䕾

79 ࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ࣑ྏ༂֋൅͹ͪΌ͹7ຬҐ৏͹Կ߻෼ηέϨʖωϱή͹ࣰࢬΏɼݗରݗࠬର੏ ͱ͏Ζ͢ٽԿΝགྷک੖ඍ͹ͪΌҫྏؽؖ౵΃͹ݗࠬର੏ ଲেϠξϨτΡ खૌΊ ֕གྷ ؖ༫ं Dx Rx Vx ֋൅ްིԿʁ ‡ ࠅແӅ͹ʰՌݜߊ䎖 ᤯ڂ࣑ྏ༂͹ݜ ֋൅οʖڂαϱϒϣʖνηέϨʖωϱήɼExtracorporeal enzyme activity test 享ʱʤݜ ‡ ౵Ν༽͏ͱɼ7ຬҐ৏͹༂෼ΏԿ߻෼ΝηέϨʖωϱή͢ɼ༙ް੓͹ Ϟʥ ઝࡋ๖״߶͏5,000༂෼Νޫึͳ͢ͱમ୔ɽҲൢద͵αϫψΤ΢ϩη Կ߻෼ ɼ༁100झྪ༂෼ͶߞΕࠒΞͲޛηέϨʖωϱήΝࣰࢬغϪϗϩ͹ॵ ηέϨʖωϱή ࣰݩΝߨ͑༩ఈ Ͱ͘ɼέϫϫΫϱɼϪخ֋൅οʖϞͺ෵਼յ͹ηέϨʖωϱήͶڂݜ ‡ ϞυεϑϩɼϓΟϑϒϧϑϩ౵͏͚͖ͯ͹༂඾Ͷ஭໪͢ͱྡজࢾݩΝ ࣰࢬ 2020೧6఼݆࣎αϫψؖ࿊͹ࡔແࢩड़ͺ༁2஻7,000Աԃ ᤯ ҫྏ෼ࣁͶؖ͢ͱͺʁ ҫ༂඾ɼ ‡ ॑གྷ͵ҫ༂඾ͺ஦ԟ੕ැ͖ΔҲׇ߬೘͢ͱ؇ཀྵ ଈ͹ҫ༂඾Ώҫྏۂةઝ঳͗शଋͤΖΉͲͺɼ״αϫψΤ΢ϩηܗҫྏ෼ࣁ͹ ‡ ৿ ͹ਫ਼ࢊͶචགྷ͹ݬࡒྋͺͤ΄ͱ੕ැ͖ΔҲׇ߬೘͢ͱฯ؇حඍட ༽඾ʀؽ ͹੣ଆ඾࣯޴৏ɼਫ਼ࢊحͶଲ͢ͱɼҫ༂඾Ώҫྏ༽඾ʀؽۂةҫ༂඾ ‡ ଁࢊ౵Ν఑঑

බಡ㢧㴲༙䎖޽ࡠద௪எʱ2020೧4݆19ೖץ旛৿غʰဍ忂Ҳ㑌ၑ޹Ӻ৚ۃ੏ḥߨ卖෼ݜ⎸࿪Ռݜߊ䎖࠹৿忂ఴ৚႐⎸ාճʱ2020೧2݆15ೖɼҫ੕ҫ؇طड़ॶʁࠅແӅʰࠅ⊈Ӆ倻๹倻߉

࣎ٺە ฑ࣎ ๑੏ౕ͹੖ඍ;ٶ൭ʁࢬઅخ֋൅ਬ਒ڂݜ ਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹֋൅Νଇ਒ʀՅଐͤΖͪΌɼ༂ࡐౌ࿧ਅ੧͹Յଐ Ώ༂඾ౌ࿧घ਼ྋ͹໖ঈ౵Νࣰࢬ͢ͱ͏Ζ ଲেϠξϨτΡ खૌΊ ֕གྷ ؖ༫ं Dx Rx Vx ʁ ᤯ٽࠅແӅ͖Δસࠅ͹ҫྏؽؖͶࣰݩ࣪؇ཀྵͶؖͤΖҐԾࣆߴΝགྷ Կ͢ɼસࠅ͹ݗड़೵ྙΝ޴৏کᶅ ࣰݩ࣪͹ݒઅΝߍͶ ᶆ ࣰݩ࣪͹གྷ݇Ͷݭग͢ͱࢾݩΝߨ͑ Կ͢ɼٗढ़૤ࡠΝඬ६Կک࿇Ν܉ᶇ ҫྏॊࣆं͹ Կ͢ɼࢾݩ඾࣯Νրવکݗରݗࠬ࣪ ᶈ ݗࠬ͹඾࣯؇ཀྵΝ Կ͢ɼγϱϕϩ͹ॴ෾Νనک͹੖ඍ ᶉ ࣰݩ࣪͹ώ΢ΨιΫϣϨτΡʖ؇ཀྵΝ ઀Ͷߨ͑ ڛͶଲ͢ͱɼ֦ஏҮ੕ැͲͺࢩԋۜ౵΍఑ٽ஦ԟ੕ැ͹གྷى৏ ʁՑ๼঴ᕍೈࢤࢤ੕ැ͖Δαϫψ֫࢐ݗࣰࠬݩ࣪͹ݒઅͶ༁2,000ຬྭ ԃΝࢩड़ ᤯᤯᤯ ۃαϫψؖ࿊͹༂඾Ͷଲ͢ͱNMPAͺҐԾͲࢩԋʁ ‡ ࠅՊ卖඾䚸ಞ؇ཀྵ ᶅ ༂ࡐౌ࿧ਅ੧͹৻ࠬʀট೟ΝՅଐ ʤNMPAʥ ੣඾͹ౌ࿧ɼ੣ଆϧ΢ιϱحෲ౵ҫྏؽޤҫྏ༽ϜηέΏҫྏ༽๹ ηɼݗࠬɼτηφ͹ͪΌ͹ಝพ͵ી஖Νࣰࢬ͢ͱট೟ϕϫιηΝ౹ NMPAͶΓΖ ࿧ৄ໎ౌحͶଲ͢ͱҫྏؽۂة͹ਫ਼ࢊΝ֋࢟ͤΖح߻ͤΖɽҫྏؽ ࣑ྏ༂ʀϭέ ট೟Νࣰࢬɽٺەॽͳ੣ଆϧ΢ιϱη͹ਅ੧ͳ οϱʀݗࠬ ஊ֌ͲϪϞυεϑϩΏϓΟϒϧϑϩ౵5غͺɼॵۃࠅՊ卖඾䚸ಞ؇ཀྵ Ϋρφ͹ౌ࿧ ە͹৿༂ɼ7ऀ͹֫࢐ਏஇࢾ༂ɼ 3ͯ͹ਏஇࢾ༂(αϫ΢χۜ๑)Νͯ ඇ༽໖ঈɼਅ ট೟ͪ͢ٺ ੧ϕϫιηਟ ᶆ ༂඾ౌ࿧घ਼ྋΝ໖ঈ ଐԿ ট೟ϕϫιηͶ೘ͮͪٺە͹ح͹ෝ୴ΝܲݰͤΖͪΌɼҫྏؽۂة ͹ౌ࿧घ਼ྋΝ໖ঈحઝ঳ؖ࿊੣඾͹ҫྏؽ״αϫψΤ΢ϩηܗ৿ ઝ঳࣑ྏʀ״αϫψΤ΢ϩηܗΖɽಝพট೟ϕϫιηͶ೘ͮͪ৿ͤ ༩๹ؖ࿊͹ҫ༂඾Ͷଲ͢ͱ΍ౌ࿧घ਼ྋΝ໖ঈ

഑Ԏ༙䎖ద卖඾ɾ໖੒卖඾஭ၿ崠ʱ2020೧2݆25ೖץʁ⯠࣑䕾࿪桫๹৿ۃड़ॶʁʰࠅՊ卖඾䚸ಞ؇ཀྵ

80 ೖຌ

81 ࣎ٺە ฑ࣎ ਫ਼ࢊ͹ؽ೵ैଏ͹ͪΌ͹଩ͬघʁγϜϨ;ٶ֋൅ڂݜ ֋൅ΝࢩԋͤΖڂͲ͹ݜۂة֋൅ਬ਒ͶՅ͓ɼ୉ָΏڂؽؖͶΓΖݜڂదݜޮ ͹಍೘౵ΝࣰࢬںΏέϧ΢ΨݨඏڛΌ͹BSL-3ࢬઅ఑ͪ ؽ೵ैଏ͹ ຎྭʁਏ - ਏஇ๑ ࣑ - ࣑ྏ༂ ϭ - ϭέοϱ ֋൅ ֋൅ ਫ਼ࢊ ਫ਼ࢊ ڂݜ ڂ଩ͬघ ݜ ਏ ࣑ ϭ ଲԢ͹ର੏੖ඍʤଲࡨຌ෨͹અཱིʥٺە કྲྀࡨఈʀ સର౹ׇ ਏ ࣑ ϭ ؽߑɼNIHSʥڷਏஇ๑ʀ࣑ྏ๑ʀϭέοϱ΃͹ঁ੔ʤ޲ਫ਼࿓ಉ঴ɼAMEDɼՌָٗढ़ް৾

ϭ ࢾݩࣰࢬ΃͹ঁ੔ʤ޲࿓঴ʥ;ٶϭέοϱਫ਼ࢊର੏੖ඍ ڱ֋൅͹਒ṁʀয়ڂݜ ਏ ࣑ ϭ ࣑ ಝच໖ӺήϫϔϨϱ੣ࡐ͹ รԿͶԢͣͪݺพҌ݇΃͹ ର੏੖ඍ΃͹ঁ੔ʤ޲࿓঴ʥڇڛฯʀ੣ଆʀ֮ ࢩԋʀղ೘ΝࣰࢬʤAMEDʥ ਏ PCRݗࠬ๑͹֋൅ɼ ;ٶ֋൅ ਏ ࣑ ϭ Τ΢ϩη͹รҡմੵڂݜ ઝݜʥ״ؽؖ΃ഓාʤڂઝݜʥ ࢾ༂Νࠅ಼ݜ״͹೼ѴɼΰόϞմੵ͹ࣰࢬʤڱਬ਒ ֨୉য় ͹ ϭं׳αϫψΤ΢ϩηܗ࣑ ৿ BSL-3ࢬઅΝ༽͏ͪϭέοϱ֋൅ʤAMEDʥ ʤNCGMʥڂϪζηφϨݜ ൭͹ߑ஛ɼخܠઝ঳ؖ࿊υʖν͹࿊״ ਏ ժ଀ਏஇ౵Νߨ͑AIٗढ़͹֋൅ਬ਒ ࣑ χϧρέηέϨʖωϱήΏ ࢋ͹ࣰࢬʤAMEDʥܯଚ༂෾ࢢྙָع ਏ ϭ ϭέοϱʀݗࠬٗढ़͹֋൅ʤNIBIOHNʥͪ͢ܠ୉ָΏҲൢࡔ஄๑ਕͳ࿊

͹ं׳αϫψΤ΢ϩηܗਏ ࣑ ϭ BSL3ࢬઅ΃͹έϧ΢Ψ ਏ ࣑ ϭ ࣑ ৿ ֋൅ ಝྭট೟੏ౕ͹ࣰߨʤPMDAʥڂݜ ᕸࡀखʤNCGMʥ݄;ٶ͹಍೘ʤชՌ঴ʥ ߇ର଎ఈں൭ ుࢢݨඏخਬ਒ ࣑ ਏ ࣑ ϭ ϭ αϫψϭέοϱ͹ܗʤઅඍʀࣁࡒʀ χϧρέϨϛζεϥωϱή͹ ༑઎ద͵ྡজࢾݩ͹ ৿ ʤAMEDʥ ૮஌૯޳͹֋અʤPMDAʥ ஭ࣻਓʀεϨϱζ͹֮ฯʤ޲࿓঴ʥڛΌ͹Կ߻෼఑ͪ ๑੏ౕ౵ʥ 30ೖޛαϫψΤ΢ϩη͹ ࣑ ϭ ྡজࢾݩΝ಩͜ड़ܗਏ ࣑ ϭ ৿ ઝݜʥ ଶͪͥͶ֋࢟Ն೵ʤPMDAʥ״ʤڛ෾཯ʀ఑ αϫψΤ΢ϩη͹෾཯Ͷ ࣑ ௧Յ༩ࢋͶΓΖҫྏؽؖ͹࣑ݩʀট೟ؖ࿊ܗਏ ࣑ ϭ ৿ ແඇ༽͹ෝ୴ܲݰʤ޲࿓঴ʥۂ ʤNIBIOHNʥڛ͹఑הཤ༽Ն೵͵ࡋ๖ ਏ ࣑ ϭ ਏ ࣑ ϭ Կʤ޲࿓঴ʥ ਅ੧ϕϫιηՅଐ͹ͪΌɼট೟ਅ੧઴͖ΔҲ෨کઝݜ͹અඍ״ ඉྡজʙྡজࢾݩυʖν͹৻ࠬΝ֋࢟ ͶଲͤΖηϏαϱ͹ंڂؽؖʀݜڂਏ ࣑ ݜ ʤRIKENʥڛ༑઎ద͵ࢬߨదཤ༽͹఑

࣎ٺە ฑ࣎ કྲྀࡨఈʀસର౹ׇ ֋൅͹ਬ਒ʀڂ֋൅๏ਓ͹खΕΉͳΌΏݜڂ߃ʀҫྏકྲྀਬ਒ຌ෨ͶΓΖݜ݊ ՅଐͶ޴͜ɼ1,930Աԃ͹௧Յ༩ࢋฦ੔͗ߨΚΗͪ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ௪ڠ ֋൅๏ਓ͹ࡨఈ ‡ ݊߃ʀҫྏકྲྀਬ਒ຌڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿ Ζ ෨ܐઝ঳Ͷ״αϫψΤ΢ϩηܗ߃ʀҫྏકྲྀਬ਒ຌ෨͗஦ৼͳ͵Εɼ৿݊ ‡ ֋൅͹๏ਓΝखΕషΌڂ੕ැસର͹ݜ 9 2020೧2݆13ೖͶͺɼਏஇ๑֋൅ɼ࣑ྏ๑֋൅ɼϭέοϱ֋൅౵Νࣰࢬ Ζ͞ͳͳ͢ɼ૱ֻ20Աԃ͹ࢩԋΝ݀ఈɽಋ೧3݆10ೖͶ൅නͪ͢खૌͤ ઝ঳״αϫψΤ΢ϩηܗΊͶ͕͏ͱͺ31Աԃ͹ࢩԋࡨΝ൅නͤΖ౵ɼ৿ કྲྀࡨఈʀ ଲࡨΝਬ਒ સର౹ׇ ਏஇ๑ʀ࣑ྏ๑ʀϭέοϱ΃͹ঁ੔ ‡ ೖຌ੕ැɼAMED Dx, Rx, Vx Ν؜΋ਏஇ๑ʀ࣑ྏ๑ʀϭέοϱ͹֋൅͹ͪΌͶ௧Յ༩ࢋ͖Δݜڂݜેخ ‡ ඇΝࢩԋڂ ‡ ௧Յ༩ࢋʁ1,930Աԃ͹༩ࢋ͹಼ɼ1,426Աԃ͗AMED΃෾ഓ

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

82 ࣎ٺە ฑ࣎ ࣎༩ࢋ͹౦Ծٺەʤࢂߡʥકྲྀࡨఈʀસର౹ׇʁ ٺەଲԢ͹ͪΌ͹કྲྀࡨఈΏٺەͶغ஦ࠅΏธࠅͲͺɼ1݆ʛ3݆Ͷ͖͜ͱ૥ ༩ࢋ͹౦ԾΝߨͮͱ͕Εɼೖຌͺॵಊ͹ଐ͠Ͷܿͪ͜

12/31 1/10 1/13 1݆ 2/7 4݆

ଠࠅ͹ ෤׿ࢤͲݬҾ෈໎͹഑Ԏ खૌΊ ൅ਫ਼Ν൅නʤWHOʥ

ʤ஦ࠅଈ͗ʥΤ΢ϩη ஦੕ැՌݜߊ䎖享ཱི৏͝ τʖϜಝఈɼڂݜٺە ͹ΰόϞഓ྽Νޮ֋ ϓΟϱυΡϱή֋࢟ NIHͳModernaऀͺ Modernaऀ͹mRNA Modernaऀɼ mRNAϭέοϱޫึ ઴೧ౕ͹௒੖ඇɼ༩ඍඇҐ֐Ͳ͹ ϭέοϱޫึ͹࠹ॵ BARDA͖Δ࠹߶$4.8 ͹ഓ྽Ν࠹शԿɽ ֋൅༩ࢋͺ4݆Ґ߳ͳଠࠅΓΕங͏ڂ͹ྡজώρο͗׮྅ Ա͹ࣁۜԋঁ͗݀ఈ ݜ NIHͺPhase1ࣰࢬΝ ࣖࠨ

2/13 3/10 4/17 4/30 6/12 11/24 12/15

ೖຌ͹ ༩ࢋٺە ౦Ծ ୊1ஆʁ20.3Աԃ ୊3ஆʁ32.5Աԃ ୊5ஆʁ609Աԃ ୊7ஆʁ425Աԃ SARS / MERS౵͹எݡΝಁΉ͓ɼ ੖ඍ͹ͪΌڧ؂ઝ঳͹࣑ྏ ࣑ྏ༂ʀϭέοϱͶଲͤΖ ࣑ྏ๑౵͹֋൅ʀ״αϫψΤ΢ϩηܗ৿ DxɼRxɼVx֋൅౵ΝଐΏ͖Ͷ ֋൅ඇ͹௧Յॴ஖ ͹खૌΊ௧ՅʤӺָ௒ࠬਬ਒ɼݜڂ֋൅Ν ߍ͵Ζݜڂ͹ݜح༂ʀϭέοϱʀؽ ֋࢟ʤ2019೧ౕࣧߨ࢔ʥ ɼࠅࡏ࿊ۂ൭૓ਫ਼ࣆخ֋൅ַ৿ڂ ߍͶՅଐʀ֨ै ܠɼ౵ʥ ୊4ஆʁ751Աԃ ୊2ஆʁ31.2Աԃ ୊6ஆʁ60.7Աԃ ʀεητح࣑ྏ༂ʀϭέοϱʀؽ ֋൅ਬ਒ڂઝ঳ଲࡨ͹ͪΌ͹ݜ״ ઝ״αϫψΤ΢ϩηܗଚ༂Ν৿ع Ϟ֋൅ΝҲ૜Յଐͦ͠ΖखૌΊΝ ঳Ͷ׈༽ͤΖͪΌ͹࣑ݩΏਟଐݗ ʤAIٗढ़಍೘ɼωϣʖόʖϜϩଲ ௧Յ ֋൅ϕ Ԣɼ౵ʥڂ͹֋൅Յଐɼݜحࠬؽ ϧρφϓΧʖϞߑ஛ʤ2019೧ౕ௒ ੖ඇɼ༩ඍඇʥ ֋൅ಊ޴Ͷͯ͏ͱʱʤ2021೧2݆ʥڂઝ঳ͶؖͤΖࠅ಼֐͹ݜ״αϫψΤ΢ϩηܗड़ॶʁModerna, “Moderna‘s Work on a COVID-19 Vaccine Candidate”ɼ୊26յ݊߃ʀҫྏકྲྀਬ਒઒໵௒ࠬճʰ৿

࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ઝݜͶΓΖΤ΢ϩη͹รҡմੵΏΰόϞմੵͶؖͤΖखૌΊ΍ߨΚΗͱ͏Ζ״ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ௪ڠ জ৚ๅͳබݬର͹৚ๅմੵର੏͹੖ඍ ‡ ޲ਫ਼࿓ಉ঴ྡ ͵ઝ঳ͶଲͤΖਟଐ״৿ͪͶ൅ਫ਼ͤΖޛ2020೧ౕ୊3࣏ึਜ਼༩ࢋҌͶͱɼࠕ ‡ ॶͳࠅཱིڂઝ঳ݜ״ҫྏؽ͖ؖΔࠅཱིྙڢଲࡨͶ޴͜ɼྡজ৚ๅʀݗର౵Ν ιϱνʖͶॄ༁͢ɼྡজ৚ๅͳබݬର͹৚ๅմੵର੏͹ߑ஛ɼڂࠅࡏҫྏݜ ൭ͳ͵Ζ࢕ૌΊΝ੖ඍ༩ఈخ֋൅͹ڂݗࠬ๏๑Ώ࣑ྏ༂ʀϭέοϱ౵͹ݜ ੔ֻʁ40Աԃঁ ‡ ௪ڠ ॶڂઝ঳ݜ״͹೼Ѵର੏͹੖ඍ ‡ ࠅཱིڱ୉য়֨;ٶΤ΢ϩη͹รҡմੵ ״ΖΰόϞմੵ౵ͶΓΖܐαϫψΤ΢ϩηͶܗ2020೧ౕึਜ਼༩ࢋҌͶͱɼ৿ ‡ ͶͱɼΰόϞմੵٗढ़Ν༽͏ͪΤ΢ϩηรۂઝ֨୉๹ࢯ͹ͪΌ͹ର੏੖ඍࣆ ԿɼรҡΤ΢ϩη͹߁͗Ε౵Ν೼ѴͤΖର੏͹ߑ஛ɼ݄ੜγϱϕکҡմੵ͹ ֋൅ ϩ͹߇ରՃ͹଎ఈٗढ़Νཤ༽ͪ͢௒ࠬର੏͹ߑ஛౵Νࣰࢬ༩ఈڂݜ ఖౕʤ੔ޯི20%ͳ͢ͱुהਬ਒ 9 ΰόϞմੵͲͺɼรҡΤ΢ϩη͹೼Ѵʀु20 100ݗରմੵʥ͹υʖνΝட੷͢ɼݗࠬ๑͹րવͶༀཱིͱɼΓΕ੠ື͵ݗ ࠬ͹੠ౕฯৄͶܪ͝Ζ͞ͳΝ໪ࢨͤ କ͢ɼܩΤ΢ϩη෾཯Ͳͺɼླྀߨࣰସ೼Ѵ͹ͪΌͶΤ΢ϩη෾཯ࢾݩΝ 9 କదͶࣰࢬ༩ఈܩPCRݗࠬΝͤΕൊ͜ΖรҡΤ΢ϩη͹෾཯΍ Ͳͺ݄ੜӺָ௒ࠬ౵΍؜΋ʥۂ੔ֻʁ6.8Աԃʤୢ͢ɼຌࣆঁ ‡ ௪ڠ ॶڂઝ঳ݜ״αϫψΤ΢ϩη͹ΰόϞմੵ͹ࣰࢬ ‡ ࠅཱིܗ৿ ઝ঳͹έϧηνʖ״αϫψΤ΢ϩηܗξ΢ϢϠϱχϕϨϱιηߺͶ͕͜Ζ৿ ‡ ൅ਫ਼ɼࠅ಼Ͳ͹ླྀߨͶͯ͏ͱΰόϞϋρφϭʖέմੵͶΓΖΤ΢ϩηΰόϞ մੵ͹඲ՃΝࣰࢬ ιϱνʖͲғབΝणͪ͜ๅࠄྭ͹ΰόϞմੵΝࣰࢬڂබݬରΰόϞմੵݜ ‡

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

83 ࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ࣑ྏ༂Ͷଲ͢ͱͺɼχϧρήʀϛζεϥωϱή͹֋൅ࢩԋΏAMEDͶΓΖԿ߻ ෼ηέϨʖωϱή͗ߨΚΗͱ͏Ζ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ Ͱ͚ϕϧρφϓΧʖϞ׈༽ͶΓΖηέϨʖωϱή ‡ AMED RxخࢋՌָͶܯ BINDS)͹΢ϱεϨαϤωρφ͹ϕ)ۂ൭ࣆخࢩԋڂ૓༂౵ϧ΢ϓγ΢Φϱηݜ ‡ ଚ༂ϧ΢ϔϧع࣑ྏ༂ޫึΝਟଐͶ୵ࡩȄوϧρφϓΧʖϞΝ׈༽͢ɼʰ৿ ϨʖΝ༽͏ͪ΢ϱεϨαηέϨʖωϱήʱΝࣰߨ ॶʁ෵਼͹Τ΢ϩηՅਭ෾մ߮ોʤϕϫτΠʖκʥΏRNAϛڂ߻ݜ૱ۂࢊ 9 ͶϙϠϫζʖϠυϩΝࡠ੔͢ɼԿ߻෼DB͹৚ๅΝཤخϨϟϧʖκ͹ߑଆΝ ༽ͪ͢ώʖοϡϩηέϨʖωϱήΝࣰࢬ ʁޮ֋͠ΗͪαϫψΤ΢ϩη͹Xત݃ধմੵυʖνΝϗʖηͶ͢ۂ޽ښ౨ 9 ଚ༂ͶعͱɼSARSɼMERS͹Յਭ෾մ߮ોͳ߻Κͦͱ෵਼͹߇HIV༂౵͹ ͯ͏ͱਫ਼ର෾ࢢεϝϣϪʖεϥϱΝࣰࢬ ఁ෾ࢢԿ߻෼͹फॄʀηέϨʖωϱή ‡ AMED Rx ڛఁ෾ࢢԿ߻෼ΝAMED΃఑͗ۂةͶΓΕ֦ܠճͳ͹࿊ڢۂ֋൅ ‡ ೖຌ੣༂޽ڂݜ Ͳߨͮͱ͏Ζ΢ϱεϨαηέϨʖωϱήͶΓΕྒྷ޹͵׈੓ۂAMED-BINDSࣆ ‡ ਬ਒ ͗೟ΌΔΗΖԿ߻෼Νಝఈ ࢩԋ ‡ ޲ਫ਼࿓ಉ঴ RxڂχϧρήϨϛζεϥωϱή͹࣑ݩʀྡজݜ 2020೧ౕึਜ਼༩ࢋҌͶͱ࣑ྏ๑͹ਟଐ͵ཱི֮Ν໪ࢨ͢ɼ৿ͪ͵ްՎ͗ๅࠄ͠ ‡ ౵Νࢩԋڂଚ༂ࡐ͹ҫࢥक಍Ͳ͹࣑ݩΏྡজݜعΗͱ͏Ζ ੔ֻʁ5.5Աԃঁ ‡ ֋൅๑ਕ Rxڂઝ঳͹࣑ྏ༂ޫึ͹୵ࡩ ‡ ࠅཱིݜ״αϫψΤ΢ϩηܗηϏαϱΝ׈༽ͪ͢৿ ॶڂ੖ඍ౏஦͹ηʖϏʖαϱϒϣʖνʰ෍ֹʱ৏Ͳ࣑ྏޫึ༂୵ࡩΏ಼࣪͹ඊວ ཀྵԿָݜ ‡ ༙ڠ঴ு౵Ͷܐ࿑༩଎౵ΝࢾߨదͶࣰࢬɽಚΔΗͪ੔Վͺؖܨ NCGM Rx ‡ ڂ͹ϪζηφϨݜं׳αϫψΤ΢ϩηܗ৿ ͹͑ͬ೘Ӆͪ͢঳ྭΝౌ࿧ͤΖϪζηφϨݜं׳ઝ঳״αϫψΤ΢ϩηܗ৿ ‡ ͳ͢ͱࣰߨڂΘ޴͘͹؏ࡱݜޛΝڂ

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ Δ͹݄ᕸࡀखͶؖΚΖࢩԋࡨ΍෵਼͖ं׳֋൅ਬ਒͹ͪΌͶյ෰ڂ࣑ྏ༂͹ݜ ߨΚΗͱ͏Ζ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ࣑ྏ༂͹֋൅ʀࣰ༽Կࢩԋ ‡ ࠅཱིҫ༂඾ৱ඾Ӷ Rx ॶڂઝ঳࣑ྏ༂͹ਟଐ͵֋൅͹ ਫ਼ݜ״αϫψΤ΢ϩηܗ2020೧ౕึਜ਼༩ࢋҌͶͱɼ৿ ‡ ͪΌ͹ର੏੖ඍΝࢩԋ ඾࣯ɼ༙ް੓ɼ҈સ੓඲ՃΝ໪దͳͪ͢෾ੵର੏͹੖ඍɼ඲Ճ๑͹ཱི֮ɼ 9 ͹֋൅ஊ֌͖Δดߨͪ͢඾࣯౵͹඲ՃͶΓΖ࣑ྏ༂͹ࣰ༽Կਬ਒ۂة ֋൅Ͷ௜ંڂͶͺର֐ਏஇ༂౵͹৶བ੓֮ฯ౵ɼݜۂ੔ֻʁ14Աԃʤຌࣆঁ ‡ దͶؖ࿊͢͵͏׈ಊ΍؜ΉΗΖʥ ֋൅๑ਕ Rxڂઝ঳߇ର੣ࡐ͹֋൅ਬ਒ ‡ ࠅཱིݜ״αϫψΤ΢ϩηܗ৿ ॶڂཀྵԿָݜ ״ઝ঳͖Δյ෰͠Ηͪ๏͖Δ״αϫψΤ΢ϩηܗ߇ର୵ࡩٗढ़Ν׈͖͢ɼ৿ ‡ ઝΝ૏֒ͤΖϐφϠόέϫʖψϩ߇ର͹ୱ཯ɼ߇ର੣ࡐ͹ࡠ੔Νਬ਒

֋൅͹ࢩԋ ‡ AMED Rxڂ֋൅ ஦࿪߇ରҫ༂඾͹ݜڂݜ ɼ݄͢ڛઝं͹݄ӹݗରΝ఑״αϫψΤ΢ϩηܗAMEDͶͱफॄ͢ͱ͏Ζ৿ ‡ Νࢩԋۂةਬ਒ ᕸ෾ժ੣ࡐͳ͵Ζ஦࿪߇ରҫ༂඾Ͷखૌ΋ ֋൅͹ࣰࢬΝݗ౾஦ڂ3ऀ͗ಋݜ ‡ ᕸࡀख ‡ NCGM Rx݄;ٶ͹߇ର଎ఈं׳αϫψΤ΢ϩηܗ৿ ६Νຮͪͦͻخ͹յ෰ं͖Δ߇ରՃ͹଎ఈΝߨ͏ɼं׳αϫψΤ΢ϩηܗ৿ ‡ ݄ᕸ͹ࡀखΝࣰࢬ

ର੏੖ඍ΃͹ঁ੔ ‡ ޲ਫ਼࿓ಉ঴ Rxڇڛಝच໖ӺήϫϔϨϱ੣ࡐ͹֮ฯʀ੣ଆʀ 2020೧ౕ୊3࣏ึਜ਼༩ࢋͶͱɼݬྋͳ͵Ζյ෰ं͖Δ͹݄ᕸࡀखͶ൒͑௧Յ ‡ ඇʤઅඍ੖ඍ౵ʥ͹ึঁɼࠅ಼݄ܨ͵ແͶචགྷۂ͹ंۂద͵ଲԢ౵ɼࡀ݄ࣆ ᕸ෾ժ੣ࡐϟʖΩʖ͹੣ଆϧ΢ϱ͹੖ඍΏ߇ରՃ౵඾࣯ࢾݩ౵͹અඍͶචགྷ ͵ܨඇʤ੣ଆࢬઅ౵੖ඍʀրर౵ʥ͹ึঁΝࣰࢬ༩ఈ ੔ֻʁ9.9Աԃঁ ‡

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

84 ࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ͢༽බݬରಝఈ͹ͪΌ͹Ҫఽࢢʀ߇ରʀ߇ݬݗࠬ͹ਬ਒ͶՅ͓ɼAIٗढ़౵Ν׈ ਏஇٗढ़͹ࢩԋ΍ߨΚΗͱ͏Ζ ଲেϠξوଚਏஇ๑Ν஖͘׷͓ΖΓ͑͵৿عͪ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ॶ Dxڂઝ঳ݜ״αϫψΤ΢ϩηPCRݗࠬ๑͹֋൅ ‡ ࠅཱིܗ৿ Ͷݗड़ͤΖͪΌ͹αϱϗϱεϥౕ״αϫψΤ΢ϩηΝ߶ܗ2020೧1݆2ೖɼ৿ ‡ ψϩPCRݗࠬ๑͹֋൅Ν׮྅ αϫψΤ΢ϩηݗࠬ༽͹ϨΠϩν΢ϞPCRݗࠬ๑͹֋൅ܗಋ೧݆̏24ೖ ɼ৿ ‡ Ν׮྅ ؽߑ Dxڷढ़֋൅ࢩԋ ‡ Ռָٗढ़৾ٗوΤ΢ϩηݗड़͹ͪΌ͹৿ ݗड़ٗढ़ͶؖͤΖٗढ़֋൅Νࢩౕ״Τ΢ϩηݗड़ٗढ़Ώఁ৷ऽ߶ଐ߶ౕ״߶ ‡ ԋ

֋൅๑ਕ Dxڂઝ঳͹ਏஇ๑ʀٗढ़ɼਏஇΫρφ͹֋൅ਬ਒ ‡ ࠅཱིݜ״αϫψΤ΢ϩηܗ৿ ॶڂʀਟଐਏஇٗढ़͹ ཀྵԿָݜౕ״SmartAmp๑Ν༽͏ͪਟଐݗड़๑͹֋൅ɼඉଁ෱ʀ߶ ‡ ֋൅ ֋൅ɼΤ΢ϩηݗड़Ϋρφ͹֋൅Νਬ਒ڂݜ ਬ਒ ֋൅๑ਕ Dxڂ൭͹ߑ஛ɼժ଀ਏஇ౵Νߨ͑AIٗढ़͹֋൅ਬ਒ ‡ ࠅཱིݜخܠઝ঳ؖ࿊υʖν͹࿊״ ൭ʀ݊߃ʀخʰAIʤਕ޽எ೵ʥϙηϒ ҫ༂غ કྲྀద΢όϗʖεϥϱ૓ଆϕϫήϧϞʤSIPʥ୊2 ‡ ॶڂઝ঳͹ ӭ཈ݜ״αϫψΤ΢ϩηܗνϩͶΓΖ߶ౕਏஇʀ࣑ྏεητϞʱ͹ԾͲɼ৿ ൭Νߑ஛ϕϫζΥخܠ֋൅υʖν͹࿊ڂҫྏ৚ๅʀྡজݗରմੵ৚ๅ౵͹ݜ έφ͗൅ଏ αϫψܗؽؖɼҫྏؽؖ౵͖Δ೘घͤΖ ৿ڂຌϕϫζΥέφͲͺɼࠅ಼͹ݜ ‡ ൭Νߑ஛ɽҫྏAI ϕϧρφϓΧʖϞͳ࿊خܠઝ঳͹ؖ࿊υʖν࿊״Τ΢ϩη ɼਏྏ৚ๅɼྡজݗରմੵ৚ๅΏժ଀৚ๅΝ༽͏ͱɼժ଀ॶݡ͹ఈྖద͢ܠ ͗͵ਏஇΏ॑঳Կ͹༩଎ͶͯغմੵΝߨ͑AI ٗढ़Νన༽ɼժ଀ݗࠬͶΓΖ૥ Ζ AI ٗढ़Ν֋൅ɼυʖνϗʖη΃͹֪೴Ν໪ࢨͤ ɼ͢ڛΖ৚ๅΝ఑ܐ੔Ώ॑঳Կɼ߇ରࢊਫ਼౵ͶܙຌυʖνϗʖηͲͺබସ 9 ଶ͠ΗΖغ࣑ྏ༂Ώϭέοϱ֋൅౵Ͷཤ׈༽͠ΗΖ͞ͳ͗

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ Կ͹ͪΌ͹༩ک֋൅׈ಊ͹ࢩԋΏϭέοϱਫ਼ࢊର੏ڂϠξϨτΡͶ͕͜Ζݜ֦ ࢋ౦Ծ͗ߨΚΗͱ͏Ζ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ਏஇʀ࣑ྏ๑͹֋൅ਬ਒ ‡ ޲ਫ਼࿓ಉ঴ Rx, Dx ಊڂઝ঳͹৿ͪ͵ݜ״αϫψΤ΢ϩηܗ2020೧ౕ୊2࣏ึਜ਼༩ࢋҌͶͱɼ৿ ‡ ޴౵ΝಁΉ͓ͪਏஇʀ࣑ྏ๑͹֋൅Νࢩԋ ֋ڂର੏͹ࡑΕ๏ݗ౾ɼݜޜઝ๹״Ͷͺබସմ໎Ώۂ੔ֻʁ50Աԃʤຌࣆঁ ‡ ൅Ͷ௜ંదͶؖ࿊͢͵͏׈ಊ΍؜ΉΗΖʥ ֋൅๑ਕ Vx,Dxڂઝ঳ϭέοϱʀݗࠬٗढ़ ‡ ࠅཱིݜ״αϫψΤ΢ϩηܗ৿ͪ͢ܠ୉ָΏҲൢࡔ஄๑ਕͳ࿊ ൭ʀ݊߃ʀخ͹֋൅ ҫ༂ ॶڂɼΤ΢ ӭ཈ݜ͢ܠճͳ࿊ڂॶɼҲൢࡔ஄๑ਕࡗ୉ඏਫ਼෼බݜڂ୉ࡗ୉ָඏਫ਼෼බݜ ‡ ϩη͹Ҫఽࢢ૤ࡠٗढ़ɼΤ΢ϩηཽ༹ࢢ͹νϱϏέ࣯߻੔ٗढ़Ν׈༽ͪ͢৿ ֋൅Νࣰࢬڂݗࠬٗढ़͹ݜ;ٶઝ঳ϭέοϱ״αϫψΤ΢ϩηܗ ֋൅ڂݜ ֋൅๑ਕ Vxڂઝ঳ϭέοϱ͹ਬ਒ ‡ ࠅཱིݜ״αϫψΤ΢ϩηܗ৿ ॶڂਬ਒ ‡ mMAPʤmutation-compatible multiple antigen peptidesʥΝ׈༽ͪ͢Կָ ཀྵԿָݜ ߻੔ϭέοϱɼϑνϝϱD3ΠζϣώϱφΝ༽͏ͪϭέοϱ֋൅Νਬ਒

ࢾݩࣰࢬࢩԋ ‡ ޲ਫ਼࿓ಉ঴ Vx;ٶϭέοϱਫ਼ࢊର੏੖ඍ 2020೧ౕ୊2࣏ʀ୊3࣏ึਜ਼༩ࢋҌͶͱɼࠅ಼֐Ͳ֋൅͠ΗͪϭέοϱΝࠅ಼ ‡ Ͳਫ਼ࢊʀ੣ࡐԿͤΖͪΌ͹ਫ਼ࢊର੏੖ඍ͹ࢩԋʤ୊2࣏ʥɼࡀ୔͠Ηͪࠅࢊϭ ΃൅බ༩๹ްՎΝ඲ՃͤΖࢾݩ͹ࣰࢬඇ༽Νึঁʤ୊3࣏ʥۂةέοϱ֋൅ ͺΠηφϧκϋΩɼKMώ΢ΨϫζέηɼԚ໼ٝ੣༂ɼ෤ీۂةࡀ୔͠Ηͪ 9 ͹6ऀڠ੣༂ɼ୊Ҳࢀ ੔ֻʁঁ ‡ 1,377Աԃʤ2020೧ౕ୊2࣏ึਜ਼༩ࢋҌʥɼ1,200Աԃʤಋ୊3࣏ึਜ਼༩ࢋҌʥ

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

85 ࣎ٺە ฑ࣎ ֋൅ਬ਒ڂݜ ੏໚͖Δ΍֋൅ΝՅଐͦ͠وແ͹ඇ༽ෝ୴ܲݰΏ༑઎৻ࣰࠬࢬ౵ɼۂট೟ؖ࿊ ΖखૌΊ͗ߨΚΗͱ͏Ζ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ແඇ༽͹ෝ୴ܲݰ ‡ ޲ਫ਼࿓ಉ঴ Rxۂҫྏؽؖ͹࣑ݩʀট೟ؖ࿊ ઝ঳͹࣑ྏ༂͹֋൅ଇ״αϫψΤ΢ϩηܗ2020೧ౕ୊3࣏ึਜ਼༩ࢋͶͱɼ৿ ‡ Ζඇ༽Ώ༂ࣆট೟ΉͲܐແͶۂ਒ʀࣰ༽ԿࢩԋΝ໪దͳ͢ɼҫྏؽؖ͹࣑ݩ Ν༩ఈۂΖඇ༽ΝึঁͤΖࣆܐແͶۂ͹ ֋൅ ‡ ঁ੔ֻʁ70Աԃڂݜ ֋࢟Ώ༑઎৻ࣰࠬࢬ ‡ PMDA Dx, Rx,Vxغઝ঳͹ྡজࢾݩ૥״αϫψΤ΢ϩηܗਬ਒ ৿ 30ೖҐ͖߳Δྡজࢾݩ͗֋࢟ͳ͵Ζ͗ɼ30ೖଶޛฑ࣎Ͳͺྡজࢾݩ͹಩͜ड़ ‡ Ͷྡজࢾݩ͗֋࢟Ն೵ͥͪ ઝ঳຤ͺؖ࿊ͤΖ঳য়ΝଲেͳͤΖҫ༂඾ɼҫ༂෨֐״αϫψΤ΢ϩηܗ৿ ‡ ࠸ਫ਼ҫྏ౵੣඾ͺ༑઎৻ࠬΝࣰࢬ;ٶɼର֐ਏஇ༽ҫ༂඾ح඾ɼҫྏؽ

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

֋൅ؽߑʤAMEDʥ͹େනద͵੔Վڂʤࢂߡʥೖຌҫྏݜ ൭ʤϠυϩಊخ֋൅ڂݜ;ٶ֋൅ڂබସմ໎ɼਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹ݜ ͹੖ඍʥͶ͕͏ͱ੔Վ૓ड़Ͷࢺͮͱ͏Ζں෼ࡠड़ɼέϧ΢Ψుࢢݨඏ

ɿ෾ࢢӺָʀබସմ໎̏ ΝࢩԋڂઝϟΩωθϞɼ॑঳ԿϟΩωθϞΝ௧੽ͤΖͪΌ͹ݜ״࿑ɼܨΤ΢ϩη͹ఽ೽ ‡ ࿑Ώླྀߨ͹෾ੵɼϭέοϱ͹֋൅Ͷͯ͵͗ΖՆ೵੓ܨઝ״Εɼν΢ϕΝ௧੽ͤΖ͞ͳͲɼ͍͗ה෤׿༟པͳϦʖϫρϏ༟པ͹̐झྪ͹ ‡ ֋൅حɿਏஇ๑ʀݗࠬؽ̐ ֋൅ɼࣰ༽Կଇ਒Νࢩԋحɼॴཀྵ೵ྙ͹߶͏ݗࠬ͹ٗढ़֋൅Ώؽౕ״Ͷݗड़ͤΖͪΌ͹੠ౕʀغઝΝ૥״αϫψΤ΢ϩηܗ৿ ‡ ͹੓೵ࣰৄΝࣰࢬɽݗड़ࢾ༂Ν3݆ͶฯݧफࡎحΤ΢ϩηΝਟଐͶݗड़ͤΖPCRݗड़ؽ ‡ ߇ݬΝਟଐʀ؈สͶݗड़ͤΖݗࠬΫρφΝ֋൅ɽ5݆Ͷ੣ଆ൤ജট೟ ‡ Νචགྷͳͦͥ໪ࢻͲ൓ఈͲ͘Ζਟଐਏஇ๑Ν֋൅حଥӹ౵͹γϱϕϩ͖Δ25෾ఖ͹ൕԢͲݗड़ؽ ‡ ̑ɿ࣑ྏ๑֋൅ ֋൅Νࢩԋح࣑ྏ༂͹֋൅ɼ঳য়րવ͹ͪΌҫྏؽوαϫψΤ΢ϩη΃͹న༽֨୉ʤχϧρήʀϨϛζεϥωϱήʥΏ৿ܗଚট೟༂͖Δ৿عΝ࣑ྏͤΖͪΌɼं׳ ‡ ଚ༂υʖνϗʖη͹༁8,000Կ߻෼͖Δ118͹ϐρφԿ߻෼ΝಋఈعࢋͲߨ͑ޫึԿ߻෼͹ߞΕࠒΊʥͶΓΕɼܯ΢ϱεϨαηέϨʖωϱήʤαϱϒϣʖνʀ਼஍ ‡ ͹Τ΢ϩη৷೘գఖΝ૏ࢯͤΖ͞ͳΝ൅ݡغઝॵ״ଚ༂ʤψϓΟϠηνρφʥ͗ع ‡ Νࢩԋڂଚ༂ʤΠϑΪϱʀΨϩϗηαʥ͹ྡজݜع ‡ ֋൅ΝࢩԋڂΏਕ޽ৼ഑ૹ஖ʤECMOʥ౵͹੓೵Ώ҈સ੓޴৏ͶؖͤΖݜحٷਕ޽ݼ ‡ ̒ɿϭέοϱ֋൅ ͹ͪΌ͹ٗढ़֋൅Νࢩԋڇڛઝ֨୉๹ࢯ͹ͪΌɼϭέοϱޫึ͹ࡠ੣Ώࠅ಼҈ఈ״͹ޛࠕ ‡ ΝࢩԋɽݳࡑɼϠυϩಊ෼͹ࡠड़౵Ͷڂ൭͹֋൅ͶؖͤΖݜخɼ mRNAٗढ़ΝԢ༽ͪ͢ϭέοϱɼؖ࿊ٗढ़ڂૌ׷͓νϱϏέ࣯Ν߇ݬͳͤΖϭέοϱ͹֋൅ͶؖͤΖݜ ‡ Ν਒ఴڂ޴͜ݜ ͹ͪΌ͹ٗढ़֋൅͹෱߁͏ஊ֌Νࢩԋڇڛɼඉྡজࢾݩɼྡজࢾݩɼʤϭέοϱʥڂݜેخਟଐ͵ࣰ༽ԿΝ໪ඬͶɼ ‡ ൭خΝࢩ͓Ζڂɿαϫψݜ̓ Νࢩԋཱི֮ܧ੖ඍɼϠυϩಊ෼ࡠड़ɼ඲Ճحɼؽڂݜેخ͵൭దخබସմ໎ɼ࣑ྏ๑ɼϭέοϱ֋൅͹ͪΌͶɼͨΗΝࢩ͓Ζ ‡ ൭Ν੖ඍخઝ঳͹੓য়մੵʀਏஇ๑͹ཱི֮ʀϭέοϱ֋൅ʀ࣑ྏ๑֋൅Νྡজݳ৖͖Δ௜݃͢ͱࣰࢬͲ͘Ζ״ڷ͹෉଒ࢬઅͶͱɼ৿ͨ;ٶBSL3ࢬઅ ‡ ౐୉ָ ʤBSL2ࢬઅʥɼ๼քಕ୉ָʤBSL3ࢬઅʥʥښࢬઅΝ੖ඍʤںබݬରմੵͶଲԢड़པΖέϧ΢Ψుࢢݨඏ ‡ ൭ݜɼ୉ࡗ୉ָʤBSL3ࢬઅʥʥخ൭͹ߑ஛ʤҫ༂خઝࣰݩ͹״ௗྪͶΓΖྸ ‡ ̔ɿࠅࡏ࿊ܠ ϕϫήϧϞʤSATREPSʥʱʰΠζΠஏྙڢໝ՟ୌଲԢࠅࡏՌָٗढ़وځʱʰஏۂࣆڂໝฯ݊՟ୌմ݀ਬ਒͹ͪΌ͹ݜوځ࠘ʱʰஏۂ൭૓ਫ਼ࣆخڂઝ঳ݜ״ڷʀ࠸ڷʰ৿ ‡ ͹Յଐڂઝ঳ͶؖͤΖݜ״αϫψΤ΢ϩηܗʱͶ͕͜Ζ৿ۂʀ࣑ݩϋρφϭʖέߑ஛ࣆڂҮͶ͕͜Ζྡজݜ

֋൅ಊ޴Ͷͯ͏ͱʱʤ2021೧2݆ʥڂઝ঳ͶؖͤΖࠅ಼֐͹ݜ״αϫψΤ΢ϩηܗड़ॶʁ୊26յ݊߃ʀҫྏકྲྀਬ਒઒໵௒ࠬճʰ৿

86 ࣎ٺە ฑ࣎ ൭ʁϨλʖη֮ฯخ֋൅ਬ਒ڂݜ ΏชՌ঴ͶΓΖέϧ΢Ψుࢢڛ͹෾཯ʀ఑הαϫψΤ΢ϩηܗઝݜͶΓΖ৿״ ߨΚΗͪ͗ڛਬ਒ΝՅଐͦ͠ΖͪΌ͹અඍʀࣁࡒ͹఑ڂ͹಍೘౵ɼݜںݨඏ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ ௪ڠ ॶڂઝ঳ݜ״ࠅཱི ‡ ڛαϫψΤ΢ϩη͹෾཯ʀ఑ܗ֋൅ ৿ڂݜ αϫψΤ΢ܗαϫψΤ΢ϩη͹෾཯Ͷ੔ޯɽ৿ܗઝݜͺ৿״൭ ‡ 2020೧1݆ɼخਬ਒ ϩηଲࡨͶༀཱིͱΖͪΌɼΤ΢ϩηͳࡋ๖ͺࠅ಼֐Ͷ߁͚ഓා ؽؖ౵༁100ΩॶͶ෾༫ڂ2020೧6఼݆࣎Ͳࠅ಼֐͹ࢾݩݜ 9 ं׳ઝ঳͹״αϫψΤ΢ϩηܗߕݗӺͶΓΕ֮೟͠Ηͪ৿ۯ2021೧1݆ɼ ‡ הรҡو౵͹ݗରΝ༽͏ͱΤ΢ϩη෾཯ࢾݩΝࣰࢬ͢ɼSARS-CoV-2৿ ؽڂͺࠅ಼֐͹ݜהVOC-202012/01͹Τ΢ϩη෾཯Ͷ੔ޯɽ෾཯ͪ͢รҡ ؖ౵Ͷ߁͚ഓාͤΖ༩ఈͳ൅නʤBSL3/ABSL3ࢬઅΝ࣍ͯࢬઅͶ෾༫ʥ ௪ڠ ֋൅๑ਕ ҫڂࠅཱིݜ ‡ ڛ͹఑הαϫψΤ΢ϩη͹෾཯Ͷཤ༽Ն೵͵ࡋ๖ܗ৿ ൭ʀ݊߃ʀӭ཈ݜخ༂ ر͹הαϫψΤ΢ϩηΝക཈ʀ෾཯Ն೵͵ࡋ๖ܗॶ͖Δ৿ڂઝ঳ݜ״ࠅཱི ‡ ॶڂ ਅ͢ࠒΊΝण͜෉͜Ζ͞ͳΝ൅නڛ୙Νण͜ɼ2020೧2݆ɼ఑ ௪ڠ Կ ‡ ޲ਫ਼࿓ಉ঴کॶ͹અඍڂઝ঳ݜ״ࠅཱི Ν໪کॶ͹ର੏ʀ೵ྙଁڂઝ঳ݜ״2020೧ౕ୊3࣏ึਜ਼༩ࢋҌͶͱɼࠅཱི ‡ ౵͹੖ඍɼுࣹ౵͹੖ඍΝࢩԋ༩ఈحదͶɼݗࠬؽ ںݨඏܗ঱఼ϪʖδʖૺࠬڠΰόϞմੵ༽ηφϪʖζγʖώʖ͹੖ඍɼ 9 ͹ਬ਒Ͷ޴ͪ͜੖ඍɼබݬڂ͹੖ඍ౵ͶՅ͓ɼ࣑ྏ༂ʀϭέοϱ֋൅ݜ ԿͶ޴ͪ͜੖ඍ౵΍؜΋کର؇ཀྵʀ݄ੜָదմੵ͹ ੔ֻʁ23Աԃঁ ‡ ͹಍೘ ‡ ช෨Ռָ঴ Vx, RxںBSL3ࢬઅ΃͹έϧ΢Ψుࢢݨඏ ;ٶ͹಍೘ں2020೧ౕ୊1յ௒੖ඇͶͱɼBSL3ࢬઅ΃͹έϧ΢Ψుࢢݨඏ ‡ ࢬઅ͹րर੖ඍඇ༽Νใ؜ ી஖͠Ηͱ͏͵͏๼քಕ୉ָ͹BSL3ࢬઅͶઅ஖ͤ͗ںέϧ΢Ψుࢢݨඏ 9 ΖݡࠒΊ ੔ֻʁ16.5Աԃঁ ‡

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

࣎ٺە ฑ࣎ ൭ʁ΢ϱϓϧ੖ඍخ֋൅ਬ਒ڂݜ ࣎͹खૌΊͳ͢ٺە͗༽ಋཤ༽ʀ֐෨ཤڠBSL-3౵͹ࢬઅΏηϏαϱ౵͹અඍ͹ ͱߨΚΗͪ ଲেϠξ གྷ ੕ࡨࣰࢬकରं ϨτΡ֕ AMED Vx ‡ ڛ͹఑ڧ؂֋൅ BSL-3ࢬઅΝ༽͏ͪϭέοϱ֋൅ڂݜ ͶۂةΝڧ؂ɼࣰݩɼϭέοϱ֋൅Ͳ͘Ζ͢ڛ൭ ‡ ࠅ಼Ͷ͍ΖBSL-3ࢬઅΝ఑خਬ਒ ڛ఑ 1ऀ͗ಋखૌΊ΃͹ࢂժΝݗ౾஦ ‡

֋൅๑ਕ Rxڂࠅཱིݜ ‡ ڛͶଲͤΖηϏαϱ͹༑઎ద͵ࢬߨదཤ༽͹఑ंڂؽؖʀݜڂݜ ॶڂઝ঳͹࣑ྏ༂ͳ͵Ε͑Ζ෼࣯͹୵ࡩΏਏஇ๑ʀ࣑ྏ ཀྵԿָݜ״αϫψΤ΢ϩηܗ৿ ‡ ֋൅Ͷଲ͢ͱɼηʖϏʖαϱڂ๑Ν޴৏ͦ͑͠Ζ՟ୌΝτʖϜͳͤΖݜ ڛϒϣʖνʰ෍ֹʱ͹ཤ༽Ν఑ ౵Ͷ෍ֹ͹ڂ౐୉ָʥ͹ͪΌ͹ݜښॶʙڂ࣑ྏ༂ޫึ͹ಋఈʤཀྵԿָݜ 9 ڛཤ༽Ν఑ αϫψϭέοϱ͹஭ࣻਓʀεϨϱζ͹֮ฯ ‡ ޲ਫ਼࿓ಉ঴ Vxܗ৿ αϫψϭέοϱ͹֋൅Νݡੀ͓ɼεϨϱܗ2020೧୊2࣏ึਜ਼༩ࢋͶͱɼ৿ ‡ ζʀ஭ࣻਓ͹ഛ৏ด;Ͷฯ؇ͶགྷͤΖඇ༽ΝࠅͲࢩอͤΖͳͳ΍Ͷɼϟʖ ғབΝߨ͏ɼεϨϱζʀ஭ࣻਓ͹ଐΏ͖͵֮ฯΝྙڢΩʖͶଲ͢ͱଁࢊ͹ ໪ࢨͤ ੔ֻʁ50Աԃঁ ‡

ઝݜΤΥϔγ΢φ౵״ॶɼAMEDɼڂ൭ʀ݊߃ʀӭ཈ݜخड़ॶʁ޲࿓঴༩ࢋʤฑ੔31೧ౕɼྫ࿪ݫ೧ࠥ3೧ౕʥɼҫ༂

87 ೖຌͶ͕͜Ζ;ٶଠࠅ .4 ࣎͹खૌΊٺەઝ঳΃͹״αϫψΤ΢ϩηܗ৿ ֋൅੔Վڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿;ٶགྷ֕ .4-1 4-2. ৆ࡋ 4-2-1. ੕ැ ࠅࡏؽؖ .4-2-2 ۂة;ٶΠΩυϝΠ .4-2-3 ;ଠࠅ͖Δ͹ָ .4-3

88 ࣎ٺە ฑ࣎ ࣎ʥٺە֋൅ࢩԋʤڂCEPIͶΓΖݜ αϫψΤ΢ϩη͹ླྀߨΝण͜ɼೖຌΝ؜΋෵਼͹ࠅ͗CEPI΃͹௧Յड़ࣁΝܗ৿ ࣰࢬ͢ɼϭέοϱ͹֋൅ՅଐΝࢩԋͤΖಊ͘Νݡͦͪ

௧Յड़ࣁ͹֭ಚ COVAX͹൅ଏ ΖϕϫήϧϞͤڇڛαϫψΤ΢ϩη޴͜ϭέοϱΝܗ֋൅ؖ࿊ „ ࢂՅࠅͶޮฑͶ৿ڂαϫψΤ΢ϩηϭέοϱݜܗɼࡔ஄͖Δ͹৿ۂة෵਼͹ࠅɼ „ ϕϫζΥέφ޴͜͹ࣁۜΝ֭ಚ ʰ COVID-19 Vaccine Global Access Facility (COVAX) ʱΝGavi the ಋͲ൅ଏڠकགྷ͵ड़ࣁ*1,2] Vaccine Alliance, WHOͳ] Ζ͞ͳΝ໪దͤڇڛϭέοϱΝ࠹΍චགྷͳͤΖਕʓ΃ޮฑͶϭέοϱΝ ‡ غड़࣎ڎ ड़ֻۜʤԱԃʥڎ ड़ࣁं ͳ͢ͱ ೧ ݆Ͷ൅ଏ Ωψξ 216.1 2020೧12݆ 2020 6 ‡ 2020೧9݆18ೖ఼࣎Ͳ੊ֆਕ޳͹70ˍΝΩώʖͤΖ170ϳࠅ͗COVAX͹ χ΢ς 156.7 2021೧2݆ खૌΊͶࢂՅ͹қࢧΝන໎ ೖຌ 120.0 2020೧4݆ɼ2020೧12݆ ༩ఈڇڛ2021೧຦ΉͲͶ20Ա౦༫෾͹ϭέοϱΝ ‡ όϩΤΥʖ 30.3 2020೧2݆ɼ2021೧2݆ ΢άϨη 27.1 2020೧2݆ ΰ΢ςࡔ஄ 21.6 2020೧11݆ ϭέοϱ֋൅͹੔Վ ؘࠅ 9.7 2020೧11݆ „ 2020೧11఼݆࣎Ͳ৿ܗαϫψΤ΢ϩηͶଲ͢ͱ9ͯ͹ϭέοϱޫึΝ ΢νϨΠ 6.3 2020೧8݆ ֋൅ ϜϪʖεΠ ೧ ݆ ΝशΚΔͦΖͪΌɼ 9ͯغ੓ٺCEPIͺɼ2021೧຦ΉͲͶϏϱυϝρέ͹ ‡ 11 2020 3.2 ໝͶ੣ଆͲ͘ɼCOVAXΝوΨʖηφϨΠ 2.4 2020೧6݆ ͹ϭέοϱޫึ͹ϛʖφϓΧϨΨΝߑ஛ɽ୉ Ն೵͵҈સͲްՎద͵ϭέοϱΝ3ͯ͹֋൅ͤΖڇڛࢀҬे༓ 1.2 2020೧10݆ ௪ͣͱήϫʖώϩͶ ͞ͳΝ໪దͳ͢ͱ͏Ζ ϭέοϱ͹֋൅ „ COVAX͹ϭέοϱ͹౦༫Ν2021೧3݆1ೖͶ֋࢟ ੣ଆ;ٶαϫψΤ΢ϩηͶଲͤΖϭέοϱ֋൅͹ਬ਒Ͷ޴ ‡ ιϧϞ΢ϱητΡτϣʖφΨϔ΢ϱυΡΠʤSIIʥͶΓͮͱ೟Նܗ2020೧3఼݆࣎Ͳ৿ „ ΗͪOxford / AstraZenecaϭέοϱΝΪʖψ΃2݆24ೖͶ60ຬյɼαʖ͠ ڛ֋൅ࣁۜΝ఑ڂͪ͜ϏʖφψʖερϕΝ7ͯగ݃ɼݜ ‡ Inovioऀʤธࠅʥ φζϚϭʖϩ΃2ೖޛ͹2݆26ೖͶ504,000յ͹౦༫෾ഓୣ έ΢ʖϱθϧϱχ୉ָʤΨʖηφϧϨΠʥ ‡ ҫྏॊࣆं޴͜͹౦༫ΝαʖφζϚϭʖϩͳΪʖψͲ2021೧3݆1ೖͶ֋ ‡ ࢟ ॶʤNIAIDʥڂઝ঳ݜ״ModernaऀʤธࠅʥɼธࠅࠅཱིΠϪϩάʖ ‡ ‡ ͶΓΖϭέοϱʰ ʱͺಋ೧ ݆ ೖͶ ‡ CureVacऀʤχ΢ςʥ Oxford / AstraZeneca COVISHIELD 2 15 ࢘༽ϨηφʤEULʥͶࢨఈٺە੊ֆฯ݊ؽ͖ؖΔ ‡ Novavaxऀʤธࠅʥ Oxford୉ָʤӵࠅʥ ‡ ߵߕ୉ָʤ஦ࠅʥ ‡

TTBϪʖφΝ࢘༽͢׷ࢋۋΝ؜΋Ն೵੓͍Εʤड़ࣁֻۜॳʥ*2. MUFG2019೧͹೧ؔฑڛ৚ๅΝϒρέΠρϕͪ͢΍͹Ͳ͍ΕɼCOVAX޴͜͹ࣁۜ఑ڛࣆ͖Δେනద͵ࣁۜ఑ىCEPI͹Website͹ .1* ड़ॶʁCEPIΤΥϔγ΢φ

89 ೖຌͶ͕͜Ζ;ٶଠࠅ .4 ࣎͹खૌΊٺەઝ঳΃͹״αϫψΤ΢ϩηܗ৿ ֋൅੔Վڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿;ٶགྷ֕ .4-1 4-2. ৆ࡋ 4-2-1. ੕ැ ࠅࡏؽؖ .4-2-2 ۂة;ٶΠΩυϝΠ .4-2-3 ;ଠࠅ͖Δ͹ָ .4-3

90 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ϕϪʖϢʖϜρϕʁ୉ָ ֋൅͗ߨΚΗͱ͏Ζ͹ͺธࠅڂઝ঳͹ਏஇ๑ͶؖͤΖݜ״αϫψΤ΢ϩηܗ৿ ͏͵͹୉ָ͗ѻౙదͶଡ͏ɽҲ๏ɼਏஇ๑͹ࣰ༽ԿͶࢺΖೖຌ͹୉ָͺ

୉ָॶࡑࠅ*1 ਏஇ๑ ธӵಢ෻஦ೖ ‡ Columbia University ‡ George Washington University ‡ Hackensack University ‡ Northwestern University ‡ Rutgers University ‡ University of Alabama ‡ University of California, ‡ University of Ҫఽࢢ Los Angeles Cambridge ʷʷʷʷ ,ݗࠬ ‡ University of California San Diego ‡ University of California, San Francisco ‡ University of Massachusetts ‡ University of North Carolina ‡ University of Texas ‡ Yale University

‡ Emory University ‡ University of ߇ରݗࠬ ‡ Heidelberg University ʷ ‡ SunYat-sen University ʷ ‡ University of Arizona Southampton

߇ݬݗࠬ ʷ ‡ University of Oxford ʷʷʷʷ

ࡎ͍Ζ୉ָ͹಼ɼຌPJηαʖϕ಼͹ࠅͶॶࡑͤΖ୉ָΝϨηφΠρϕɽӵࠅʀχ΢ςʀ஦ࠅͺUS News͹Best Global Universities for Infectious DiseasesͶϧϱέ΢ϱͤΖ୉ָ͹಼ɼىBiocentury COVID-19 DiagnosticsͶ .1* ֋൅ΝࣰࢬͤΖ୉ָΝ௧ՅڂCOVID-19͹ਏஇ๑͹ݜ ड़ॶʁBiocentury COVID-19 Diagnostics (2020೧11݆20ೖ఼࣎)ɼUS News, ”Best Global Universities for Infectious Diseases”, ”Best Global Universities for Infectious Diseases”ɼ֦୉ָΤΥϔγ΢φ

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ۂةϕϪʖϢʖϜρϕʁ ੊ֆͲ300݇Ν௔͓ΖݗࠬΫρφ͗ট೟͠Ηͱ͏Ζɽ3ϳࠅ຤ͺஏҮҐ৏Ͳ ͹ਏஇ๑ͺ෍࢞ϪϑΨऀ͹ΊͲ͍Ζۂةܧট೟͠Ηͱ͏Ζೖ ຌऀॶࡑࠅ*1 ਏஇ๑ธӵಢ෻஦ೖ

‡ Abbott ‡ Bio-Rad ‡ PerkinElmer Ҫఽࢢ ‡ Becton, Dickinson and ‡ Siemens ʷ ‡ bioMerieux ʷʷ .ݗࠬ Company ‡ Qiagen N.V ‡ Luminex ६Ͷͺຮͪ͵͏͗ɼخ Thermo Fisher Scientific ‡ ‡ Hologic εηϟρέη౵͗ଚࡑ

‡ Abbott ‡ Bio-Rad ‡ PerkinElmer ‡ Beckman Coulter ‡ Hangzhou Biotest ‡ Cellex ‡ Abingdon Health ‡ Beijing Wantai ‡ Healgen ‡ Siemens ‡ bioMerieux ʷ ‡ ߇ରݗࠬ ‡ Ortho Clinical Diagnostics BBI Solutions ‡ Guanngzhou Wondfo ‡ VivaCheck ‡ Innovita ‡ Luminex ‡ Thermo Fisher Scientific ‡ Danahear

‡ Abbott ‡ ෍࢞ϪϑΨ ‡ ߇ݬݗࠬ Becton, Dickinson and ʷʷʷʷ ६Ͷͺຮͪ͵͏͗ɼخ Company ‡ Quidel ଠͶ΍εηϟρέη౵ ͗ଚࡑ

ࡎɽՅ͓ͱɼӵࠅͺUK Rapid TestىΝۂةࡎ͍ΖىࡎɽΉͪɼࢤ৖ϪϛʖφͶͱ2ͯҐ৏ͶىΝۂة͹಼ɼট೟਼͗3ஏҮʙࠅҐ৏ͲຌPJηαʖϕ಼͹ࠅͶॶࡑͤΖۂةࡎ͍ΖىBiocentury COVID-19 DiagnosticsͶ .1* Ν௧Յɽۂة֋൅ΝࣰࢬͤΖڂ͹಼ɼCOVID-19͹ਏஇ๑͹ݜۂةConsortiumՅ໏ ʤࢤ৖ϪϛʖφͺʤʰInfectious Disease Diagnostics Market by Product & Service (Assay, Kit & Reagent, Instruments), Disease Type (Hepatitis, HIV, HAI, HPV, TB, Influenza), Technology (Immunodiagnostics, PCR, NGS), End User (Hospital, Research Institute) - Global Forecast to 2022ʱɼʰINFECTIOUS DISEASE DIAGNOSTICS MARKET - GROWTH, TRENDS, AND FORECASTS (2020 - 2025)ʱɼʰGlobal Infectious Disease Diagnostics Market, Forecast to 2027ʱɼʰInfectious Diseases In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product, By Application, By Technology (Immunochemistry, Molecular Diagnostics), By End Use, By Region, And Segment Forecasts, 2020 - 2027ʱʥ ड़ॶʁBiocentury COVID-19 Diagnostics (2020೧11݆20ೖ఼࣎)ɼDepartment of Health and Social Care, “Government invests in UK-developed antibody tests from UK Rapid Test Consortium” ౵

91 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔ՎʁAbbottʤธʥٺەฑ࣎ʀ ࣎͹ϨλʖηॄٺەͶʥ੣඾ୱճ͹ࣰ੹ͶՅ͓ɼڠଡ༹͵ʤଲেٗढ़ʀබݬର ͪͮ͗ܪͲ͹ଡ਼੣඾৏ࢤͶؔغ஦౦Ծ͹൓இ͹ଐ͠ʀ౦Ծྖ͗୻

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ ֋൅કྲྀ Ҫఽࢢʀ߇ݬʀ߇ରݗࠬڂ֋൅કྲྀ ݜڂݜ ઝ঳͹ਏஇ๑֋൅Ν ͶؖͤΖਏஇΫρφΝ֋൅״αϫψΤ΢ϩηܗϏϱυϝρέ࣎͹༹ʓ͵ωʖθͶԢ͓ΔΗΖଡ ¾ ৿ ¾ ֋൅͹ਬ਒ڂ੣඾ఴ֋Ν໪ࢨ͢ͱ͏Ζʤଡ͚͹ਕΝଲে સऀ࠹༑઎ͳͪ͢ݜ͵༹ ͶݗࠬͲ͘ΖΓ͑҈Ճ͵Ճ֪અఈɼݗࠬ͹৖ॶ 9 CEOक಍Ͳ͹ʰ1ϳ݆Ͳ͹ࢤ৖౦೘ʱΝ໪ඬͳ͢ɼ ֋൅੣඾ ֋൅͹ਬ਒ڂΝમͻͥݗࠬՆ೵ɼਟଐͶ݃ՎΝड़ͤɼ౵ʥ ͪݜ ¾ ༹ʓ͵ωʖθͶ߻஗ͤΖΓ͑ɼ෵਼͹৿ܗαϫ 14झྪ ઝ঳༽ਏஇ๑Ν֋൅ ʤID NowʤҪఽࢢʥɼ״ψΤ΢ϩη ֋൅Νࣰࢬ BINAXNOWʤ߇ݬʥ౵ʥڂસͱ͹ਏஇٗढ़͹੣඾ԿͶ޴͜ݜ 9 ଵΠϕϨ࿊ಊܠ֋൅ਬ਒ 9 ॊཔ͹ݽఈਏஇΫρφୱରͶՅ͓ɼڂݜ ܗ͹Ϋρφ֋൅΍ਬ਒ ઝ঳͹ਏஇ״Ҫఽࢢʀ߇ରʀ߇ݬݗࠬͶ͕͏ͱ ¾ ֋൅ਬ਒ڂݜ ͵ʀकغ๑Ν֋൅ʀ৏ࢤʤ੊ֆॵ͹HIV߇ରݗࠬ؜΋ʥ ট೟࣎ ੊ֆॵ͹HIV߇ରݗࠬ͹֋൅ʀ৏ࢤΝ࢟Όɼ෵਼͹ ¾ ऀ಼͹༑ऴ͵ਕࡒΝডॄ͢ɼਏஇٗढ़ຘͶؽ೵ ট೟खಚࠅʙஏҮ 9 බݬରʤHIVɼHBV౵ʥΏਏஇٗढ़ʤҪఽࢢʀ߇ ԥஇοʖϞΝ2݆Ͷૌ੔ɼ3݆Ͷͺট೟खಚ ઝಊ޴Ν௧͏ɼ2020೧2݆ΉͲͶ ‡ RealTime SARS-CoV-2 assayʁ״ରʀ߇ݬݗࠬʥ΃͹எݡΝฯ༙ 9 2019೧຦͖Δ ՆʤEUAʥɼڒ༽࢘ٺەਏஇ๑֋൅ͶଲͤΖકྲྀʀસऀ๏ਓࡨఈ ธࠅʤ ֋൅ɼਫ਼ࢊɼࣰ༽Կ͹ؽ೵ԥஇͲɼݗࠬझྪຘ 2020೧3݆ʥɼEUʤCEϜʖέڂݜ 9 ෈໎ʥغͶ֋൅οʖϞΝૌ੔͢ɼಋ࣎ดߨͲ༹ʓ͵ݗࠬΫρ खಚɼ࣎ ൭ φΝ֋൅ ‡ ID NowʁธࠅʤEUAɼ2020೧خ֋൅ਬ਒ڂݜ 3݆ʥɼೖຌʤড়݇෉͘੣ଆ൤ ൭ ജট೟ɼ2020೧10݆ʥɼEUخ֋൅ਬ਒ڂබݬରγʖϗ΢ϧϱηؽ೵ʀର੏͹۫ඍ ݜ ¾ ෈໎ʥغ఼Ν3ϳ݆Ͳݒ ʤCEϜʖέखಚɼ ࣎ڎήϫʖώϩͲ͹HIVΏHBV͹γʖϗ΢ϧϱηͶΓΖ ¾ ੊ֆ஦͹ऩགྷͶଲԢͶඍ͓ɼ3 9 รҡझΝ͏ͬ૥͚ࡱஎͤΖͪΌ͹ର੏Ν۫ඍ અʤ௪৙1೧Ґ৏Νགྷͤʥ ‡ BINAXNOW COVID-19 Ag Card Ͷ Home TestʁธࠅʤEUAɼغ༎͢ɼ૥ۯΝح੣ଆؽܗӨࣁݱ͹ฯ༙ 9 ௪৙઩สͲ༎ૻͤΖ୉ܨ͵๝෍ ¾ 2020೧12݆ʥ ήϫʖώϩ͹ର֐ਏஇ༂ࢤ৖Ͳͺ୊2Ғɽଠऀͳർ ਫ਼ࢊର੏Ν੖ඍ 9 ઝ״αϫψΤ΢ϩηܗ֋൅ʀਫ਼ࢊର੏ ¾ ଠ੣඾͹੣ଆϧ΢ϱΝ৿ڂӨࣁݱʤࣁۜɼݜܨ͵ͱ๝෍ֳ͢ ࡎىΝڱͺɼೖຌɼธࠅɼEUͲ͹ট೟য়ى৏* ʤઅඍɼགྷҽʥΝ؜΋ʥΝฯ༙ ঳޴͜ਏஇ๑Ͷ࢘༽͢ྖࢊର੏ͶଲԢ

ड़ॶʁAbbottऀΤΥϔγ΢φɼForbes, “Innovation at Speed and Scale | 2020 Forbes Healthcare Summit”ʤ2020ʥ౵

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔ՎʁInnovitaʤ஦ʥٺەฑ࣎ʀ ࣎͹ଁࢊଲԢΝՆ೵ͳͪ͢ɽΉͪɼऀ֐઒໵ՊΝডٺەଚ͹߶͏ਫ਼ࢊ೵ྙ͗ع ࣙऀ಼͹෈ଏஎݡΝึ׮ͤΖ͞ͳͲ1ुؔͲ͹߇ରݗࠬ͹֋൅Ͷࢺͮͪ͢ॄ

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ ֋൅કྲྀ 1ुؔͲڂ֋൅કྲྀ ݜڂݜ ΝಁΉ͓ͪ੣඾֋൅͹ࣰࢬ ߇ରݗࠬΝ֋൅׮྅ڱͳ͢ɼ෵਼͹ࠅՊɼ঴ ¾ ࠹৿͹ླྀߨয়ۂݗࠬΫρφΝक࣢͹ࣆ ¾ ؇ཀྵοʖϞ;ٶαϫψΤ΢ϩη઒໵͹ླྀߨ؄ࢻܗʤࢤʥक಍͹Ռָٗढ़ϕϫζΥέφ΃ࢂժ 9 ৿ ժʥΏ஦ঘ Νઅཱི ֋൅੣඾ܯժʤࠅՊ863ܯ൅ఴڂࠅՊύ΢τέݜ 9 ͹खૌΊɼ঴ʤࢤʥͶΓΖ ¾ ࠅՊՌָ෨͹གྷ੧ͶԢ͓ਟଐͶਏஇΫρφΝԢۜخ΢όϗʖεϥϱۂة ট೟޴͜Ͷਅ੧ 2019-nCoV Ab Testٺ ౵Ͷؖ༫ڂकགྷ͵ݜ য়බಡIgM/IgG倻ץܗӵ寡ಝ2019-৿) (αϫψΤ΢ϩη ߻㢧㴲宼∩ᚭʤ囹ରۜ๑ʥܗ2020೧2݆8ೖͶࠅՊՌָ෨͗৿ 9 ট೟ਅ੧Ϊ΢χΝޮ֋ɼͨ͹ٺ֋൅ਬ਒ ਟଐݗࠬΫρφ͹Ԣڂݜ 2ुؔఖౕͲট೟Ν֭ಚޛ ߶͏ٗढ़ྙʀਫ਼ࢊ඾࣯͹ैଏ ¾ ֋൅ਬ਒ڂϕϫζΥ ݜۂࢊڷࠅՊ֋൅րַҗҽճͶΓΖકྲྀద৿ 9 έφͶ೟ఈ͠ΗΖ ͵ʀकغͲ͹੔Վ૓ड़ ট೟࣎ؔغͶΓΖਫ਼ࢊ ¾ ઒໵Պॄ஄ͶΓΖ୻ۃ஦ࠅࠅՊ༂඾؄ಞ؇ཀྵ 9 ϧ΢ιϱηট೟Νखಚ ֋ ট೟खಚࠅʙஏҮڂऀ֐ϟϱώʖ؜΋ҫࢥ6໌ͳദ࢞15໌ͶΓΖݜ 9 ൅οʖϞΝฦ੔ ൭خ֋൅ਬ਒ڂݜ ώ΢ښΏ๼ंڂઝ঳ݜ״ॶͲ͹ڂݜ֫݃܋ਕ຿մ๎ 9 ݩ ‡ 2019-nCoV Ab Testʁܨ͹ਏஇ༂֋൅͹ܧॶ͹໖Ӻڂਫ਼ࢊ೵ྙ͹ң࣍ʀ֨୉ Ψτέόϫζʖݜ ¾ ট೟ɼ2020೧2݆ٺ໖ӺൕԢΏ֫࢐౵͹෵਼झྪ͹ਏஇ༂͹ਫ਼ࢊϧ΢ϱ ं౵͹֦෾໼͹઒໵Պ؜΋ ஦ࠅʤԢ 9 αϫψΤ΢ϩη߇ର͹ݗड़ࢾ༂͹֋൅Ν1ुؔ *1ʥɼธࠅʤEUAɼ2020೧11ܗΝฯ༙͢ɼ೧ؔ4,000ຬਕ෾͹ਏஇࢾ༂Νਫ਼ࢊ 9 ৿ ট೟Ν֭ಚ ݆ʥɼEUʤCEϜʖέखಚɼ࣎ٺە஦ࠅͲ͹ޛ๼ธͳΠζΠΝ؜΋20ϳࠅҐ৏Ͷਏஇࢾ༂Ν༎ड़ Ͳࣰࢬ͢ɼͨ͹ 9 ෈໎ʥغ ͵ಋ͢ͱ3.5Աݫ͹౦ࣁΝߨ͏৿ͪڠ஦ࠅՌָӅͳ 9 ൭خ֋൅ڂ఼౵Νઅཱི ݜڎ͹֋൅ح੠ືؽ ຌۂةͺɼೖຌɼธࠅɼEUɼ஦ࠅʤ֋൅ىԿͶΓΖਫ਼ࢊ೵ྙ޴৏ *৏کԿ ¾ གྷҽର੏ک֋൅གྷҽ͹ү੔ڂݜ ¾ ࡎىΝڱऀॶࡑࠅʥͲ͹ট೟য় ඾࣯୴౲ंͶΓΖ؄ࢻළౕΝ;ٶಋର੏Νཱི֮ 9 ݳ৖ϪϗϩͲݗࠬڠ஦ࠅՌָӅΏ๼஦ࠅ޽Ռ୉ָ౵ͳ 9 ढ़ं͹φϪʖωϱήࣰࢬ͹ͪΌͶ਼ඨຬݫΝ౦ࣁ ଁՅ͢ɼ໲ୌ఼ΝਟଐͶरਜ਼ͤΖ͞ͳͲਫ਼ࢊ೵ྙΝٗ 9 5ຬ͖Δ50ຬ/ೖͶΉͲଁՅ

*1. ࠹ॵͶট೟Νणͪ͜͹ͺ2020೧2݆22ೖͫ͗ɼͨ͹ޛ੣඾͹໌সรߍͶ൒͏ɼಋ೧3݆Ͷট೟Ν৿ͪͶखಚ ࿪ࠅՌָٗढ़෨ΤΥϔγ΢φʤwww.most.gov.cnʥ౵ڠʤNMPAʥΤΥϔγ΢φɼ஦՜ਕ຿ۃड़ॶʁInnovitaΤΥϔγ΢φɼ஦ࠅࠅՊ༂඾؄ಞ؇ཀྵ

92 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔Վʁੜ՜୉ָʤ஦ࠅʥٺەฑ࣎ʀ ࣎ٺەΝ׈͖͢ɼܐؖۂڢ౵ͳ͹෱߁͏ۂةฑ࣎Ͷ͕͜Ζ੕ැɼଠ୉ָɼ຿ؔ ֋൅Νਬ਒ڂͶϕϫζΥέφΝཱིͬ৏͝ɼ෵਼ϠξϨτΡͲݜغͶ͕͏ͱ૥

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ ֋൅કྲྀ ֫࢐ݗࠬΫρφΝ֋൅ڂ֋൅કྲྀ ݜڂݜ ϕϫٺەαϫψΤ΢ϩηͶଲԢͤΖͪΌ͹ܗτʖϜͳ͢ͱ໖ӺָָՌɼఽઝබ ¾ ৿ڂҫָӅ͹ݜ ¾ Ͷཱི৏͝ ֋൅੣඾ٺɼιϱνʖΝ࣏ʓͶઅཱི ζΥέφΝ૥͝ܟ߃ָΝ݊ڠɼޮָ ιϱνʖ 9 2020೧2݆Ͷ֫࢐ݗड़ࢾݩٗढ़ɼϭέοϱɼϠόέڂʁੜ՜୉ָΦ΢θ૱߻ݜڂઝ঳ݜ״ 9 ಕබಡ֫࢐㢧㴲宼∩ᚭٷιϱνʖ ϫʖψϩ߇ର༂ɼੜ՜COVID-19΢ϱτϨζΥϱη ࿣桠ݼڂઝ঳ݜ״ʤ2008ʥɼੜ՜୉ָҫָ෨ ϕϫζΥέφΝ֋࢟ ʤ߅Ի㉐⃩਌ฤ๑ʥڂॶ ϕϫζΥέφ౵͹8ͯ͹ݜڂʁੜ՜୉ָ໖Ӻָݜڂʤ2013ʥɼ໖Ӻָݜ Νઅཱིۜخٺەιϱνʖ ¾ 1Ա5000ຬݫʤ23ԱԃʥͶ৏Ζڂ߃ݜ݊ڠ߃ָʁޮ݊ڠʤ2014ʥɼޮ ʤ2010ʥ য়බಡ2019-nCoV֫࢐㢧㴲ץܗઅཱི ৿ۜخ2020೧3݆Ͷ3೧ؔࢩԋΝߨ͑ॡ͹ͨΓ෫ 9 宼∩ᚭ(਼࣊PCR๑) ֋൅ਬ਒ڂݜ ֋൅ਬ਒ڂݜ ڠͶΓΖΤ΢ϩη໖Ӻָ͹ܠࠅʀ঴ʀ୉ָ͹࿊ ¾ ͵ʀकغద͵ࢂՅɼ຿ ট೟࣎ۅ੕ැ͹ޮูϕϫζΥέφ΃͹੷ ¾ ಋ΢όϗʖεϥϱιϱνΝઅཱིɼΤ΢ϩη໖Ӻ ֋൅ΝՅଐڂͶΓΕݜۂڢͳ͹ۂةؔ Ν޴৏ ট೟खಚࠅʙஏҮྙڂ͹ݜָ ಕබಡ֫࢐㢧㴲宼∩ᚭٷҗ ‡ ࿣桠ݼۜخՌָٗढ़঴ɼช෨঴ɼࠅՊฯ݊җҽճɼࠅՊ 9 2014೧10݆ΓΕ෤׿୉ָक࠷Ͳ஦ࠅՌָӅ͹෤׿ 9 ϕϫζΥέφͶؖ༫ ʤ߅Ի㉐⃩਌ฤ๑ʥʁ஦ࠅٺەࢤ౵͹11͹ښҽճɼ๼ ॶɼਫ਼෼෼ڂॶɼ৏քϏηςʖϩݜڂΤ΢ϩηָݜ ট೟2020೧2݆ʥٺɽ500ຬݫ ʤNMPAԢۂڢ࣎Ͷ޴ͪ͜ 9 Tencentͳϭέοϱ֋൅Ͷͯ͏ͱٺەɼ͢ܠॶɼ՜஦Ռٗ୉ָ࿊ڂཀྵָݜ ෉ ʤ੔౐ദԠধ਌ਫ਼෼Ռ༙ٗݸޮرඍ͓Ν໪ඬͶ׈ಊ ʤ༁8ԳԃʥΝTencent͗੠՜୉ָͶ *3 2020೧2݆22ೖͶͺ࢝ઔ୉ָɼCapital Bio ࢚ ʥ 9 αϫψΤ΢ϩηΝ ‡ Novel Coronavirus (2019-ܗಋ֋൅ͪ͢৿ڠ൭ Corporationͳخ֋൅ਬ਒ڂݜ *1 ժ 1.5࣎ؔҐ಼Ͷݗड़Ն೵͵֫࢐ݗࠬΫρφ͗NMPA nCov) Nucleic Acid Detectionܯࢬઅ͹୉෱͵֨୉Νڂ5೧ؔͲ͹ݜ ¾ 12,000Ϋρ Kit (Digital PCR Method)ʤCEܯট೟͠Ηɼ2݆26ೖͶͺ߻ٺͶΓΕԢ ॶΝ5೧ؔͲ12ࢬઅ͖Δ20ࢬઅͶଁΏͤڂ໖Ӻָݜ 9 ଅ ট೟ ೧ ݆ʥʤ৿㪝੏ଆՌرφΝ4ͯ͹෤׿͹බӅͶ खૌΊΝ֋࢟͢ɼBSL-3ࣰݩ࣪અ஖Ͷ޴ͪ͜׈ಊΝ 2020 4 *4 ʥ༙ݸޮ࢚ ʥښ൭ ٗʤ๼خ֋൅ਬ਒ڂΝऔͯ͘͜Ζ ݜंڂਬ਒Ώ༑ऴ͵ݜڂௗࣰ͗ࢬʤݜָ ࡎىΝڱͺɼ஦ࠅͲ͹ট೟য়ى֋൅Ϩλʖηɼ *৏ڂ޴͜Ͷҫ༂඾ݜंڂҟͶ॑ࢻʥ ¾ ੊ֆ͹ݜ ΝՅଐ ͨ͹ଠ࣑ྏ༂ɼϭέοϱͶڂͶΓΕҪ ϕϧρφϓΧʖϞΝໃྋ֋๎͢ɼݜۂڢͳ͹ۂة੕ැɼࠅ࿊ɼࡔ஄Ώ຿ؔ ¾ Ν੖ඍڧ؂ڂఽࢢഓ྽݀ఈٗढ़౵Ν؜΋ݜ ֋൅஦ڂGHDDI*2͹खૌΊͳ͢ͱ12,000͹༂ࡐΝ؜΋ ͯ͏ͱ΍ݜ 9 ॶΏΰ ReFRAMEԿ߻෼ϧ΢ϔϧϨʖΏAIχϧρήηέڂͶΓΖҫྏεητϞਫ਼෼ָݜۂڢࠅ࿊ͳ͹ 9 Ͷͯ͏ͱͺ෈໎ʥڱʤୢ͢ট೟য় ڛͶΓΖGHDDI*2Νઅཱི ϨʖωϱήεητϞ΃͹Πέιη౵Ν఑ۂڢ΢ςࡔ஄ͳ͹

ݒઅ͠ΗͪGlobal Health Drug Discovery Institute;ٶಋͲઅཱིڠࢤ੕ැͶΓͮͱښʥ *2. ΰ΢ςࡔ஄ɼੜ՜୉ָɼ๼ۃNational Medical Products AdministrationʤࠅՊ༂඾؄ಞ؇ཀྵ .1* *3. CapitalBio Technology Corporation *4. Targeting One Ltd. ड़ॶʁੜ՜୉ָΤΥϔγ΢φ

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔Վʁ෍࢞ϪϑΨʤೖʥٺەฑ࣎ʀ ܠͳ͹࿊ۂة֋൅ͳࣰ੹ɼؖ࿊ճऀΏք֐ڂͶోΖݜغઝ঳ݗࠬ΃͹ௗ״ ͪͮ͗ܪ֋൅஥घΏ߇ରݗࠬ͹֋൅Ͷڂݜغ࣎Ͷ͕͜Ζ૥ٺەର੏͹ߑ஛͗ɼ

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ ֋൅કྲྀ ߇ݬݗࠬΫρφ͹ڂ֋൅કྲྀ ݜڂݜ ք֐ট೟Ν֭ಚ;ٶԿΝඬᒙ ࠅ಼کժͶͱPOCT*2͹ܯӨܨغʥ͹ࠅ಼ ¾ ৿ͪ͵஦ۂʤϩϝϏϩη*1ࣆحસࣙಊݗࠬؽ ¾ ˏ (ժʰH.U. 2025 ʛHiyaku(ඊ༄ܯӨܨغԿͶ஭ྙ 9 ஦کεΥΠ֨୉ʀք֐ఴ֋͹ ժʰTransform!2020ʱʤ19ࠥ20೧ʥ Unitedʛʱʤ21ࠥ25೧ʥΝ2020೧9݆Ͷࡨఈ क͵֋൅੣඾ܯӨܨغ஦ 9 Ͷͱඬᒙ ֋൅ਬ਒ ߇ݬݗࠬΫρφʀࢾ༂ΝकͶ֋൅ڂݜ ֋൅ਬ਒ ¾ ࠅ಼ͶՅ͓ɼք֐Ͳ͹൤ജͶ޴͜ͱਬ਒ ‡ Φηϕϧ΢ϱSARS-CoV-2ڂݜ ʤ߇ݬਟଐݗࠬΫρφʥ ߇ݬݗࠬࢾ༂ͺ2020೧8ౕ݆״ઝ঳͹ਏஇΫρφʀࢾ༂౵͹֋൅ࣰ੹ 9 ߇ݬݗࠬΫρφɼ߶״෱߁͏ ¾ Ͷ ϜʖέΝखಚ ‡ ϩϝϏϩη 1966೧ɼ੊ֆॵ͹ഗಡݗࠬࢾ༂Ν੣඾ԿɽζΩ೦ɼ CE SARS-CoV-2 Ag 9 ߇ݬݗࠬࢾ༂ʥౕ״Ͷ֋൅ ʤ߶ڊͶգخ֋൅Νࣰࢬ ¾ ஦ࠅݳ๑ऀҽ͖Δ͹࠹৿৚ๅΝڂSARS൅ਫ਼࣎Ͷͺݗࠬࢾ༂͹ݜ ڂͶݜغਟଐਏஇΫρφͲͺ΢ϱϓϩΦϱδΤ΢ϩηɼHBVɼ ͪ͢SARSࢾ༂͹όΤύΤΝ׈͖͢ɼ૥ 9 ͵ʀकغʀ ֋൅Νਬ਒ ট೟࣎حHIVɼΠυόΤ΢ϩηɼRSΤ΢ϩη౵ɼݗࠬؽ ࢾ༂Ͳͺ΢ϱϓϩΦϱδΤ΢ϩηɼHBVɼHCVɼ 9 2020೧1݆஦२ɼ෤׿ࢤ͹ϟϱώʖΓΕࣰସΝ೼Ѵ ট೟खಚࠅʙஏҮ -ʀࢾ༂Νघ ‡ Φηϕϧ΢ϱSARSحHTLVΝఴ֋ ͢ɼଲԢ๏ਓΝݗ౾ɼݗࠬͶචགྷ͵ؽ ഓɽಋ݆ΓΕ߇ରݗࠬࢾ༂͹֋൅Ͷ஥घ CoV-2 ʁೖຌʤড়݇෉͘੣ଆ൤ ൭ 9 SARSαϫψΤ΢ϩηࢾ༂͹ഓ྽ͳ͹ྪࣇ੓͖Δɼ ജট೟ɼ2020೧5݆ʥɼEUخ֋൅ਬ਒ڂݜ Ͷधཱིͪ͢߇ର͹Ҳ෨ཤ༽͗Ն೵Ͷ ʤ Ϝʖέखಚɼ ೧ ݆ʥڊգ ֆφρϕ͹๝෍͵ࣁݱ CE 2020 8ۂࠅ಼ ¾ ͺࠅ಼Ͷͱ20ڻ൭ ʷജ৏߶΃͹Ӫخ֋൅ڂήϫʖώϩࢤ৖Ͳ͹εΥΠͺࠅ಼੐ͲͺH.U.ήϩʖ ݜ 9 ʛ50Աԃͳ͹ݡࠒΊ*3 Ͷ޴͜ɼࠅ಼Ͷ৿ͪ͵੣ڇڛϕͺ୊2Ғ ¾ ਏஇΫρφ͹҈ఈ -఼Νݒઅ ‡ ϩϝϏϩη SARSڎର੏͹ߑ஛ ଆܠ͹࿊ܗࢢճऀԥஇ ¾ ʁೖຌʤড়݇෉͘੣ ଚ޽৖ͳ߻ CoV-2 AgعͲ͹ٗ 9 ৿અ޽৖ͺ2021೧1݆ͶՖಉΝ൅නɽܗ2019೧ͶͺH.U.ήϩʖϕ಼Ͳήϩʖϕԥஇ 9 ढ़ʀ੣඾඲ՃοʖϞΝઅཱི Κͦɼु40ຬτηφҐ৏͹ਫ਼ࢊΝ໪ࢨͤ ଆ൤ജট೟ɼ2020೧6݆ʥ ͺࠅ಼Ͷͱ࠹ڻର੏Νཤ༽͢ɼࢾ༂͹֋൅ ʷജ৏߶΃͹ӪܠΝघֽ͜ΖΦ ¾ ࢢճऀԥஇͲ͹࿊ۂH.U.ήϩʖϕ಼Ͷͺण୙ྡজݗࠬࣆ 9 Ͳࣰࢬ ୉50Աԃͳ͹ݡࠒΊ*3ؔغηΠʖϩΦϩ΍ଚࡑ ࠥ඲ՃʀրྒྷΝ୻ ʀ౹ׇͺ஦ԟڂݜેخ͹क͵୴౲ͺɼۂةؽؖʀ֦ 9 ܠͳ͹Πϧ΢Πϱη఑ۂة஦ࠅ ¾ ࡎىΝڱͺɼೖຌɼธࠅɼEUͲ͹ট೟য়ىॶɼࢾ༂֋൅ͺ෍࢞ϪϑΨɼ඲ՃͺΦηΠʖϩ *৏ڂ஦ࠅ͹୉घۜ༧ήϩʖϕฑ࿪ฯݧήϩʖϕͳ͹߻อ ݜ 9 ॶڂճऀΝ௪ͣɼݗࠬϧϚΝ஦ࠅࠅ಼֦ஏͶఴ֋ Φϩʀ஦ԟݜ

ࡎىʱΓΕڱ੹֕ۂغϩϝϏϩηͺસࣙಊԿָ൅ޭ߮ો໖Ӻ଎ఈεητϞ *2. ྡজݳ৖ଊ࣎ݗࠬΝࢨͤ *3. H.U.ήϩʖϕϙʖϩυΡϱήηʰ2020೧ౕ୊1࢝ൔ .1* ड़ॶʁ෍࢞ϪϑΨΤΥϔγ΢φɼ޲ਫ਼࿓ಉ঴ΤΥϔγ΢φ 93 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊٺەͶ͕͜Ζۂةʤࢂߡʥͨ͹ଠ ͶΓΕ100ຬΫρφ͹ਫ਼ࢊΝՆ೵ۂڢAbingdonHealthͺαϱλʖεΠϞͲ͹ Ͷট೟Ν֭ಚغ֋൅ྙΝ׈༽͢૥ڂͳ͢ɼSinopharmͺήϩʖϕસର͹ݜ

Abingdon Healthʙ Sinopharmʤ஦ࠅʥ UK Rapid Test Consortiumʤӵࠅʥ

֋൅ਬ਒ڂ֋൅ਬ਒ ݜڂݜ 2020೧4݆Ͷཱིͬ৏͝ΔΗͪUK Rapid Test ¾ ࠅ刭஦ࠅਫ਼෼৏քণ媸ਫ਼෼Ռ༙ٗݸޮ࢚ ¾ ͹ࢢճऀͲ͍ΖΨϧϱξ͹ͨ;ٶಋ֋൅ʀਫ਼ࢊ ʤGENEODXʥڠConsortium͹ϟϱώʖͳ͢ͱɼ Νक಍ PathoFinderͶͱ৿ܗαϫψΤ΢ϩηਏஇΫρ ͳਫ਼ࢊ֨ φΝ֋൅ڛ఑ٺࠅ಼΃͹αϫψਏஇτηφ͹ࢺ 9 ୉͹ͪΌ΢άϨη੕ැ͖ΔࢩԋΝಚͱɼ ֋൅੔ՎڂConsortiumΝઅཱི ݜ ɼਏ͢ܠͳ࿊ۂةࢂՅ͹ՌָंΔͳ 9 য়බಡ2019-nCoV֫࢐㝾㰉媓℀ᚭʤ別ޭץܗConsortium ¾ ৿ ಋ֋൅Νߨ͑ڠ͹࠹నԿͶ͕͜Ζܯஇઅ PCR๑ʥʤReal Accurate Corona-plus PCR 9 ಋऀͺॊཔ10ϳ݆Άʹ͹֋൅ʀਫ਼ࢊϕϫιηΝ Kitʥ Ͷ୻क़ؔु਼ 9 SARS-CoV-2ͶՅ͓ɼMERS΍ಋ࣎ͶਏஇՆ೵ ɼຘु100ຬݺ͢ܠConsortium͹ϟʖΩʖͳ࿊ 9 ¾ ট೟ೖʁ ೧ ݆ ೖ ਏஇΫρφ͹ਫ਼ࢊ೵ྙͶࢺΖ NMPA 2020 11 20 ¾ CEট೟ೖʁ2020೧4݆ ¾ *1 ֋൅੔Վ WHO EUL ʁ2020೧6݆11ೖڂݜ ¾ ਟଐ߇ରਏஇΫρφʤAbC-19TMʥ͹੓೵ 9 99.40% accurate 20෾Ґ಼Ͷݗࠬ݃Վ͗෾͖Ζ 9 ¾ ট೟ೖʤCE-Markedʥʁ2020೧7݆30ೖ Ն͠Ηͱ͏Ζڒ͗༽UKɼEUͲ͹࢘ ¾ ¾ 2020೧10݆ɼ΢άϨη੕ැ͖ΔUK Rapid Test ConsortiumͶ100ຬݺ͹AbC-19TMण஭͍͗Ε

*1. Emergency Use Listing ड़ॶʁAbingdon HealthΤΥϔγ΢φɼGov.UK “Government invests in UK-developed antibody tests from UK Rapid Test Consortium”ɼ ࿪ࠅ஦ԟਕ຿੕ැΤΥϔγ΢φʤwww.gov.cn/ʥ౵ڠʤNMPAʥΤΥϔγ΢φɼ஦՜ਕ຿ۃSinopharmΤΥϔγ΢φɼ஦ࠅࠅՊ༂඾؄ಞ؇ཀྵ

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ϕϪʖϢʖϜρϕʁ୉ָ ͹ྡজغޛ֋൅ͺɼธӵ஦͹୉ָͲͺڂઝ঳࣑ྏ༂͹ݜ״αϫψΤ΢ϩηܗ৿ ͏͵ࢾݩஊ֌ΉͲਬ਒஦ɽҲ๏ɼೖຌͲͺྡজࢾݩͶ਒ΞͲ͏Ζ୉ָͺ ୉ָॶࡑࠅ*1 Phase ธӵಢ෻஦ೖ ট೟ࡃΊ ʷʷʷʷʷʷ

Phase ‡ Cornell University ‡ King's College London ʷʷʷʷ IV ‡ University of Miami Phase ‡ Imperial College London ‡ Vanderbilt University ʷʷʷʷ III ‡ Johns Hopkins University ‡ University of Hawaii ‡ Cambridge University ‡ University of Alabama at ʷʷʷʷ Phase II (Phase II/III) Birmingham ‡ Emory University ‡ University of Pennsylvania ‡ University of Chicago ʷʷʷʷʷ Phase I ‡ University of Utah ‡ University of Virginia ‡ University of Minnesota ‡ MIT ‡ University of Colorado Denver ‡ Columbia University ྡজ ‡ Free University of Berlin ‡ University of Wisconsin- ʷ ʷ ʷʷ ‡ University of Bonn ࢾݩ઴ Madison ‡ University of Georgia ‡ Case Western Reserve University ਅ੧ ‡ Yale University ʷʷʷʷʷ ʤINDʥ ୉֨ ʷ ‡ University of Liverpool ʷʷʷʷ Πέιη

ࡎىࡎ͍Ζ୉ָ͹಼ɼຌPJηαʖϕ಼͹ࠅͶॶࡑͤΖ୉ָΝىBiocentury COVID-19 therapies and vaccines: Clinical͹TherapyͶ .1* ड़ॶʁBiocentury COVID-19 therapies and vaccines: Clinicalʤ2020೧12݆4ೖ఼࣎ʥ

94 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ۂةϕϪʖϢʖϜρϕʁ ଠࠅΓΕଡ͏ɽ਼͗ۂةͲͺট೟ࡃΊ͹΍͹Ν؜Όɼ֋൅஦͹ۂةธࠅ ͶΓΖ֋൅͗਒΋ۂةӵࠅʀχ΢ςʀϓϧϱηͲͺ୉घ੣༂

ຌऀॶࡑࠅ*1 Phase ธӵಢ෻஦ೖ ‡ Gilead Sciences ‡ Eli Lilly ‡ Incyte ট೟ࡃΊ ʷʷ ‡ CytoSorbents ‡ Equillium ‡ Amgen Phase IV ‡ AbbVie ʷʷ

Boehringer GlaxoSmithKline Sanofi ʷ Ingelheim Phase ʤ֚ͤ౲Phaseͺ ʤ֚ͤ౲Phaseͺ ६Ͷͺຮͪ͵͏͗ɼخ ʷ ʤ֚ͤ౲Phaseͺ ʷ ೟Ͳ͘ͱ͏͵͏ʥ ֮೟Ͳ͘ͱ͏͵͏ʥ֮ III ֮೟Ͳ͘ͱ͏͵͏ʥ ஦֐੣༂ɼ෍࢞ϓ΢ϩϞ ෍ࢃԿָ౵͗ଚࡑ

‡ AbbVie ʷʷ Phase II ‡ Pfizer

Phase I ʷ ʷʷ

ࡎىΝۂةࡎ͹͍Ζىࢤ৖ϪϛʖφͶͱ2ऀҐ৏;ٶۂة͹಼ɼຌPJηαʖϕ಼͹ࠅͶॶࡑͤΖۂةࡎ͍ΖىBiocentury COVID-19 therapies and vaccines: Clinical͹TherapyͶ .1* ʤࢤ৖ϪϛʖφͺʤʰInfectious Disease Diagnostics Market by Product & Service (Assay, Kit & Reagent, Instruments), Disease Type (Hepatitis, HIV, HAI, HPV, TB, Influenza), Technology (Immunodiagnostics, PCR, NGS), End User (Hospital, Research Institute) - Global Forecast to 2022ʱɼʰINFECTIOUS DISEASE DIAGNOSTICS MARKET - GROWTH, TRENDS, AND FORECASTS (2020 - 2025)ʱɼʰGlobal Infectious Disease Diagnostics Market, Forecast to 2027ʱɼʰInfectious Diseases In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product, By Application, By Technology (Immunochemistry, Molecular Diagnostics), By End Use, By Region, And Segment Forecasts, 2020 - 2027ʱʥ ड़ॶʁBiocentury COVID-19 therapies and vaccines: Clinicalʤ2020೧12݆4ೖ఼࣎ʥ౵

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔ՎʁGilead Sciencesʤธʥٺەฑ࣎ʀ αϫψܗ֋൅ͶΓͮͱட੷͠ΗͪஎݡΏ֋൅υʖν͗ɼ৿ڂSARSʙMERS͹ݜ ͪͮ͗ܪ֋൅Ͷغઝ঳࣑ྏ༂͹૥״Τ΢ϩη

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ

ઝ঳״αϫψΤ΢ϩηܗ֋൅કྲྀ ৿ڂ֋൅કྲྀ ݜڂݜ ɼϪϞυεϑϩ͹߇Τ͢ۂڢదؽؖʀΠΩυϝΠͳޮ ¾ ֋൅Νࣰࢬ ࣑ྏ༂ͳ͢ͱڂઝ঳྘ҮΝ஭ྙ྘Үͳ͢ͱݜ״Τ΢ϩη ¾ ʥ Ҳ൬ॵΌͶธࠅͲট೟ڛಋ֋൅Ώ࣑ݩ༂͹఑ڠͶݗৄʤغ΢ϩηްՎΝ૥ Ґ֐Ͷఁʀ஦ॶಚࠅ ¾ ఁʀ஦ॶಚࠅ΃͹ҫྏΠέιη͹֮ฯىHIVɼHCV͗कྙ੣඾Ͳ͍Ζ͗ɼ৏ 9 ઝ঳ʤΦϚϧɼMERSɼSARSɼυ״ڷͲ൅ਫ਼͢ͱ͏Ζ৿ ༁Ν݃;ɼܘ֋൅Ͷ΍खૌ΋ 9 ζΥϋϨρέϟʖΩʖͳඉಢઐϧ΢ιϱηڂϱή೦ʥͶଲͤΖݜ ର੏Ν֮ฯɽϏϱυڇڛఁʀ஦ॶಚࠅ΃͹ϪϞυεϑϩ ֋൅੣඾ ֋൅ਬ਒ ϝρέशଋ҅͏ͺଠ͹༙ް͵࣑ྏ༂ʀϭέοϱࣰ͗༽Կڂݜ ͏͵ͺϫ΢ϢϨτΡඇ༽ͺ൅ਫ਼ؔ͢غΗΖΉͲ͹͠ ઝ঳ͶଲͤΖ਼ଡ͚͹੣඾Ν֋൅ ϪϞυεϑϩ״Τ΢ϩη ¾ 9 ֋൅ਬ਒ ʤ੣඾໌ʁϗέϩϨʖʥڂHCV7ݺɼ΢ϱϓϩΦϱδ1ݺ͹੣඾ ݜ;ٶHIV11ݺɼHBV HDVͲ4݇͹ྡজࢾݩΝࣰࢬ;ٶ৏ࢤɼHIV9݇ɼHBV *4 ࢂՅंูॄ͹ࢩԋ;ٶΝࣰߨ ¾ NIAID ͶΓΖྡজࢾݩඇ༽ɼڂಋݜڠ2015೧ΦϚϧླྀߨ࣎ͶͺUSAMRIID*1ͳ 9 Νण͜ɼϪϞυεϑϩ͹ྡজࢾݩΝࣰࢬ 2Νଲেͳͪ͢*׳MERSɼSARSɼΦϚϧΝ؜΋෵਼࣮ ¾ ϪϞυεϑϩ͹ඉྡজʀྡজࢾݩΝࣰࢬ 9 Phase 3ʤACTT-1ʥΝ2020೧2݆21ೖͶ֋࢟ɼ 2020೧5 ݆1ೖͶͺFDAͶΓΖEUAΝ࣑ྏ༂ͳ͢ͱॵΌͱखಚ 9 ΦϚϧɼSARSͲPhase 3ɼMERSɼϜʖήϔϩέɼ್Ϗ क͵ট೟खಚࠅʙஏҮɼ 9 ೧ ݆ ೖʛ ݆ ೖΉͲͶɼธࠅʤ ࢬઅʥɼυ غΤ΢ϩηͲPhase 1ྡজࢾݩΝࣰࢬ஦ 2020 2 21 4 19 45 ট೟࣎ ϱϜʖέʤ8ࢬઅʥɼӵࠅʤ5ࢬઅʥɼάϨεϡʤ4ࢬ *3 Νࣰࢬ͢ͱ͏ΖUAB ͗NIH͖Δ2019೧3݆Ͷݜ અʥɼχ΢ςʤ ࢬઅʥɼؘࠅʤ ࢬઅʥɼϟΫεαʤڂಋݜڠ 9 3 2 2 ‡ ธࠅʤEUAɼ2020೧5݆ʙট೟ɼ ੔ۜͳ͢ͱ$37.5 millionΝ֭ಚ ࢬઅʥɼηϘ΢ϱʤ2ࢬઅʥɼೖຌʤ1ࢬઅʥɼεϱΪঁڂ దؽؖʤNIHɼNIAIDɼCDC౵ʥΏWHOɼΠΩυϝΠ ϛʖϩʤ1ࢬઅʥͲ1,062ਕ͹ࢾݩࢂՅंΝૌΊ೘Ηͪ 2020೧10݆ʥޮ 9 ֋൅Νࣰࢬͪ͢ΕɼϪϞυεϑϩ͹in-vitroυʖ ‡ ೖຌʤಝྭট೟ɼ2020೧5݆ʥɼڂ౵ͳݜ ൭ ‡ EUʤড়݇෉͘੣ଆ൤ജট೟ɼخ֋൅ਬ਒ڂݜ ڛν౵Ν఑ ͶΓΕ੊ֆ஦΃͹ϪϞυζϑϩ͹ྖࢊʀ 2020೧7݆ʥۂڢ൭ ¾ ଠऀͳ͹خ֋൅ਬ਒ڂݜ ର੏ߑ஛ڇڛ ࡎىΝڱͺɼೖຌɼธࠅɼEUͲ͹ট೟য়ىઝ *৏״ڷͳ৿ۂةธ੕ැʀޮదؽؖɼΠΩυϝΠɼଠ ¾ 9 ੣ଆʁPfizer͹੣ଆઅඍΝ༽͏ͱϪϞυεϑϩ͹ྖࢊର੏ Ν௪ͣͪϨϪʖεϥϱߑ஛ۂڢͲ͹ڂ঳ݜ Ν੖ඍɽ 3ϳ݆Ͳ50ຬյ෾͹ϪϞυεϑϩΝਫ਼ࢊ ఁʀ஦ॶಚࠅ΃͹ҫྏΠέιηΝ֮ฯ 9 ੣ଆͳླྀ௪ʁMylanɼCiplaɼFerozsons Laboratoriesɼ ¾ ༁గ݃ͶΓܘઝ঳͹༩๹౵Ν஦ৼͶҫ༂඾ Jubilant Life SciencesɼHetero Labsऀͳ͹״઎਒ࠅͶཻΉΔͥɼ HIV 9 ΠέιηΝཱི֮ ΕΠζΠΏΠϓϨΩ౵127͖ࠅ΃͹੣ଆླྀ௪ର੏Ν੖ඍ *1. The United States Army Medical Research Institute of Infectious Diseases *2. Influenza, flaviviruses like dengue, West Nile virus and Zika, coronaviruses that cause SARS and MERS, and alphaviruses such as Venezuelan equine encephalitis virus and chikungunya. *3. University of Alabama in Birmingham *4. The National Institute of Allergy and Infectious Disease ड़ॶʁGilead Annual Report (2018)ɼGileadΤΥϔγ΢φɼbusinesswire “Pfizer Announces Agreement with Gilead to Manufacture Remdesivir for Treatment of COVID-19”ɼFDAΤΥϔγ΢φ౵

95 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔Վʁ෍࢞ϓ΢ϩϞʤೖʥٺەฑ࣎ʀ ฯ͹ͪΌ͹ଁࢊ֮ྖڇڛজࢾݩ֋࢟ͶՅ͓ɼট೟઴͖Δࠅ಼ྡغΠϑΪϱ͹૥ ઝ঳ʀਏஇ๑ͶଲͤΖஎݡΝ׈༽͢ਏஇ๑͹֋൅Ͷ΍खૌ΋״Νࣰࢬɽ

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ

֋൅કྲྀڂ֋൅કྲྀ ݜڂݜ Δࠅ಼͖غ࣑ྏમ୔ࢸ֨୉͹ͪΌ͹஭ࣻࡐ͹֋൅ ࣑ྏ༂ʁ૥ ¾ ઝ঳Ν஭ྙ྘Үͳ͢ͱखૌ΋״ ¾ 9 ΠϑΪϱ͹࣑ྏમ୔ࢸΝ߁͝ΖͪΌɼ஦ࠅ͹Carelinkऀ Phase 3Ν֋࢟ ಋͲ஭ࣻࡐ͹֋൅Νࣰࢬڠઝ঳΍৿༂֋൅͹஭ྙ྘ ͳ״ͳด;ɼ׳࣮ܨΞΏ஦਽ਈ͗ 9 ֋൅ΝࣰࢬڂҮͳ͢ͱݜ ֋൅ਬ਒ ֋൅੣඾ڂ৏ࢤ඾ɼ֋൅඾ͶͺҐԾΝ؜΋ ݜ 9 ߇ਇۗ͹ϝαψμʖϩͳ߇Τ΢ϩη༂͹ϓΟϑϒϧϑ ¾ ΢ϱϓϩΦϱδΤ΢ϩηͳಋझ͹RNAΤ΢ϩηͲ͍ ‡ ଶΝण͜ɼ૥ ϓΟϑϒϧϑϩغαϫψΤ΢ϩηͶଲͤΖްՎ͹ܗϩʤΠϑΪϱʥΝ൤ജ Ζ৿ জ࢘༽Ͷ޴ͪ͜खૌΊΝࣰࢬ ʤ੣඾໌ʁΠϑΪϱʥྡغ ߇ۗ༂͹λϨηϫϜ΢εϱΝPhase 3Ͳ֋൅஦ ‡ Կָɼώ΢Ψɼժ଀ɼAI౵ଡ෾໼͹ٗढ़ΝૌΊ߻Κͦɼ 9 ࠅ಼Phase 3Ν2020೧3݆31ೖͶ֋࢟ ¾ ʰਏஇʱͳʰ࣑ྏʱΝҲରԿͤΖΠϕϫʖοΝܟ͝Ζ 9 ธࠅͲPhase 2Ν2020೧4݆9ೖ֋࢟ क͵ট೟खಚࠅʙஏҮɼ غট೟࣎ ֋൅ਬ਒ ¾ ʰCOVID-19໖Ӻ֭ಚݗࠬεητϞ͹֋൅ʱ͗AMEDڂݜ Ͳࡀ୔ۂઝ঳ଲࡨٗढ़֋൅ࣆ״ͶΓΖΤ΢ϩη౵ ¾ ߇΢ϱϓϩΦϱδΤ΢ϩη༂ͳ͢ͱ2014೧Ͷ ‡ ஦ࠅ ʤট೟ɼ2020೧2݆ʥ ൭خ֋൅ਬ਒ڂΠϑΪϱΝ৏ࢤ ݜ *ೖຌɼธࠅɼEUͲͺາট೟ ೧Ͷͺୈ࿹੕ැؽؖ͗ɼ ೧Ͷͺೖຌ੕ැ͗΢ϱ 9 ͶΓΕݬࡒྋ͹ଁࢊΝ؜Όɼ୻ܠͳ͹࿊ۂةࠅ಼֐͹ ¾ 2017 2015 ϓϩΦϱδ͹ླྀߨͶඍ͓ඍடΝ݀ఈ Ͳଁࢊର੏ߑ஛Νਬ਒ؔغ ༂ࡐଳ੓Νݡੀ͓࣑ͪྏ༂͹֋൅Νਬ਒ ¾ 9 ೖຌ੕ැ͹ଁࢊགྷ੧Νण͜ɼ2020೧7݆Ͷͺ༁10ຬਕ෾/ ಡ੓Τ΢ϩη͹࣑ྏ༂ͶՅ͓ɼਟଐ੓ʀ ݆ʤਫ਼ࢊ֋࢟͹3݆৏२ർ༁2.5ഔʥɼಋ9݆Ͷͺ༁30ຬ ਏஇ๑ʁAMED͖Δঁ੔ۜک஗ࢰི͹߶͏ 9 ΊΝ࣍ͯର֐ਏஇ༂Ν༽͏ͪۗʀΤ΢ϩη͹ ਕ෾/݆ʤಋ༁7ഔʥ͹ਫ਼ࢊΝ໪ඬͶઅఈک؈ҝ੓͹ ඬద࣑ྏΝࣰݳ͢ɼ༂ࡐଳ੓ۗΝݡੀ͓ͪۗझಝҡద߇ Νण͜ਏஇ๑Ν֋൅஦ ࣞճऀͶͱҫ༂඾஦ؔର͹੣ଆה෍࢞ϓ΢ϩϞ࿪ޭ९༂ 9 ༂͹֋൅Νਬ਒ۗ ໝݗࠬͶଲԢՆ೵͵ɼ؈สوࣞճऀͶͱ3೧ؔంࢯ͢ͱ͏ͪઅඍ ‡ ୉הɼυϱΩکઅඍΝଁ Ν6ुؔͲ࠸Ֆಉͦ͠ɼݬྋʤϜϫϱ࢐ζΦοϩʥΝଁࢊ ൭ Ͳਜ਼֮͵COVID-19໖Ӻ֭ಚݗخ֋൅ਬ਒ڂݜ ࠬεητϞ͹֋൅Νࣰࢬ ܗ༁గ݃ɼք֐ࢤ৖Ͷ޴͜ͱ৿ܘͳۂةฑ͖࣎Δ͹ΠϑΪϱਫ਼ࢊઅඍ͹੖ඍ ¾ ΢ϱχΏ஦ࠅ ¾ ڛઝ঳࣑ྏ༂ͳ͢ͱΠϑΪϱΝ఑״αϫψΤ΢ϩη 9 ߇΢ϱϓϩΦϱδ༂ͳ͢ͱɼೖຌΏୈ࿹੕ැ͖Δ͹ඍட ༁గ݃ͶΓΕܘGRAऀͳ͹;ٶགྷ੧ͶଲԢ͢ಚΖਫ਼ࢊର੏Ν੖ඍ 9 χένʖʀϪυΡʖθऀ ʤͤҲ๏Ͳɼ੊ֆద͵ϏϱυϝρέླྀߨΝ૟ఈͪ͢ਫ਼ࢊ ք֐Ͳ͹֋൅ݘʀ੣ଆݘʀ൤ജݘ౵ΝಢઐదͶ෉༫ ༎೘ҫ༂͢ܠ஦ࠅͶ޴ͪ͜ఴ֋͹ͪΌͶCarelinkऀͳ఑ 9 ٺە໤ͺ۫ඍ͢ͱ͏͵͖ͮͪͪΌɼڇڛΫϡϏετΡʀ ແΝࣰࢬ༩ఈۂචགྷͳ͵ͮͪʥ ඾ট೟͹ਅ੧͗ܠ͹఑ۂة࣎Ͷͺࠅ֐ ࣞճऀΤΥϔγ΢φהड़ॶʁ෍࢞ϓΡϩϞΤΥϔγ΢φɼυϱΩ

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊٺەͶ͕͜Ζۂةʤࢂߡʥͨ͹ଠ χϧρήϨϛζεϥωϱ;ٶ֋൅ڂ࣑ྏ༂͹ݜوͶΓΖ৿ۂڢAbCelleraͳ͹ αϫψΤ΢ϩη࣑ྏ༂ͳ͢ͱট೟Ν֭ಚܗͶ৿ڠή͹૔๏ͶखૌΊɼ

Eli lillyʤธࠅʥ

֋൅ਬ਒ڂݜ ಋ֋൅ڠαϫψ࣑ྏ༂ΝܗAbCelleraͳ৿ ¾ 9 500ຬΝ௔͓Ζ໖Ӻࡋ๖ΝηέϨʖωϱή͢ɼ 500Ν௔͓Ζಢࣙ͹׮સϐφ߇ରഓ྽͖Δɼ LY-CoV555ʤLY3819253ʥ౵͹࣑ྏ༂ޫึΝ ൅ݡ 9 Phase 1Ν2020೧6݆1ೖɼPhase 2/3Νಋ೧6 ݆11ೖͶ֋࢟ ¾ Ϩϛζεϥωϱή͹ྡজ֋൅ 9 ώϨεοωϔPhase 3Ν2020೧6݆15ೖͶ֋࢟ ༁గ݃ܘͶؖͤΖڇڛธ੕ැͳ͹༂ࡐ ¾ 9 ธ੕ැͳ3Ա7,500ຬχϩ͹ܘ༁ͲώϞϧωϑ ހͺࣙं׳ժΝ൅න͢ɼܯΝߨ͑ڇڛϜϔ͹ ෝ୴͵͢Ͳ༂ࡐΝ࢘༽Ն೵ͳ͵ͮͪ

֋൅੔Վڂݜ ʥɼώϨεοωϔʤϨϛوώϞϧωϑϜϔʤ৿ ¾ Ն͹खಚڒ༽࢘ٺەζεϥωϱήʥ͹ ʀक͵खಚࠅغট೟࣎ ¾ 9 ώϞϧωϑϜϔʁ 2020೧11݆9ೖʤธࠅɼ EUAʥ 9 ώϨεοωϔʁ2020೧11݆19ೖʤธࠅɼEUAʥ

ड़ॶʁEli LillyΤΥϔγ΢φɼAbCelleraΤΥϔγ΢φ

96 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ϕϪʖϢʖϜρϕʁ୉ָ Phase2Ґ߳͹୉ָͲ͹ϭέοϱ֋൅ͺಝͶ஦ࠅͲ׈൅Ͳ͍Εɼธӵಢ෻Ͳͺ ಋͲ֋൅Ν਒ΌΖڠͳۂةͶർ΄ͱ׈ಊྖ͗ঙ͵͏ɽೖຌͲࡗ୉͗ۂة

࢘༽ ୉ָॶࡑࠅ*1 ढ़ ธӵಢ෻஦ೖٗ

୉ࡗ୉ָ ‡ ʷʷʷʷʷ ६Ͷͺຮͪ͵͏͗ɼخ ࢐ϭέοϱ֫ ଠͶ΍౨୉ҫՌݜ͗ଚࡑ

‡ Beijing Institute of ʷ Τ΢ϩηϗέ Biotechnology ʷ ‡ University of Oxford ʷʷ‡ University of Hong νʖϭέοϱ Kong ‡ Xiamen University

γϔϤωρφ ʷʷʷʷ‡ Sichuan University ʷ ϭέοϱ

෈׈Կ ʷʷʷʷʷʷ ϭέοϱ

Τ΢ϩηཽ༹ ʷʷʷʷʷʷ ࢢϭέοϱ

ࡎى֋൅ΝͤΖ୉ָΝڂͶɼPhase2Ґ߳͹ϭέοϱ͹ݜخWHOͶΓΖDraft landscape and tracker of COVID-19 candidate vaccines (2021೧1݆29ೖߍ৿൝ʥΝ .1* ड़ॶʁWHO, Draft landscape and tracker of COVID-19 candidate vaccines (2021೧1݆29ೖߍ৿൝ʥ౵

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ۂةϕϪʖϢʖϜρϕʁ ͹ϭέοϱ֋൅ͺɼธࠅʀ஦ࠅ͗෱߁͏ٗढ़Ͳ਼݇΍ଡ͏ɽۂةPhase 2Ґ߳͹ Ҳ๏ɼೖຌͺଠ͹Ԧय੐ͳಋఖౕ͹ϭέοϱ֋൅਼݇Ͳ͍Ζ

࢘༽ ຌऀॶࡑࠅ*1 ढ़ ธӵಢ෻஦ೖٗ ‡ Moderna ‡ Pfizer ‡ AnGes/νΩϧώ΢Ψ ‡ Arcturus ‡ CureVac AG ‡ Advaccine ࢐ϭέοϱ ʷ ʷ֫ ६Ͷͺຮͪ͵͏͗ɼخ Therapeutics ‡ BioNTech Biopharmaceutical ଚࡑ͗ڠInovio ଠͶ΍୊Ҳࢀ ‡ Pharmaceuticals Τ΢ϩηϗέ ‡ Janssen ‡ AstraZeneca ʷʷ‡ CanSino Biological ʷ νʖϭέοϱ Pharmaceutical

‡ Anhui Zhifei Longcom ʷ γϔϤωρφ ‡ Novavax ‡ Clover ʷʷ ६Ͷͺຮͪ͵͏͗ɼخ United Biomedical ‡ GSK Biopharmaceuticals ‡ ϭέοϱ ‡ ‡ Dynavax Medigen Vaccine IDϓΟʖϜɼԚ໼ٝʙ Biologics UMNϓΟʖϜ͗ଚࡑ

‡ Sinovac Research and Development ‡ Sinopharm/Wuhan Institute of Biological ʷ ෈׈Կ Products ʷʷʷʷ ६Ͷͺຮͪ͵͏͗ɼخ ϭέοϱ ‡ Sinopharm/Beijing Institute of Biological KMώ΢Ψϫζέη͗ Products ଚࡑ ‡ Beijing Minhai Biotechnology Τ΢ϩηཽ༹ ʷʷʷʷʷ ʷ ࢢϭέοϱ

ࡎىΝۂة֋൅ΝͤΖڂͶɼPhase2Ґ߳͹ϭέοϱ͹ݜخWHOͶΓΖDraft landscape and tracker of COVID-19 candidate vaccines (2021೧1݆29ೖߍ৿൝ʥΝ .1* ड़ॶʁWHO, Draft landscape and tracker of COVID-19 candidate vaccines (2021೧1݆29ೖߍ৿൝ʥ౵

97 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔ՎʁModernaʤธʥٺەฑ࣎ʀ Ώࣙऀࢬઅ͹ܐؖ͵ືە੕ැؽؖͳ͹;ٶڂઝ঳ϭέοϱݜ״ฑ͖࣎Δ͹ ͪͮ͗ܪ࣎͹ਟଐ͵֋൅ର੏ʀࢾݩ͹ࣰࢬɼট೟΃ͳٺەฯ༙͗

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ ֋൅કྲྀڂ֋൅કྲྀ ݜڂݜ ธࠅͲPfizer/BioNTechͶ ֋൅Νਬ਒ͪ͢ܠͳ࿊ۂة੕ැؽؖʀ୉घ੣༂ ¾ ՆΝखಚڒ༽࢘ٺەฑ͖࣎Δ͹ࣰ੹ʀٗढ़ྙ͹඲ՃΝण͜ɼธࠅ੕ କ͘ɼ ¾ ࣁۜΝ֭ಚڂBARDAΏDARPA͖Δ͹ζΩ೦ɼοέϱήωΠ೦ ැΏࠅࡏద͵΢ωεΠοϔΓΕݜ 9 ౵΃͹ϭέοϱ֋൅΃͹ঁ੔Ν֭ಚ ֋൅΃͹ঁ੔ͶՅ͓ɼ1Այ ֋൅੣඾ڂBARDA͖Δ͹ݜ 9 Ͷ൒͑15Աχϩ௔͹ࢩԋ΍֭ಚڇڛઝ঳͹༩๹ʀ࣑ྏ ෾͹״2015೧ɼRSΤ΢ϩηΝ؜΋ 9 ֋൅ʀࣰ༽ԿͶ޴͜ɼ 9 CEPI͖Δ100ຬχϩ͹ࢩԋΝ֭ಚ ‡ ٗढ़ʁmRNAڂͶࣁͤΖmRNAҫ༂඾͹ݜ ϟϩέͳકྲྀదΠϧ΢ΠϱηΝగ݃ ‡ झྪʁ1झྪ ֋൅ਬ਒ڂݜ ֋൅ਬ਒ڂݜ ¾ ฑ࣎ΓΕ࿊ܠ͢ͱ͏ΖNIH͹ࢩԋΝण͜ɼΰό ֋൅Ͷ஭ྙڂઝ঳ͶଲͤΖϭέοϱ͹ݜ״ ¾ ͶͺPhase1ࢾݩΝ֋࢟ޛ༁2ϳ݆ޛϞഓ྽ޮ֋ 9 ζΩ೦ɼοέϱήωΠ೦ɼRSV͹ϭέοϱͺ 9 ΰόϞഓ྽ޮ֋͹3ೖޛͲ͍Ζ2020೧1݆13ೖɼ Phase1೘ΕɽNIHͳͺSARSɼMERSΝӀً͘͞ mRNAϭέοϱޫึ͹ഓ྽ΝNIHͳ࠹शԿ ౵Νਬ਒ڂαϫψΤ΢ϩη͹ݜͤ ಋ೧3݆16ೖɼϭέοϱޫึ͹ྡজࢾݩPhase1 9 Ν॑གྷϛζεϥϱͲ Ν֋࢟ɽࢾݩΝߨͮͪࢬઅͺɼNIH͗2019೧Ͷंڂड़ਐ͹ݜۃ੏౲و੕ැ ¾ ࣎Ͷϭέοϱ౵͹ྡজࢾݩͶ࢘༽ क͵ট೟खಚࠅʙஏҮɼٺەɼϭέοϱ͹ࣰ༽ԿͶ޴͜ͱՅଐԿ અཱིͪ͢͢༽ౌ 9 ೧ɼ Ͳϭέοϱਅ੧͹ট೟౵ɼ Ͳ غFDA CDC ͤΖࢬઅVTEUͳ͢ͱࢨఈΝण͜Ζ ট೟࣎ 2018 ݩΝ༙ͤΖWellington Sunܨڂυϱή೦౵͹ݜ ༽੏ؖ࿊͹੻೜ंͶࡀوദ࢞Νϭέοϱકྲྀʀ ൭ ‡ ธࠅʤEUAɼ2020೧12݆ʥخ֋൅ਬ਒ڂݜ ͹͍Ζ֋൅ཱིͬ ‡ EUʤড়݇෉͘੣ଆ൤ജট೟ɼ״൭ ¾ ࣙऀࢬઅΝ׈༽͢ɼηϒʖχخ֋൅ਬ਒ڂݜ ৏͗ΕΝࣰݳ 2021೧1݆ʥ ੣ଆʛ࢕৏͝ 9 ηίʖϩΠρϕ઴ΉͲͺ੣ଆؽ೵ΉͲฯ༙ͤΖ;ٶڂຌऀͳಋय಼Ͷͱྡজݜ ¾ ࡎىΝڱͺɼೖຌɼธࠅɼEUͲ͹ট೟য়ىΉͲ͹ؽ೵Ν׮ඍͤΖ੣ଆࢬઅΝฯ༙ ࣙऀࢬઅͲฑ࣎ΓΕ֋൅ͶॊࣆͤΖοʖϞ͗֋ *৏ mRNAϭέ ൅Νߨ͑͞ͳͲɼCDMOཤ༽ͶΓΖν΢Ϟϫη;ٶ2018೧ɼธࠅPhase1ʀ2͹ࣰࢬ 9 ͹୉ྖਫ਼ࢊΝޛɼϭέοϱ֋൅ޛΝյඈɽͨ͹ ͗ۂοϱޫึ͹੣ଆΏࢾݩɼैలʀ࢕৏͝ࡠ ܠՆ೵ͳ͵Ζ޽৖Νݒઅ ݡੀ͓ɼLonza౵͹CDMO*1ͳ࿊

ҫ༂඾ण୙੣ଆ֋൅ؽؖ .1* ड़ॶʁModerna Corporate PresentationsɼଠModernaΤΥϔγ΢φ

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔ՎʁSinopharmʤ஦ʥٺەฑ࣎ʀ ࣎ͶࣙऀϨλʖηٺە֋൅ʀਫ਼ࢊ೵ྙΝ׈͖͢ɼڂ஦ࠅࠅ಼φρϕ͹ݜ ʤࣁۜ؜΋ʥ͹౦ԾͶՅ͓ɼ੕ැࢩԋͶΓΕϭέοϱ֋൅ΝՅଐͦͪ͠

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ ֋൅કྲྀڂ֋൅કྲྀ ݜڂݜ αϫψΤ΢ϩηͶؖ͢ͱɼਏஇɼ࣑ྏɼ༩ 2020೧12݆Ͷɼܗώ΢Ψҫ༂඾ɼԿָҫ༂඾ɼݳେ׿๏༂Ͷ஭ྙ ¾ ৿ ¾ Νฯ࣍ ๹͹྘ҮસͱͲ߫ݛͤΖ͞ͳΝ໪ඬͳ͢ͱ׈ಊ ࠅ಼֐Ͳট೟ΝखಚڒήϩʖϕસରͲ༁2,340݇͹ಝ 9 ֋൅ɼ੣ଆͶ΍खૌ΋ڂϭέοϱ͹ݜ ¾ ֋൅ਬ਒ڂݜ ౦ࣁ ֋൅੣඾ֻڌͶϕϫζΥέφΝཱིͬ৏͝ɼٺ֋൅ਬ਒ ¾ ૥ڂݜ ͳ͢ͱ 9 2020೧1݆19ೖɼ஦ࠅਫ਼෼ٗढ़*1ʤCNBGʥେනۂة஦ԟ੕ැ؇׍͹ࠅӨήϩʖϕ ¾ ֋൅οʖϞΝ ‡ ٗढ़ʁ෈׈Կڂໝ͗୉͚͘ɼ୉ൔ͹ࢤ৖ΝઐΌΖ ͹༸ᐃ໎ࢱΝϨʖξʖͳͤΖݜوਫ਼ࢊ ֋൅ඇΝ౦ࣁ ‡ ੣඾ʁBBIBO-CorVڂήϩʖϕસରͲ͹ϭέοϱ੣ଆ೵ྙͺ೧ؔ7Աຌ અཱིɽಋऀ͗10Աݫ͹ݜ 9 ֋൅ΝՅଐڂ࣎͹੕ැࢩԋΝಚͱɼݜٺە ¾ ࢢճऀ͹஦ࠅਫ਼෼ٗढ़ʤCNBGʥ ͺɼ஦ࠅ࠹୉͹ 9 ͹ޮูҌ݇ͲڂͲ͍Εɼ೧ؔ50झྪ͹ 9 2020೧2݆ɼՌָٗढ़෨͹఼॑ݜۂةϐφϭέοϱ͹֋൅ ڠؽؖͳϭέοϱ͹ڂࣁۜΝ֭ಚɽࠅ͹ݜڂϭέοϱΝਫ਼ࢊ͢ɼࠅ಼ࢤ৖εΥΠͺ80ˍ ݜ ʀ֋൅Νਬ਒ڂΝਬ਒ ಋݜڂಋݜڠ෵਼͹୉ָͳ ¾ ৏քި௪୉ҫָӅͳ͹ҫ༂Ӷਫ਼੕ࡨ྘ҮͶ͕͜ ‡ Sinopharm Wuhan Institute of Biological Products 9 ͵ʀकغʀ ট೟࣎ڂಋݜڠॶ͗෤׿Ͳڂͳ஦ࠅՌָӅ෤׿Τ΢ϩηݜ ڛࣁۜΝ఑ڂͶݜۂڢΖ5೧ؔ͹ ֋൅ Ͷ ট೟खಚࠅʙஏҮۂڢɼྡজ྘ҮͲ͹ڂ߁౨ҫՌ୉ָͳ͹ݜ 9 Beijing Institute of Biological Productsͳ஦ࠅ࣮බ༮ ‡ ڛSinopharm͖Δٗढ़ࢩԋΝ఑ ʀ֋൅ڂಋݜڠͲښ๹߉੏஦ৼʤCCDCʥ͗๼ ൭ 9 ஦ԟʀஏ๏੕ැؽ͖ؖΔ΍ࢩԋΝಚͱɼ ‡ ஦ࠅخ֋൅ਬ਒ڂݜ ֋൅ΝՅଐڂඉྡজ͹ݜ ֋൅Ͷ஭ྙ ʤ2020೧12݆Ͷਜ਼ࣞট೟ʥڂϭέοϱ͹ݜ ¾ ΍ਬ਒ڂϭέοϱҐ֐͹ϠξϨτΡ͹ݜ ¾ ؽؖʤ13ϴॶʥͶڂࢁԾ͹ࠅՊϪϗϩ͹ݜ 9 ຌۂةͺɼೖຌɼธࠅɼEUɼ஦ࠅʤ֋൅ىήϩʖϕճऀͲݗࠬΫρφɼ࣑ྏ๑Ν֋൅ *৏ 9 ࡎىΝڱ1ຬ ऀॶࡑࠅʥͲ͹ট೟য়ܯҽ਼ͺڂ͜Ζϭέοϱʀ࣑ྏ༂྘Ү͹ݜ͕ ൭خ֋൅ਬ਒ڂਕҐ৏ ݜ 9 2019೧ɼࢢճऀ͹୉घϭέοϱϟʖΩʖ஦ࠅਫ਼෼ ֋൅ֻͺ14Ա8,400ຬݫ ¾ ήϩʖϕͲ೧ؔ10Աຌ͹ϭέοϱਫ਼ࢊΝ໪ࢨ͢ɼڂढ़*1ʤCNBGʥ ͹ݜٗ کͳ෤׿Ͳϭέοϱਫ਼ࢊઅඍΝݒઅʙଁښʤജ৏߶͹12.3%ʥ ๼

஦ࠅਫ਼෼ٗढ़ʤChina National Biotech Group CompanyʥͺSinopharm͹ࢢճऀͲ୉घϭέοϱϟʖΩʖ .1* ड़ॶʁSinopharmΤΥϔγ΢φ

98 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊͳ੔ՎʁAnGesʙ୉ࡗ୉ָʤೖʥٺەฑ࣎ʀ ֋൅ࢬڂݜ;ٶઝ঳͹எݡ״ʀϭέοϱ֋൅͹ࣰ੹Ν࣍ͯAnGesͳڂઝ঳ݜ״ ͪͮ͗ܪ࣎͹ϭέοϱ֋൅΃ͳٺەΖ͞ͳͲͤܠઅΝ༙ͤΖࡗ୉͗࿊

࣎͹कགྷ͵खૌΊ ੔Վٺە ฑ࣎͹कགྷ͵खૌΊ ֋൅કྲྀڂ֋൅કྲྀ ݜڂݜ Ҫఽࢢҫ༂͹ήϫʖώϩϨʖξʖΝ໪ࢨ͢ɼ ݳࡑɼP2/3Νࠅ಼Ͳࣰࢬ஦ ¾ ֋൅Νਬ਒ڂAnGes ¾ ΨʖϩζϡϏϱͲ͹ݜ ༽ର੏Ͳ҈સͲްՎ͹߶͏ϭέοϱ͹ࣰܠ֋൅Νਬ਒ 9 ࢊָ࿊ڂϭέοϱʀ࣑ྏ༂͹ݜ ֋൅ ԿΝ໪ࢨͤڂઝ঳Ν஭ྙ෾໼͹1ͯͳ͢ͱݜ״ ࡗ୉ ¾ ֋൅੣඾ ֋൅ਬ਒ڂ֋൅ਬ਒ ݜڂݜ AnGes ‡ ٗढ़ʁDNAϭέοϱ ઝ঳ͶଲͤΖDNAϭέο״αϫψΤ΢ϩηܗ͹ࣰ੹ ¾ ৿ڂઝ঳ݜ״;ٶϭέοϱ ¾ *1 ‡ ಋ֋൅ झྪʁ1झྪڠҪఽࢢ࣑ྏ༽੣඾͹੣඾ԿͶΓΕϕϧηϝχ ͹ ϱΝ ¾ ಋ֋൅Ν֋࢟ ʤAG0302-COVID19ʥڠόΤύΤΝฯ༙ɽ߶݄ѻDNAϭέοϱ΍֋൅஦ 9 AnGesɼࡗ୉Ͳͺ2020೧3݆ΓΕ ઝ঳ͶଲͤΖ ͢ɼಋ݆஦ͶDNAϭέοϱ໼੣ଆΝ׮྅͢ɼඉྡ״Ν௪͢ɼܠธώ΢Ωϩऀͳ͹࿊ ¾ DNAϭέοϱ͹֋൅όΤύΤΝட੷ জࢾݩΝ֋࢟ ώ΢Ωϩऀͺ௙΢ϱϓϩΦϱδΤ΢ϩη౵͹ 9 P1/2ࢾݩΝ2020೧6݆Ͷ֋࢟͢ɼ10݆Ͷંझ׮྅ɽ 9 DNAϭέοϱΝ֋൅ P2/3ࢾݩΝ2020೧12݆Ͷ֋࢟*2͢ɼ2021೧3݆Ͷ ઝ঳Ͷ͕͜Ζஎݡʀࣰ੹ ંझ׮྅ͳ͵ΖݡࠒΊ״ࡗ୉ ෱߁͏¾ ͵ʀकغɼοέϱήωΠ ট೟࣎ڂݜેخHIVΏυϱήΤ΢ϩη౵͹ ¾ ౵͹ྡজ֋൅Νࣰࢬ ൭ ট೟खಚࠅʙஏҮخ֋൅ਬ਒ڂݜ ൭خ֋൅ਬ਒ڂݜ າఈʥغϭέοϱ͹֋൅ʀਫ਼ࢊͶචགྷ͵ٗढ़ΏϨλʖη ‡ າট೟ʤ৏ࢤ࣎ ¾ ܠϕϪ΢Ϣʖͳ͹࿊ܧͶΓΖ֋൅ʀ੣඾Կ Ͳͺଠ͹ೖܠͳ͹఑ۂةAnGes ଠ¾ ɼAIͶΓΖ߇ݬഓ྽౵͹અ͢ܠΝ௪͢ͱ࣑ྏ༂Ώϭ 9 ϓΡʖοϡʖऀͳ࿊ܠͳ͹఑ۂةΏք֐ۂةࠅ಼୉घ ¾ έοϱ͹֋൅Νਬ਒ ܯΝਬ਒ ֋൅Ͷචགྷͳ͵ΖࢬઅΏઅඍ͹ฯ༙ 9 νΩϧώ΢ΨऀɼAGC BiologicsऀɼεΨόάڂࡗ୉ ݜ¾ ܠ֋൅Ͷචགྷ͵ࢬઅʀઅඍΝ ϓΟʖϜऀ౵ͳ੣ଆͶ͕͏ͱ఑ڂઝಊ෼ࣰݩࢬઅ౵ɼݜ״ ¾ ܠฯ༙ɽҫָ෨෡଒͹බӅ΍ฯ༙ 9 ξ΢ιϩऀͳͺ౦༫υώ΢η͹֋൅Ͳ఑ ࡗ୉ҫָ෨෡଒බӅΝ؜΋ࢬઅͲ࣑ݩΝࣰࢬ ¾ ܐ͖࣎Δ͹ືં͵ؖۂAnGes/¾ ࡗ୉ ૓ گ෉ߪ࠴رदͺ୉ࡗ୉ָ୉ָӅگ͹ਁԾंۂ૓ ¾ AnGes 9 P1/2ࢾݩ͹Ҳ෨ͺࡗ୉ҫָ෨෡଒බӅͲࣰࢬ द

ΗΖDNA෾ࢢ͹૱স͗ܩϕϧηϝχͳͺ୉ௐۗ౵͹ࡋۗΏ߮฾͹֫֐Ͷଚࡑ͢ɼࡋ๖෾࿀ͶΓͮͱ໊ࡋ๖΃Ӏ͘ .1* ࢾݩ͹ν΢Ϟϧ΢ϱ͖ΔͺP1/2Ͳ͹ૌΊ೘Η͗ஙΗͪ͞ͳ͗ਬ଎͠ΗΖ .2* ௒ࠬϪϛʖφۂةFISCOऀͶΓΖ;ٶ୉ࡗ୉ָΤΥϔγ΢φɼ޲ਫ਼࿓ಉ঴ΤΥϔγ΢φɼShared Researchऀ;ٶड़ॶʁAnGes

࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊʤ1/2ʥٺەͶ͕͜Ζۂةʤࢂߡʥͨ͹ଠ ޛΝ֋࢟ɽͨ͹ڂͶ2020೧1఼݆࣎ͲϭέοϱݜڠOxford୉ָ;ٶBioNTech ͪ͝ܪɼϭέοϱ͹ࣰ༽Կ΃ͳ͢ܠࣁۜྙ͹͍ΖPfizerΏAstraZenecaͳ఑

Pfizerʤธࠅʥ ʙBioNTechʤಢʥ Oxford୉ָʤӵࠅʥʙAstraZenecaʤӵࠅʥ

֋൅ਬ਒ڂ֋൅ਬ਒ ݜڂݜ ͹֋࢟ڂϭέοϱݜغ͹֋࢟ ¾ ૥ڂϭέοϱݜغBioNTech¾ ૥ 2020೧1݆Ͷͺ20ݺ͹ϭέοϱޫึΝಝఈ 9 2020೧1݆Ͷ஦ࠅ͗αϫψΤ΢ϩη͹સΰόϞ৚ 9 ༽ΫϡϏε ๅΝޮ֋ͪ͢͹Νण͜ɼαϫψΤ΢ϩηڇڛ࣑ݩ༽ʀྡজ༽ϭέοϱ͹ਫ਼ࢊʀ 9 ֋൅Ν֋࢟ڂ઎ͳ͢ͱ ChAdOx1ϭέοϱ͹ݜۂڢτΡΝ͹ैଏΝՆ೵ͳ͑͢ΖPfizerΝ Oxford୉ָͳAstraZenecaͶΓΖਟଐ͵֋൅ ¾ ͪ͝ܪฯ͢ɼࣙऀϭέοϱޫึΝࣰ༽ԿͶ֮ қࢧ݀ఈ 9 2020೧4݆ɼAstraZenecaͳOxford୉ָ͗غPfizer¾ ऀ಼Ͷ͕͜Ζ૥ ڠಋ֋൅͹૮஌Νण͜ ChAdOx1nCoV-19 ʤ౲࣎ϓΥʖθ̏ʥͶ͕͜Ζڠ2020೧3݆ɼBioNTech͖Δ 9 ಋ֋൅͹қࢧ݀ఈΝࣰࢬ ಋ֋൅Ν൅නɽಋ೧12݆ϓΥʖθ3݃Վ൅නڠͶPfizer಼Ͳޛ1ुؔͪ ൭خ֋൅ਬ਒ڂজࢾݩ݃Վ͗ड़Ζ઴͖ΔηίʖϩΠρϕͶଲԢ ݜྡ 9 ਫ਼ࢊઅඍ͹ݒઅΝ֋࢟ ¾ AstraZenecaͶΓΖɼϭέοϱ͹ήϫʖώϩͲͪ͢ ໤͹֮ฯڇڛ఑ड़ ͹ਫ਼ࢊʀغPfizer¾ ྡজࢾݩਅ੧͹૥ 4݆ͶྡজࢾݩϕϫφαʖϩΝҲ෨ඉྡজࢾݩυʖ 9 mAbxienceऀɼCobra BiologicsऀɼCatalentऀ౵ɼ 9 ڛͳ͹ϭέοϱਫ਼ࢊۂةຘೖ௧ ӵࠅ಼֐͹ϭέοϱ੣ଆޛ΃఑ड़ɽͨ͹ۃν͗ܿ͜ͱ͏Ζয়ସͲ౲ ໤ڇڛ༁Ν௪ͪ͢कགྷࠅͲ͹ϭέοϱ੣ଆʀܘڇ ՅυʖνΝ఑ड़ɽΉͪɼ࣑ݩ͹੔ޯི֮Ν߶ΌΖ Όɼ4ޫึ͹ࢾݩΝಋ࣎ͶࣰࢬͤΖ͞ͳͳͪ͢ ͹֮ฯͪ ൭ ¾ Τ΢ϩηϗένʖϭέοϱ͹֋൅ʀ੣ଆ͹எخ֋൅ਬ਒ڂݜ Pfizer¾ ࣙऀࣁۜͶΓΖ֋൅ʀਫ਼ࢊ΃͹߈Ε ࣟʀٗढ़Ν༙ͪ͢ਕࡒ͹֮ฯ ͶΓΖ 9 University of OxfordͶͺɼಋஎݡʀٗढ़Ν༙ͤΖۃธࠅ੕ැ͹ঁ੔ۜΝण͜खΖ͞ͳͲɼ౲ 9 ڂΉͮͱ͏Ζʤϗένʖϭέοϱ͹ݜॄ͗ंڂজࢾݩυδ΢ϱ΃͹ղ೘ͶΓΖ࣑ݩஙԈΝݔ೨ ݜྡ Ζঁ੔ۜͺण͜खΔ͵͖ͮͪ ֋൅͹Ϛφϩϋρέ͹Ҳͯͳ͢ͱஎݡʀٗढ़Ν༙ܐ֋൅Ͷڂɼݜ͢ ΔΗͱ͏Ζʥ͝ڏ2,000ԱԃҐ৏Νϭέοϱ͹ਫ਼ࢊઅඍͶ౦ࣁ ͤΖ઒໵ਕࡒ͹෈ଏ͗ 9 ֋൅੔Վڂ֋൅੔Վ ݜڂݜ غট೟कགྷࠅʀট೟࣎ ¾ غট೟कགྷࠅʀট೟࣎ ¾ Նɼ2020೧12݆30ೖʥڒ༽࢘ٺەՆɼ2020೧12݆11ೖʥ 9 ӵࠅʤڒ༽࢘ٺەธࠅʤ 9 9 ӵࠅʤҲ࣎࢘༽ট೟ɼ2020೧12݆2ೖʥ 9 EUʤড়݇෉͘ট೟ɼ2020೧1݆29ೖʥ 9 ೖຌʤಝྭট೟ɼ2021೧2݆14ೖʥ

ड़ॶʁPfizerΤΥϔγ΢φɼThe Wall Street Journal “How Pfizer Delivered a Covid Vaccine in Record Time: Crazy Deadlines, a Pushy CEO”ɼAstraZenecaΤΥϔγ΢φɼJenner InstituteΤΥϔγ΢φ

99 ࣎ ਏஇ๑ ࣑ྏ༂ ϭέοϱٺە ฑ࣎ ࣎͹खૌΊʤ2/2ʥٺەͶ͕͜Ζۂةʤࢂߡʥͨ͹ଠ ϭέوΗΉͲ͹߇Τ΢ϩη༂֋൅ࣰ੹ΏUMNϓΟʖϜഛफͶΓΕ֭ಚͪ͢৿͞ οϱٗढ़ΝᑑࢢͶਏஇ༂ʀϭέοϱʀ࣑ྏ༂સͱ͹ϠξϨτΡ͹֋൅Ͷखૌ΋

Ԛ໼ٝʤೖຌʥ

ਏஇ๑֋൅ ͶΓΖਏஇ๑֋൅ۂڢΠΩυϝΠͳ͹ ¾ Ͱ͘خҫՌ୉ͳ͹ϧ΢ιϱηͶښഇ୉ʀ౨܊ೖ୉ʀ 9 ৿ద֫࢐ଁ෱๑ʤSTATIC๑ʥΝ༽͏ͪਟଐਏஇַ ʥغΝԈڛΫρφΝ֋൅஦ʤ2020೧஦͹఑

࣑ྏ༂֋൅ ࣰࢬڂಋݜڠΠΩυϝΠͳ͹ ¾ ҫ༂݊ӭ;ٶઝ঳Ϩγʖοιϱνʖ״௪ڠ๼୉ਕॏ 9 ࣰࢬʤඉྡজஊ֌ɼ2020೧ྡজ೘ڂಋݜڠݜͳ͹ ʥغΕͺԈ

ϭέοϱ֋൅ ϭέοϱٗढ़ΝوಋͶΓΖ৿ڠΠΩυϝΠͳ͹ ¾ ׈༽ͪ͢֋൅Νਬ਒ ͶΓΕɼ߇ݬνϱϏέۂڢय୉ָͳ͹۟;ٶઝݜ״ 9 ͳΠζϣώϱφΝમఈ ಋͲҪఽࢢૌ׷νϱϏέϭέοڠ୉ͳښ;ٶઝݜ״ 9 ϱ͹֋൅ࣰࢬʤP1/2ࢾݩ2020೧12݆֋࢟ʥ ͶΓΖਫ਼ࢊର੏ʙࣁࡒ͹֮ฯۂڢଠऀͳ͹ ¾ UNIGENऀʤݬ༂੣ଆʥɼΠϒऀʤ੣ࡐ੣ଆʥ ͳ࿊ 9 ਫ਼ࢊର੏Νߑ஛غɼ2020೧಼ౕͶ୊Ҳ͢ܠ 9 2021೧຦ΉͲͶ3,000ຬਕ෾Ґ৏͹ϭέοϱਫ਼ࢊର ੏੖ඍΝ໪ࢨͤ

ड़ॶʁԚ໼ٝ੣༂ϙʖϞϘʖζ

100 ೖຌͶ͕͜Ζ;ٶଠࠅ .4 ࣎͹खૌΊٺەઝ঳΃͹״αϫψΤ΢ϩηܗ৿ ֋൅੔Վڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ৿;ٶགྷ֕ .4-1 4-2. ৆ࡋ 4-2-1. ੕ැ ࠅࡏؽؖ .4-2-2 ۂة;ٶΠΩυϝΠ .4-2-3 ;ଠࠅ͖Δ͹ָ .4-3

101 ܟ࣎ ࠸ٺە ฑ࣎ ଠࠅ͖Δ͹ָ;ʁฑ࣎ خαϫψଲԢͶͱ੔Վ૓ड़Ͷࢺͮͱ͏Ζธӵ஦ͺՁΗ΍ʰฑ࣎͹ඍ͓ʱͶܗ৿ Ͱ͏ͱ੔Վࣰ͗ݳ͠Ηͱ͕Εɼฑ͖࣎Δ͹खૌΊ͹୉ࣆ͗͠րΌͱ֮೟͠Ηͪ

Ҙ౵͖ڶฑ࣎Ͷ͕͜Ζ SARS/ MERS͹ླྀߨΏɼώ΢Ψτϫ͹ 01 ͳ໎֮͵ Δɼʰ৿ͪ͵Ϗϱυϝρέʱ΃͹ଲԢΝ໪ඬͶ״ؽث߶͏ ໪ඬઅఈ ܟ͝ͱͪ͘ ԿΝඬᒙکઝ঳ଲࡨ״ήϫʖώϩϖϩηιΫϣϨτΡકྲྀ౵Ͷͱࠅ಼֐Ͳ͹ ଲেͳ͢ͱ13ݺ͹஭ྙබݬରΝఈٝ͢ͱ͏ΖڂNIAID͹ώ΢ΨυΡϓΥϱηݜ ઝ঳΃͹ଲԢΝ҈સฯ্ΏݺพકྲྀͲ॑གྷࢻ״ؽͳ͢ͱܘΦϚϧΝ ͏͵ΔΗͱ͏͝ܟ΢ϱϓϩͳ༂ࡐଳ੓ۗҐ֐͹Ϗϱυϝρέ΃͹ଲԢͺ໎֮Ͷܗ৿ ଲেͳͤΖබݬର͹ಝఈͺ͠Ηͱ͕Δͥڂઝ঳ଲࡨͳ͢ͱ஭ྙݜ״ڷ৿

Ͷ৏ࢤ͢ͱ͏Ζ΍͹عฑ͖࣎Δ͹෱߁ʀ ϭέοϱʀ࣑ྏ༂ՁΗ΍ 02 ֋൅ਬ਒ͳ ͺɼฑ͖࣎Δۛ͢͏ٗढ़ʀΤ΢ϩηͲྡজࢾݩڂ஥ࣰ͵ݜ ੕ැͶΓΖ೼Ѵ ஊ֌ΉͲ਒ΞͲ͏ͪ

΃͹ϓΟϱυΡϱήΝ༑઎దͶׄΕ౲ͱڂUK Vaccine NetworksͶΓΖ஭ྙබݬର͹ಝఈͳ֚౲ݜ ΝࣰࢬڂModernaͲͺฑ࣎ΓΕmRNAٗढ़͹ݜ ൭Νߑ஛خDARPA͹ࢩԋΝण͜AbCelleraͺϏϱυϝρέ࣎͹֋൅Յଐ͹ͪΌ͹ٗढ़ ઝ঳Ͷଲ͢ͱ΍ธࠅ͹1/6ҐԾɼ஦ӵ͹1/2ఖౕ͹࿨ช਼ͶཻΉΖ״ڷࣙର͗ݰঙܑ޴Ͳɼ৿ڂΤ΢ϩηݜ

౹Ώࣁࡒʀઅඍ֮ฯɼܧྫໍض࣎͹ࢨٺە ࣎Νݡੀ͓ͪٺە 03 ੏౵͹੖ඍ͗ߨΚΗͱ͕Εɼਪ௜ཱིͬ৏͝و๑ ൭੖ඍ ͹६ඍ͗੖ͮͱ͏ͪخਬ਒

֋൅ࢩԋର੏Νߑ஛͢ɼฑ͖࣎Δ͹ਫ਼ࢊ༲ྖ֮ฯ౵Νࣰࢬڂ࣎͹ݜٺەBARDAΝ஦ৼͶͪ͢ ઝ঳ΉͲͺ૟ఈ͠Ηͱ͕Δͥɼ״ڷժʤ2005೧ʥΏ༂ࡐଳ੓ʤAMRʥ͗஦ৼͲɼଠ͹৿ܯ΢ϱϓϩΦϱδͶଲͤΖ੕ැߨಊܗ৿ າ੖ඍ

࣎ٺە ฑ࣎ ࣎ٺەଠࠅ͖Δ͹ָ;ʁ ֋൅ཱི৏͝Ώࣁۜ౦ԾΝߨڂ࣎Ͷ͕͏ͱ΍ը͗ࠅΓΕ͏ͬ૥͚ݜٺەธӵ஦ͺ ɼ૱ྙΝ݃ॄ͢ͱखૌΞͲ͏Ζ͝ܟԾͲ΍໎֮͵βʖϩΝڱɼ෈ಃ໎͵য়͏ ஥घΏɼୈ਼Ώ౦ڂ࣎Ͷ͕͜Ζ ঳ྭๅࠄ͖Δ2ुؔͲ͹ݜٺە 04 ڂ֋൅ ༫ʀંझ֋࢟ೖఖ౵໎֮͵βʖϩΝఈΌͱݜڂࠞΝ௔͓ͪݜ֠ ͹ਪ௜ཱིͬ৏͝ ֋൅Νਬ਒ ΃͹ݼ;͖͜ͺธࠅ͗ଠࠅͶ઎ۨ͜ɼ͏ͬ૥ࣰ͚ࢬۂة֋൅Ώڂଚٗढ़ΝᑑͶͪ͢ݜع ͹ϭέοϱޫึʀ࣑ྏۂة΃ݼ;͖͜ʤBARDAʥʤ2020/1ʥɼۂة஥घʤ2020/1/13ʥɼਏஇ๑֋൅Ͷ޴͜غ֋൅͹૥ڂNIHͳModerna͹ϭέοϱݜ ‡ ֋൅΃ঁ੔ʤBARDAʥʤ2020/2ʥ౵ڂ༂ʀਏஇ๑͹ݜ ઝ঳ϭέο״αϫψΤ΢ϩηܗͱ͕Εɼ৿͢ڂOxford୉Ͳͺɼฑ͖࣎ΔϏϱυϝρέΝඍ͓ͪϭέοϱ֋൅ՅଐϕϫιηΝݜ ʤ2020/1ʥͪͮ͗ܪ஥घͶڂݜغϱ͹૥ ͏͵ϕϪʖϢʖͶΓΖϭέοϱͺາͫট೟͠Ηͱ͏ܧΖ΍ɼೖ͗ڏଠࠅͶർ΄ཱིͬ৏͗͝ஙΗɼϭέοϱޫึ͗ βʖϩΝࣰݳͤ΄͚ɼฑ͖࣎Δ६ඍ͢ͱ͏ى࣎Ͷ͕͜Ζ ৏ٺە 05 චགྷࣁࡒʀઅඍ౵͹ ͪࣁࡒʀࢬઅ͹ཤ༽ʀ఺༽ͶՅ͓ɼ௧ՅͲ͹֮ ॄ஦౦Ծ ฯΝୣ੔ͪ͢

ʤ༁230Աԃʥک෵਼͹ϭέοϱ੣ଆઅඍ͹ଁ

αϫψΤ΢ϩܗ֋൅Ώਫ਼ࢊର੏Ν৿ڂήϫʖώϩφρϕεΥΠΝઐΌΖϕϪʖϢʖʤAbbottɼGileadɼGSKɼPfizer౵ʥ͗ࣙऀ͹ݜ ୱҒͲ΍ೖຌͳർ͢ͱଡ͚͹Ϩλʖη͗౦Ծ͠Ηͪۂةઝ঳༽ਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹֋൅Ͷॄ஦౦ԾͤΖ͞ͳͲ״η 1,377Աԃʥ ۜخ੖ඍٺەࠅ಼֐Ͳ֋൅͠ΗͪϭέοϱΝࠅ಼Ͳਫ਼ࢊʀ੣ࡐԿͤΖͪΌ͹અඍ౵͹੖ඍʤϭέοϱਫ਼ࢊର੏౵

࢚ྫ౟ؽ೵ͶΓΖ ෈ಃ໎੓͗߶͏ஊ֌Ͳ઎ਠΝ઀ͮͪસର׈ಊ͹ Ͷୈ਼Ώ౦༫ʀંझغ͜ΞӀʀ౹ׇͶՅ͓ɼ૥ 06 Ζ͗ܪ͹஥ࣰ͵ਬ਒ͳ ֋࢟ೖఖ౵໎֮͵βʖϩΝఈΌͱ੔ՎͶى৏ ੔Վ͹ୣ੔ ׈ಊΝਬ਒ Ͷɼ2021೧1݆ΉͲ͹ϭέοϱ͹ਫ਼ࢊྖɼ2020೧12݆ΉͲ͹ࠅ಼ݗࠬ༲ྖ͹ڠOperation Warp Speed ɼRADx΢ωεΠοϔͺ ໪ඬΝઅఈ ֋൅͹਒ṁ؇ڂ֋൅͹༑઎ॳҒ෉͜Ώݜڂ֋൅οʖϞʰՌݜߊ䎖享ʱͶΓΕɼݜڂʀਬ਒ͤΖ੕ැ͹ݜض֋൅Νࢨڂ࣎͹ݜٺە ཀྵʀղ೘౵Νࣰࢬ ֋൅͹βʖϩ఑ࣖͶͺࢺΔͥڂ֋൅ਬ਒ཱི͗ͬ৏͗͝ஙΗɼݳ఼࣎Ͳ΍ݜڂଠࠅͶർͤΖͳݜ 102 ࣎ٺە ฑ࣎ ʤࢂߡʥ੊ֆͶ઎ۨͪ͜ϭέοϱ֋൅Ͷචགྷ͵ࢬࡨ ݩΝಁΉ͓ɼଠࠅͶঋΖͳ΍྾Δ͵͏ϭέοϱ֋൅͹ܨࠕյ͹Ϗϱυϝρέ͹ ࣰݳͶͺકྲྀ͖Δ๑੏ౕΉͲ͍ΔΑΖଈ໚Ͳ͹՟ୌ΃͹ଲԢ͗චགྷ ઝ঳ࢤ৖ͺଠࠅͳർ΄ঘ͠͏״ఁ͚ɼϭέοϱՃ֪΍ଠࠅͳർ͢ͱఁ͏ܑ޴Ͷ͍Εɼࠅ಼͹ི͗׳ઝ঳ጸ״ ¾ ওΉͲ͹ௗ͠Ώϭέοϱ͹෯ൕԢͶଲͤΖऀճద͵ݔ೨͹߶͠౵ͶΓΕϭέοϱʀάϡρϕ͗൅ਫ਼͢ͱ͏ͪשझંغϭέοϱ͹ ¾ ϭέοϱఈ ֋൅͹෈ࣰ֮੓ڂઝ঳ͶଲͤΖݜ״ڷઝ঳͹ླྀߨ͹෈ࣰ֮੓ʀ༩଎ೋౕ͹߶͠৿״ໝͲɼوϟʖΩʖͺք֐Ͷർ΄ͱঘۂ֋൅Ν ¾ ࠅ಼ϭέοϱ઒ڂݜ ֋൅ࢩԋ͗ঙ͵͏ͪΌɼଠࠅͳർ΄ͱϏϱυϝρέڂઝ঳͹ݜ״ڷͶΓΖࢤ৖ࢂ೘͗ঙ͵͚ɼ੕ැͶΓΖ৿ۂة͹߶͖͠Δࠅ಼୉घ੣༂ ͖ͪͮ͵͚ ͶଲͤΖ६ඍ͗ॉ෾ͲתखΕ ͏͵Ώ׈ಊྖͺଠࠅͶർ΄ঙ਼ंڂͺҲ෨ؽؖͶཻΉΕɼݜڂઝ঳྘Ү͹ݜ״ڷ୉ָͶ͕͏ͱ΍੕ැͶΓΖࢩԋ͹ঙ͵͖͠Δ৿ ¾ ڱը͗ࠅ͹য় ؽқࣟ͗ఁ͖ͮͪثઝ঳ͶଲͤΖ״ڷݸఈదͲ͍ͮͪͪΌɼ৿͗ڻ͹ϏϱυϝρέͶΓΖӪڊ͹ఁ͠ͶՅ͓ɼգི׳ઝ঳ጸ״ ¾

֋൅͹໪ඬΏଲে൥ҕʤබݬରʀٗढ़౵ʥ͹໎֮Կڂ֋൅ਬ਒͹୉ٝ໌෾ͳ͵Ζݜڂઝ঳ଲࡨΏݜ״ڷ৿ ¾ કྲྀ ժ͹ݗ౾ʀࡨఈܯ֋൅Ͷ͕͏ͱ໪ࢨͤਭ६ʀڂಋͲ͹ݜڠΝಁΉ͓ͪࢊָׯى֋൅ਬ਒Ͷ޴ͪ͜ɼ৏ڂࢊָׯҲରͲ͹ݜ ¾

ໝ͹ࣁۜ౦Ծʤҫྏ෾໼ؖ࿊૱༩ࢋ͹10%Ґ৏ʥوକద׎ͯҲఈܩজ֋൅੔Վ૓ड़Ͷ޴ͪ͜ɼྡ;ٶ֋൅׈ಊྖଁՅڂઝ঳͹ݜ״ڷʀ୉ָͶΓΖฑ࣎͹৿ۂة ¾ ੊ ɼΰόϞΏྡজ৚ๅυʖνϗʖηߑ஛౵΃͹ঁ੔کಋ؜΋ʥɼਫ਼ࢊઅඍଁڠΏք֐ؽؖͳ͹ܠ֋൅ʤࢊָׯ࿊ڂֆ ༩ࢋ ‡ કྲྀͶͱಝఈ͠ΗͪබݬରΏϭέοϱٗढ़͹ݜ ֋൅͹ਬ਒ࢩԋڂݜ;ٶ֋൅΃͹౦ࣁ͹݀இՆ೵ͳ͵Ζ༩ࢋ֮ฯʀ౦Ծڂʀ୉ָ͗ݜۂة࣎Ͷٺە ¾ Ͷ ϭέοϱٗوઝ঳સରકྲྀࡨఈΏકྲྀͲઅఈͪ͢ଲেබݬରΏٗढ़ʤ৿״ڷͶͪ͢ɼฑ࣎Ͷ͕͜Ζ۫ରద͵৿خ֋൅͹໪ඬ౵Νڂ઎ ¾ ʰકྲྀʱͲઅఈͪ͢ݜ ݺพ׈ಊ͹౹ׇΝ୴࢚͑ྫ౟ؽ೵͹ཱི֮;ٶ࣎Ͷ͕͜Ζਟଐʀؽಊద͵સରٺە֋൅ਬ਒͹ࣰߨ؇ཀྵɼڂढ़؜΋ʥ౵͹ݺพݜ ۨ କద͵ϠωνϨϱήʀݳஏ࠹৿৚ๅ͹फॄର੏ʀεητϞ͹ߑ஛ܩઝ঳͹״෾ੵͶࣁͤΖ੊ֆͲ൅ਫ਼ͤΖڻઝ঳͹ླྀߨʀӪ״ ¾ ͜ ର੏ ͜Ζϭέοϱ͹Ϗ΢ϕϧ΢ϱ͹਒ṁ؇ཀྵʀϠωνϨϱή͕ۂة࣎͹஭ྙࢩԋ઎ಝఈ͹ͪΌɼฑ࣎ΓΕঁ੔઎୉ָʀٺە ¾ ͪ ϭ ର੏͹ߑ஛ܠʀք֐ؽؖ࿊ܠ࣎Ͷ࠹ଐͲ૱ྙΝ݃ॄͤΖͪΌ͹ࢊָׯ࿊ٺە;ٶΖͪΌɼ͝ܪ੔ՎΝࣰ༽ԿͶڂ࣎໲ΚͥΠΩυϝΠ͹ݜٺەฑ࣎ʀ ¾ έ ʀࢾݩࢬઅϋρφϭʖέ͹੖ඍڂ࣎͹࣑ݩ΃ଊԢͤΖͪΌ͹ྡজݜٺە ¾ ο ର੏Ώࣰݩઅඍ͹੖ඍڇڛ෈ଏ΃ଲԢͤΖͪΌ͹ࣰݩಊ෼͹ڇڛ͵ϱ ¾ ࣰݩಊ෼͹੊ֆద ʥ͹ಝఈʀ֮ฯɼABSL-3Ґ৏͹ಊ෼ࣰݩࢬઅ͹֮ฯɼ౵ۂةʤंۂ֋ અඍʀ ‡ ಊ෼ࣰݩ ʀ֋൅ʀਫ਼ࢊର੏ʀઅඍ͹੖ඍڂ൅ ࢬઅ ¾ અඍʀࢬઅາ੖ඍͶΓΖ֋൅ஙԈյඈ͹ͪΌɼ৿͢͏ϭέοϱٗढ़Ͷ΍ଲԢ͢ಚΖݜ ϭέοϱٗढ़Ͷ΍ଲԢͪ͢ਫ਼ࢊઅඍ͹ଁઅʀ֮ฯɼ౵و֋൅͗௜͛ͶՆ೵͵BSL-3ࢬઅ਼͹֮ฯɼ৿ڂҗ୙ؽؖ͹ಝఈʀ֮ฯɼݜڂͶ ‡ ࠅ಼Ͷ͕͜Ζݜ ච ηΫϩ෈ଏͶΓΖ֋൅ஙԈյඈ͹ͪΌɼ৿͢͏ϭέοϱٗढ़Ͷ΍ଲԢ͢ಚΖਕҽ͹ү੔ʀ֮ฯ;ٶ֋൅ʀਫ਼ࢊਕҽ͹ਕҽ਼෈ଏڂݜ ¾ གྷ ਕࡒ ֋൅ʀਫ਼ࢊਕҽ͹ү੔ʀ֮ฯɼ౵ڂϭέοϱٗढ़Ͷ΍ଲԢͪ͢ݜو֋൅ʀਫ਼ࢊਕҽ͹ү੔ʀ֮ฯɼ৿ڂজࢾݩʀਫ਼ࢊࢬઅͶ͕͏ͱଊ࣎ͶՖಉՆ೵͵ݜྡ ‡ ͵ ࢬ Ͳ͹ট೟͗Ն೵ͳ͵Ζট೟ϕϫιηՅଐԿࢩԋ੏ౕ͹ӣ༽ର੏੖ඍؔغ࣎Ͷ୻ٺە ¾ ࡨ ؜΋ʥ෉༫ʙϨηέఁݰ͹ܗ֋൅΢ϱιϱτΡϔʤϕϩڂ֦࣎ʓͶ͕͜Ζݜٺە֋൅͹׈ಊྖଁՅͶ޴ͪ͜ɼฑ࣎ʀڂઝ঳͹ݜ״ڷʀ୉ָͶΓΖ৿ۂة ¾ ๑੏ౕɼ ࢕ૌΊߑ஛ ౵ ͹Ԉௗ੏ౕ౵ؔغฑ࣎ʁ༑઎৻ࠬώΤοϡʖ੏ౕɼࣆ઴ഛखฯৄ੏ౕɼ੣ଆ൤ജট೟खಚๅও੏ౕɼࢤ৖ಢઐ ‡ ໖੻੏ౕ౵ंۂ࣎ʁࣆ઴ഛखฯৄ੏ౕɼ੣ଆٺە ‡

103 ੔Վ૓ड़Ͷ޴͜ͱචགྷ͵ؽ೵ͳ໪ࢨͤਭ६ .5

104 হͲ͹௒ࠬΠϕϫʖο

֋൅Ͷ͕͜ΖʤՀʥ໪ඬͳ͢ͱҐԾΝڂຌহͲͺɼචགྷؽ೵ຘ͹໪ࢨͤਭ६ΝఈٝͤΖͪΌͶɼը͗ࠅ͹ݜ ¾ અఈͪ͢ ͤڇڛ࣎Ͷ͕͏ͱɼ੊ֆͶ઎ۨ͜ͱਏஇ๑ʀ࣑ྏ༂ʀϭέοϱΝ֋൅͢ɼ͏ͬ૥͚ࠅ຿΃ٺەՀ໪ඬʁ ‡ Ζ

֋൅Ͷ͕͏ͱɼ੔Վ૓ड़Ͷࢺͮͱ͏Ζଠࠅڂઝ঳͹ݜ״αϫψΤ΢ϩηܗ2হͲఈٝͪ͢චགྷؽ೵ͶՅ͓ɼ৿ ¾ ʤՀʥ໪ඬΝୣ੔ͤΖͪΌ͹໪ࢨͤਭ६Νؽ೵ຘͶઅఈͪ͢ى͹ؽ೵ਭ६Νࢂߡͳ͢ɼ৏

໪ࢨͤਭ६Ͷ͕͜Ζଠࠅͳೖຌ͹ݳߨਭ६Ν௒ࠬ͢ɼ֦ࠅ͹໪ࢨͤਭ६ͶଲͤΖؽ೵ैଏౕ͹;ٶචགྷؽ೵ ¾ ෾ੵΝߨͮͪ

ը͗ࠅͶ͕͜ΖʤՀʥ໪ඬΝୣ੔ͤޛͶ໪ࢨͤਭ६ͶଲͤΖݳߨೖຌ͹ؽ೵ैଏౕΝಁΉ͓ɼࠕޛຌহ͹࠹ ¾ ΖͪΌ͹੕ࡨΠ΢υΡΠΝ఑ࣖ͢ͱ͏Ζ

105 ੔Վ૓ड़Ͷ޴͜ͱචགྷ͵ؽ೵ͳ໪ࢨͤਭ६ .5 ؽ೵Ͷ͕͏ͱ۫ඍͤ΄͘ਭ६֦ .5-1 ؽ೵Ͷ͕͜Ζଠࠅͳը͗ࠅ͹ݳয়֦ .5-2 ໪ࢨͤਭ६͹ࣰݳͶ޴ͪ͜੕ࡨΠ΢υΡΠ .5-3

106 ໪ࢨͤਭ६͹ఈٝ๏๑;ٶචགྷؽ೵ ਭ६ΝಁΉ͓ɼը;ٶઝ঳྘ҮͶͱ੔Վ૓ड़Ν͢ͱ͏Ζଠࠅ͹ؽ೵۫ඍ״ڷ৿ ࠅͶ͕͜Ζ໪ඬʤՀʥΝࣰݳͤΖͪΌ͹චགྷؽ೵ͳ໪ࢨͤ΄͘ਭ६Νఈٝ͗ ࣎Ͷ͕͏ͱɼ੊ֆͶ઎ۨ͜ͱٺەʤՀ໪ඬʥ Ζͤڇڛਏஇ๑ʀ࣑ྏ༂ʀϭέοϱΝ֋൅͢ɼ͏ͬ૥͚ࠅ຿΃

චགྷؽ೵ ؽ೵ຘ͹໪ࢨͤ΄͘ਭ६ ઝ঳͹ݜ״αϫψΤ΢ϩηܗଠࠅͲ۫ඍ͢ͱ͏Ζؽ೵Ώ઒໵Պ΃͹ϐΠϨϱήͶΓΕ॑གྷͳಝఈ͠Ηͪؽ ¾ ৿ ¾ ֋൅Ͷ͕͏ͱɼ੔Վ૓ड़Ͷڂ ͶɼϠξϨτΡຘ͹චགྷؽ೵Νఈٝخ೵Ν ҐԾͺϭέοϱ͹චགྷؽ೵͹ྭɽਏஇ๑ɼ࣑ྏ༂Ͳ΍චགྷؽ೵Νࡠ੔ ࢺͮͱ͏Ζଠࠅ͹ؽ೵ਭ६Νࢂ ¾ ߡͳ͢໪ࢨͤਭ६Νઅఈ A. કྲྀࡨఈʀસର౹ׇ ଇ਒ ࣁ֮ۜฯʀഓ෾ܠકྲྀࡨఈ ࢊָׯ࿊ චགྷ༩ࢋ͹ׄΕ౲ͱɼ౵ ‡ ״αϫψΤ΢ϩηܗકྲྀࡨఈɼ༑઎ॳҒ෉͜ɼ౵ ¾ Յ͓ͱɼ৿ ‡ Ծ͹ָ;ΝಁΉ͓ɼචڱ௒ ઝ঳য়ڢ͹ϠωνϨϱή ࠅࡏڱࣰߨয় ࣎ٺە;ٶԿ གྷͳ೟ࣟ͠Ηͪฑ࣎ک֋൅ର੏͹ڂϠωνϨϱή ‡ ݜ ‡ કྲྀʀ༩ࢋഓ෾͹ݡ௜͢ɼ౵ ‡ ྡজࢾݩ͹ࣰࢬɼ౵ Ͷ͕͜Ζਭ६Νઅఈ ‡ ֋൅ਬ਒ڂB. ݜ εʖθ୵ࡩʛඉྡজ ਫ਼ࢊٗढ़ʀର੏ জࢾݩ ‡ ࣑ݩ༽ϭέοϱ͹֋൅ʀਫ਼ࢊٗढ़ཱི֮ྡ ‡ εʖθ୵ࡩ ʀ ඉྡজ͹ࣰࢬ ඾࣯؇ཀྵࢾݩ ʀ୉ྖਫ਼ࢊର੏ ‡ ϭέοϱαϱιϕφݗ౾ ‡ ؇ཀྵށढ़֋൅ ‡ ਫ਼ࢊʀࡑٗ ϭέοϱٗढ़֋൅ ট೟৻ࠬو৿ ‡ ϭέοϱ੣ଆٗढ़ʤ߇ݬ෾཯੠ ‡ ੣౵ʥ ൭ʤઅඍʀࣁࡒʀ๑੏ౕ౵ʥخ֋൅ਬ਒ڂC. ݜ ੣ଆ༽ࣁࡒ;ٶ఼ڎસ੓ʙGxPଲԢࢬઅʀઅඍ ਫ਼ࢊ҈ ͹ฯ؇הබݬରΏ ‡ ఼ڎজࢾݩࣰࢬࢬઅʀඅݩं ‡ ਫ਼ࢊྡ ݬӹ੣ଆࢬઅ ‡ ౵حϭέοϱݬྋɼώ΢Πϩ༲ ‡ ‡ ΰόϞ৚ๅմੵઅඍ ֋൅ϕϧρφϓΧʖϞڂබݬରγϱϕϩ ݜ බݬରΰόϞ৚ๅಝఈ༽΢ϱϓϧʙ ‡ γϱϕϩ DB༽ڂฑ࣎͹ݜ ‡ ‡ ౵͹ Ϗϱυϝρέ൅঳࣎͹බݬରγϱϕϩEHR RWD DB ‡ ക཈ࡋ๖ʀඉྡজ༽ಊ෼ ྡজࢾݩʀট೟ͶؖΚΖ๑੏ౕ

ؽ೵ਭ६ʁA. કྲྀࡨఈʀસର౹ׇ ܟઝ঳ଲࡨͶଲͤΖ໎֮͵ϑζϥϱΝ״ڷ੔Վ૓ड़Ͷ޴͜ɼΉͥͺฑ͖࣎Δ৿ ΌΔΗΖٽϠωνϨϱή͗;ٶɼϑζϥϱࣰݳͶ޴ͪ͜કྲྀࡨఈ͝

໪ࢨͤਭ६ A. કྲྀࡨఈʀ ࣎ٺە સର౹ׇ ฑ࣎ ઝ঳ଲࡨͶଲͤΖϑζϥϱʁ״ڷ৿ ‡ કྲྀࡨఈ ໪ద͗ఈٝ͠Ηͱ͏Ζ ଲࡨ͹ଲে൥ҕʤබݬରʙϠξϨτΡʥΏ໪ࢨͤؽ೵ਭ६͗໎ࣖ ‡ ͠Ηͱ͏Ζ ׈ಊ֋࢟ʁغබݬର͹૥وͶΓΖ৿ܠ֋൅ʁ ࢊָׯ࿊ڂͶΓΖݜܠࢊָׯ࿊ غͶ͕͜Ζ૥ڂಋݜڠ͹αϱλʖεΠϞΏޛઝ঳൅ਫ਼ઑݶ״ ‡ ԿͤΖखૌΊࣰ͗ک֋൅ର੏ʀؽ೵ΝڂࠒΊͶΓΕݜתࢊָׯ͹ ‡ ࢬ͠Ηͱ͏Ζ ׈ಊ֋࢟Ώ׈ಊྖ͹ଁՅʤࢂՅं͹ଁՅɼϕϫζΥέφ਼͹ ଇ਒ܠࢊָׯ࿊ దͶ׈ಊΝߨͮͱ͏Ζ ଁՅʥ౵غ͹खૌΊͲͺఈى৏ ‡ ֋ڂಋݜڠ࣎Ͷ͕͜Ζٺە͗ܠ͹खૌ ‡ ҅͏ͺɼฑ͖࣎Δ͹ࢊָׯ࿊ܠͱ͏Ζ໪దʙϑζϥϱͳࢊָׯ࿊͝ܟઝ঳ଲࡨͲ״ڷ৿ ‡ Ί͗࿊ಊ͢ͱ͏Ζ ൅Ͷܪ͗ͮͪ ͹ϠωνϨϱήʁڱ֋൅ਬ਒য়ڂ࣎͹ଲࡨʀݜٺە ϠωνϨϱήʁڱઝ঳ଲࡨ͹કྲࣰྀߨয়״ڷ৿ ֋൅ΝϠωνϨϱήͤΖकର͗ಝఈ͠Ηͱ͏Ζڂકྲྀʀࢬࡨ͹਒ṁ؇ཀྵ͗ߨΚΗɼචགྷͶԢͣͪݺพࢬࡨ΃͹ղ೘ ‡ ଲࡨʀݜ ‡ ͹ Ώ༩ࢋഓ෾ݡ௜͗͢ߨΚΗͱ͏Ζڱࣰߨয় ֋൅͹਒ṁ؇ཀྵɼ༩ࢋഓ෾͹ݡ௜͢ɼචགྷͶԢͣͪݺพڂϠωνϨϱή ‡ ݜ ֋൅Ҍ݇΃͹ղ೘Νߨͮͱ͏Ζڂݜ Ζ׈ಊͳ͵ͮͱ͏Ζ͗ܪϠωνϨϱή͗੔Վ΃ͳ ‡ ʁؔغઝ঳൅ਫ਼ઑݶ͖Δɼ༩ࢋฦ੔ʀট೟ΉͲ͹״චགྷ༩ࢋ͹ׄ౲ʁ WHOͶΓΖ ઝ঳൅ਫ਼ઑݶ͖Δ3ϳ݆Ґ಼͹௧Յ༩ࢋฦ੔״ ‡ ࣁ֮ۜฯʀഓ෾ ‡ ҫྏ෾໼ؖ࿊૱༩ࢋ͹10%Ґ৏ ʤ2019೧ౕ༩ࢋϗʖηͲ༁200Աԃʥ ճ٠ࣰࢬʁܠʁ ࠅࡏ࿊ܠ֋൅ର੏ͶؖͤΖकགྷࠅͳ͹࿊ڂઝ঳͹ݜ״ڷ৿ غઝ঳൅ਫ਼ઑݶ͖Δ ुؔҐ಼ɼҐ߳ఈ״ͶΓΖ ‡ ֋൅ਬ਒͹ͪΌ͹ଡࠅؔͲ͹ WHO 2ڂઝ঳ଲࡨ͹ݗ౾Ώݜ״ڷ௒ ‡ ৿ڢࠅࡏ ֋൅ਬ਒͹ͪΌ͹ଡࠅؔͲ͹ڂઝ঳ଲࡨ͹ݗ౾Ώݜ״ڷʤ৿ ۂڢ ٠ʥڢ౵Νۂڢ ʤఈ৙ճ٠͹ૌ੔ʀ߫ݛɼCEPI౵͹ࠅࡏؽؖ΃͹߫ݛ౵ʥ

107 ֋൅ਬ਒ڂؽ೵ਭ६ʁB. ݜ ״ڷ࣎Ͷ͕͏ͱ੊ֆͶ઎ۨ͜੔ՎΝ૓ड़ͤΖͪΌͶͺɼฑ࣎ΓΕଡ༹͵৿ٺە ੔ՎΝ৏͝ͱ͕͚චགྷ͍͗Ζ;ٶ֋൅͹ਬ਒ڂઝ঳Νଲেͳ͢ͱɼݜ ໪ࢨͤਭ६ ࣎ٺە ֋൅ਬ਒ ฑ࣎ڂB. ݜ Δ6ϳ݆͹࿨ช਼ʁ͖ޛઝ঳࿨ช਼ʁ බݬର൅ਫ਼֮೟״దؽؖͶΓΖޮ ‡ 1,000݇ʙ೧ ‡ 500݇Ґ৏ εʖθ୵ࡩʛ [ଚ͹ਏஇ๑Ν஖͘׷͓Ζ৿ͪ͵ٗढ़֋൅͹ࣰ੹ʁ[Dxع ࿨ช͹͑ͬʰଲেබݬରʱ͗ઐΌΖׄ߻ʁڂઝ঳ݜ״ ඉྡজʙ ढ़֋൅ΝՅଐͤٗوͺޮదࣁۜ͹ঁ੔ͶΓΕ৿͏҅ܠ10%Ґ৏ ‡ ࢊָׯ࿊ ‡ αϱιϕφ݀ఈ ΖखૌΊ͗ߨΚΗͱ͏Ζ ֋൅͗਒ΞͲ͏Ζ਼݇ʁڂଲেබݬରͶ͕͏ͱPhase 1ΉͲݜ [وබݬରͲ1݇Ґ৏ [Vx] [Rx-৿֦ ‡ ϭέοϱϠξϨτΡͲPhase 2Ґ৏ΉͲ਒ΞͲ͏Ζ਼݇ʁوढ़֋൅ ৿ٗو৿ ʤϭέοϱʥ ‡ ֦ϠξϨτΡͲ1݇Ґ৏ Ͳ͹ྡজࢾݩ͹ࣰࢬʀট೟֭ಚʁؔغ֋൅͗਒ΞͲ͏Ζʁ ୻ڂʰ஭ྙබݬରʱͶ͕͏ͱPhase 2ΉͲݜ ઝ঳൅ਫ਼ઑݶ͖Δ״ ‡ [බݬରͲ1݇Ґ৏ [Vx] [Rx֦ ‡ [জࢾݩʙ 12ϳ݆Ґ಼͹ট೟ [Vxྡ [੣඾֋൅ʀݗৄ ‡ ಋɼ6ϳ݆Ґ಼ [Rx-RP [وಋɼ12ϳ݆Ґ಼ [Rx-৿ ‡ ‡ ಋɼ3ϳ݆Ґ಼ [Dx] ট೟ϕϫιη͹Յଐʁ ଲԢ͗खΔΗͱ͏Ζٺەট೟৻ࠬ ‡ ট೟৻ࠬϕϫιηՅଐ͹ͪΌ͹ ট೟ਅ੧͖Δ4ुؔͲ͹ট೟ ‡

࣎Ͷචགྷ͵ਫ਼ࢊྖ͹໎֮ԿͳϠξϨτΡ͟ͳ͹ਫ਼ࢊྖ֮ฯʁ[Vx] චགྷ͵੣ଆΫϡϏετΡ͹֮ฯʁٺە [ઝ঳൅ਫ਼ઑݶ͖Δ6ϳ݆ [Vx״චགྷਫ਼ࢊྖ͗ಝఈ͠Ηͱ͏Ζ ‡ WHOͶΓΖ ‡ ࣎ଁࢊͶؖͤΖ ਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹චགྷྖ͹֮ฯʁٺەϠξϨτΡຘ͹ਫ਼ࢊྖ֮͗ฯ͠Ηͱ͏Ζʤ؜΋ ‡ ༁ʥܘ౵ͳ͹ۂة ͳ͹ؔͲਫ਼ࢊྖͶؖͤΖखΕ݀Ό͗ߨΚΗͱ͕Εɼۂة੕ැͳ ‡ [ਫ਼ࢊٗढ़ʀର੏ චགྷྖ͗ࠅ಼ਫ਼ࢊͶΓͮͱ֮ฯ͠Ηͱ͏Ζ [Vx Ώਫ਼ࢊྖͶؖͤΖखΕ݀Ό͗ߨΚڇڛͳ͹ؔͲ༑઎ۂة੕ැͳ ‡ [وΗͱ͕Εɼචགྷྖ֮͗ฯ͠Ηͱ͏Ζ [Rx-৿ ɼ໪ඬ஍ͶԢͣͪචགྷྖ֮͗ฯ͠Ηͱ͏Ζ;ٶ໪ඬ஍͹અఈ ‡ [Dx]

൭ʤ1/2ʥخ֋൅ਬ਒ڂؽ೵ਭ६ʁC. ݜ ֋൅ΝՅଐͤΖͪΌͶͺɼฑ͖࣎Δ͹ڂ࣎Ͷ͕͏ͱɼϨλʖηΝଁΏ͢ݜٺە ΌΔΗΖٽઅඍɼࣁࡒɼ๑੏ౕ͹ඍ͓ʀ੖ඍ͗ ໪ࢨͤਭ६ ൭خ֋൅ਬ਒ڂC. ݜ ࣎ٺە ʤઅඍʀࣁࡒʀ๑੏ౕ౵ʥ ฑ࣎ ಋཤ༽ʀ༑઎ׄ ಊ෼ࣰݩࣰࢬՆ೵͵ࢬઅ͹֮ฯʁڠ࣎͹ٺەBSL3ࢬઅ͹ैଏʤ؜΋;ٶࠅ಼BSL-4ࢬઅ Ε౲ͱϩʖϩࡨఈʥʁ ‡ ABSL-3ࢬઅ20ࢬઅҐ৏ କ੓͹؏఼΍ಁΉ͓࠹ఁ2ࢬઅʥܩۂBSL-4ࢬઅ2ࢬઅҐ৏ʤࣆ ‡ ಋཤ༽ʀ༑઎ׄΕ౲ͱʁڠ͹ͪΌ͹ࢬઅʀઅඍ͹ڂઝ঳ݜ״BSL-3ࢬઅ70ࢬઅҐ৏ʤݳߨࢬઅਭ६Νң࣍ͤΖʥ ౲֚ ‡ ʀοʖϞ΃͹ࢬઅʀઅඍׄ౲ंڂؽؖʀंͶΓΖΠέιη֮ฯ ‡ ݜڂBSL-3ࢬઅ΃͹ݜ ‡ સ੓ʙGxP ‡ BSL-3ࢬઅ͹ଊ࣎ӣ༽͹ࣰݳʤࢬઅઅඍ໚ͶՅ͓ɼBSL-3૮౲͹බ҈ ଲԢࢬઅʀઅඍ ݬର͹खΕѽ͏͗ਕࡒʀηΫϩ໚Ν؜ΌՆ೵ʥ ฯʁ֮غҗ୙ؽؖ͹૥ڂҗ୙ؽؖ͹֮ฯʁ ݜڂઝ঳ਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹ݜ״ ɼ ‡ ฑ͖࣎Δಝఈʙ֮ฯ͢ͱ͏Ζۂةҗ୙ؽؖʤΠΩυϝΠɼҫ༂඾ڂ࣎Ͷ͕͏ͱғབͤΖݜٺە ‡ ғབΝࣰࢬڂݜغҗ୙઎΃͹૥ڂCROʥ͗ಝఈʙ֮ฯ͠Ηͱ͏Ζ ݜ ʀΠΩυϝΠͳ੕ැؔͲۂة༲಼͗ڛແ͹఑ۂ࣎Ͷ͕͜Ζҗ୙ٺە ‡ खΕ݀ΌΔΗͱ͏Ζ ೘घʁغ͹ฯ؇ʀΠέιηʁ බݬର͹૥הઝ঳බݬର״ڷଲে৿ ઝ঳൅ਫ਼ઑݶ͖Δ10ೖҐ಼״దͶࣰࢬ ‡ WHOͶΓΖغබݬରγϱϕϩ͹फॄ׈ಊΝఈ ‡ බݬରγϱϕϩ Ҳׇฯ؇ ‡ ؽؖʀं΃͹Πέιη֮ฯڂݜ ‡

[ࣰࢬʁ[Vx] [Rxغࡨ͹૥ڇڛͰ͚҈ఈخ࣎Ͷ͕͜Ζࣰݩಊ෼͹֮ฯϩʖϩʀର੏ʁ[Vx] [Rx] ֮ฯϩʖϩͶٺە ժ௪Εࣰߨ͠Ηͱ͏Ζܯࣰݩಊ෼֮ฯϩʖϩʀର੏͗ࡨఈ͠Ηͱ͏Ζ ‡ ༩Ό੖ඍ͠Ηͱ͏֮ͪฯϩʖϩ͗ ‡ รԿͶԢͣɼؽಊదͶϩʖϩ͗ݡ௜͢ʙన༽͠Ηͱ͏Ζڱͳ͹߻қɼ౵ʥ ‡ য়ۂة༎೘͹Ϊ΢χϧ΢ϱɼٺەʤଁࢊʀ༑઎ׄ౲ɼ ക཈ࡋ๖ʀ ࣰݩಊ෼ʤྸௗྪʥ͹֮ฯʁ Կ߻෼ࣁݱʀ ‡ ࠅ಼Ͷ͕͜Ζྸௗྪखѽ͏ࢬઅ3ࢬઅҐ৏ ֋൅΃͹׈ڂඉྡজ༽ಊ෼ʀ ޮదԿ߻෼ϧ΢ϔϧϨʖ͹ߑ஛ʁ[Rx] ޮదԿ߻෼ϧ΢ϔϧϨʖ͹ଲেබݬରͶ͕͜Ζݜ ࢾ༂ ‡ ֋൅஦ࢯΏ৏ࢤࡃΊ͹Կ߻෼ϧ΢ϔϧϨʖͳ͵ͮͱ͏Ζ ༽ʁ[Rx] ଡ਼ࣰࢬ͗ڂබݬରͶଲͤΖϨϛζεϥωϱήݜوΨʖϕϱΠέιη͵ϧ΢ϔϧϨʖͳ͵ͮͱ͏Ζ ‡ ৿ ‡

[֋൅ʁ[Dxغࢾ༂͹૥ ઝ঳൅ਫ਼ઑݶ1ϳ݆Ґ಼״WHOͶΓΖ ‡

108 ൭ʤ2/2ʥخ֋൅ਬ਒ڂؽ೵ਭ६ʁC. ݜ ֋൅ΝՅଐͤΖͪΌͶͺɼฑ͖࣎Δ͹ڂ࣎Ͷ͕͏ͱɼϨλʖηΝଁΏ͢ݜٺە ΌΔΗΖٽઅඍɼࣁࡒɼ๑੏ౕ͹ඍ͓ʀ੖ඍ͗ ໪ࢨͤਭ६ ൭خ֋൅ਬ਒ڂC. ݜ ࣎ٺە ʤઅඍʀࣁࡒʀ๑੏ౕ౵ʥ ฑ࣎ ׮྅ʁغʀྡজࢾݩࣰࢬઅඍ͹ಝఈʀର੏੖ඍʁ[Vx] [Rx] ྡজࢾݩ͹૥ڂ࣎ྡজݜٺە জࢾݩࣰࢬྡ [وজࢾݩࣰࢬઅඍ͗ಝఈ͠Ηɼࣰࢬର੏͗੖ඍ͠Ηͱ͏Ζ ‡ 4ϳ݆Ͳ͹ྡজࢾݩ׮྅ [Vx] [Rx-৿ྡ ‡ ࢬઅʀඅݩं [4ϳ݆Ͳ͹ྡজࢾݩ׮྅ [Rx-RP ‡ ׈ಊ֋࢟ʁغ֋൅ϕϧρφϓΧʖϞʁ ฑ࣎Ͷཱིͬ৏ͪ͝ϕϧρφϓΧʖϞͶΓΖ૥ڂઝ঳Νଲেͳͪ͢ݜ״ڷ৿ ֋൅ڂݜ ֋ڂʤ2ुؔఖౕʥͲ͹ݜغɼ૥ޛઝ঳൅ਫ਼ઑݶ״֋൅ϕϧρφϓΧʖϞ͗ߑ஛͠Ηͱ͏Ζ ‡ WHOͶΓΖڂݜ ‡ ϕϧρφϓΧʖϞ ͹׈ಊྖ͹ଁՅɼ౵ޛઝ঳൅ਫ਼ઑݶ״ϕϧρφϓΧʖϞΝ׈༽͢ͱ͏Ζ ൅͹֋࢟Ώɼىࠅ಼֐͹ϕϪʖϢʖ͗৏ ‡ ࣎͹ྡজࢾݩ؉࿪ϩʖϩ͹న༽ʁٺە ࣎͹ྡজࢾݩ؉࿪ϩʖϩ͹੖ඍʁٺە ժ௪Εࣰߨ͠Ηͱ͏Ζܯ௒͠Ηͪྡজࢾݩ؉࿪ϩʖϩ͗ఈΌΗͱ͏Ζʤঙ঳ྭ਼ɼ ‡ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩ͗ڢࠅࡏ ‡ ͹รԿͶԢͣɼؽಊదͶϩʖϩ͗ݡ௜͢ʙన༽͠Ηͱ͏ΖڱRWDཤ༽ɼࣰࢬघକ͘͹؈ોԿɼ༑઎૮஌૯޳͹ଲԢɼ౵ʥ ‡ য় ຌ๏ਓ͹ࣰߨʁخ੏؉࿪و࣎͹ٺە ੏؉࿪ϩʖϩ͹੖ඍʁو࣎Ͷ͕͜Ζٺە ժ௪Εࣰߨ͠Ηͱ͏Ζܯ௒͠Ηͪট೟؉࿪ϩʖϩ͗ࡨఈ͠Ηͱ͏Ζʤ࠸৻ࠬΝ઴఑ͳ ‡ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩ͗ڢজࢾݩʀট೟Ͷ ‡ ࠅࡏྡ ͹รԿͶԢͣɼؽಊదͶϩʖϩ͗ݡ௜͢ʙన༽͠Ηͱ͏ΖڱؖΚΖ๑੏ౕ ͢ড়݇෉͘ট೟ɼ౵ʥ ‡ য় ֋൅қཋΝ߶ΌΖ੕ࡨʁڂઝ঳ݜ״ ‡ ଠࠅ༹͹੕ࡨʤྭʁFDA Priority Review Voucherɼ੕ැͶΓΖϭ έοϱ͹ࣆ઴ഛखΕฯৄ੏ౕʤඍடʥɼ੣ଆ൤ജট೟खಚๅও੏ౕɼ ༂Ճ͹અఈɼϭέοϱϟʖΩʖ΃͹໖੻ɼ౵ʥ͗෵਼಍೘͠Ηͱ͏ Ζ

109 ੔Վ૓ड़Ͷ޴͜ͱචགྷ͵ؽ೵ͳ໪ࢨͤਭ६ .5 ؽ೵Ͷ͕͏ͱ۫ඍͤ΄͘ਭ६֦ .5-1 ؽ೵Ͷ͕͜Ζଠࠅͳը͗ࠅ͹ݳয়֦ .5-2 ໪ࢨͤਭ६͹ࣰݳͶ޴ͪ͜੕ࡨΠ΢υΡΠ .5-3

110 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁA. કྲྀࡨఈʀસର౹ׇ - ਭ६Ν୉͚͘௔͓ͱ͏Ζ۫ ઝ঳ଲࡨ͹״ڷ໪ࢨͤਭ६Ν໎֮Ͷͪ͢৿;ٶଲেͳ͵ΖබݬରΏϠξϨτΡ ΌΔΗΖٽҌཱི͗ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ઝ঳ଲࡨͶଲͤΖ ธࠅ״ڷฑ ৿ ଲࡨʀકྲྀͲ໪దͺఈٝ͠Ηͱ͏ىϑζϥϱʁ ‡ ࠅՊકྲྀͲͺ໪దͺఈٝ͠ΗΖ΍ɼϭέοϱʀ ‡ Ծ ໪ద͗ఈٝ͠Ηͱ͏Ζ MCMͶଲͤΖ۫ରద͵൥ҕʀ໪ࢨͤਭ६ͺ໎ Ζ͗ɼ൥ҕʤබݬରʙϠξϨτΡʥͺ ‡ ͏͵Ηͥ ໎֮Ͷఈٝ͠Ηͱ͏͠ى ଲࡨ͹ଲে൥ҕʤබݬର ‡ ๹Ӷકྲྀʤ2018೧ʥͲͺɼϭ ‡ ΉͪɼҲ෨බݬରΝଲেͶ໪ࢨͤਭ६حʙϠξϨτΡʥΏ໪ࢨͤ – ࠅՊਫ਼෼ฎ ؽ೵ਭ६͗໎ࣖ͠Ηͱ͏ έοϱΝ؜΋MCMͶؖ͢ͱɼ࢘༽घॳ͹ࡨ ͗અఈ͠Ηͱ͏Ζ͗ɼଲেබݬର͗ݸ ࣎͹ྡজࣰݩࣰࢬͶ޴ͪ͜ϕϫφ ఈదͳ͵ͮͱ͏ΖٺەΖ ఈɼ ΢ϱϓϩΦϱδ౵ଲࡨ੕ැߨಊܗݸΔΗͪ༩ࢋΝࠅͳ͢ͱ॑ࢻͤΖ αϩ͹ཱི֮ɼ֋൅ʀ௒ୣ͹༑઎ɼ੣ଆγʖ – ৿] ɼϭέޛ΢ϱϓ൅ਫ਼ܗժͲͺɼ৿ܯ බݬରʀϠξϨτΡͶ౦Ծ͢੔Վ ζ೵ྙ͹ཱི֮౵ɼήϫʖώϩϖϩηιΫϣ [ਭ६ΝઅఈىΝ৏͝ΖͪΌ৏ ఈ͠Η݀͗הϨτΡકྲྀʤ2019೧ʥͲͺɼླྀߨͶඍ͓ͪ οϱ੣ଆ༽͹Τ΢ϩη MCM͹ྡজࢾݩࣰࢬ౵͹ࢬࡨ఑ࣖͶཻΉΖ ͱ͖Δ̔ϳ݆Ґ಼Ͷસࠅ຿෾͹Ϗϱ ‡ ୢ͢ɼ୴౲঴ுϪϗϩ͹કྲྀΏ࿊๞ഐැҗҽճ υϝρέϭέοϱ੣ଆΝ໪ࢨͤ ͹ๅࠄॽͲͺ൥ҕΝ఑ࣖ –AMRଲࡨΠέεϥϱϕϧϱʤ2016 τʖϜɼڂ೧ʥͲͺɼਬ਒ͤ΄͘ݜ ״ڷժʤ2017೧ʥͲͺɼ৿ܯNIAID͹કྲྀ – Ζ΍ਭ६ΉͤٶͶͯ͏ͱݶܯકྲྀࡨఈ ઝ঳͹ΠΤφϔϪ΢έͶඍ͓༙ͪ๮͵ϭέ ੏ౕઅ ͏͵ఈ͠Ηͱ͏وΏྡজࢾݩ͹΢ϱϓϧΝ؜ Ͳͺڂοϱޫึ͹ݜ کઝ঳ଲࡨ͹״Ҙͳ͵Ζڶ֋൅ – ࠅࡏదͶڂ΋ؽ೵޴৏ɼTBɼHIV͹ϭέοϱ͹ݜ ժʤ2016೧ʥΏ݊ܯຌخΝ༑઎ࣆߴͶ؜΋ ԿͶؖͤΖ Ωτ ߃ʀҫྏકྲྀʤ2016೧ʥͶͱɼࠅࡏڂΉͪɼNIAID͹ώ΢ΨυΡϓΥϱηݜ – ֋൅ର੏ͶؖͤΖڂΏࠅ಼͹ݜܠβϨʖAͲͺɼଠࠅͳർ͢ͱ෱߁͏බݬରΝ ࿊ ଲেͳ͢ͱ͏Ζ ໪ࢨͤ΄͘ࢡΝܟ͝ΔΗΖ΍ɼଲে ͏͵ఈ͠Ηͱ͏وࡃࣀ໲җҽճ͹ๅࠄॽʤ2019೧ʥ ൥ҕΏਭ६ͺܨ୉౹྘ – ՟Ͳͺɼ2019ʛڂઝ঳ݜ״Ͳͺ΢ϱϓϩΦϱδ͹ླྀߨͶඍ͓ͪϭέο –AMED͹ ଲেͳ͢ͱΤ΢ϩηڂϱ֋൅΃͹౦ࣁ͗චགྷͲ͍ΕɼܴཝҐ֐͹ 2020೧ౕ͹ݜ ɼԾ;ٶ6झɼܯබݬରܧʀࡋۗܧ ࡋ๖ϗʖηΏૌ׷͓ϭέοϱ౵͹৿͢͏ٗ ɽڏઝ঳ɼঘࣉ॑঳഑ԎΝ྽״ཫ঳ ٶढ़ͶઞࡑదՆ೵੓͍͗Ζͳݶ ఈ͠Ηوୢ͢ɼ໪ࢨͤਭ६ͺ໎֮Ͷ ܨಋๅࠄॽͲͺ΢ϱϓϩΦϱδླྀߨͶΓΖ – ͏͵ࡃଝࣨ͹؏఼͖Δϭέοϱ֋൅΃͹౦ࣁ౵ ͱ͏ ٶͶͯ͏ͱݶ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁA. કྲྀࡨఈʀસର౹ׇ - ਭ६Ν୉͚͘௔͓ͱ͏Ζ۫ ΖͪΌͶ͝ܪ౵͹ࣰࢬ͗ΠΩυϝΠ൅͹εʖθΝࣰ༽ԿͶڂಋݜڠࢊָׯͲ͹ ΌΔΗΖٽ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ֋൅ʁ ธࠅڂͶΓΖݜܠฑ ࢊָׯ࿊ ͹׈ಊܠઝ঳ͶଲͤΖࢊָׯ࿊״ڷ͹αϱλʖεΠϞཱི͗ͬ৏ ‡ ৿ܠ֋൅ ‡ ׯָ࿊ڂࠒΊͶΓΕݜתࢊָׯ͹ ‡ ԿͤΖखૌΊ͗ ͗ͮͱ͏Ζ ࣰ͗ࢬ͠Ηͱ͏Ζکର੏ʀؽ೵Ν αϱλʖεΠϞ –AMED߇ۗ༂ࢊָׯ࿊ཙճͲͺɼ੣ڂઝ঳ྡজݜ״ – ࣰࢬ͠Ηͱ͏Ζ ͢ܠΏؖ࿊ָճ౵ɼࢊָׯͲ࿊ڢదͶ׈ಊ ʤIDCRCʥͲͺฑ͖࣎Δ͹ྡজࢾݩ ༂غ͹खૌΊͲͺఈى৏ ‡ ࣎Ͷͺྡজࢾ ͱAMRͶؖͤΖ՟ୌ͹ݗ౾ɼNPOΏٺەΝߨͮͱ͏Ζ ͹ର੏Ν੖ඍ͢ɼ ͱ͏Ζ໪ ݩ͹৖ͳ͢ͱ୉ָ౵͹ࢬઅΝࢨఈ ࠅࡏద͵ࡔ஄ͳ͹ϋρφϭʖέΝߑ͝ܟઝ঳ଲࡨͲ״ڷ৿ ‡ ͹ү੔ ஛ͶखૌΞͲ͏ΖंڂΝ઒໵ͳͤΖݜڂઝ঳ݜ״ ‡ ͹खܠదʙϑζϥϱͳࢊָׯ࿊ ૱ढ़ٗۂ൭ؽߑɼࢊخૌΊ͗࿊ಊ͢ͱ͏Ζ ࢩԋ౵؜Όఈ৙దͶ׈ಊΝࣰࢬ – ੣඾඲Ճٗढ़ ܠͳ࿊ۂةॶΏΠΩυϝΠʀڂઝ঳ଲࡨ͹ϑζϥϱ ߻ݜ״ڷೖຌ͹՟ୌͳ͵ͮͱ͏ΖΠΩυϝΠ͖Δ΢ ‡ ୴౲঴ு͹৿] ԿͤΖͪΌࢊָ Ͷ͕͜Ζࢬࡨͳ࿊ಊ͢ͱ͏Ζ ͢ɼ෾ࢆ͢ͱ͏Ζళષ෼ϧ΢ϔϧکΝ͢ోڰϱξηφϨʖ΃͹ ੔ܙΝਭ६ͳ͢ͱઅఈ] Ϩʖ͹ॄ༁ΏαϝϣωτΡΝܠׯ࿊ জࢾݩࢬઅ͹੖ඍͺɼNIAID͹કྡ – ʤ૓༂ϔʖۂΏྡজࢾݩ΢ϱ –AMED૓༂૱߻ࢩԋࣆڂʤ2017೧ʥ͹ݜྲྀ ֆۂϓϧΝ؜΋ؽ೵޴৏ͶࣁͤΖखૌΊ ηνʖʥͶΓΕΠΩυϝΠͳࢊ ࢩԋ΍ࣰࢬ͢ోڰ΃͹ ࢊָׯ ӵࠅ ઝ঳ଲࡨͲ״ڷ׈ಊ͗৿ىҲ๏Ͳɼ৏ ‡ ͹׈ಊܠઝ঳ͶଲͤΖࢊָׯ࿊״ڷ৿ ‡ ͱ͏Ζϑζϥϱʤ஭ྙබݬରʙϠ͝ܟ ଇ਒ܠ࿊ ࣰ͗ࢬ͠Ηͱ͏Ζ ξϨτΡ͹ఈٝɼ໪ࢨͤਭ६͹఑ࣖ UK Vaccine Networkͺɼࢊׯָ͖Δ ౵ʥͳචͥ͢΍࿊ಊ͢ͱ͏͵͏ʤݳࡑ – ͏͵͹ϟϱώʖͲߑ੔͠Ηɼླྀߨ͹Ն೵ ͺ໎֮͵ϑζϥϱ͗ఈٝ͠Ηͱ͏ ઝ঳ͶଲͤΖ༙๮͵ϭέ ͪΌʥ״੓͍͗Ζ ઝ঳͗״οϱͳͨ͹ٗढ़΃͹౦ࣁɼ ൅ਫ਼ͤΖఁ஦ॶಚࠅࢩԋΝ໪దͶ׈ ಊ ౲NetworkͲͺɼ஭ྙଲেͳͤΖබݬ ‡ ΃͹ঁ੔ۜ఑ڂର͹ಝఈɼؖ࿊ͤΖݜ ಋݗڠઝ঳ଲࡨ͹WHOͳ͹״ڷɼ৿ڛ ౾౵͹׈ಊΝఈ৙దͶࣰࢬ ‡ ฯ݊঴͹Chief Scientific Adviser͗UK Vaccine Network͹chairΝແΌɼฯ ݊঴͹੕ࡨʀϑζϥϱͳ͹੖߻੓͗୴ ฯ͠Ηͱ͏Ζͳਬࡱ 111 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁA. કྲྀࡨఈʀસର౹ׇ - ਭ६Ν୉͚͘௔͓ͱ͏Ζ۫ Ζ͞ͳ͗͗ܪ࣎͹ॵಊ͹ଐ͠Ͷٺەߑ஛͗ܐฑ͖࣎Δߑ஛͢ͱ͏Ζࢊָׯ͹ؖ ଶ͠ΗΖغ ݳߨਭ६

චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ غබݬର͹૥وͶΓΖ৿ܠࢊָׯ࿊ ە ׈ಊ֋࢟ʁ ธࠅ Ͳ͍Ζ૓༂ϔʖηۂଚࣆعAMED ‡ ;ٶ͹αϱλʖε ‡ IDCRCαϱλʖεΠϞͶΓΖ׈ಊޛઝ঳൅ਫ਼ઑݶ״ ‡ ֋൅ਬڂ׈ VTEUʤϭέοϱ ʀ ࣑ྏ༂ޫึ͹ྡজ νʖ͹࢕ૌΊΝ׈༽͢ɼݜغͶ͕͜Ζ૥ڂಋݜڠΠϞΏ ͢ోڰ΃͹ۂةಊ֋࢟Ώ׈ಊྖ͹ଁՅʤࢂՅं ࢾݩΝਟଐͶ֋࢟Ͳ͘ΖΓ͑Ͷ֮ฯ͠ ਒ΏΠΩυϝΠ͖Δ α Νࢩԋܗ͹ଁՅɼϕϫζΥέφ਼͹ଁ Ηͪࢬઅʥ͹׈༽ͶΓΕ෵਼͹৿ Յʥ౵ Ͷݜغઝ঳࣑ྏ༂ʀϭέοϱ ‡ ௧Յ༩ࢋฦ੔઴Ͷ࢔༩ࢋͲ૥״ϫψΤ΢ϩη ܠࢊָׯ࿊ ͹֋൅Νਬ਒ ܠͺɼฑ͖࣎Δ͹ࢊָׯ࿊͏҅ ‡ ֋൅ࢩԋΝࣰࢬڂ ଇ਒ ֋൅ ӵࠅڂಋݜڠ࣎Ͷ͕͜Ζٺە͗ Ͷܪ͗ͮͪ ઝ঳ͶଲͤΖUK״αϫψΤ΢ϩηܗ৿ ‡ ࣎͹ॵಊ͹ଐ͠ͺฑ͖࣎Δ͹ࢊָׯ࿊ Vaccine Network͹खૌΊ෈໎ٺە] [ਭ६Νઅఈى͹༙ໃ͗॑གྷ͵ͪΌ৏ܠ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁA. કྲྀࡨఈʀસର౹ׇ - ਭ६Ν୉͚͘௔͓ͱ͏Ζ۫ ࣎Ͷͺଲࡨ͹஦ৼͳ͵ΖकରΝઅٺە͹؇ཀྵͶՅ͓ɼڱฑ͖࣎Δ͹ࢬࡨ਒ṁয় ֋൅͹ਬ਒Νԃ׊Ͷߨ͑ର੏͹੖ඍ͗චགྷڂɼݜཱི͢ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ

Ϡω ธࠅڱઝ঳ଲࡨ͹કྲࣰྀߨয়״ڷฑ ৿ νϨϱήʁ ‡ કྲྀʀࢬࡨ͹਒ṁ؇ཀྵΝࣰࢬ ‡ કྲྀʀࢬࡨ͹਒ṁ؇ཀྵͺݸఈద ͰخժͶܯਬ਒;ٶકྲྀʀࢬࡨ͹਒ṁ؇ཀྵ͗ߨΚΗɼ – NIAID඲٠ճͲͺɼNIHॶௗ΃͹ – ݊߃ʀҫྏકྲྀ ‡ Ζࣆߴ ͚ࢬࡨ͹੔Վ඲Ճͺࣰࢬ͠ΗΖ͗ɼܐ׈ಊͳؽ೵ͶڂචགྷͶԢͣͪݺพࢬࡨ΃͹ղ೘ NIAID͹ݜ ஦Ͳ͹ղ೘Ώ༩ࢋഓ෾ݡ௜͢ͺߨغ ٠ʀਬওͶՅ͓ɼঘҗҽڢΏ༩ࢋഓ෾ݡ௜͗͢ߨΚΗͱ͏ ͹ঁݶʀ ͏͵༁͹୊್ஊ֌͹৻ ΚΗܘΖ ճͶͱঁ੔ۜΏ ݸΔΗͪϨλʖηΝ༙ް׈༽ͤΖͪΌͶͺɼ ࠬΝࣰࢬɽΉͪɼNIAIDࣧߨҗҽճ] ٠ڢรԿͶԢͣͪકྲྀʀ༩ࢋ͹ݡ௜͗॑͢གྷ ͲNIAIDસର͹॑གྷ͵੕ࡨ౵Νڱয় [ਭ६Νઅఈىͳ͵ΖͪΌ৏ ͢ͱ͏Ζ͞ͳ͖ΔɼྈҗҽճͲɼક ʀ਒ṁ؇ཀྵΝࣰࢬ͢ͱ͏Ζͳਬ଎ྲྀ ͹ ธࠅڱ֋൅ਬ਒য়ڂ࣎͹ଲࡨʀݜٺە ە ϠωνϨϱήʁ ‡ BARDAक಍͹MCMνηέϓΧʖη͗ ‡ ଲࡨຌ෨͗ૌ੔͠Ηͱ͏Ζ ઝ঳൅ਫ਼ઑݶ͖Δ4ु״֋൅ΝϠωνϨϱή 2020೧1݆Ͷૌ੔͠Ηɼ֦ϠξϨτΡ –WHOͶΓΖڂ͹ ‡ ଲࡨʀݜڱࣰߨয় ઝ঳ଲࡨ״αϫψΤ΢ϩηܗ֋൅ϠωνϨϱήΝࣰࢬ ؔͲ৿ڂϠωνϨϱ ͤΖकର͗ಝఈ͠Ηͱ͏Ζ ͹ݜ ֋൅͹਒ṁ؇ཀྵɼ༩ࢋഓ෾ ‡ ಋ೧5݆͹Operation Warp Speed ຌ෨͗ૌ੔͠Ηɼଲࡨຌ෨͹ༀׄ͗ڂή ‡ ݜ ఈ͠Ηͱ͏Ζو ͺɼOWS಼Ͳ֦ϠξϨޛ͹ݡ௜͢ɼචགྷͶԢͣͪݺพݜ ʤOWSʥ֋࢟ รԿͶԢͣͪݺڱ֋൅͹਒ṁʀয়ڂ֋൅Ҍ݇΃͹ղ೘Νߨͮͱ͏ τΡ୴౲ं͗Πγ΢ϱ͠Ηͱ͕Εɼݜ ‡ ݜڂ ֋൅਒ṁΝ؇ཀྵ͢ͱ͏Ζͳਬఈ พҌ݇΃͹ࢩԋʀղ೘Νࣰࢬڂ Ζ ‡ ϠωνϨϱή͗੔Վ΃ͳܪ͗Ζ ஦ࠅ –AMEDͲࡀ୔ͪ͢՟ୌͲͺɼAMED ࢩԋΝࣰࢬ͢਒ṁ؇ܗ֋൅ΝखΕషΌΖοʖ ୴౲ं͗൒ૺڂ׈ಊͳ͵ͮͱ͏Ζ ‡ ஦ԟ੕ැͶݜ Կ Ϟ͗ૌ੔͠Ηͱ͕Εɼ֦֋൅Ҍ݇͹਒ ཀྵ΍߶ළౕͲࣰࢬڧ؂รԿ͗ଡ͏ڱ࣎Ͷ͕͏ͱͺɼয়ٺە] ṁͶԢͣͪղ೘Νࣰࢬ ىΌΔΗΖͪΌ৏ٽ֋൅͹ਬ਒͗ڂݜغͲ૥ ֋൅ڂਭ६Νઅఈ] ‡ ਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹ݜ ͱ͏Ζ͗ɼͮ͗ܪ֋൅οʖϞʥΝ ͹ਬ਒౵Ҳఈ͹੔ՎͶڂՌݜߊ䎖享 ʤݜ – ֋൅͹੔Վ૓ड़Ͷࢺͮͱڂ֋ ଠࠅఖ͹ݜڂ2020೧1݆Ͷૌ੔ɽ࣑ྏ༂͹ݜ ͏͵͏ ൅Ͷ͕͏ͱͺɼྡজࢾݩ͹਒ṁʀ੔ ՎͶ߻Κͦ౦ԾϨλʖη͹௒੖౵ղ ೘Νࣰࢬ͢ͱ͏Ζ

112 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁA. કྲྀࡨఈʀસର౹ׇ - ਭ६Ν୉͚͘௔͓ͱ͏Ζ۫ ٽໝ͹༩ࢋ֮ฯ͗وΝҲఈ਒Όͱ͕͚ͪΌͶͺɼҲఈڂઝ঳͹ݜ״ڷฑ࣎Ͷ৿ ΌΔΗΖ ݳߨਭ६

චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ

ฑ චགྷ༩ࢋ͹ׄ౲ʁ ธࠅ ҫྏ෾໼ؖ࿊૱༩ࢋ͹10%Ґ৏ ‡ 4.4% ‡ ϧ΢ϓγ΢Φϱηؖ࿊͹૱༩ࢋ͹ ‡ ༁3.6%ʤ2019೧ౕ༩ࢋͺ74Աԃʥ ״ڷʤ2019೧ౕ༩ࢋϗʖηͲ༁200 – ҫྏ෾໼ؖ࿊૱༩ࢋͶઐΌΖ৿ Աԃʥ ઝ঳͹ׄ߻ͺঙ͵͏ֻ͗ۜͺ2,084 ઝ঳༩ࢋ͹༁30״ڷ੔Վ૓ड़͢ͱ͏Ζӵࠅ͹ਭ६Ν໪ࢨͤɽʤธ Աԃʤೖຌ͹৿] ໝͺ୉͘͏ʥ] ഔʥوࠅͺർིͺఁ͏ֻ͗ۜ ӵࠅ ‡ 9~10% ઝ״UKRIͺ10%ɼNIHRͺ9-10%͗– ঳༩ࢋ͹ׄ߻ ஦ࠅ ࣁ֮ۜฯʀ ‡ 27.6% ߶͏ͪΌɼ͗׳ઝ঳࣮״ഓ෾ – ଠࠅͳർ͢ͱ ౲ർི΍߶͏ͳࢧΚΗΖ

ઝ঳൅ਫ਼ઑݶ͖Δɼ ธࠅ״WHOͶΓΖ ە ʁ ‡ 3ϳ݆Ͳ͹௧Յ༩ࢋฦ੔ ‡ 4ϳ݆Ͳ͹௧Յ༩ࢋฦ੔ؔغ༩ࢋฦ੔ʀট೟ΉͲ͹ *1 ໝ΍ – ௧Յ༩ࢋฦ੔ͺɼ2020೧4݆Ͷ݀ఈوઝ঳൅ਫ਼ઑݶ ͖Δ3ϳ݆Ґ಼ – ༩ࢋഓ෾͹ଐ͠ͶՅ͓ɼֻۜ״ ‡ ͹௧Յ༩ࢋฦ੔ ଠࠅͳർ͢ͱ୉͘͏ ͠Ηͪ ઝ঳൅״ଚ༩ࢋ͹࢔෾ͺɼع੔Վ૓ड़͢ͱ͏Ζธࠅʀӵࠅ͹ਭ६Ν໪ࢨͤ] ӵࠅ – Ҳ๏ɼ] و2ϳ݆Ͳഓා͠Ηͪ͗ɼޛ3ϳ݆Ͳ͹௧Յ༩ࢋฦ੔ ਫ਼֮೟ ‡ ໝͺݸఈద ஦ࠅ ‡ 2ϳ݆Ͳ͹௧Յ༩ࢋฦ੔

ઝ঳൅ਫ਼ઑݶʤ2019/12/31ʥ״αϫψΤ΢ϩηܗWHOͶΓΖ৿ .1*

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁA. કྲྀࡨఈʀસର౹ׇ - ਭ६Ν୉͚͘௔͓ͱ͏Ζ۫ ճ٠΃͹ࢂՅܠ࣎͹ࠅࡏ࿊ٺەର੏͹ཱི֮ɼྙڢద͵ଠࠅͳ͹غฑ͖࣎Δ͹ఈ ΌΔΗΖٽ࣎Ͷ͕͏ͱਟଐ͵ଲԢΝखΖͪΌͶٺەͺɼ ݳߨਭ६

චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ֋൅ର੏Ͷ ธࠅڂઝ঳͹ݜ״ڷฑ ৿ ʁ ‡ ธࠅक಍͹ԾͲήϫʖώϩ͵खૌΊ͗ ‡ ธࠅक಍͹ήϫʖώϩ͵खૌΊͶܠؖͤΖकགྷࠅͳ͹࿊ ઝ঳ଲࡨ͹खૌΊΝ ࢂՅ״֋൅ ൅ଏ͢ͱ͕Εɼڂઝ঳ଲࡨ͹ݗ౾Ώݜ״ڷ৿ ‡ ࣰࢬ – ੊ֆ݊߃҈સฯ্ΠζΥϱξ ۂڢਬ਒͹ͪΌ͹ଡࠅؔͲ͹ ʤఈ৙ճ٠͹ૌ੔ʀ߫ݛɼCEPI౵ – 2014೧2݆ɼธࠅ͗क಍͹ԾͲ੊ֆ ʤGHSAʥͶࢂՅ ͹ࠅࡏؽؖ΃͹߫ݛ౵ʥ ߃҈સฯ্ΠζΥϱξʤGHSAʥ ‡ CEPIઅཱི౲ॵʤ2017೧ʥ͖Δ͹ؖ༫Ώ݊ ௒ͺฑ࣎ ͗൅ଏ क͵ड़ࣁंͳ͢ͱ΍ ͹׈ಊͶ߫ݛڢʀܠ࣎Ͷ͕͜Ζଡࠅؔͳ͹࿊ٺە] ਭ६Νઅ CEPIىߑ஛͗॑གྷͳ͵ΖͪΌ৏ܐΔ͹͖ؖ ఈ] EU – ड़ࣁं͹஦Ͳ3൬໪Ͷଡ͚ड़ࣁΝࣰ ద͵ ࢬʤ2019೧఼࣎Ͳ135ԱԃʥغՅ໏ࠅ͹ฯݧ୉਋͗ࢂՅͤΖఈ ‡ ٠ڢઝ঳ଲࡨΝ״ճ߻Ͷͱ –EUޑ༽ʀऀճ੕ࡨʀ݊߃ʀভඇं໲ ୌཀྵࣆճʤEPSCOʥͶͱEUՅ໏ࠅ͹ దͶճ߻Ν֋࠷ɽۛغฯ݊୉਋ͺఈ ೧ͲͺɼΦϚϧɼ΢ϱϓϩΦϱδɼ Ҙڶઝ঳ͶΓΖ״௒ HIV/AIDS౵Ν؜΋ڢࠅࡏ ٠ୌͶ؜ΉΗΖ͵གྷ॑͗ क͵ड़ࣁंͳ͢ͱCEPI΃߫ݛ ‡ – ड़ࣁं͹஦ͲҲ൬ଡ͚ड़ࣁΝࣰࢬ ʤ2019೧఼࣎Ͳ241Աԃʥ ճ٠ࣰࢬʁ ธࠅʀӵࠅܠࠅࡏ࿊ ە ઝ঳Ͳͺɼ ‡ ธࠅक಍͹ࠅࡏճ٠ͶࢂՅ״αϫψΤ΢ϩηܗઝ঳൅ਫ਼ઑݶ ‡ ৿״WHOͶΓΖ ‡ බݬର൅঳֮೟͖Δ3ϳ݆Ͳࠅࡏ غΔ2ुؔҐ಼ɼҐ߳ఈ͖ ֋ ճ٠͗ૌ੔ڂઝ঳ଲࡨ͹ݗ౾Ώݜ״ڷʤ৿ ൅ਬ਒͹ͪΌ͹ଡࠅؔͲ͹ – ธࠅक಍ͲೖӵͺࢂՅɼ஦ࠅͺࢂՅ ٠ʥ ं͗ଚࡑͤΖ͖ͺ෈໎ڢ౵Νۂڢ ઝ঳Ͳͺɼธࠅ͗3ϳ݆״αϫψΤ΢ϩηܗ৿] ໝ͹ϏϱυوͲࠅࡏճ٠Νૌ੔ͪ͗͢ɼ੊ֆ ͹ճ٠ૌ੔͗غϝρέ൅ਫ਼࣎ͺɼࠕյΓΕ΍૥ [ΌΔΗΖٽ

113 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ ׈ಊྖΝڂໝ͹ݜو֋൅Νਬ਒ͤΖͪΌͶͺɼҲఈڂઝ঳͹ݜ״ڷฑ࣎ΓΕ৿ ຮͪͤචགྷ͍͗Ζ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ઝ঳࿨ช਼ʁ״ฑ ޮదؽؖͶΓΖ ‡ 1,000݇ʙ೧ ‡ ธࠅʁ༁4,000݇ ‡ ༁500݇ʙ೧ [੔Վ૓ड़͢ͱ͏Ζӵࠅʀ஦ࠅ͹ਭ६Ν໪ࢨͤ] ‡ ӵࠅʁ༁1,000݇ ‡ ஦ࠅʁ༁1,000݇

Δ6ϳ݆͹࿨ช͖ޛබݬର൅ਫ਼֮೟ ە ਼ʁ *1 ‡ 500݇Ґ৏ ‡ ธࠅ ʁ༁1,500݇ ‡ ༁150݇*1 εʖθ୵ࡩ [੔Վ૓ड़͢ͱ͏Ζӵࠅʀ஦ࠅ͹ਭ६Ν໪ࢨͤ] ‡ ஦ࠅ*1ʁ༁1,200݇ ʛ ‡ ӵࠅ*1ʁ༁500݇ ඉྡজʙ ࿨ช͹͑ͬʰ஭ྙබݬڂઝ঳ݜ״ ฑ αϱιϕφ ରʱ͗ઐΌΖׄ߻ʁ ธࠅʁ ݀ఈ ઝ঳࿨ชͶઐ״ઝݜ͗൅න͢ͱ͏Ζ״ ‡ ઝ঳࿨ชͶઐ״10%Ґ৏ ‡ NIAID͗൅න͢ͱ͏Ζ ‡ *2 ੔Վ૓ड़͢ͱ͏Ζธࠅ͹ਭ६Ν໪ࢨͤ] ΌΖҐԾබݬର ͹࿨ชׄ߻ʁ12.5% ΌΖҐԾබݬର͹࿨ชׄ߻*3ʁ26%] – υϱή೦ɼοέϱήωΠ೦ɼ୺᙭ɼ – ΢ϱϓϩΦϱδɼοέϱήωΠ೦ɼ ϚςϨϊηɼέϨϝΠʀαϱβड़݄ υϱή೦ɼ༂ࡐଳ੓ۗ ೦ɼΦϚϧɼύϱνΤ΢ϩηɼϧρ ೖຌͶ͕͜Ζ஭ྙබݬର͗ઐΌΖ࿨ช ‡ γ೦ɼϜʖϔϩή೦ɼϘηφɼϨϓ ͹ׄ߻ͺ୉͘͏͗ɼࠅͳ͢ͱखૌ΋਼ φώϪʖ೦ɼళષ౳ɼςϧϪϝΠ ͘ʰ஭ྙබݬରʱ͹ಝఈͳͨΗΝಁ΄ ٽਬ਒͗ڂࣁۜ͹౦ԾΏݜڂΉ͓ͪݜ ΌΔΗΖ

Ҍ಼ 2019-2020ʱͶͱक͵ݜۂ՟ ࣆڂઝ঳ݜ״͹ΩτβϨʖAͶ֚౲͢ͱ͏ΖබݬରΝபड़ɼ*3. ʰ஭ྙබݬରʱͺఈΌΔΗͱ͏͵͏͗ɼAMED͹ʰڂ2020೧4఼݆࣎ɼ*2. ஭ྙබݬରͳ͢ͱNIAID͹ώ΢ΨυΡϓΥϱηݜ .1* ଲেͳ͠Ηͱ͏ΖබݬରΝଲেͶ෾ੵڂ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ ͱ͏ΖʤʻҲఈ਼͹ͮ͗ܪฑ࣎ΓΕࣰࢬ͠ΗͱҲఈ͹੔ՎͶ͗ڂॉ෾͵ྖ͹ݜ ΌΔΗΖٽজ೘ΕΝՎͪ͢ͱ͏Ζʥ͞ͳ͗ྡ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ฑ ʰ஭ྙබݬରʱͶ͕͏ͱPhase 1ΉͲ ธࠅ ֋൅͗਒ΞͲ͏Ζ਼݇ʁ ‡ ஭ྙබݬର12झྪ஦ɼ10झྪͶ͕͏ͱ ‡ Phase 1ΉͲ਒ΞͲ͏Ζ਼݇*3ʁڂݜ බݬରͲ1݇Ґ৏ [Vx] [Rx-৿ ͺྡজࢾݩ೘Ε͢ͱ͏Ζ – υϱή೦ʁ16֦݇ ‡ 1* [2*و Phase 1ΉͲ਒ΞͲ͏Ζ਼݇ ʁ – ༂ࡐଳ੓ۗʁ0݇ ‡ ݇ ੔Վ૓ड़Ν଎Ζͪ υϱή೦ʁ;ٶ͹ࣰࢬڂॉ෾͵ྖ͹ݜ] Όɼεʖθ͗ྡজ೘Ε͢ͱ͏Ζ͞ͳΝਭ६ͳͤ – 58 – οέϱήωΠ೦ʁ0݇ ଲڂΖ] – ୺᙭ʁ31݇ ‡ ʤࢂߡʥธࠅͲͺɼAMEDͲक͵ݜ εʖθ୵ࡩ – ϚςϨϊηʁ8݇ েͳ͢ͱ͏Ζ༂ࡐଳ੓ۗͺ19݇ɼοέ ʛ – έϨϝΠʀαϱβड़݄೦ʁ0݇ ϱήωΠ೦ͺ10݇͹࣑ݩ͗P1ΉͲ਒Ξ ඉྡজʙ Ͳ͏Ζ – ΦϚϧʁ37݇ αϱιϕφ – ύϱνΤ΢ϩηʁ3݇ ݀ఈ – ϧργ೦ʁ1݇ – Ϝʖϔϩή೦ʁ7݇ – Ϙηφʁ0݇ – ϨϓφώϪʖ೦ʁ4݇ – ళષ౳ʁ35݇ – ςϧϪϝΠʁ3݇

Ҍ಼ 2019-ۂ՟ ࣆڂઝ঳ݜ״࣑ྏ༂ - າট೟͹֋൅ޫึ඾ɼ*3. ʰ஭ྙබݬରʱͺఈΌΔΗͱ͏͵͏͗ɼAMED͹ʰو͹ΩτβϨʖAͶ֚౲͢ͱ͏ΖබݬରΝபड़ *2. ৿ڂ஭ྙබݬରͳ͢ͱNIAID͹ώ΢ΨυΡϓΥϱηݜ .1* ଲেͳ͠Ηͱ͏ΖබݬରΝଲেͶ෾ੵڂ2020ʱͶͱक͵ݜ

114 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ ઝ঳͹ಝ੓Ώ੕ැʀࢤ຿͹ωʖθͶݡ߻ͮ״࣎Ͷଲেٺەਏஇ๑Ͷ͕͏ͱͺɼ ΌΔΗΖٽλϨϣʖεϥϱ͹֋൅͗ͪ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ٗ͵ଚ͹ਏஇ๑Ν஖͘׷͓Ζ৿ͪع ە ढ़֋൅͹ࣰ੹ʁ[Dx] ธࠅ ढ़֋൅͹ࢩٗوढ़֋൅͹ࢩԋ ‡ AMEDͶΓΖঁ੔Ͳ৿ٗوͺޮదࣁۜ͹ঁ੔ ‡ NIHͶΓΖঁ੔Ͳ৿͏҅ܠࢊָׯ࿊ ‡ ढ़֋൅ΝՅଐͤΖख Νࣰࢬ ԋΝࣰࢬٗوͶΓΕ৿ ෾ੵૹ – ୉ࡗ୉ָ͗AIٗढ़ͳψόϛΠιϱγـεʖθ୵ࡩ ૌΊ͗ߨΚΗͱ͏Ζ – University of Michiganͺݼ αϫψΤ΢ϩη͹ݗ ͲΤ΢ϩη͹෵਼झࣟพͶ੔ޯɽΤܗΌΔΗΖٗढ़ ஖Ν༽͏ͪ৿ٽ࣎Ͷଲেබݬର͹ਏஇͶٺە] ʛ ͹ஊ֌Ͳغઝॵ״͏͵ΌΗΖͪΌ৏ ड़Ν֋൅஦ ΢ϩη਼͗ঙٽ֋൅ʀࣰ༽ԿͤΖ͞ͳ͗غΝ૥ [ਭ६Νઅఈى ඉྡজʙ ΍Τ΢ϩη͹ݗड़ΝՆ೵ͳͤΖ αϱιϕφ – Stanford UniversityͺɼFitBitͶΓΖ Ґ֐͹ࣰ੹ىৼധ਼౵͹ώ΢νϩυʖνΝ׈༽͢ ‡ ৏ ݀ఈ ઝਏஇ͹ٗढ़Ν֋൅஦ – ޮదࣁۜ͹ԋঁͺण͜ͱ͏͵͏͗ɼ״ɼͪ ઔ࡜॑޽ͺࣙಊPCRݗࠬϫϚρφ ઝϨηέΝ״γʖϑηΝϨϨʖηɽ ൒͑޽ఖΝϫϚρφͲࣙಊԿ͢ɼݗ ରण෉͖Δ༁80෾Ͳݗࠬ݃ՎΝ൓ఈ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ ״ઝ঳״ڷ࣎͹ॵಊΝ૥ΌΖͪΌͶͺɼฑ͖࣎Δ͹ϭέοϱٗढ़֋൅Ώ৿ٺە ΌΔΗΖٽઝ঳͹֋൅ਬ਒͗ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ϭέοϱϠξϨτΡͲPhase 2Ґوฑ ৿ ৏ΉͲ਒ΞͲ͏Ζ਼݇ʁ ӵ஦ ೖ ϠξϨτΡͲ1݇Ґ৏֦ ‡ *1 *2 Ͳࣰ༽ԿΉͲ਒΋ͪΌͶɼDNA / RNA 0݇ 0݇ 1݇ؔغ࣎Ͷ୻ٺە] و৿ ढ़֋൅ ฑ͖࣎ΔPhase 2ΉͲ֋൅Ν਒Όͱ͕͚ basedٗ ͞ͳΝ໪ࢨͤ] ʤϭέοϱʥ Recombinant 12݇ 2݇*1 ֮೟Ͳͥ͘ Vial Vectors Subunit / 2݇ 0݇ 1݇*3 Protein based ฑ ʰ஭ྙබݬରʱͶ͕͏ͱPhase 2ΉͲ ธࠅ ֋൅͗਒ΞͲ͏Ζʁ ‡ ஭ྙබݬର12झྪ஦ɼ8झྪͶ͕͏ͱ ‡ Phase 2ΉͲ਒ΞͲ͏Ζ਼݇*5ʁڂݜ බݬରͲ1݇Ґ৏ [Vx] [Rx] Phase 2ΉͲྡজࢾݩ͗਒ΞͲ͏Ζ – υϱή೦ʁ13֦݇ ‡ Ͳࣰ༽ԿΉͲ਒΋ͪΌͶɼฑ *4ؔغ࣎Ͷ୻ٺە Phase 2ΉͲ਒ΞͲ͏Ζ਼݇ ʁ – ༂ࡐଳ੓ۗʁ0݇ ‡ ] ͖࣎ΔPhase 2ΉͲ֋൅Ν਒Όͱ͕͚͞ͳΝ໪ ࣎Ͷ੔Վ૓ड़Ͷࢺͮͱ͏Ζธࠅ͹ਭ – υϱή೦ʁ11݇ – οέϱήωΠ೦ʁ0݇ٺەࢨͤɽ ६Ν໪ࢨͤ] ଲڂ୺᙭ʁ15݇ ‡ ʤࢂߡʥธࠅͲͺɼAMEDͲक͵ݜ – ϚςϨϊηʁ4݇ েͳ͢ͱ͏Ζ༂ࡐଳ੓ۗͺ15݇ɼοέ – জࢾݩʙ – έϨϝΠʀαϱβड़݄೦ʁ0݇ ϱήωΠ೦ͺ6݇͹࣑ݩ͗Phase 2ΉͲྡ ੣඾֋൅ʀ ਒ΞͲ͏Ζ – ΦϚϧʁ11݇ ݗৄ – ύϱνΤ΢ϩηʁ1݇ – ϧργ೦ʁ0݇ – Ϝʖϔϩή೦ʁ0݇ – Ϙηφʁ0݇ – ϨϓφώϪʖ೦ʁ4݇ – ళષ౳ʁ25݇ – ςϧϪϝΠʁ3݇

P1Ͳͺ1݇͹ࣰ੹͍Εɼ*2. AnGes͹߶݄ѻϭέοϱ P2/3ࣰࢬ஦ɼ*3. Ԛ໼ٝʙΨϱαιϧϒʖʀγ΢Φϱη͹͗ΞΝଲেͳͪ͢ϭέοϱʤϘϕοχϭέοϱʥP1ʛ3ࣰࢬ஦ɼ*4. ஭ྙබݬରͳ͢ͱNIAID͹ώ΢ΨυΡϓΥϱ .1* ଲেͳ͠Ηͱ͏ΖබݬରΝଲেͶ෾ੵڂҌ಼ 2019-2020ʱͶͱक͵ݜۂ՟ ࣆڂઝ঳ݜ״͹ΩτβϨʖAͶ֚౲͢ͱ͏ΖබݬରΝபड़ɼ*5. ʰଲেබݬରʱͺఈΌΔΗͱ͏͵͏͗ɼAMED͹ʰڂηݜ

115 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ ࣎Ͷ͕͏ͱ੊ֆͶ઎ۨ͜ͱ੔ՎΝ૓ड़ͤΖͪΌͶͺɼࠕΓΕ΍૥͚ϭέοٺە ΌΔΗΖٽϱΏ࣑ྏ༂͹֋൅͗ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ Ͳ͹ྡজࢾݩ͹ࣰࢬʀট೟֭ Vx Vxؔغ୻ ە ಚʁ ธӵ஦ ೖ ઝ঳൅ਫ਼ઑݶ͖Δ 12ϳ݆ 12ϳ݆ 12ϳ݆ 12ϳ݆Ґ৏*3״ ‡ ઝݜ x״ 12ϳ݆Ґ಼͹ট೟ [Vx] [Moderna] [Oxford x AZ] [Sinopharm] [Ԛ໼ٝ x ‡ ಋɼ6ϳ݆Ґ಼ [Rx-RP*1] 12ϳ݆ UMNϓΟʖϜ] [Pfizer x [AnGes x ࡗ୉] [2*وಋɼ12ϳ݆Ґ಼ [Rx-৿ ‡ BioNTech] ‡ ಋɼ3ϳ݆Ґ಼ [Dx] ࣎Ͷ੔Վ૓ड़Ͷࢺͮͱ͏Ζٺە] ธࠅʀӵࠅʀ஦ࠅ͹ਭ६Ν໪ࢨͤ] Rx Rx ʛ ธӵ஦ ೖ Ϩϛζεϥ 5ϳ݆ 5ϳ݆ জࢾݩʙ ωϱή ʨϪϞυεϑ ʨϪϞυεϑϩʩྡ ϩʩ 7ϳ݆ ੣඾֋൅ʀ 11ϳ݆ ʨυΫγϟνμϱʩ ݗৄ ʨώϨεοω ϔʩ 11ϳ݆ ʤ֚౲ࣆྭໃ͢ʥ و৿ ʨώϞϧωϑ Ϝϔʩ

Dx Dx ธӵ஦ ೖ 3ϳ݆ 7ϳ݆ 2ϳ݆ 5ϳ݆ ʨAbbottʩ ʨAbingdon ʨInnovitaʩ ʨ෍࢞ϪϑΨʩ Healthʩ

͏͵఼࣎Ͳট೟ਅ੧Ͷࢺͮͱ͏ͪͮܨͺ෈໎ͫ͗ɼ12ϳ݆غ࣑ྏ༂ - າট೟͹֋൅ޫึ඾ *3.৏ࢤ༩ఈ࣎وϨϛζεϥωϱή - ট೟ࡃΊ࣑ྏ༂ɼ҅͏ͺ֋൅஦ࢯ͠Ηͪ֋൅ޫึ඾ *2. ৿ .1*

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ ট೟غ࣎Ͷ͕͏ͱͺ૥ٺە֋൅͹ՅଐͶՅ͓ͱɼট೟ϕϫιηͶ͕͏ͱ΍ڂݜ ΌΔΗΖٽΝՆ೵ͳͤΖର੏੖ඍ͗ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ট೟ϕϫιη͹Յଐʁ ە ธࠅ Vx ەট೟৻ࠬϕϫιηՅଐ͹ͪΌ͹ ‡ ઝ঳ؖ࿊͹ҫ༂״αϫψΤ΢ϩηܗଲԢ͗खΔΗͱ͏Ζ ‡ EUAট೟͹৖߻ɼট೟ਅ੧઴͖ΔҲ෨ ‡ ৿ٺ ট೟ਅ੧Ͷଲ͢ͱ༑઎దحট೟ਅ੧͖Δ4ुؔͲ͹ট೟ ඉྡজʙྡজࢾݩυʖν͹৻ࠬΝ֋࢟ ඾ʀҫྏؽ ‡ ͤΖ͞ͳͲট೟৻ࠬϕϫιηΝՅଐ ࣎Ͷ੔Վ૓ड़Ͷࢺͮͱ͏Ζธࠅ͹ਭ६Ν Ͷ৻ࠬΝࣰࢬͤΖର੏Ν੖ඍٺە] ͶՅ͓ɼট೟ਅ੧઴͖ΔҲ෨ඉྡى໪ࢨͤ] ‡ ϭέοϱʁFDAͶΓΖ3ुؔͲ͹ট೟ ‡ ৏ ʤEUAʥ জʙྡজࢾݩυʖν͹৻ࠬΝ֋࢟ Modernaʁ༁3ुؔ ‡ ট೟ਅ੧͖Δ༁2ϳ݆Ͳ͹ট೟– Pfizer x BioNTechʁ༁3ुؔ –Pfizer/BioNTech͹ࠅ಼ਅ੧ͺ༁ – ‡ ࣑ྏ༂ʁFDAͶΓΖ༁1ʛ1.5ϳ݆Ͳ͹ 2ϳ݆Ͳট೟ ট೟ʤEUAʥ 9 2020೧12݆18ೖ͹ট೟ਅ੧઴Ͷ Regeneron Pharmaceuticalsʁ༁ ͺք֐࣑ݩ݃ՎΏඉྡজࢾݩ͹ࣁ – *1 ʥ ྋΝPMDA΃఑ड़ࡃΊ وট೟৻ࠬ 1.5ϳ݆ʤRx-৿ RP*2ʥ 9 ࠅ಼࣑ݩυʖνͺ1݆຦Ͷট೟ਅ/وEli lillyʁ༁1ϳ݆ʤRx-৿ – ੧ޛͶ఑ड़ ஦ࠅ Rx ϫʖϨϱήϪϑϣʖ৻ࠬͶΓΕྡজࢾ ‡ ࠅ಼Ͳ࣑ݩࣰࢬʀট೟Νखಚ࣑ͪ͢ྏ ‡ ͢͵ݩ׮྅઴͖Δɼ৻ࠬΝ֋࢟ ༂ͺݳ఼࣎Ͳͺ ϭέοϱʁট೟ਅ੧͖Δ༁1ुؔͲ͹ট – ੣ଆ൤ജট೟ࣆߴҲ෨รߍট೟ਅ੧ ‡ ೟ ͺ2020೧10݆ʤΠϑΪϱʥ Sinopharmʁ༁1ुؔʤ2020೧12݆– 23ೖਅ੧ɼ2020೧12݆30ೖট೟ʥ Dx ਏஇ๑ʁট೟ਅ੧͖Δ༁2ुؔͲ͹ট೟ ‡ ট೟ਅ੧͖Δ༁2ुؔʛ1ϳ݆Ͳ͹ট೟ ‡ Innovitaʁ༁2ुؔ – ෍࢞ϪϑΨʁ༁2ुؔʛ1ϳ݆ –

͏͵఼࣎Ͳট೟ਅ੧Ͷࢺͮͱ͏ͪͮܨͺ෈໎ͫ͗ɼ12ϳ݆غ࣑ྏ༂ - າট೟͹֋൅ޫึ඾ *2. Ϩϛζεϥωϱή - ট೟ࡃΊ࣑ྏ༂ɼ҅͏ͺ֋൅஦ࢯ͠Ηͪ֋൅ޫึ඾ *3. ৏ࢤ༩ఈ࣎و৿ .1*

116 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ ϭέοϱϠξϨτΡ͹ਫ਼ࢊର੏͗ॉ෾Ͷ੖ඍ͠Ηͱ͏͵͏ͪΌɼوࠅ಼Ͳͺ৿ ΌΔΗΖٽ͹ϏϱυϝρέͶඍ͓ͪϭέοϱϠξϨτΡຘ͹ର੏੖ඍ͗ޛࠕ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ࣎Ͷචགྷ͵ਫ਼ࢊྖ͹໎֮ԿͳϠٺە ฑ ξϨτΡ͟ͳ͹ਫ਼ࢊྖ֮ฯʁ[Vx] ธࠅ ‡ චགྷਫ਼ࢊྖ͗ಝఈ͠Ηͱ͏Ζ ‡ ΢ϱϓϩΦϱδϭέοϱͺɼචགྷྖ͗ ‡ ΢ϱϓϩΦϱδϭέοϱͺɼචགྷྖ͗ ϠξϨτΡຘ͹ਫ਼ࢊྖ֮͗ฯ͠Η ಝఈʀ֮ฯ͠Ηͱ͏Ζ ಝఈʀ֮ฯ͠Ηͱ͏Ζ ‡ ΢ϱϓϩΦϱδ౵ଲࡨ੕ැߨಊܗ৿ – ەͲܠ࣎ଁࢊͶؖͤΖ –H1N1ླྀߨΝण͜ɼࢊָׯ࿊ٺەͱ͏Ζʤ؜΋ ΢ϱϓϩΦϱδ൅ਫ਼ܗժͲͺɼ৿ܯ ࣆସͶଲԢͤΖϭέοϱ੣ଆʀैٺ ༁ʥܘ౵ͳ͹ۂة ͗הɼϭέοϱ੣ଆ༽͹Τ΢ϩηޛ ࣎Ͷ੔Վ૓ड़Ͷࢺͮͱ͏Ζธࠅʀ஦ࠅ͹ లʀ࢕৏͝ࢬઅΝઅཱིٺە] ϭέοϱϠ – ΢ϱϓϩΦϱδͶΓΖϏϱυϝρέ ݀ఈ͠Ηͱ͖Δ̔ϳ݆Ґ಼Ͷસࠅ຿وਭ६Ν໪ࢨͤɽΉͪɼࠅ಼Ͳͺ৿ ͏͵఼͗ॉ෾Ͷ੖ཀྵ͠Ηͱ͏ڎξϨτΡ͹੣ଆ ਭ६Νઅఈ] ൅ਫ਼͖Δ3ϳ݆Ͳસࠅ຿͹ϭέοϱ ෾͹ϏϱυϝρέϭέοϱΝ੣ଆΝىΌ৏ͪ Νࠅ಼੣ଆͲ͘Ζ੣ଆΫϡϏετΡ ໪ࢨ͢ͱ͏Ζ ΢ϱϓϩΦϱδ౵ଲࡨ੕ැߨಊܗΝ֮ฯ͢ͱ͏Ζ – ৿ ‡ ϠξϨτΡຘ͹ਫ਼ࢊྖͺಝఈ͠Ηͱ͏ ܯժͲͺɼϕϪϏϱυϝρέϭέο ਫ਼ࢊٗढ़ʀ ͵͏ ϱͳϏϱυϝρέϭέοϱ͹֮ฯ͹ ͪΌ͹ܯժࡨఈ͗͠Ηͱ͏Ζ ର੏ – ୢ͢ɼBARDAͶΓͮͱ֋൅ʀ੣ଆ͹ ఼ʤCIADMʥͳ͢ͱಝఈ͠Η 9 Ϗϱυϝρέϭέοϱ͹֋൅ʀ੣ڎऩགྷ ͶҲఈ͹͖͖࣎ؔ͗ޛଆͶͺ൅ਫ਼ و఼ͺɼϗένʖϭέοϱ౵৿ڎͪ ͹הϭέοϱٗढ़΍༙͢ͱ͏Ζ ΖͪΌɼ৿͢͏෾཯Τ΢ϩη ༽ͶԢͣͱϭέοϱ੣ଆڱ஦ࠅ ೘घয় ͹ݡ௜͢Ν஠࣏ݗ౾͢ɼה͹ޫึ ࣎Ν૟ఈͪ͢ਫ਼ࢊΫϡϏετΡ͹ٺە ‡ ͨ͹݃ՎͶଊ͢ͱ੣ଆΝߨ͏ɼϕ ฯ֮ ϪϏϱυϝρέϭέοϱ͹ંझΝ ࣎ͶචགྷྖΝ֮ฯͲ͘ΖΓ͑ɼ ߨ͓ΖΓ͑ɼͨ͹ݬӹ͹੣ଆʀඍٺە – ϭέοϱͶଲ͢ͱ2ऀΉͪͺ2ͯ͹ டʤҲ෨ͺ੣ࡐԿʥΝ਒ΌΖ͞ͳ֦ ಢཱིͪ͢ਫ਼ࢊϧ΢ϱͶΓΕਫ਼ࢊ֮ฯ ͗ఈٝ͠Ηͱ͏Ζ ɼਫ਼ࢊΫϡϏετΡΝ೧ؔࢤ৖ऩ͢ ϠξϨτΡຘ͹ਫ਼ࢊྖ֮ฯͺ֮೟Ͳ͘ ‡ གྷ150ˍͶଁՅͤΖ͞ͳΝ໪ࢨͤ ͱ͏͵͏ ʤ౲કྲྀͺࡨఈஊ֌Ͳ͍Εɼາࣰ ߨʥ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ ఼͹֨୉Ͷଡ͚͹ࣁۜΝචགྷͳͤΖͪΌɼ੕ැࢩԋ΍ಁΉ͓ڎϭέοϱͺ੣ଆ ΌΔΗΖٽ੣ଆΫϡϏετΡ͹֮ฯ͗ͪ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ චགྷ͵੣ଆΫϡϏετΡ͹֮ฯʁ ธࠅ ە ઝ঳൅ਫ਼ઑݶ͖Δ ‡ 6~7ϳ݆ ‡ 6ϳ݆Ґ৏״WHOͶΓΖ ‡ ͺ೼Ѵغ֋൅Ώ੣ଆ౵Ν – ਫ਼ࢊΫϡϏετΡ֮ฯ͹࣎ڂ6ϳ݆ [Vx] – ҫ༂඾͹ਟଐ͵ݜ ఼ʤCIADMʥͲ͹αϫψ Ͳ͘͵͖ͮͪ͗ɼ੕ැͶΓΖϭέοڎ࣎Ͷ੔Վ૓ड़Ͷࢺͮͱ͏Ζธࠅ͹ਭ६Ν ୴͑॑གྷٺە] ͺ2020೧ۂ੖ඍࣆٺە໪ࢨͤ] ϭέοϱ͹੣ଆ೵ྙΝ2020೧6~7݆ ϱਫ਼ࢊର੏౵ Ͷͺ֮ฯ 6݆͹୊್࣏ึਜ਼༩ࢋ͹ึঁଲেͳ – ธ੕ැͺEmergent BioSolutionsऀ ͵ͮͱ͏Ζ͹Ͳɼ੣ଆΫϡϏετΡ Ͷ6Ա2,800ຬχϩʤ2020೧6݆ʥɼ ͹ʰ֮ฯʱͺɼ6݆Ґ߳ͳ૟ఈ͠Η τΫγηA&M୉ָ͹CIADMͶ2Ա Ζ 6,500ຬχϩʤಋ೧7݆ʥ͹νηέ ΨʖξʖΝ൅ߨ͢ɼϭέοϱ͹ਫ਼ࢊ ೵ྙΝ֮ฯ ӵࠅ ‡ 10ϳ݆Ґ৏ ਫ਼ࢊٗढ़ʀ ࣙࠅϭέοϱ੣ଆΫϡϏετΡΝ֨ – ର੏ ୉ͤΖͪΌɼ2020೧6݆Ͷͺޮదࣁ ఼ͺ࠹୻Ͳ2020೧ڎ౦Ծ͢ɼҲ෨ۜ 10݆Ֆಉ༩ఈ ϭέοϱ੣ଆΫϡϏετΡ֨୉ 9 ʤ1,000Lώ΢ΨϨΠένʖɼ਼ ඨຬຌʙु͹ਫ਼ࢊʥ͹ͪΌɼӵ੕ ැΓΕ2020೧5݆ͶVMIC΃ˌ6.6 એຬ౦Ծɼಋ೧7݆ͶCGT Catapult΃ˌ1Ա౦Ծ 9 VMICͺ2021೧ՈՖಉ༩ఈɽҲ๏ɼ VMIC͹ࢬ޽׮྅ΉͲͺɼՀࢬઅ Ν2020೧10݆ͶՖಉͦ͠ਫ਼ࢊ ΫϡϏετΡΝ֮ฯ ڎCGT Catapult͹ϭέοϱ੣ଆ 9 ఼ͺ2021೧12݆Ֆಉ༩ఈ

117 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ֋൅ਬ਒ - ਭ६Ν୉͚͘௔͓ͱ͏Ζڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁB. ݜ۫ Ͷ֮ฯͲ͘Ζਫ਼ࢊରغ࣎Ͷ͕͏ͱචགྷྖ͹ϭέοϱʀ࣑ྏ༂ʀਏஇ๑Ν૥ٺە ΌΔΗΖٽ੏͗ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹චགྷྖ ϭέοϱ ϭέοϱ ە ͳ͹ؔͲਫ਼ࢊྖ͹ख ‡ ࠅ಼ਫ਼ࢊͶΓΖචགྷྖΝ֮ฯͤΖͪΌɼۂة͹֮ฯʁ ‡ ӵࠅʁ੕ැͳ ԿΝࢩԋکͳ͹ؔͲਫ਼ࢊྖͶؖͤ Ε݀Ό͗ߨΚΗɼࠅ಼ਫ਼ࢊྖ֮ฯͤΖ ੕ැͺਫ਼ࢊର੏ۂة੕ැͳ ‡ ɼڠ΍ࣰࢬ – Ԛ໼ٝʙUMNϓΟʖϜɼ୊ҲࢀکΖखΕ݀Ό͗ߨΚΗͱ͕Εɼචགྷ ͪΌ͹੣ଆࢬઅଁ ࠅ಼ਫ਼ࢊͶΓͮͱ֮ฯ͠Ηͱ – UK Vaccine TaskforceͶΓΕɼ3ऀ νΩϧώ΢ΨɼKMώ΢Ψϫζέη͗ྖ ੖ඍࣆٺەΖ [Vx] ʤAstraZenecaɼValnevaɼ ౵΃ঁ੔ʤਫ਼ࢊର੏౵͏ ʥۂ Ώਫ਼ Novavaxʥ͹ϭέοϱࠅ಼ਫ਼ࢊઅඍڇڛͳ͹ؔͲ༑઎ۂة੕ැͳ ‡ ͳ͹ਫ਼ࢊྖ͹खΕ݀Ό༙ໃͺ෈ۂة – Νࢩԋ͢ͱ͏ΖکࢊྖͶؖͤΖखΕ݀Ό͗ߨΚΗͱ ͹֮ฯʀଁ ۂةԿͶΓΖ֦ک߻қ਼ͺҐԾ͹௪Εʤ2020೧ ໎ͫ͗ɼਫ਼ࢊର੏ྖڇڛ – Εɼචགྷྖ֮͗ฯ͠Ηͱ͏Ζ͕ *1 ΔΗͱ͏Ζ͝ܟ12఼݆࣎ʥʁ ͹ਫ਼ࢊ໪ඬྖͺ [ وRx-৿] ɼ໪ඬ஍ͶԢͣ 9 AstraZeneca 5,000ຬਕ෾;ٶ໪ඬ஍͹અఈ ‡ [චགྷྖ֮͗ฯ͠Ηͱ͏Ζ [Dxͪ ࣑ྏ༂وNovavax 3,000ຬਕ෾ ৿ 9 ࣎Ͷ੔Վ૓ड़Ͷࢺͮͱ͏Ζธࠅʀӵࠅ͹ٺە] ਫ਼ࢊٗढ़ʀ ة࣑ྏ༂Ͳ͹චགྷྖ֮ฯͶؖͤΖوਭ६Ν໪ࢨͤ] 9 Valneva 3,000ຬਕ෾ ‡ ৿ ͳ͹खΕ݀Όͺ֮೟͠Ηͥۂ ର੏ ઝ঳״αϫψΤ΢ϩηܗ࣑ྏ༂ – ݳ఼࣎Ͳ৿و৿ ࣑ྏ༂ͳ͢ͱͺɼາট೟͹ΠϑΪϱ ͳ͹ؔͲট೟઴ΓΕۂةธࠅʁ੕ැ͗ ‡ Ͷؖ͢ͱͺɼ੕ැ͗ଁࢊགྷ੧Ν෍࢞ ௒ୣΝखΕ݀Ό ϓ΢ϩϞͶड़͢ͱ͏Ζ – ࠹୉155ຬյ෾ʨREGN-COV2ʩ – ࠹୉95ຬյ෾ʨώϞϧωϑϜϔʩ ਏஇ๑ ໪ඬݗ਼ࠬ͹અఈ͗͠Ηɼචགྷ਼͹ݗ ‡ ฯ͠Ηͱ͏Ζ֮͗حਏஇ๑ ࠬ༂ʀؽ ธࠅʁ໪ඬ஍ݗ਼ࠬ͹અఈ͗͠Ηͱ͕ ‡ ୢ͢ɼ໪ඬݗ਼ࠬ͹અఈ๏ਓ͗ݗࠬՆ ‡ ฯ͠Η ೵͵ΫϡϏετΡΝಁΉ͓ͪઅఈ͹֮ͪ͗حΕɼචགྷ਼͹ݗࠬ༂ʀؽ ͱ͏Ζ Ό໪ඬ਼ͺଠࠅͳർ͢ͱݸఈద *2 – ༁600ຬ݇ʙೖ ʤਕ޳͹༁2ˍʥ – ༁2ຬ݇ʙೖ*3ʤਕ޳͹༁0.02ˍʥ

࣑ྏ༂ - າট೟͹֋൅ޫึ඾ *2. 2020೧4݆຦఼࣎Ͳ͹ಋ೧12݆ΉͲ͹໪ඬ஍ *3. 2020೧4݆ड૮ʤ౲࣎ʥන໎و৿ .1*

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ֋൅Νࣰڂ࣎Ͷॉ෾͵ݜٺەΝਬ਒ͪ͢Εɼڂઝ঳ͶؖͤΖݜ״ڷฑ͖࣎Δ৿ ΌΔΗΖٽBSL-4ࢬઅ͹੖ඍ͗;ٶࢬͤΖͪΌͶͺҲఈ਼͹BSL-3 ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ BSL3ࢬઅ͹ैଏ ธࠅ;ٶฑ ࠅ಼BSL-4ࢬઅ ಋཤ༽ʀ༑઎ׄΕ ‡ BSL-4ࢬઅʁ10ࢬઅ ‡ BSL-4ࢬઅʁ1ࢬઅʤʶ1ࢬઅࢬ޽஦ʥڠ࣎͹ٺەʤ؜΋ ౲ͱϩʖϩࡨఈʥʁ ‡ BSL-3ࢬઅʁ200ࢬઅҐ৏*1 ‡ BSL-3ࢬઅʁ70~80ࢬઅҐ৏ ‡ BSL-4ࢬઅ2ࢬઅҐ৏ ؽؖʀंͶΓΖΠέڂؽؖʀंͶΓΖΠέ ‡ BSL-3ࢬઅ΃͹ݜڂBSL-3ࢬઅ΃͹ݜ ‡ କ੓͹؏఼΍ܩۂʤࣆ ࣎Ͷ͕͏ͱͺAMED͗BSL-3ٺەιηΝ֮ฯ͢ͱ͏Ζ ιηʁ ಁΉ͓࠹ఁ2ࢬઅʥ Ͳ͘ΖΓڛͶ ࢬઅΝϭέοϱ֋൅༽Ͷ఑༽ڂNIHɼBARDAͲͺঁ੔ͤΖݜ– ‡ BSL-3ࢬઅ70ࢬઅҐ৏ BSL-3ࢬઅ͹ΫϡϏετΡΝ֮ฯ ͑ର੏੖ඍ ʤݳߨࢬઅਭ६Νң࣍ͤΖʥ BSL-3ࢬઅ͹ଊ࣎ӣ༽͹ࣰݳʁFSAP ‡ BSL-3ࢬઅ͹ଊ࣎ӣ༽͹ࣰݳʁBSL-3ࢬ ‡ ؽؖʀंͶΓڂસ੓ʙ ‡ BSL-3ࢬઅ΃͹ݜ҈ ఈ͠ΗΖΤ΢ϩηوʤ࿊๞බݬରમพϕϫήϧϞʥͶౌ࿧ અͲ͹खΕѽ͏͗ ΖΠέιη֮ฯ GxP ͤΖBSLࢬઅͲͺಝఈ͹බݬର΃͹Πέ ͶࣰࡏͶଲԢՆ೵͵ηΫϩΝ༙ͤΖਕ ࿇Νࣰࢬɽ ࡒͺঙ͵͚ɼBSL-3ਭ६͹Τ΢ϩηͶଲ܉Ն͠Ηͪਕ෼΃͹ڒଲԢࢬઅʀ ‡ BSL-3ࢬઅ͹ଊ࣎ӣ༽͹ࣰݳʤࢬ ιη͗ ֋൅͹ࣰແΝ؜΋͖ͺ෈໎ ͤΖଊ࣎ӣ༽͗Ն೵͵ࢬઅͺඉ৙Ͷݸڂઅඍ અઅඍ໚ͶՅ͓ɼBSL-3૮౲͹බ ୢ͢ɼݜ ݬର͹खΕѽ͏͗ਕࡒʀηΫϩ໚ ఈద ࠙ࢂߡࠚ Ν؜ΌՆ೵ʥ ธӵ஦ ೖ BSL-4 10ࢬઅ 4ࢬઅ 2ࢬઅ 1ࢬઅ*3 ʤ+1ࢬઅ ʤʶ1ࢬઅ ࢬ޽஦ʥ ࢬ޽஦ʥ BSL-3 200ࢬઅʶ*1 600ࢬઅ*2 40ࢬઅʶ 70~80ࢬઅ

*1. ෵਼͹৚ๅλʖηͶΓΕҡ͵Ζ৚ๅ͗֋ࣖ͠Ηͱ͏Ζʤ2005೧఼࣎Ͳ277ࢬઅʤNIAIDʥɼ2007೧఼࣎ͲBSL4ͳ߻Κͦͱ633ࢬઅͳਬܯʤHHS)ɼ2019೧఼࣎Ͳ199ࢬઅʤFSAP೧࣏ๅࠄʥʤHouse of RepresentativeࣁྋΓ գ͢ͱ͕ΕɼҢ఺ʀ৿અΝݗ౾஦ܨ39೧ޛΕʥʥ *2. 150ࢬઅҐ৏͗ΠΩυϝΠ *3. ୢ͢ɼBSL-4ࢬઅͺݒ஛

118 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ΌΔٽฑ͖࣎Δࣰݩಊ෼͹֮ฯͶՅ͓ɼࣰݩಊ෼Νѽ͓ΖABSL-3ࢬઅ͹֮ฯ΍ ΗΖ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ฑ ಊ෼ࣰݩࣰࢬՆ೵͵ࢬઅ͹֮ฯʁ ‡ ABSL-3ࢬઅ20ࢬઅҐ৏ ҈સ੓ʙ [஦ࠅʀธࠅ͹ਭ६Νࢂল͢અఈ] ธӵ஦ ೖ GxP ABSL-3 72ࢬઅ ෈໎ 13ࢬઅ 9ࢬઅʤΠΩυϝΠʥ ଲԢࢬઅʀ ࢬઅ਼ અඍ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ͹๨͝Ͷ͵Δ͵͏Γ͑ɼࢬઅ౵ڂ࣎Ͷ͕͏ͱࢬઅʀઅඍ΃͹Πέιη͗ݜٺە ΌΔΗΖٽಋཤ༽Ώ༑઎ׄΕ౲ͱ͹࢕ૌΊ͗ڠ͹ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ͹ͪΌ͹ࢬઅʀઅඍ ธࠅڂઝ঳ݜ״౲֚ ە ઝ঳͹࣑ྏ༂ͳ״αϫψΤ΢ϩηܗϨλʖη ‡ ৿༽ڂಋཤ༽ʀ༑઎ׄΕ౲ͱʁ ‡ NIAID͹஭ྙබݬର͹ݜڠ͹ Ε͓Ζ෼࣯͹୵ࡩΏਏஇ๑ʀ࣑ྏ๑͵ ڂʀοʖϞ΃͹ࢬઅʀઅඍׄ ʤࢾ༂ɼςʖϩɼ৚ๅʥΝॄ༁͢ݜंڂݜ ‡ ౲ αϝϣωτΡΏਏஇ༂֋൅ं΃֋ࣖ Ν޴৏ͦ͑͠Ζ՟ୌΝτʖϜͳͤΖݜ ֋൅Ͷଲ͢ͱɼηϏαϱʰ෍ֹʱ͹ڂ ࣎Ͷ͕͏ͱࢬઅʀઅඍ΃͹Πέιη͗ݜ – BEI resource repositoryͺɼNIAIDٺە] ڛਭ६Νઅఈ] ͲΩτβϨʖAɼBɼCͶࢨఈ͢ͱ͏ ཤ༽Ν఑ى֋൅͹๨͝Ͷ͵Δ͵͏Γ͑৏ڂ ΖබݬରΝଲেͳ͢ͱ͏Ζ – ଲেͳ͵Ζ͹ͺช෨Ռָ঴͗਷࣎݀ ՟ୌͲ͍Εɼਏஇ๑ʀ࣑ڂNational Science FoundationͶΓΖ ఈͤΖݜ ‡ ಋཤ༽ ྏ๑ɼ࣑ྏ༂͹୵ࡩ౵͗؜ΉΗΖڠηϏαϱ͹ ॶʙڂCOVID-19 HPC Consortium͹खૌΊ – ࣑ྏ༂ޫึ͹ಋఈʤཀྵԿָݜ – ౵Ͷཤ༽Νڂ౐୉ָʥ͹ͪΌ͹ݜښ ಋཤ༽ΝՆ೵ͳڠͳ͢ͱηϏαϱ͹ ڛʤUniversity of Texas͗ฯ༙ͤ ఑ͪ͢ ҈સ੓ʙ Ζ Frontera supercomputer΍͞͹ ͳ͠Ηͱ͏Ζʥ؂GxP खૌΊ͹Ҳ ଲԢࢬઅʀ ԦयʤEUݏʥ અඍ΃͹ΨʖϕϱΠέڂઅඍ ‡ CERICͶΓΖݜ ڛιη͹Fast Trackਅ੧఑ –CERICͲͺฑ࣎ΓΕEU8ϳࠅͶ͍Ζ ࢬઅ΃͹ΨʖϕϱΠέιηڂ෵਼ݜ ڛ޴͜Ͷ఑ंڂΝݜ ઝ঳ؖ࿊͹ݜ״αϫψΤ΢ϩηܗ৿ – ࢩԋ͹ͪΌɼಝఈؽࡒͶଲ͢ͱཤڂ ༽ਅ੧ϕϫιηՅଐʤ௪৙͹඲Ճϕ Ζ͞ͳ͵͚ɼ1ϳ݆ͲؽܨϫιηΝ ࡒʀࢬઅ΃͹Πέιη͗Ն೵ʥʤ5 ࢬઅͶ͍Ζ෵਼͹ؽࡒ – έϧ΢Ψు ΏX-ray diffractionںࢢݨඏ beamline౵͗ଲেʥ

119 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ җ୙ؽؖ͗ݸΔΗͱ͏ΖͪΌɼҗ୙ؽؖΝଁڂઝ঳Νଲেͳͪ͢ݜ״ࠅ಼Ͳͺ ΌΔΗΖٽଚ͹җ୙ؽؖΝฑ͖࣎Δ೼Ѵ͢ͱ͕͚͞ͳ͗عΏͤ͞ͳͶՅ͓ɼ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ઝ঳ਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ͹״ ฑ җ୙ؽؖ͹֮ฯʁ ธࠅڂݜ җ୙઎ؽؖ͗෈ଏ͢ͱ͏Ζڂ࣎Ν૟ఈͪ͢ฑ͖࣎Δ͹ख݀Ό͹ ‡ ࠅ಼ݜٺە ‡ җ୙ڂ࣎Ͷ͕͏ͱғབͤΖݜٺە ‡ җ୙ؽؖͺڂ࣎͹ࡏ͹ݜٺەɼ ༙ໃͺ֮೟Ͳͥ͘ ‡ Յ͓ͱɼۂةؽؖʤΠΩυϝΠɼҫ༂඾ ͏͵ΊΝ࣍ͯ ಝఈʙ֮ฯ͠Ηͱ͏کઝ঳Ͷ״CROʥ͗ಝఈʙ֮ฯ͠Ηͱ͏Ζ – ୢ͢ɼฑ࣎ΓΕ Ζؽؖͺ͍͗ܐແҗ୙ؖۂ෵਼CROʤICONɼSouthern – ฑ࣎ΓΕ ಼ڛແ͹఑ۂ࣎Ͷ͕͜Ζҗ୙ٺە ‡ ࣎Ͷඍ͓ͪҗ୙ՆٺەʀΠΩυϝΠͳ੕ැؔͲ researchɼSRI International౵ʥ΃ ଚࡑͤΖ͗ɼۂة༲͗ ͏͵ԿͶ ೵ؽؖ͹ಝఈͺߨΚΗͱ͏ڧ؂җ୙͢ͱ͕Εɼ͖ͯΖڂસ੓ʙ खΕ݀ΌΔΗͱ͏Ζ ݜ҈ ͍Ζͳ૟ఈ͠ΗΖ ࣎Ͷ͕͜Ζख݀Όͺߨٺەҗ୙ؽؖ͹෈ଏΏ֮ฯͶ՟ୌΝ༙͢ͱ͕ ‡ җ୙ؽؖͳڂݜ] ֋൅ਬ਒Ν๨͝ͱ͏Ζͪڂ࣎Ͷ͕͜ΖݜٺەGxP Ε ͏͵ਭ६Νઅఈ] ΚΗͱ͏ىଲԢࢬઅʀ Ό৏ ฯʁ ธࠅ֮غҗ୙ؽؖ͹૥ڂઅඍ ݜ җ୙઎ؽؖ͗෈ଏͶΓΕɼ૥ڂҗ୙৚ ‡ ࠅ಼ݜڂฑ͖࣎Δಝఈʙ֮ฯ͢ͱ͏Ζ ‡ NIHʙNIAID͖ΔCRO΃͹ݜ ‡ ە Ͷҗ୙઎Ν֮ฯͲͥ͘غ ғབΝࣰ ๅͺ֮೟Ͳͥ͘ڂݜغҗ୙઎΃͹૥ڂݜ ͹ण୙઎͗ࠅ಼ڂΊΝ࣍ͯ –AMEDͶΓΖݜکઝ঳Ͷ״ࢬ – ୢ͢ɼฑ࣎ΓΕ җ୙͢ͱ͏ΖͪΌɼ CROͲͺݡ͖ͯΔͥɼք֐CRO΃͹ڂͶਬ਒ͤΖͪ ෵਼CRO΃ݜغ֋൅Ν૥ڂ࣎Ͷ͕͏ͱݜٺە] ғབΝ җ୙ΝࣰࢬڂͶݜغ࣎Ͷ͕͏ͱ΍૥ٺە [ਭ६ΝઅఈىΌͶ৏ ࣰࢬͪ͢ͳ૟ఈ͠ΗΖ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ؽؖʀं͗ଡ༹͵බݬରΝڂฑ͖࣎ΔබݬରγϱϕϩΝҲݫ؇ཀྵ͢ɼࠅ಼͹ݜ ΌΔΗΖٽΏͤ͏ର੏Ν੖ඍͤΖ͞ͳ͗͢ڂݜ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ͹ฯ؇ʀΠ ӵࠅהઝ঳බݬର״ڷฑ ଲে৿ ໝ͵බݬ੓Τ΢وέιηʁ ‡ ޮ़Ӷਫ਼ு(PHE)͗୉ ͹הઝݜͶ͕͜Ζබݬର״ϩη͹αϪέεϥϱʰNCTCʱΝ؇ཀྵɽ ‡ Ҳׇฯ؇ʁ غබݬରγϱϕϩ͹फॄ׈ಊΝఈ ‡ ɽΤ ฯ؇৚ๅͺ֮೟Ͳͥ͘ڛͱࠅ಼֐΃఑ܨదͶࣰࢬ ॶఈ͹घକ͘Ν ΢ϩηΝฯ؇ͤΖޮద͵αϪέεϥϱ ઝݜͶ͕״ฯ؇ʀΠέιηʁהҲׇฯ؇ ‡ බݬର ‡ ໝوͳ͢ͱͺ୉ ؽؖʀं΃͹Πέιηϩʖϩڂؽؖʀं΃͹Πέιη֮ฯ ͜Ζݜڂݜ ‡ ϪϗϩͲ͹खΕѽ͏͗චགྷ͵ ؽؖʀं΃Πέ –BSL3/4 Ͷؖ͢ͱͺ֮೟Ͳͥ͘ڂΝҲݫԿͶΓΕݜהබݬର] ιηՆ೵ͳ͢ɼฑ͖࣎Δଡ༹͵බݬରͶଲͤΖ ϐφබݬରΤ΢ϩηΝकͶฯଚ͢ͱ ਬ਒ΝࢩԋͤΖ] ͕ΕɼΠυόΤ΢ϩηɼαϫψΤ΢ڂݜ ϩη౵͗؜ΉΗΖ Ԧय ‡ Ԧयҗҽճ͹ࢩԋΝण͜ɼήϫʖώϩ ໝΤ΢ϩηΠʖوͲΠέιηՆ೵͵୉ බݬର Ω΢ϔ͹ߑ஛͗਒΋ɽԦयҮ಼֐͹ଡ ॶ͗Ϗʖφψʖͳ͢ͱࢂՅ͢ɼڂγϱϕϩ ਼͹ݜ ΗΔ͹ؽؖ͗ฯ༙ͤΖҲ෨Τ΢ϩη͞ ڛ΃͹ΠέιηΝ఑ – 2021೧3݆৏२఼࣎ͲͺΩνϫή৏ ͹੣඾਼ͺ2,958݇ͲɼϧργΤ΢ ϩηɼυϱήΤ΢ϩη౵͗؜ΉΗΖ ೘घʁ ธࠅغබݬର͹૥ ͺາޮ֋غ೘घ࣎הͺາޮ֋ ‡ බݬରغ೘घ࣎הઝ঳൅ਫ਼ઑݶ͖Δ ‡ බݬର״WHOͶΓΖ ‡ ە ઝݜ͗2020೧1݆Ͷͺ෾཯ͪ͢Τ״ – ઝݜʤೖʥ͗෾཯ͪ͢Τ΢ϩηΝ״ – 10ೖҐ಼ ڛ֋൅Νਬ਒ͤΖͪΌͶͺබ ೘घʤ2020೧1݆Ґ߳ʥ ΢ϩηΝธࠅؽؖ΃఑ڂ੊ֆͶ઎ۨ͜ݜ] ਭ६ΝઅىΌΔΗΖͪΌ৏ٽ೘घ͗غݬର͹૥ ॶ΃͹Τ΢ϩڂઝݜͶΓΖࠅ಼ݜ״ – [ఈ ઝ঳൅ਫ਼ઑݶ͖Δ༁2ϳ״η෾༫ͺ ݆ޛ

120 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ࣎Ͷ͕͏ͱ෈ଏ͗ৼഓ͠ΗΖࣰݩಊ෼͹֮ฯʙ༑઎ׄΕ౲ͱΝࣰࢬͤΖͪٺە ΌΔΗΖٽࡨ͹ࡨఈ͗ڇڛΌ͹҈ఈ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ࣎Ͷ͕͜Ζࣰݩಊ෼͹֮ฯϩʖٺە ฑ ϩʀର੏ʁ[Vx] [Rx] ธࠅ ͹৚ๅ͗Ҳݫ؇ཀྵ͠ंۂ͹৚ๅͺҲݫ؇ཀྵয় ‡ ࣰݩಊ෼खѽंۂ͹৚ๅ ‡ ࣰݩಊ෼खѽंۂࣰݩಊ෼͹ࠅ಼खѽ͏ ‡ ͏͵ͺ෈໎ʤखૌΊ৚ๅͺ֮೟Ͳͥ͘ʥ Ηͱ͏ڱ Ҳݫ؇ཀྵʙ೼Ѵ͠Ηͱ͏Ζ͗ ৚ๅ͗Ҳݫ؇ंۂAMEDͲͺखѽ͏– ڱࣰݩಊ෼֮ฯϩʖϩʀର੏͗ࡨఈ ‡ ࣰݩಊ෼֮ฯϩʖϩʀର੏͹੖ඍয় ‡ ࣎Ͷ͕ٺەͺ෈໎ʤखૌΊ৚ๅͺ֮೟Ͳͥ͘ʥ ཀྵ͠Ηͱ͏͵͖ͮͪͪΌ ەΗͱ͏Ζʤଁࢊʀ༑઎ׄ౲ɼ͠ ୵͢͹ଲԢ͖Δචགྷͫͮͪंۂͳ͹߻ ͏ͱۂة༎೘Ϊ΢χϧ΢ϱɼٺ қɼ౵ʥ ฯϩʖϩʀର੏ͺາ੖ඍ֮ ‡ ࣎Ͷ෈ଏ͗༩଎͠ΗΖࣰݩಊ෼Ν֮ฯͤٺە] [ਭ६ΝઅఈىΖͪΌͶฑ࣎͹६ඍͳ͢ͱ৏ ࡨ͹૥ڇڛͰ͚҈ఈخฯϩʖϩͶ֮ ࣰࢬʁ[Vx] [Rx] ธࠅغ ە ക཈ࡋ๖ʀ ‡ ༩Ό੖ඍ͠Ηͱ͏֮ͪฯϩʖϩ͗ ‡ ༩Ό੖ඍ͠Η֮ͪฯϩʖϩͲͺ͵͏͗ɼ ‡ ֮ฯϩʖϩʀର੏ͺາ੖ඍ ࣎Ͷ͕͏ͱ Ͳࣰࢬ͢ͱ͏Ζݜٺە ժ௪Εࣰߨ͠Ηͱ͏Ζܯ Կ߻෼ ACTIV ͤ༽֋൅ΝଲেͶNIHͺྸௗྪΝ࢘ڂ รԿͶԢͣɼؽಊదͶϩʖϩڱয় ‡ ͹༑઎ׄΕ౲ͱΝࣰࢬڂࣁݱʀ ͗ݡ௜͢ʙన༽͠Ηͱ͏Ζ Ζݜ ࣎Ͷ෈ଏ͗༩଎͠ΗΖࣰݩಊ෼Ν֮ฯͤٺە] ༽ඉྡজ [ਭ६Νઅఈىಊ෼ʀࢾ༂ ΖͪΌͶ৏ ࣰݩಊ෼ʤྸௗྪʥ͹֮ฯʁ ธࠅ ฑ ௗྪࣄүιϱνʖ21ࢬઅΝฯ ‡ ྸௗྪࣄүιϱνʖΝ3ࢬઅฯ༙ྸ༽ڂࠅ಼Ͷ͕͜Ζྸௗྪखѽ͏ࢬઅ3 ‡ ݜ ‡ ॶҐ֐Ͳ͹खΕڂ౐୉ָྸௗྪݜښ – Νण͜ͱڛࢬઅҐ৏ ༙ʤ಼7ࢬઅ͗NIH͹ࣁۜ఑ ॶʥ ѽ͏ྸௗྪ͹झྪͺݸఈదڂ࣎Ͷ෈ଏ͗ݔ೨ ͏ΖࠅཱིݜٺەಝͶࣄүʙ೘घ͗ࠖೋͲ] ͠ΗΖྸௗྪͶଲͤΖਭ६Νઅఈɽগཔ͹Ϗϱ –21݇͹ιϱνʖΝฯ༙͢ͱ͏Ζ͗ɼ ॶʤωϙϱδڂ౐୉ָྸௗྪݜښ υϝρέ΍ಁΉ͓ɼݳয়ң࣍ͳ͢ͱਭ६Νઅ 9 ఈ] গཔదͶࣰݩಊ෼༽͹ྸௗྪ͹਼͗ ϩɼΠΩΰδϩɼοϱϏϱζʖɼ ෈ଏͤΖݡࠒΊͲ͍Ζͳ͹෾ੵ͗ߨ αϠϱϜʖϠιρφɼ౵ʥ ΚΗͱ͏Ζ ॶʤωϙϱδϩʥڂਫ਼ཀྵָݜ 9 ஦ࠅ 9 ೖຌSLCʤΩωέ΢δϩɼࣄү͹ ௗྪࣄүιϱνʖΝ7ࢬઅฯ༙ Ίʥྸ༽ڂݜ ‡ ؽ೵΍۫ڂʤ಼4ࢬઅͺࣄүͶՅ͓ݜ ඍʥʤ2006೧఼࣎͹৚ๅʥ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ฑ͖࣎ΔޮదؽؖΏΠΩυϝΠͶΓΖԿ߻෼ϧ΢ϔϧϨʖߑ஛ʙԿ߻෼඲Ճࣰ Ζ͗ܪ࣑ྏ༂͹֋൅΃ͳغ࣎Ͷ૥ٺەࢬ͹ର੏Ν੖͓Ζ͞ͳͲ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ฑ ޮదԿ߻෼ϧ΢ϔϧϨʖ͹ߑ஛ʁ [Rx] ธࠅ ୉ָ૓༂ؽߑͶΓΖԿ߻෼ϧ΢ϔښ֋൅஦ࢯΏ৏ࢤࡃΊ͹Կ߻෼ϧ΢ ‡ ޮదؽؖʤࠅཱི઎਒φϧϱηϪʖεϥ ‡ ౨ ‡ ϔϧϨʖͳ͵ͮͱ͏Ζ ψϩՌָιϱνʖʤNCATSʥʥͶΓΖ ϧϨʖ͹ߑ஛ Կ߻෼ϧ΢ϔϧϨʖ͹ߑ஛ ‡ ΨʖϕϱΠέιη͵ϧ΢ϔϧϨʖ –7ͯ͹ϧ΢ϔϧϨʖΝฯ༙ɽFull ͳ͵ͮͱ͏Ζ –7झྪ͹Կ߻෼ϨηφΝߑ஛ʤ35ຬ LibraryͲͺҲൢԿ߻෼༁21ຬݺ͗؜ Ͷͳͮͱͺචͥ͢΍Ϩϛζεϥωϱή͹ Ν௔͓Ζఁ෾ࢢ͹MLSMR*1 ΉΗΖۂة] ΢ϱιϱτΡϔ͗Κ͖͵͏ͪΌɼΠΩυϝΠ͗ collectionΏ2,400͹FDA͗ট೟ͪ͢ ਭ६ સͱ͹Կ߻෼ΝϨηφͪ͢NPC*2౵ى֋൅Νਬ਒Ͳ͘ΖΓ͑৏ڂ஦ৼͳ͵Εݜ Νઅఈ ؜ΉΗΖʥ͗ [ దԿ߻෼ϧ΢ϔϧϨʖ͹ଲেබݬޮ ֋൅΃͹׈༽ʁ[Rx] ธࠅڂക཈ࡋ๖ʀ ରͶ͕͜Ζݜ ە Կ߻෼ ઝݜͶΓΖԿ߻෼ϧ΢״;ٶαϫψ ‡ Ҳ෨୉ָܗබݬରͶଲͤΖϨϛζεϥω ‡ ޮదؽؖʤNCATSʥͶΓΖ৿و৿ ‡ ״֋൅Ν ϔϧϨʖ͹ηέϨʖωϱήΝ௪ͣͪڂઝ঳༽࣑ྏ༂͹ݜ״ଡ਼ࣰࢬ Τ΢ϩη͗ڂࣁݱʀ ϱήݜ ඉྡজ༽ [੔Վ૓ड़͢ͱ͏Ζธࠅ͹ਭ६Ν໪ࢨͤ] ໪దͳͪ͢Կ߻෼඲Ճ݃Վ֋ࣖϛʖν ઝ૏֒෾ࢢ͹୵ࡩ͹ࣰࢬ ڛϩ͹఑ ઝݜɼ๼քಕ୉ָɼ๼཮୉ָɼ۟״ – ಊ෼ʀࢾ༂ ଚট೟༂ϧ΢ϔϧϨʖعSARS-CoV-2ؖ࿊Πρι΢Ν༽͏ͱ य୉ָͲͺ– 10,000Ґ৏͹Կ߻෼ʤ಼NCATS͗ฯ ͨ͹ଠԿ߻෼ϧ΢ϔϧϨʖ͹ηέ ઝ״Ζ৏ࢤࡃΊ༂ࡐ͹3,000݇͹Կ Ϩʖωϱή౵Ν௪͢ͱΤ΢ϩη༙ͤ ઝ૏֒෾ࢢ͹୵ࡩΝࣰ״߻෼؜΋ʥ͹ηέϨʖωϱήΝࣰࢬ Νཊ੏ͤΖ – Πρι΢৚ๅɼΠρι΢࢘༽घॳɼ ࢬɽୢ͢ɼ࢘༽͠ΗΖϧ΢ϔϧϨʖ ؽ঄ɼηέ ͹ΨʖϕϱΠέιη੓Ͷͯ͏ͱͺ෈ۂԿ߻෼νʖΰρφɼࡠ ʀ ໎ंڂϨʖωϱή݃Վ౵͹৚ๅΝݜ ؽؖ΃֋ࣖ – ੔ՎͶͯ͏ͱͺາޮ֋ ͹݃ՎͳڂϨϛζεϥωϱήݜى৏ – ͢ͱɼ6ͯ͹Կ߻෼͹ઞࡑద͵༙ް ੓֮͗೟͠Ηͪ

*1. MLSMR - Molecular Libraries Small Molecule Repository *2. NPC - NCATS Pharmaceutical Collection

121 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ Ͷࢾ༂Ν೘घغ֋൅ͤΖͪΌͶͺ૥غ࣎Ͷ͕͏ͱଲেබݬର͹ਏஇ๑Ν૥ٺە ΌΔΗΖٽʙ֋൅ͤΖ͞ͳ͗ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ֋൅ʁ[Dx] ธࠅغࢾ༂͹૥ ە αϫψܗઝݜ͗৿״ઝ঳൅ਫ਼ઑݶ1ϳ݆ ‡ 2020೧2݆4ೖͶCDC֋൅͹PCRݗࠬ๑ ‡ 2020೧1݆24ೖͶ״WHOͶΓΖ ‡ ക཈ࡋ๖ʀ Ґ಼ ͗EUAΝखಚɼཎೖͶࠅ಼֐͹ಝఈϧ Τ΢ϩηݗࠬ༽͹ϨΠϩν΢ϞPCRݗ ϚͶૻ෉ Կ߻෼ [ਏஇ๑͹੔Վ૓ड़Ͷࢺͮͱ͏Ζธࠅ͹ਭ६Ν ࠬ๑͹֋൅Ν׮྅ɼ1݆29ೖͶસࠅ͹ஏ ॶɼݗӺॶͶϨڂ஄ର͹Ӷਫ਼ݜڠҲ෨Ͷ඾࣯͹໲ୌ͗൅ ๏ޮޛࣁݱʀ ࢂߡͳͤΖ] – ୢ͢ɼૻ෉ ɼFDAͲͺ৿ͪ͵ݗࠬΫρφΝ Πϩν΢ϞPCRͶචགྷ͵ࢾ༂Ν൅ૻְ͢ ඉྡজ༽ ੣ଆͤΖͳͳ΍Ͷɼ2݆Ծ२Ͷͺ Ͷଲ͢ͱͺಋۃಊ෼ʀࢾ༂ ωϣʖϦʖέयฯ݊ यϧϚ͗֋൅ͪ͢ਏஇ๑ͶEUAΝ੏ Նڒݸ෉͘Ͳ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ࣎͹ྡজࢾݩࣰࢬࢬઅΏର੏Ν༩Ό੖ඍ͢ͱ͕͚͞ͳͲɼ֋൅͹ՅଐΝ໪ٺە ࢨͤ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ʀྡজࢾݩࣰࢬઅඍڂ࣎ྡজݜٺە ฑ ͹ಝఈʀର੏੖ඍʁ[Vx] [Rx] ธࠅ ࣎Ͷ޴ͪ͜ࢾݩࢬઅϋρφϭʖέ ‡ ʤҲ෨͹ψεϥψϩιϱνʖΏ୉ָබٺە ‡ জࢾݩࣰࢬઅඍ͗ಝఈ͠Ηɼࣰྡ ‡ ࣎Ͷඍ͓ͪର੏ͺ੖ٺەࢬର੏͗੖ඍ͠Ηͱ͏Ζ ͹અཱི ӅΝঈ͏ͱʥ ͏͵ඍ͠Ηͱ͏ ڂઝ঳ྡজݜ״2019೧12݆஦२ ɼ – αϱλʖεΠϞΝઅཱིɽޮ़Ӷਫ਼৏ ࣆସ࣎Ͷͺɼϭέοϱʀ࣑ྏٺە͹ ඲ՃϤωρφʤVTEUʥͳ ݼͻΗΖ ࢬઅͲ ϭέοϱ ʀ ࣑ྏ༂ޫึ͹ྡ জࢾݩΝਟଐͶ֋࢟ͤΖର੏Ν੖ඍ ׮྅ʁ ธࠅغজࢾݩ͹૥ྡ ە জࢾݩྡ ͶͺPhase 1͗ۂةͶΓΖPhase 3֋࢟ ‡ ϭέοϱʁࠅ಼ۂةࣰࢬࢬઅʀ ‡ 4ϳ݆Ͳ͹ྡজࢾݩ׮྅ [Vx] [Rx- ‡ ϭέοϱʁࠅ಼ Δট೟ਅ੧ΉͲ༁4ϳ݆ 2020೧6݆ʤΠϱζΥηʥɼ12݆ʤԚ͖ [2*وඅݩं RP*1] [Rx-৿ ͶΓΖྡজࢾݩ ໼ٝʥ͖Δ֋࢟͢ɼྡজࢾݩ֋͖࢟Δۂة࣑ྏ༂ʁࠅ಼و੔Վ૓ड़͢ͱ͏Ζธࠅ͹ਭ६Ν໪ࢨͤ] ‡ ৿] ֋͖࢟Δট೟ਅ੧ΉͲ༁4ϳ݆ ༁2ʛ8ϳ݆ܨգͤΖ΍ɼPhase 3Ͷͺ ࢺͮͱ͏͵͏ – ώϞϧωϑϜϔͺPhase 2֋࢟ɼ REGN-COV2ͺPhase1/2/3 Studies ‡ ϨϛζεϥωϱήʁΠϑΪϱ͹ྡজࢾ ݩͺ2020೧3݆ΓΕ֋࢟ͤΖ΍ɼາͫ ؔغΔ͹͖غ͹֋࢟࣎ ট೟ͳͺ͵Δͥ ͶΓΖྡۂةϨϛζεϥωϱήʁࠅ಼ ‡ জࢾݩ֋͖࢟Δ༁2.5ʛ4ϳ݆ ϪϞυεϑϩͺNIHͶΓΖྡজࢾݩ – ֋࢟ɼώϨεοωϔͺPhase3֋࢟࣎ ؔغΔ͹͖غ

͏͵఼࣎Ͳট೟ਅ੧Ͷࢺͮͱ͏ͪͮܨͺ෈໎ͫ͗ɼ12ϳ݆غ࣑ྏ༂ - າট೟͹֋൅ޫึ඾ *3. ৏ࢤ༩ఈ࣎وϨϛζεϥωϱή - ট೟ࡃΊ࣑ྏ༂ɼ҅͏ͺ֋൅஦ࢯ͠Ηͪ֋൅ޫึ඾ *2. ৿ .1*

122 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ֋൅ϕϧρφϓΧʖϞΝߑ஛͢ɼڂฑ͖࣎Δࠅ಼֐͹ϕϪʖϢʖ͗׈༽Ն೵͵ݜ ֋൅Ν׈੓ԿΝ໪ࢨͤڂઝ঳؜΋ҫྏ෾໼Ͳ͹ݜ״ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ӵࠅ ڂઝ঳Νଲেͳͪ͢ݜ״ڷฑ ৿ ώ΢Ψώϱέ͹ώ΢Ψʀώϱέ׳͹ΰόϞմ ‡ ΠζΠ࠹୉͹࣮ं׳ઝͪ͢״ઝ঳Ͷ״ڷ֋൅ϕϧρφϓΧʖϞʁ ‡ ৿ ֋൅ϕϧρφϓΧʖ ੵΝߨ͑υʖνϗʖη͹ߑ஛ ζϡϏϱΝ࢟ΌɼࢾྋΏྡজ৚ๅΝฯ༙ͤΖ෵਼͹ڂݜ ‡ *1 ΃͹෾ৣंڂ໪దͲ͹ݜڂϞ ͗ߑ஛͠Ηͱ͏Ζ – GenOMICCαϱλʖεΠϞͶΓͮͱ ώ΢Ψώϱέ͗ଚࡑɽݜ ࡎ͠ΗܟߨΚΗͱ͕ΕɼͨΗΔΝ׈༽͢ͱ൅නʀ͗ ״ڷࠅ಼֐͹ϕϪʖϢʖ͗৏ 2016೧ΓΕSARSɼMERS؜΋৿ ‡ ΍ࣰࢬ͠Ηͱ͏Ζڂಋݜڠ͹ΰόϞ৚ๅ ͪ࿨ชΏं׳ϕϧρφϓΧʖϞΝ׈ ઝ঳Νଲেͳͪ͢ى ͱ͏Ζ Νफॄʀ෾ੵ͢ɼබݬର͹ཀྵմΏ࣑ ‡ ୢ͢ɼࠅ֐ϕϪ΢ϢʖͶΓΖ׈༽ౕ߻͏ͺ෈໎͢༽ Νࣰࢬ – ώ΢ΨώϱέʀζϡϏϱͲͺೖຌਕ20ຬਕ͖Δڂ֋൅ΝՅଐʀ੔ޯͶ಍ ྏ๑͹ݜڂ࣎Ͷݜٺە] फॄͪ͢DNAΏ݄ੜγϱϕϩΝྡজ৚ๅͳͳ΍ ڂ൭Νฑ͖࣎Δ६ඍ͢ͱ͕ – ౲ϕϧρφϓΧʖϞͺࠅ಼֐͹ݜخ͚ͪΌ͹ [ਭ६Νઅఈى͚͞ͳ͗॑གྷ͵ͪΌ৏ ΗͪࢾྋΏਏ͠ڛɽ఑ڛ΃఑ंڂؽؖʀंͶ׈༽͠Ηͱ͏Ζ Ͷฯ؇͢ɼݜ ෾زʀ൅න͠Ηͪ࿨ชͺଡڂজࢾݩυʖνϗʖηʤNHS ྏ৚ๅΝ༽͏ͱݜྡ ‡ DigiTrialsʥ͹ߑ஛ ໼ͶΚͪΖ ໝྡজࢾݩ͹ްིԿΝ໪దͶɼ – ౨๼ϟυΡΩϩʀϟΪώϱέؽߑͲͺɼҲൢेو֋൅ – ୉ڂݜ ໝ͹઴޴͘αϙʖφ͖Δ੔Ζώ΢Ψو͹ҫྏ ຿15ຬਕं׳ϕϧρφ ྡজࢾݩ৚ๅΏඅݩंʀ ϓΧʖϞ υʖνΝॄ༁ͪ͢υʖνϗʖηΝߑ ώϱέΝߑ஛͢ͱ͕ΕɼυʖνϓϨʖθ͹श ஛ Κͮͪݗର༟པ͹ࢾྋʀ৚ๅ͖Δஊ֌దͶ෾ৣ Νࣰࢬɽώ΢Ψώϱέ͹ཤ༽࿨ช਼ͺଁՅܑ޴ ۂةӵࠅ੕ැʤNHS DigitalʥΏଠࠅ – Ͷ͍Εɼྩ੷Ͳͺ2019೧12݆1ೖ఼࣎Ͳݬஸ࿨ ʤIBMɼmicrosoftऀʥ͗υʖνϗʖ ชͺ284݇ɼӀ༽ʀϪϑϣʖʀָճঠ࿧౵ͺ63 ηߑ஛Ͷؖ༫ ݇ – ψεϥψϩιϱνʖʀώ΢Ψώϱέϋρφϭʖ ιڂέʤNCBNʥͺɼ6ͯ͹ࠅཱི߶ౕ઒໵ҫྏݜ ಋ͹ώ΢Ψώϱέߑ஛ͶखૌڠϱνʖʤNCʥ͗ ౵Ν௪ͣͱώ΢ΨڂಋݜڠΊɼ6NCͳ͹෱߁͏ ͱ׈༽Ͳ͘ΖΓ͑͵࢕͢ܠϨλʖηΝࢊָׯ࿊ ૌΊࡠΕΝ໪ࢨ͢ͱ͕Εɼώ΢ΨϨλʖηΝ׈ ΍ࣰࢬ͠ΗڂಋݜڠࡎΏܟ࿨ช͹൅නʀͪ͢༽ ͱ͏Ζ

֋൅͹࣯Ν߶ΌΖʙՅଐͤΖͪΌ͹υʖνϗʖηɼλϓφΤΥΠɼςʖϩڂϕϧρφϓΧʖϞʁݜ .1*

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ࣎Ͷ׈༽ͤΖ͞ͳͲٺە֋൅ϕϧρφϓΧʖϞΝڂฑ͖࣎Δ੖ඍ͠Ηͱ͏Ζݜ ଶ͠ΗΖغ֋൅͹Յଐ͗ڂݜ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ฑ࣎Ͷཱིͬ৏ͪ͝ϕϧρφϓΧʖϞ ӵࠅ ە ͢༽2020೧5݆Ͷͺώ΢ΨώϱέΝ׈ ‡ ܗ׈ಊ֋࢟ʁ ‡ GenOMICCαϱλʖεΠϞͲͺɼ৿غͶΓΖ૥ Νࣰࢬɽࠅࡏ΢ωεΠοϔͶ΍ڂݜͪ ͗ܪઝ঳͹॑ಠԿͶ״ɼ૥ αϫψΤ΢ϩηޛઝ঳൅ਫ਼ઑݶ״WHOͶΓΖ ‡ ઝ״αϫψΤ΢ϩηܗ֋൅͹ Ζ4ͯ͹ҪఽࢢΝಝఈ ؖ༫ɽୢ͢ɼ৿ڂʤ2ुؔఖౕʥͲ͹ݜغ ΃͹׈༽΍ڂઝ঳൅ਫ਼ ঳Ͷؖ࿊͹͵͏௪৙͹ݜ״͹׈ಊ – ੔Վ૓ड़ͶࢺΖͪΌͶɼޛઝ঳൅ਫ਼ઑݶ״֋࢟Ώɼ ͹׈ಊྖͺଁՅͪ͢ͳਬࡱ ߨͮͱ͕Εɼ׈ಊྖ͗ଁՅͪ͢͹͖ͺޛ͹ଁՅɼ౵ ઑݶྖ ෈໎ ֋൅ ‡ NHS DigiTrialsͺɼ2020೧3݆Ͷ֋࢟ڂ࣎͹ݜٺە͗༽ϕϧρφϓΧʖϞ͹׈] ܗਭ६ – ώ΢ΨώϱέʀζϡϏϱͲͺɼ৿ىͱ͏Ζ͞ͳ͗॑གྷ͵ͪΌ৏ͮ͗ܪਬ਒Ͷ ઝ঳࣑ྏ״αϫψΤ΢ϩηܗ֋൅ Νઅఈ] ͠Ηͪ৿ڂݜ ઝ঳͹॑঳ԿϨη״ໝྡজࢾݩʤRECOVERYʥͶ αϫψΤ΢ϩηو༂͹୉ Νߨ͑ࠅࡏద΢ωεڂϕϧρφ ࢘༽͠Ηͪ έͶؖͤΖݜ ϓΧʖϞ ΠοϔʰCOVID-Host Genetics InitiativeʱͶϏʖφψʖͳ͢ͱࢂՅ ౨๼ϟυΡΩϩʀϟΪώϱέؽߑɼψ ‡ εϥψϩιϱνʖʀώ΢Ψώϱέϋρ φϭʖέΝߑ੔ͤΖؽؖ͹1ͯͲ͍Ζࠅ ιϱνʖ ϟυΡΩϩڂௗथҫྏݜཱི ΰόϞιϱνʖͲͺɼ৿ܗαϫψΤ΢ Ͷώ΢Ψώϱέυʖڂઝ঳͹ݜ״ϩη ڛνΝ఑

123 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ڎ࣎Ν૟ఈͪ͢ٺە఼Ώࣁࡒ͹෈ଏ͗૟ఈ͠ΗΖͪΌɼ༩Όڎ࣎Ͷͺਫ਼ࢊٺە ఼ʀࣁࡒ͹༑઎ׄΕ౲ͱ౵͹ϩʖϩ͗੖ඍ͠Ηͱ͏Ζ͞ͳ͗๮Ή͢͏ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ఼ʀࣁࡒ͹༑ڎ࣎Ͷ͕͜Ζਫ਼ࢊٺە ฑ ઎ׄΕ౲ͱʁ ธࠅ ఼ʀࣁࡒ͹༑઎ڎ࣎Ͷ͕͜Ζ੣ଆٺە ‡ ࣎Ͷ࢘༽Ͳ͘Ζ੣ଆࢬઅ͗ࢨఈ͠ٺە ‡ ఼ɼڎ࣎Ͷ͕͏ͱ࢘༽ͤΖਫ਼ࢊٺە ‡ ༑઎֮ฯͤ΄͘ࣁࡒΏࢩԋʤࣁۜɼ Ηͱ͏Ζ ׄΕ౲ͱͶؖͤΖख݀ΌͺߨΚΗͱ͏ ͏͵ ࣎Ͷ࢘༽Ͳ͘Ζ3ͯٺە੏؉࿪ʥ͗۫ରదͶఈٝ͠Ηͱ –BARDAͺɼو ͏Ζ ࡨͳ͢ͱɼڇڛ͹ࢬઅʤCIADMʥΝࢨఈ͢ɼ౲֚ࢬ – ୢ͢ɼϭέοϱ҈ఈ ʀΠΩυϝΠͳ5 ݬӹ͹֮ฯʤඍடʥɼ੣ࡐԿʀ࠹शۂة࣎͹҈ఈ֮ฯ͹ͪΌ͹௒ୣ઎ અΝฯ༙ͤΖٺە ‡ ؔغ༁Νగ݃ ੣඾Կ͹ਫ਼ࢊ੓޴৏ɼ඾࣯֮೟ܘʤϭέοϱϟʖΩʖɼݬྋ͹࢕೘ ೧ ͹ϭέοϱਫ਼ࢊྖ͹ؔۂة࣎͹੕ැͶΓΖϭέοϱ੣ଆ͹ғ ͹୻क़ɼٺە ‡ ઎ɼεϨϱζʀ஭ࣻਓ౵͹ࣁࡒ བϕϫιηཱི֮͗͠Ηͱ͏Ζ ௒੖ଲԢ౵ͺɼ޲ਫ਼Ռָ৻٠ճ༩๹ ڇڛϟʖΩʖɼ౵ʥ͗મఈ͠Ηɼ ੕ැࢩԋ಼༲͗߻қ͠Η;ٶ༲಼ ΢ϱϓϩΦϱδ͹୉ླྀߨΝ૟ఈͪ͢ɼ ંझʀϭέοϱ෾ՌճͶͱݗ౾͠Η – ͱ͏Ζ ࣎Ͷ͕͜Ζϭέοϱ੣ଆͺɼ֦ ͱ͏Ζʤ2019೧11఼݆࣎ʥٺە ࣎Ͷ͕͏ͱన઀Ͷഓ य͹ऩགྷΝಁΉ͓ɼ ͗ϭέοϱٺە఼ [ݸΔΗͪϨλʖηΝڎਫ਼ࢊ ාͤΖͪΌͶฑ͖࣎Δ͹ख݀Ό͗॑གྷ͵ͪΌ৏ HHS ਭ६Νઅఈ] ϟʖΩʖͶଲ͢ͱ੣ଆғབͤΖϕϫى ;ٶ ੣ଆ༽ࣁࡒ ιηཱི֮͗͠Ηͱ͏Ζ ੣ଆ༽ࣁࡒ͹༑;ٶ఼͹֮ฯڎਫ਼ࢊ ە ઎ׄΕ౲ͱʀ֮ฯʁ ธࠅ ༩Ό੖ඍ͠Ηͱ͏ͪखΕ݀ΌͶΓ ‡ CIADMͶΓΖ੣ଆΫϡϏετΡ֨୉౵ ‡ ฑ͖࣎Δ͹੖ඍ͠Ηͪख݀Όͺໃ͏͗ɼ ‡ ઝ঳͹൅ਫ਼Νण״αϫψΤ΢ϩηܗ఼Ν֮ ৿ڎΕࣁࡒ͹ׄΕ౲ͱʀ֮ฯࣰ͗ߨ͠ ͹खૌΊΝߨ͏ɼචགྷ͵ਫ਼ࢊ Ηͱ͏Ζ ฯ ͜ɼ੕ැͶΓΖࣁࡒ͹֮ฯ͗ߨΚΗͪ αܗ͹รԿͶԢͣɼؽಊదͶ௒ୣ ‡ ࣁࡒ͹༑઎ׄΕ౲ͱͶଲͤΖख݀Όͺ – 2020೧୊2࣏ึਜ਼༩ࢋͶͱɼ৿ڱয় ‡ ઎ΏׄΕ౲ͱ઎͹ݡ௜͗͢ߨΚΗ ໃ͏͗ɼBARDAΏDODɼHHS Ͳͺώ ϫψϭέοϱ͹֋൅Νݡੀ͓ɼεϨ ౵͹ؖ ϱζʀ஭ࣻਓ͹ഛ৏ด;Ͷฯ؇ͶགྷحΏΠρι΢ɼ஭ࣻحͱ͏Ζ ΢Πϩ༲ ෾Ν֮ ͤΖඇ༽ΝࠅͲࢩอͤΖͳͳ΍Ͷɼڇڛ࣎Ͷචགྷྖ͹ਏஇ๑ʀ࣑ྏ༂ʀϭέοϱ ࿊༽඾͹ࠅ಼੣ଆ͹֨୉ʀٺە] ғབΝྙڢਭ६Ν ฯ ϟʖΩʖͶଲ͢ͱଁࢊ͹ىΖͪΌ͹ର੏͗॑གྷ͵ͪΌ৏ͤڛΝ఑ અఈ] ߨ͏ɼεϨϱζʀ஭ࣻਓ͹ଐΏ͖͵ ฯΝ໪ࢨ͢ͱ͏Ζ֮

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ฑ࣎ΓΕྡজࢾݩ؉࿪ϩʖϩ͹੖ඍ͗චགྷɽΉͪɼք֐ϕϪʖϢʖ͗ࠅ಼Ͳ͹ ௒͠Ηͪϩʖϩ͹ࡨఈ΍॑གྷڢదͶࣰࢬͤΖͪΌͶͺࠅࡏۅ֋൅Ν੷ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ࣎͹ྡজࢾݩ؉࿪ϩʖϩ͹੖ EUٺە ฑ ඍʁ ‡ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩͺ֮೟ ‡ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩͺ֮೟ ͏͵௒͠Ηͪྡজࢾݩ؉࿪ϩʖ ͠Ηͱ͏͵͏ ͠Ηͱ͏ڢࠅࡏ ‡ ϩ͗ఈΌΗͱ͏Ζʤঙ঳ྭ਼ɼ ธࠅ – ୢ͢ɼʰ৿ܗ΢ϱϓϩΦϱδ౵ଲࡨ RWDཤ༽ɼࣰࢬघକ͘͹؈ોԿɼ ܗ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩͺ֮೟ Ϊ΢χϧ΢ϱ ʱͲͺ༩଎ࠖೋ͵৿ ‡ ༑઎૮஌૯޳͹ଲԢɼ౵ʥ ͶהܗΗͱ͏͵͏ ΢ϱϓϩΦϱδΤ΢ϩη͹ѧ͠ ΝรߍͲ͘Ζϕϫφה֋൅Νਬ Ԣͣͱɼ੣ଆڂ࣎Ͷ͕͏ͱ੊ֆͶ઎ۨ͜ͱݜٺە] ਒ͤΖͪΌͶͺɼฑ࣎ΓΕϩʖϩ͹੖ඍ͗චགྷɽ ν΢ϕϭέοϱ͹֋൅Ν਒ΌΖ๏ਓ దۅΉͪɼք֐ϕϪʖϢʖ͗ࠅ಼Ͳ͹֋൅Ν੷ ௒͠Ηͪϩʖϩ͹ࡨ Ν఑ࣖɽ౲ϕϫφν΢ϕϭέοϱ͹ڢͶࣰࢬͤΖͪΌͶͺࠅࡏ ΖΪ΢χϧܐਭ६Νઅఈ] ྡজࢾݩΏট೟ਅ੧Ͷىఈ΍॑གྷ͵ͪΌ৏ ΢ϱΝ2011೧Ͷ൅ߨ͢ͱ͏Ζ ࣎͹ྡজࢾݩ؉࿪ϩʖϩ͹నٺە ە ༽ʁ EU জࢾݩʀ ‡ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩ͗ ‡ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩ͖ͺ֮ ‡ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩ͖ͺ֮ྡ ܯժ௪Εࣰߨ͠Ηͱ͏Ζ ೟͗खΗ͵͖ͮͪ͗ɼ ͶΓΖྡজ ট೟Ͷ EMA ೟͗खΗ͵͖ͮͪ͗ɼྡজࢾݩ༑઎૮ ͹รԿͶԢͣɼؽಊదͶϩʖ ࢾݩυδ΢ϱͶؖͤΖ༑઎૮஌ଲԢΝڱয় ‡ 30ೖΝଶޛؖΚΖ ஌͹ࣰࢬΏྡজࢾݩ಩͜ड़ Ͷ֋࢟Ն೵ͳͤΖ؉࿪ϩʖϩࣰ͗ͥͪ ڛϩ͗ݡ௜͢ʙన༽͠Ηͱ͏Ζ ఑ ೖΝགྷ ߨ͠Ηͪۂ๑੏ౕ [༩Όఈٝ͠Ηͪϩʖϩ͹ࣰߨͫ͜Ͳ͵͚ɼ – ௪৙ଲԢͤΖ͹Ͷ40-70Ө ೖҐ಼ͶଲԢۂΌΔΗ ͤΖॶɼ20Өٽ࣎Ͷͺٺەϩʖϩ͹ݡ௜͢ʀौೊ੓΍ [ਭ६ΝઅఈىΖͪΌ͹৏ ธࠅ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩ͖ͺ֮ ‡ ೟͗खΗ͵͖ͮͪ͗ɼଠࠅΓΕ΍૥͚ ͶྡজࢾݩͶ͕͜ΖΪ΢χϧ΢ϱΝ൅ ߨͪ͢ – 2020೧3݆ͶΪ΢χϧ΢ϱ൅ߨҐ߳ɼ ਼յͶోΕߍ৿ ʤೖຌͲͺಋ༹͹Ϊ΢χϧ΢ϱͺಋ ೧9݆ͶPMDAΓΕ൅ߨɽธࠅ͹ଲ Ԣͺೖຌͳർ͢ͱ૥͖ͮͪʥ Ήͪɼྡজࢾݩυδ΢ϱͶؖͤΖ༑઎ ‡ ૮஌ଲԢ౵΍ࣰࢬ 124 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ ੏؉࿪ϩʖϩͶ͕͏ͱ΍ฑ͖࣎Δ͹੖ඍ͗ཀྵ૟దͲ͍ΖɽΉͪɼք֐ϕϪʖو ௒͠Ηͪϩʖϩࡨఈ΍॑གྷڢదͶࣰࢬͤΖͶͺࠅࡏۅϢʖ͗ࠅ಼Ͳ͹֋൅Ν੷ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ੏؉࿪ϩʖϩ͹੖ EUو࣎Ͷ͕͜Ζٺە ฑ ඍʁ ‡ Ϗϱυϝρέ൅ਫ਼࣎ͶɼEU಼Ͳ͹ট೟ ‡ ਟଐ͵ট೟Ν໪దͳͪ͢ҐԾ͹੏ౕ͗ ੏؉࿪ϩʖϩ͗ఈΌΔ ੖ඍ͠Ηͱ͏Ζو௒͠Ηͪট೟؉࿪ϩʖϩ͗ Νଲেͳͪ͢ڢࠅࡏ ‡ ࡨఈ͠Ηͱ͏Ζʤ࠸৻ࠬΝ઴఑ͳ Ηͱ͏Ζ – ಝྭট೟੏ౕ ͢ড়݇෉͘ট೟ɼ౵ʥ ট೟੏ౕغগཔ͹ϏϱυϝρέΝ૟ఈͪ͢ɼ – ড়݇෉͘૥ – ʰϏϱυϝρέ६ඍϭέοϱʱট೟ ͤڇڛ࣎Ͷ͕͏ͱ੊ֆͶ઎ۨ͜ͱ੣඾Νٺە] ઎ۨ͜৻ࠬࢨఈ੏ౕ – ੏؉࿪ϩʖϩ͹੖ඍ͗ ੏ౕʤ΢ϱϓϩΦϱδΝଲেͳͪ͢وΖͪΌͶͺɼฑ࣎ΓΕ ͮ͵௒͠Ηͪ๏ਓͶͺڢචགྷɽΉͪɼք֐ϕϪʖϢʖ͗ࠅ಼Ͳ͹֋൅Ν ‡ Ҳ๏Ͳɼࠅࡏ ௒͠Ηͪϩʖ Pandemic preparedness vaccineʥڢదͶࣰࢬͤΖͪΌͶͺࠅࡏۅ੷ ͱ͵͏ ਭ६Νઅఈ] 9 ϏϱυϝρέΝӀًͤ͘͞Ն೵੓ىϩ͹ࡨఈ΍॑གྷ͵ͪΌ৏ ΝଲেͶྡה͹͍Ζ෵਼͹බݬର জࢾݩΝࣰࢬ͢ɼʰϏϱυϝρέ ६ඍϭέοϱʱͳ͢ͱEMAͶΓ Εট೟Νण͜ΔΗΖʤୢ͢ɼϏϱ জࢾݩʀ υϝρέ͗൅ਫ਼͢ͱ͏͵͏ͪΌɼྡ ট೟Ͷ ট೟ͺण͜Ζ͗ɼ൤ജͺͲ͘͵ ͏ʥ ؖΚΖ 9 Ϗϱυϝρέ൅ਫ਼͹ࡏɼʰϏϱυ ๑੏ౕ ϝρέ६ඍϭέοϱʱ͹ট೟Νण ΝϏהͪ͜ϟʖΩʖͺ֚౲බݬର ϱυϝρέ६ඍϭέοϱͶ؜Όট ೟ਅ੧Νߨ͏ɼ࠹शద͵ʰϏϱυ ϝρέϭέοϱʱͳ͢ͱɼট೟Ν ण͜Ζ Ͷଠ͹ྪࣇ͹බݬରعEMAͲͺ 9 ͹υʖνΝϪϑϣʖ͢ͱ͏Ζͪה Όɼট೟ϕϫιηΝՅଐͤΖ͞ͳ ͗Ն೵ ট೟ʁ༑઎దͶਅ੧಼༲ΝϪٺە – ۂϑϣʖͤΖ͞ͳͶΓΕ௪৙210Ө ೖགྷͤΖϪϑϣʖϕϫιηΝ࠹୻70 ೖͶ୻क़ۂӨ

͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ รԿͶԢͣͱؽಊదͶݡ௜ͤڱ࣎͹য়ٺە੏؉࿪ϩʖϩΝɼوฑ࣎Ͷ੖ඍͪ͢ ΌΔΗΖٽ࣎Ͷͺٺەͳ΍͞ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ຌ๏ਓ͹ EUخ੏؉࿪و࣎͹ٺە ە ઝ঳͹࣑ྏ༂Ν״αϫψΤ΢ϩηܗઝ঳Νଲেͳͤ ‡ ৿״αϫψΤ΢ϩηܗࣰߨʁ ‡ ৿ ট೟੏ౕΝన༽ ଲেͶಝྭট೟੏ౕ͗నԢ͠Ηͪٺە༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩ͗ Ζ੣඾Ͷ΍ ‡ ઝ঳ؖ࿊͹ҫ༂״αϫψΤ΢ϩηܗೖགྷͤΖϕϫιηΝ ‡ ৿ۂժ௪Εࣰߨ͠Ηͱ͏Ζ – ௪৙210Өܯ ট೟ਅ੧Ͷଲ͢ͱ༑઎దحೖҐԾͶ୻क़ ඾ʀҫྏؽۂ͹รԿͶԢͣɼؽಊదͶϩʖ 150Өڱয় ‡ জࢾݩʀ ϩ͗ݡ௜͢ʙన༽͠Ηͱ͏Ζ ‡ ༩Ό੖ඍ͠Ηͱ͏ͪ؉࿪ϩʖϩ͖ͺ֮ Ͷ৻ࠬΝࣰࢬྡ ট೟Ͷ [༩Όఈٝ͠Ηͪϩʖϩ͹ࣰߨͫ͜Ͳ͵͚ɼ ೟͗खΗ͵͖ͮͪ͗ɼ”Rolling ΌΔΗ review”৻ࠬϕϫιηΝࣰࢬٽ࣎ͶͺٺەؖΚΖ ϩʖϩ͹ݡ௜͢ʀौೊ੓΍ [ਭ६ΝઅఈىΖͪΌ͹৏ ๑੏ౕ – ྡজࢾݩ͗਒ߨ஦͹ஊ֌͖Δɼ෵਼ ఑ड़Ն೵͗ۂةյͶోΕͨ͹఼࣎Ͳ জࢾݩυʖνΝEMA͗Ϫϑϣʖྡ͵ غɼট೟ਅ੧͖Δট೟खಚΉͲ͹͢ Ν୻क़ͤΖؔ ʹRolling Reviewͺ2ुؔΆ֦ –

125 ͏͵ຎྭʁ ฑ - ฑ࣎͹໪ࢨͤ΄͘ਭ६ - ؽ೵ਭ६Νຮͪͦͱ͏ ࣎͹໪ࢨͤ΄͘ਭ६ - Ҳ෨͹ؽ೵ਭ६ͺຮͪͦͱ͏Ζٺە - ە સͱ͹ؽ೵ਭ६Νຮͪͦͱ͏Ζ - ൭ - ਭ६Ν୉͚͘௔͓ͱ͏Ζخ֋൅ਬ਒ڂඍͤ΄͘ਭ६ͳը͗ࠅ͹ݳয়ʁ C. ݜ۫ దͶࢂ೘ͪ͢͏྘ҮͲͺ͵͏ͪΌɼ੕ۅઝ঳྘Үͺචͥ͢΍੷״Ͷͳͮͱۂة ΌΔΗΖٽැͶΓΖ֋൅қཋΝ߶ΌΖखૌΊ͹಍೘ʀ੖ඍ͗ ݳߨਭ६ චགྷؽ೵ ໪ࢨͤਭ६ ଠࠅ ೖຌ ֋൅қཋΝ߶ΌΖ ธࠅڂઝ঳ݜ״ ฑ ੕ࡨʁ ‡ Priority Review Voucher੏ౕ͗಍೘͠Ηͱ͏Ζ ‡ ੕ැͶΓΖϭέοϱഛखฯৄ੏ ‡ ଠࠅ༹͹੕ࡨʤྭʁ༑઎ ‡ PREP๑ʤPublic Readiness and Emergency ౕ͹಍೘ ৻ࠬώΤοϡʖ੏ౕɼ੕ Preparedness Actʥ͗಍೘͠Ηͱ͏Ζ ‡ ธࠅͳർֳͤΖͳ଩ͬघ͹਼͗ ැͶΓΖϭέοϱ͹ࣆ઴ ͹ ݸఈదحқ͹ҩ๑ߨҟ͗͵͏ݸΕɼ༂෼ɼਫ਼෼੣ࡐ ɼؽބ – ഛखΕฯৄ੏ౕɼ੣ଆ൤ ֋൅ʀݗࠬʀ੣ଆʀླྀ௪ʀ௒ࡐͶؖ༫ͤΖݺਕΉͪͺ ജট೟खಚๅও੏ౕɼ༂ ٽ͹ࠠཛྷɼΉͪͺ෼దଝ֒͹੧ۂૌ৭Ͷਕਐউ֒ɼࣆ Ճ͹અఈɼϭέοϱϟʖ ͶଲͤΖ໖੻Ν༫͓ΖݘݸΝHHSௗׯͶ෉༫ Ωʖ΃͹໖੻ɼ౵ʥ͗෵ ͹ԈௗʤGAIN๑ʥؔغ಍೘͠Ηͱ͏Ζ ‡ ࢤ৖ಢઐ਼ ઝ঳྘Үͺචͥ͢΍ – ଳ੓ۗͶ༙ް͵߇ۗ༂͹֋൅ଇ਒͹ͪΌͶɼGAIN๑״Ͷͳͮͱۂة] దͶࢂ೘ͪ͢͏྘ҮͲͺ͵͏ͪ ʤThe Generating Antibiotic Incentives Now Act ofۅ੷ Όɼ੕ැͶΓΖ֋൅қཋΝ߶ΌΖख 2011ʥ͗੏ఈ͠Ηͪɽ༙ް͵߇ۗ༂ޫึͺ༑઎৻ࠬ͠ [ΌΔΗΖٽૌΊ͹੖ඍ͗ ͹Ԉௗ͗ؔغʀ༑઎ݘڒজࢾݩʀ Ηɼট೟͠ΗΗͻ5೧ؔ͹ಝྡ ೟ΌΔΗΖ ট೟Ͷ ޛؖΚΖ ‡ ʤࢂߡʥPASTEUR๑Ҍʤ2020೧9݆৏ӅͲ఑ड़ɼͨ͹ ͹Πέεϥϱͺ͵͢ʥ ๑੏ౕ – 2020೧9݆ɼPASTEUR๑ҌʤPioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 ʥ͗৏ӅͲ఑ड़͠Ηͪ͗ɼͨ ͹ޛ͹Πέεϥϱͺ͵͢ ಋ๑ҌͲͺɼHHSͶଲ͢ͱ॑གྷ͵߇ۗ༂͹γϔηέϨ – Ͱخ༁͹గ݃Νߨ͑ݘཤΝ෉༫͢ɼ๑ҌͶܘϕεϥϱ ڛ͚׈ಊͶ10೧ؔͲ110Աχϩ͹༩ࢋΝ఑ ӵࠅ ߇ۗ༂Νଲেͳͪ͢೧ؔఈֻ෹͏Ϡυϩ͹ࢾߨϕϫζΥ ‡ έφࣰࢬ஦ ΢ϱιϱܗଳ੓ۗͶ༙ް͵߇ۗ༂֋൅͹ͪΌ͹ϕϩ – τΡϔͳ͢ͱɼ೧ؔఈֻ෹͏Ϡυϩ͹ࢾߨϕϫζΥέ φΝࣰࢬ஦

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127 ຌ๏ਓخ੕ࡨΠ΢υΡΠ಍ड़͹ ଠࠅ͖Δ͹ָ;ɼ໪ࢨͤؽ೵ਭ६ͳೖຌ͹ݳয়ΝಁΉ͓Ζͳɼ͞ΗΉͲͳͺҡ ΌΔΗΖٽΖ࣏ݫͲ͹੕ැक಍͹खૌΊ͗͵

ΖʤՀʥͤڇڛ࣎Ͷ͕͏ͱɼ੊ֆͶ઎ۨ͜ͱਏஇ๑ʀ࣑ྏ༂ʀϭέοϱΝ֋൅ʀٺە

࣎͹੔Վໃ͢ʱ͹઴఑Ͳฑ͖࣎Δ͹खૌΊΝમఈͤΖٺەʰฑ࣎͹ඍ͓ໃ͚͢ͱ ࣎͹ଲԢΝఈٺە֋൅͗਒ΞͲ͹΍͹Ͳ͍Εɼট೟੏ౕ౵΍ฑ͖࣎ΔڂΉͲ͹ଠࠅ੔Վͺસͱฑ࣎ͶҲఈݜ͞͞ 1 ΌΖ౵͹ඍ͓͗਒ΞͲ͏ͪ͞ͳͶΓΕਟଐͶଲԢड़པͪͪΌɼೖຌ΍แ͏ฑ͖࣎Δ͹ॉ෾͵ඍ͓Ͷ౔ΌΖ ʰ୉͘͵Ϩηέͺ੕ැʱ͹ࢧ૟Ͳ੕ැ͗क಍ͤΖ ͗ۂة͹෱߁͠Ώɼਫ਼ࢊΫϡϏετΡ͹֮ฯ౵ڂखૌΊକ͜Ζ͞ͳͺೋ͚͢ɼݜ͗ۂةາͫݡͷබݬରͶଲ͢ͱ 2 ෝ͏͘Η͵͏Ϩηέ͹ਫ਼ͣΖखૌΊͺ੕ැक಍Ͳߨ͑ ׈ಊྖʀ੔Վ͹ඊ༄ద͵ଁՅͶ޴ͪ͜ࣁۜ౦Ծʀର੏੖ඍΝߨ͑ ΌΔΗΖͪΌɼݳࡑͳͺસ͚ҡ͵Ζٽ੔Վ͗ڂ઴ߴ͹ਭ६ΝࣰݳͤΖͪΌͶͺɼ࿨ชҲͯͳͮͱ΍ݳࡑ͹ഔ͹ݜ ֋൅Νक؇ͤΖͪΌ͹ର੏੖ඍ͗චགྷͳ͵ΖڂໝͲ͹ࣁۜ౦ԾΏݜو 3 దͶߨ͑ۅ࣎΃͹ඍ͓ͶՅ͓ɼฑ࣎͹ٗढ़ʀϨλʖη෈ଏΝึ׮ͤ΄͚ք֐ϨλʖηΝ੷ٺە ͹ଡ༹੓ΏϕϪʖϢʖ͹਼Ͳք֐Ͷ୉͚͘ݡ྾ΕͤΖͪΌɼٗढ़ʀϨλʖη෈ଏΝմভ͢͵͗Δɼڂݳ఼࣎Ͳݜ ֋൅ਬ਒Νߨ͑ڂ֋൅੔ՎΝ૓ड़ͤΖͪΌͶɼք֐ϨλʖηΝैͱͶͪ͢ݜڂݜ 4 ຳྙౕ޴৏ΝਦΖۂઝ঳྘Ү͹ࣆ״ϕϪʖϢʖ֨ैͶ޴͜ɼۂة૜͹മ͏ࠅ಼ कରͳ͵Ζචགྷ͍͗Εɼͨ͹ͪ͗ۂةʛ֋൅ͺڂݜغޛͺޮదࣁۜͶΓΖΠΩυϝΠ͗कରͳ͵Ζ͗ɼڂݜغ૥ ͹஭ྙౕΏϕϪʖϢʖ਼Ν߶ΌΖͪΌ͹ຳྙౕ޴৏ࡨ͗චགྷͳ͵ΖۂةΌͶͺ 5

੕ࡨΠ΢υΡΠʤ1/6ʥA. કྲཱྀིҌʀસର౹ׇ ֋൅͹໪దʀ໪ඬΝ໎֮Ͷఈڂઝ঳ݜ״ڷΗΉͲචͥ͢΍໎֮Ͳ͵͖ͮͪ৿͞ ͹ࣰݳΝਦΖ͞ͳ͗॑གྷ͵୊Ҳิͳ͵ΖܠԿΏ࿊کΌɼͨ͹ࣰݳͶචགྷ͵ؽ೵

ؽ೵෾ྪ ੕ࡨΠ΢υΡΠ

ઝ঳ଲࡨ͹୉ٝ໌෾Ν໎֮ͶͤΖͳͳ΍Ͷɼ״ڷA. કྲཱྀིҌʀ ը͗ࠅͶ͕͜Ζ৿ ઝ঳ଲࡨ״ڷ໎֮͵৿ ࣎Ͷ͕͏ͱଠࠅͶ઎ۨ͜ͱਏஇ๑ʀҫ༂඾ʀϭέοϱΝ֋൅ʱٺەસର౹ׇ ʰ ׈ಊਭ६ΝఈΌͱबஎͤΖڂϑζϥϱ͹ࡨఈͳਃಃ ͹ࣰݳͶචགྷ͵ؽ೵۫ඍʀݜ ֋൅͹໪ద͹໎֮Կڂઝ঳ݜ״ڷ৿ .1 ժ͹໎֮Կܯ໪ඬʀ;ٶಋɼ൥ҕʤබݬରʀٗढ़౵ʥ .2 ʤͤ໪ඬਭ६Ͷؖ͢ͱͺ઴ߴࢂলʥ

͹෈ࣰ֮੓ΝؓΊΖͳɼڂઝ঳ݜ״ڷ৿;ٶઝ঳஭ྙౕ״͹ۂةࠅ಼ ͹஦ৼͶ͵Θ͑͞ͳ͖ΔɼೖࠔΓΕͨΗΔڂࢊָׯʀࠅՊ͹֠ࠞΝ ฑ࣎ͲͺΠΩυϝΠ͗ݜ ͘ࠒתΝۂة؜΋ʥΝߨ͑ͳͳ΍Ͷɼ͢ోڰ͹ࣰݳ ׈ಊΝ೼Ѵʀਬ਒ࢩԋʤܠ௔͓ͪ࿊ ܠ࣎͹࿊ٺەΝਬ਒ͤΖ͞ͳͲɼڂಋݜڠΞͫαϱλʖεΠϞΏݺพ ͳࣰ༽ԿͶ޴ͪ͜׈ಊ֋࢟Ν࠹ଐԿͤΖ ͹ଇ਒ڂಋݜڠࢊׯָαϱλʖεΠϞʀ .1 ଇ਒ܠؽؖͳ͹࿊ڂք֐ݜ .2 ׈ಊ΃͹ࢂժͶΓىԿʤ৏ک஧ղؽ೵ܠ࣎͹࿊ٺە੕ැͶΓΖ .3 ֋൅׈ಊ೼ѴʥڂॶͲ͹ݜ֦;ٶߑ஛ܐΖ֦ॶͳ͹ؖ

ਬ਒Νࣰߨܠ֋൅ਬ਒ɼࢊָׯ࿊ڂฑ͖࣎Δ͹સରકྲྀࡨఈΏݺพݜ ݺพ׈ಊΝ౹ׇ͢ɼք֐ͳ͹;ٶ࣎ͶͺਟଐʀؽಊదͶસରٺەԿ ͢ɼک࢚ྫ౟ؽ೵͹ ࢚ྫ౟ؽ೵Νཱི֮ͤΖ͵ྙکΖ͞ͳ͗ड़པΖ͝ܪ΍؜Όɼ੔ՎͶܠ࿊ ݺพ׈ಊ͹ࣰߨ؇ཀྵΝ୴࢚͑ྫ౟ؽ೵͹۫ඍ;ٶસରકྲྀ .1 ର੏͹ߑ஛ܠ࣎Ν૟ఈͪ͢ք֐ͳ͹࿊ٺە .2 ੏؉࿪ϩʖϩ͹੖ඍɼ౵ʥو௒͠Ηͪڢʤࠅࡏ

128 ൭ʤસൢʙࣁۜʥخ֋൅ڂ֋൅ਬ਒ʙC. ݜڂ੕ࡨΠ΢υΡΠʤ2/6ʥB. ݜ ֋൅Ν਒Όͱ͕͚ͪΌͶͺɼݜڂ࣎΃͹ඍ͓ͳ͢ͱଏΖਭ६ΉͲฑ࣎͹ݜٺە ֋൅ଲে͹෱߁͠ͶՅ͓ɼϕϪʖϢʖ͹֨ैͶ΍खૌ΋͞ͳ͗॑གྷͳ͵Ζڂ

ؽ೵෾ྪ ੕ࡨΠ΢υΡΠ Ν਒Όɼڂઝ঳΃͹ඍ͓ͳ͢ͱɼ෱߁͏බݬରʀٗढ़͹ݜ״ڷ֋൅ਬ਒ ଲেබݬରʀٗढ़౵΃͹ າஎ͹৿ڂB. ݜ ࣎͹ٺەΝү੔͢ɼ֦ϠξϨτΡͶ͕͏ͱंڂ͹੆໼Ν߁͝ɼݜڂͶଲͤΖ෱߁͏ʀචགྷ ݜڂ൭ ݜخ֋൅ڂC. ݜ ͱ͕͚චགྷ͍͗͝ڏ൅ࣻୈͳ͵Ε͑Ζ֋൅Ϗ΢ϕϧ΢ϱ͹ητʖζΝ ੖ඍʤસൢʙࣁۜʥ ॉ෾͵ϓΟϱυΡϱή कରͳ͵Ζ͞ͳͺೋ͢͏ͪΌɼޮదࣁۜ͗ۂة੓͹؏఼ΓΕۂΖɽࣆ ਬ਒͗චགྷͳ͵Ζڂؽؖʀ୉ָͲ͹ݜڂͶΓΕޮదݜ ͹ਬڂଲেබݬରʀٗढ़౵΃͹ϓΟϱυΡϱήͶΓΖ෱߁͏ݜ֦ .1 ࣎ͶBSL-3૮౲Ґ৏͹බݬରΝٺەү੔ʤ݃Վͳ͢ͱंڂ਒ʀݜ ਦͤΖʥةѽ͓Ζਕࡒ΍ү੔͠ΗΖ͞ͳΝ ϕϫζΥέφ΃͹ϓΟϱυΡϱήܠࢊָʙࢊָׯ࿊ .2

Կ͹؏఼ͶՅ͓ɼݳ఼࣎Ͳͺ७ୖͳݶ͓͵͏ݜکܠ࣎Ͷ޴ͪ͜࿊ٺە ढ़ʀϕϪʖϢʖ֨ै͹ٗ Ώࠅ಼΃͹༢ڂಋݜڠؽؖͳ͹ڂʀஎݡΝึ׮ͤΖ΄͚ɼք֐ݜंڂ ؽؖʀڂΌ͹ք֐ݜͪ ֋൅ਭ६ڂదͶք֐ϨλʖηΝखΕࠒΊɼࠅ಼͹ݜۅ஗౵ͶΓΕɼ੷ ܠ͹༢஗ʀ࿊ंڂݜ Ν࣯ྖͳ΍Ͷ߶ΌΖ ͶଲͤΖϓΟϱυΡϱήڂಋݜڠؽؖͳ͹ڂք֐ݜ .1 ͹༢஗ंڂؽؖʀݜڂք֐ݜ .2

΄͹׈ಊྖΝ߶ΌΖۂةઝ঳྘ҮͶ͕͜Ζ״͏͵దຳྙౕ͹߶͚ۂࣆ وΖࢬࡨΝߪͣΖචགྷ͍͗Ζɽ߻Κͦͱɼ஦ঘͣ״ຳྙΝ͗ۂةԿ ͚ɼک͹༢஗ʀۂةಋɼࠅ಼ ϟʖΩʖ͹ү੔ʀࢩԋͶखૌ΋ۂଡ͏ਏஇ๑ʀϭέοϱ઒͗ۂةໝ͹ ࠅࡏఴ֋ࢩԋ;ٶ֋൅΃͹ঁ੔ɼڂࠅ಼ਏஇ๑ϟʖΩʖ͹ݜ .1 ΃͹ঁ੔کਫ਼ࢊઅඍଁ;ٶ֋൅ڂઝ঳ݜ״͹ۂةࠅ಼୉घ੣༂ .2 ʤϠοϗʖεϥϱ޴৏͹ͪΌ͹ๅও੏ౕ౵Ν؜΋ʥ ΃͹ঁ੔کਫ਼ࢊઅඍଁ;ٶڂݜوϭέοϱϟʖΩʖ͹৿ۂࠅ಼઒ .3

൭ʤઅඍʀ΢ϱϓϧʥخ֋൅ڂ੕ࡨΠ΢υΡΠʤ3/6ʥC. ݜ ׈ಊྖଁՅͶଳ͓͑Ζઅඍʀ΢ϱϓϧ͹;ٶτʖϜʀϕϪʖϢʖ͹ଡ༹੓֨୉ ੖ඍ͗චགྷͳ͵Εɼ୉઴఑ͳ͵ΖBSLࢬઅҐ֐ͶDB੖ඍ౵͗ଲেͳ͵Ζ

ؽ೵෾ྪ ੕ࡨΠ΢υΡΠ

ΠΩυϝΠͫ͜Ͳ150͍ΖͳݶΚΗΖӵࠅΝͺͣΌͳͤΖ֦ࠅͶଲ͢ɼ ͪ͏͵ࢬઅ͹ଁઅ ࠅ಼͹BSL-3ࢬઅɼಝͶΠΩυϝΠ͗ΠέιηͲ͘Ζࢬઅ͗ঙڂ൭ BSLݜخ֋൅ڂC. ݜ ಋཤ༽౵͹ϩʖϩڠ࣎͹ٺەʤઅඍʀ΢ϱϓϧʥ ʀཤ׈༽ਬ਒ Όɼઊଲ਼ͳ͢ͱଁΏͤͳͳ΍Ͷฑ࣎ʀ ժͶܯ࣎Νқࣟͪ͢ٺە౵Νઅ͜Ζචགྷ͍͗ΖɽBSL-4ͺธࠅΝঈ͘ Ͱ͚અ஖͗͠Ηͱ͕Δͥɼೖຌͳ͢ͱ͹ࡑΕ๏͖Δݗ౾͗චགྷخ ؽؖʀ୉ָͶ͕͜ΖBSL-3ࢬઅ͹ଁઅʀཤ׈༽ଇ਒ڂదݜޮ .1 ͹ैଏɼBSL-3૮౲͹බݬରΝखΕѽحʤBSL-3ࢬઅ಼͹અඍʀؽ Ζਕࡒ͹ү੔౵Ν؜΋ʥ͓ BSL-4ࢬઅ͹֨ैʤ༑઎ౕགྷݗ౾ʥ .2

Ͷ΢ϱϓϩΦϱδ౵͹સΰόϞυʖνϗʖηߑ஛ͺ਒ΌΔΗͱ͏Ζع ΰόϞʙྡজ৚ๅ υʖνϗʖη͹੖ඍ ͗බݬର͗ݸΔΗΖͪΌɼࠅ಼Ͳ͹υʖνϗʖηΝ֨ैͤΖͳͳ΍Ͷɼ ϠξϨτΡ֦;ٶʀΠέιη֮ฯ ք֐͹υʖνϗʖη΃͹ΠέιηΝ֮ฯ͢ɼබݬର ΝՅଐͤΖڂݜ ଡ༹͵බݬରΝଲেͳͪ͢સΰόϞυʖνϗʖη͹ߑ஛ .1 ࣎Ͷ͕͜Ζҫྏ৚ๅ್࣏ཤ༽ϩʖϩ͹໎֮Կٺە .2 ͹ΰόϞυʖνϗʖηͶଲͤΖΠέιη͹֮ฯंڂݜ .3 Կکܠؽؖʀυʖνϗʖηฯ༙ૌ৭ͳ͹࿊ڂք֐ݜ .4

͵ࣰࢬ͹ଲেͳڂ఼અ஖ʀݜڎઝ঳ླྀߨஏͲ͹״Ͷ਒ΌΔΗͱ͏Ζع ؽڂઅ஖ஏΝ֨୉ͤΖͳͳ΍ͶɼླྀߨஏҐ֐͹઎਒ࠅݜ;ٶ఼͹੖ඍ Ζබݬରڎڂք֐ݜ ఼અ஖౵ͶΓΕɼබݬରΠέιηͫ͜Ͳ͵͚઎୼எݡ΃͹Πڎକʥ ؖ΃͹ܩʤ ࣎Ͷ޴ͪ͜ϋρφϭʖέͰ͚ΕΝ໪ࢨͤٺەέιηΏ Կک఼અ஖ʀ׈ಊڎؽؖ΃͹ڂ઎਒ࠅݜ;ٶઝ঳ླྀߨஏ״ .1

129 ൭ʤઅඍʀ΢ϱϓϧʥخ֋൅ڂ੕ࡨΠ΢υΡΠʤ4/6ʥC. ݜ ʀࢾݩࣰࢬΏྖࢊର੏ཱི֮Ͷචགྷ͵અڂ࣎Νݡੀ͓ͪ৖߻ɼಝͶਟଐ͵ݜٺە ඍʀ΢ϱϓϧΝฑ͖࣎Δ੖ඍͤΖ͞ͳ͗චགྷͳ͵Ζ

ؽ೵෾ྪ ੕ࡨΠ΢υΡΠ

໲ΚͥଠࠅͶർ΄ͱਟଐ੓ʀྖՁΗ΍՟ୌ͗ࢨఢ͠Ηͱ͏Ζ͗ɼ׳൭ ࣮خ֋൅ڂC. ݜ ʀࢾݩࣰࢬڂজݜྡ ण༲ࢬઅࣙର΍ݸΔΗΖ͞ं׳ઝ঳Ͷ͕͏ͱͺઅඍैଏࢬઅΏ״ʤઅඍʀ΢ϱϓϧʥ ಝͶ ࢬઅ͹֮ฯ ͳ͖Δɼೖ͟Θ͖Δଲেࢬઅ͹ಝఈΝߨ͑ͳͳ΍ͶଊԢର੏Ν߶ΌΖ ΄͚६ඍʀү੔ΝਦΖචགྷ͍͗Ζ ʀࢾݩࣰࢬࢬઅϋρφϭʖέ͹ߑ஛ڂজݜྡ .1 җ୙ؽؖ͹੖ඍڂBSL-3૮౲Ґ৏͹බݬରΝखѽ͓Ζݜ .2 ؽؖͲ͹ण୙؜΋ʥڂʤޮదݜ ʀࢾݩࣰࢬෝ՛ܲݰڂଲেࢬઅͶ͕͜Ζݜ .3 ౵͹େߨ౵Ν؜΋ʥۂʤࣆແࡠ

୉ྖਫ਼ࢊͶҲఈ࣎ؔΝགྷͤΖϭέοϱΝͺͣΌͳͤΖਫ਼෼੣ࡐΏɼ຿ ढ़Ν༽͏ͪϠξϨٗوʀγʖϑη؜Όͱਫ਼ࢊ೵ྙ͗ݸఈద͵৿ۂةؔ ਫ਼ࢊઅඍʤ࣑ݩ༽؜΋ʥ ͹֮ฯ τΡ͹ਫ਼ࢊͶචགྷ͵અඍΝ֮ฯͤΖචགྷ͍͗Ζʤࣁࡒʀགྷҽ΍߻Κͦ ͱ֮ฯ͗චགྷʥ ౲ϠξϨτΡͶଲԢͪ͢ਫ਼ࢊઅඍʀΫϡϏετΡ͹֮ฯ֚ .1

බݬରͶ࠹న͵ಊ෼ϠυϩΝཱི֮ͤΖͪΌͶͺ৙Ͷଡ༹͵ಊ෼Ͳࣰ֦ ΌΔΗΖɽಝͶชٽࢬઅʥ͹੖ඍ͗ڂݜ;ٶڇڛʤಊ෼ڧ؂ಊ෼ࣰݩࢬઅ ݩͲ͘Ζ ʤಝͶྸௗྪʥ͹֨ै ԿదͶϐφοϡϪϱζࢾݩ͗ण͜༲ΗΔΗ͵͏͞ͳ΍ؓΊΖͳɼྸௗ ΌΔΗΖʤը͗ࠅͺԦธͶർ΄Ζͳಊ෼ࣰݩͶٽ͹ैࣰ͗ڧ؂ࣰݩྪ Ίʱͳ͍ͯͯ͢Ζ஦ࠅΆʹͲͺ͵͏ʥک༲ͫ͗ɼʰװଲ͢ͱ ಊ෼ͶଲԢՆ೵͵ABSL-3Ґ৏ࢬઅ͹֨ैܗ୉ .1 फ़ʥىʤࣰݩಊ෼͹֮ฯͺ࣏นͶͱ

൭ʤࣁࡒʥخ֋൅ڂ੕ࡨΠ΢υΡΠʤ5/6ʥC. ݜ ֋൅Νଇ਒ͤΖͪΌ͹බݬରγϱϕϩ؇ཀྵΏԿ߻෼ϧ΢ϔϧϨʖߑڂฑ࣎͹ݜ ฯ͗චགྷ֮ڇڛ࣎Ͷ෈ଏ͗ͬ͢͵ݬࡒྋΏࣰݩಊ෼౵͹ٺە஛ͶՅ͓ɼ

ؽ೵෾ྪ ੕ࡨΠ΢υΡΠ

ઝ঳͹බݬରγϱϕϩΝ͏ͬ૥͚फॄͲ͘״ڷ൭ कͶք֐Ͳ൅ਫ਼ͤΖ৿خ֋൅ڂݜ C. ଲেබݬରγϱϕϩ͹ ࣎Ͷ޴ͪ͜खΕ݀ΌΝިΚͤɽΉͪɼٺەͳܠʤࣁࡒʥ ΖΓ͑ɼฑ͖࣎Δ͹࿊ ઝݜҐ֐Ͷ΍୉ָ౵Ͷ෾ࢆ͢ͱ͏ΖබݬରγϱϕϩΝॄ༁؇ཀྵ͢ɼ״ Ҳׇ؇ཀྵ ΠέιηͲ͘ΖΓ͑ϩʖϩʀ࢕ૌΊΝߑ஛ͤΖ͗ंڂన࣎ݜ බݬରγϱϕϩ͹फॄηΫʖϞཱི֮ .1 ಋɼॄ༁ʀΠέιη֮ฯ .2

਒ΞͲ͏Ζ͗ɼ͗ڂͶΓΖݜڛΔ͹Կ߻෼఑͖ۂةଚ༂ʀ֋൅Կ߻෼ ࠕյ΍AMEDक಍Ͳع କʀ֨୉ͤΖ΄͘ɽ֋൅ஊ֌΃਒Ξͫ৖߻͹࣑ܩʤ؜΋஦ࢯԿ߻෼ʥ ฑ࣎͹खૌΊͳ͢ͱ ΌΔΗΖٽ΍ԃ׊ͶߨΚΗΖ࢕ૌΊ͗ڛϧ΢ϔϧϨʖ͹੖ඍ ݩ༂఑ ΃͹Πέιη֮ฯंڂదϧ΢ϔϧϨʖ͹੖ඍͳ߁͏ݜޮ .1 ϩʖϩ͹੖ඍڛ࣑ݩࣰࢬ࣎͹࣑ݩ༂఑ .2

͹ଁࢊ͗ೋ͢͏ࣰݩغք֐΃͹ғଚౕ͗߶͏ݬ༂ΏݬࡒྋͶՅ͓ɼ୻ ;ٶݬࡒྋʤ؜΋ݬ༂ʥ ۂةڇڛΝՆ೵͵ݸΕࣰݳͤ΄͚ɼೖ͟Θ͖Δ͹ڇڛ࣎ٺەࣰݩ༽ಊ෼ʀࣁࡒ͹ ༽ಊ෼͹ ΌΔΗΖٽ࣎Ϊ΢χϧ΢ϱ͹߻қ͗ٺەΏɼܠԿ ͳ͹࿊ک໤ڇڛ ү੔ʀ֮ฯۂةڇڛࣰݩ༽ಊ෼ʀࣁࡒ͹;ٶݬࡒྋ .1 ͹৚ๅҲݫԿंۂ֋൅ʛྖࢊͶචགྷ͵γϕϧ΢οΥʖϱࣆڂݜ .2 ʤࣰݩಊ෼͹ϔϨʖξʖ౵ʥ ͳ͹߻қۂةΪ΢χϧ΢ϱࡨఈɼڇڛ࣎͹ଁࢊʀ༑઎ٺە .3

130 ൭ʤ๑੏ౕʥخ֋൅ڂ੕ࡨΠ΢υΡΠʤ6/6ʥC. ݜ ʀࢾݩ͗ਟଐͶࣰࢬͲ͘ΖΓ͑๑੏ౕΏڂ࣎ՁΗͶ͕͏ͱ΍ྡজݜٺەฑ࣎ʀ ͹׈ಊқཋΝ߶ΌΖ࢕ૌΊΝߑ஛ͤΖۂة૮஌૯޳Ν੖ඍͤΖͳͳ΍Ͷɼ

ؽ೵෾ྪ ੕ࡨΠ΢υΡΠ

࣎͹ྡজࢾݩࣰࢬʀট೟ٺە֋൅׈ಊࣙର͹ཱིͬஙΗͶՅ͓ɼڂԿʤ६ඍʀ ݜغ൭ ྡজࢾݩ૥خ֋൅ڂC. ݜ ଲԢ͹ஙΗ͗ࢨఢ͠Ηͱ͕Εɼ֦ϕϪʖϢʖۃՁΗ΍ʥͶ޴ͪ͜ ϩʖϩ͹෈໎֮͠ɼ౲ؔغʤ๑੏ౕʥ ࣰࢬ ϩʖϩʀର੏੖ඍ ͹खૌΊΝՅଐ͢ɼ͏ͬ૥͚ࠅ຿ʀ੊ֆ΃಩͜ΖͪΌͶͺฑ͖࣎Δ͹ ର੏͹੖ඍ͗෈Նܿͳݶ͓Ζ;ٶϩʖϩ ʀࢾݩΪ΢χϧ΢ϱ͹໎֮Կڂ࣎ʤรҡର؜΋ʥ͹ྡজݜٺە .1 චགྷʥ͗ܠʀࢾݩࣰࢬࢬઅ͹֮ฯʱͳ͹࿊ڂʤʰઅඍʷྡজݜ ६ʀϕϫιη͹໎֮Կخಋɼট೟ .2 PMDA༑઎૮஌૯޳͹અ஖ʤͤ໪ඬਭ६Ͷؖ͢ͱͺ઴ߴࢂলʥ .3 ໖੻੏ౕ͹੖ඍंۂ࣎͹੣ଆٺە .4

ওͶૌࠒΉΗΖΉͲ͹࣎ש΍ંझޛ֋൅αηφ͹୉͘͠ͶՅ͓ɼট೟ ͏͵Ͱ͖خͶڎ΍੊࿨౵Ͷԣ͠ΗͱՌָదࠞޛওૌΊ೘Η ؔΝགྷ͢ɼΉͪૌࠒΊשϭέοϱંझ କ౦ࣁΝ૏֒ͤΖয়ସΝմভͤΖܩ͹ࢂ೘ʀۂةϕϫιηݡ௜͢ ݀ఈ͗͵͠ΗΖ౵ɼ ΌΔΗΖٽͳ͗͞ ওંझϩʖϩݡ௜͢שϭέοϱ .1 2. ϭέοϱͶଲͤΖࠅ຿ཀྵմ͹޴৏

֋൅׈ಊͶଲͤΖঁڂຳྙౕΝ߶ΌΖ΄͚ɼ઴फ़ݜۂઝ঳྘Ү͹ࣆ״ ΌΔΗΖٽ͹ϠοϗʖεϥϱΝ ੔ͶՅ͓ɼ੔ՎͶଲ͢ͱ͹ๅঊ΍߶Όͱ͏͚͞ͳ͗ۂة ߶ΌΖๅঊ੏ౕ͹੖ඍ ༂Ճʙഛ৏౵ͶΓΖ௜ંదϨνʖϱ͹֨୉ .1 ༑઎৻ࠬώΤοϡʖ੏ౕ౵͹ؔંదϨνʖϱ֨୉ࡨ͹಍೘ .2

131 ෉࿧

132 A. ྲྀޢ

133 ྲྀޢʤ1/7ʥ ຌๅࠄॽͲ࢘༽͠Ηͱ͏ΖྲྀޢͺҐԾ͹௪Ε

ૌ৭ ˛ࠅࡏ

ઝ঳ླྀߨଲࡨ΢όϗʖεϥϱ࿊߻״ CEPI Coalition for Epidemic Preparedness Innovations

The International Council for Harmonization of Technical Requirements for ੏௒࿪ࠅࡏճ٠وICH ҫ༂඾ Pharmaceuticals for Human Use

WHO World Health Organization ੊ֆฯ݊ؽؖ ˛ธࠅ ACIP Advisory Committee on Immunization Practices ༩๹ંझ͹ࣰࢬ౵ͶؖͤΖ࿊๞ࣀ໲җҽճ

ॶڂANL Argonne National Laboratory Πϩβϱϊࠅཱིݜ

ۃASPR Assistance Secretary for Preparedness and Response ࣆ઴६ඍʀଲԢ୴౲࣏ׯึ

ۃ֋൅ڂBARDA Biomedical Advanced Research and Development Authority ਫ਼෼ҫָ઎୼ݜ

CDC Centers for Disease Control ࣮බ༩๹؇ཀྵιϱνʖ

CIADM Centers for Innovation in Advanced Development and Manufacturing ઎୼֋൅ʀ੣ଆַ৿ιϱνʖ

CLSI Clinical & Laboratory Standards Institute ธࠅྡজݗࠬඬ६඲٠ճ

ۃժܯڂDARPA Defense Advanced Research Projects Agency ࠅ๹߶౵ݜ

DOD Department of Defense ࠅ๹૱঴

DOE Department of Energy Φϋϩάʖ঴

ۃFDA U.S. Food and Drug Administration ৱ඾ҫ༂඾

GHSA Global Health Security Agenda ੊ֆ݊߃҈સฯ্ΠζΥϱξ

HHS Department of Health and Human Services ฯ݊ෳࢳ঴

αϱλʖεΠϞڂઝ঳ྡজݜ״ IDCRC Infectious Diseases Clinical Research Consortium

ॶڂLANL Los Alamos National Laboratory ϫηΠϧϠηࠅཱིݜ

MIT Massachusetts Institute of Technology Ϝγοϣʖιρς޽Ռ୉ָ

NCATS The National Center for Advancing Translational Sciences ࠅཱི઎਒φϧϱηϪʖεϥψϩՌָιϱνʖ

ࡃճ٠ܨNEC National Economic Council ࠅՊ

ॶڂઝ঳ݜ״NIAID National Institute of Allergy and Infectious Disease ࠅཱིΠϪϩάʖ

ྲྀޢʤ2/7ʥ ຌๅࠄॽͲ࢘༽͠Ηͱ͏ΖྲྀޢͺҐԾ͹௪Ε

ૌ৭ ˛ธࠅ

ॶڂNIBIB National Institute of Biomedical Imaging and Bioengineering ࠅཱིժ଀ਫ਼෼ҫָʀਫ਼෼޽ָݜ

ॶڂNIH National Institute of Health ࠅཱིӶਫ਼ݜ

ॶڂNIST National Institute of Standards and Technology ࠅཱིඬ६ٗढ़ݜ

NSC National Security Council ࠅՊ҈સฯ্ճ٠

NSTC National Science and Technology Council ࠅՊՌָٗढ़ճ٠

ۃOMB Office of Management and Budget ߨ੕؇ཀྵ༩ࢋ

ۃOSTP Office of Science & Technology Policy Ռָٗढ़੕ࡨ

PCAST President's Council of Advisors on Science and Technology ୉౹྘Ռָٗढ़ࣀ໲ճ٠

ϋρφϭʖέڂPOCTRN Point-of-Care Technologies Research Network ࣑ྏݳ৖ٗढ़ݜ

UAB University of Alabama in Birmingham ΠϧώϜ୉ָώʖϝϱΪϞߏ

ॶڂઝ঳ҫྏݜ״܋USAMRIID The United States Army Medical Research Institute of Infectious Diseases ธ཰

VA United States Department of Veterans Affairs ୂༀ܋ਕ঴ ˛ӵࠅ

કྲྀ঴ۂBEIS Department for Business, Energy and Industrial Strategy ϑζϋηʀΦϋϩάʖʀࢊ

ճڢۂBIA BioIndustry Association ӵࠅώ΢Ψࢊ

CERIC Central European Research Infrastructure Consortium CERIC

CGT catapult Cell and Gene Therapy Catapult CGTΩνϏϩφ

COG-UK COVID-19 Genomics UK Consortium COVID-19ΰόϞʀαϱλʖεΠϞʤCOG-UKʥ

CPPC COVID-19 Protein Production Consortium COVID-19ϕϫτ΢ϱ੣ଆʀαϱλʖεΠϞʤCPPCʥ

CRUK Cancer Research UK Cancer Research UK

DHSC Department of Health Sciences ฯ݊ʀऀճෳࢳ঴

GenOMICC Genetics of Susceptibility and Mortality in Critical Care GenOMICC

HDR-UK Health Data Research UK HDR UK

134 ྲྀޢʤ3/7ʥ ຌๅࠄॽͲ࢘༽͠Ηͱ͏ΖྲྀޢͺҐԾ͹௪Ε

ૌ৭ ˛ӵࠅ

ճʤISARICʥαϫψΤ΢ϩηྡজಝ੓αڢઝ঳״ڷʀ৿حٷ੓ݼٺࠅࡏ॑঳ ISARIC4C ISARIC Coronavirus Clinical Characterization Consortium ϱλʖεΠϞʤ4C)

੏ுوMHRA Medicines and Healthcare products Regulatory Agency ҫ༂඾ҫྏ੣඾

ճ٠ڂMRC Medical Research Council ҫָݜ

MRC-CTU MRC Clinical Trials Unit MRCྡজࢾݩϤωρφ

ॶڂMRC-LMB MRC-Laboratory for Molecular Biology ෾ࢢਫ਼෼ָݜ

NHS National Health Service ࠅ຿ฯ݊γʖϑη

ॶڂNIHR National Institute for Health Research ࠅཱིӶਫ਼ݜ

ۃOLS Office for Life Sciences ϧ΢ϓγ΢Φϱη

PHE Public Health England ޮ़Ӷਫ਼ு

࣎Ռָঁݶήϩʖϕٺە SAGE Scientific Advisory Group for Emergencies

(UK-CIC UK coronavirus immunology consortium ӵࠅαϫψΤ΢ϩη໖ӺָαϱλʖεΠϞʤUK-CIC

ʀ΢όϗʖεϥϱؽߑڂUKRI UK Research and Innovation ӵࠅݜ

VMIC Vaccines Manufacturing Innovation Centre ϭέοϱਫ਼ࢊʀ΢όϗʖεϥϱιϱνʖ

VTF UK Vaccine Taskforce ϭέοϱʀνηέϓΧʖη ˛ EU ECCLS European Committee for Clinical Laboratory Standards Ԧयྡজݗࠬඬ६җҽճ

EMA European Medicines Agency Ԧयҫ༂඾ு

EPSCO Employment, Social Policy, Health and Consumers Affairs EUޑ༽ʀऀճ੕ࡨʀ݊߃ʀভඇं໲ୌཀྵࣆճ ˛஦ࠅ CCDC ஦ࠅ࣮බ桫๹߉੏஦ৼ ஦ࠅ࣮බ༩๹੏ޜιϱνʖ

ʥښ֋൅ιϱνʖʤ๼ڂGHDDI Global Health Drug Discovery Institute ੊ֆ݊߃༂඾ݜ

ۃNMPA National Medical Products Administration ࠅՊ༂඾؄ಞ؇ཀྵ

ྲྀޢʤ4/7ʥ ຌๅࠄॽͲ࢘༽͠Ηͱ͏ΖྲྀޢͺҐԾ͹௪Ε

ૌ৭ ˛ಢࠅ Bundesministeriums für Bildung und Forschung㸦Federal Ministry of ঴ڂүݜگBMBF ࿊๞ Education and Research㸧

Bundesministerium für Wirtschaft und Energie㸦Federal Ministry for BMWi ࿊๞ܨࡃΦϋϩάʖ঴ Economic Affairs and Energy㸧

ճڢڷ৾ڂDFG Deutsche Forschungsgemeinschaft 㸦German Research Foundation㸧 χ΢ςݜ ˛෻ࠅ

ؽߑڂANR Agence Nationale de la Recherche ϓϧϱηࠅཱིݜ

౦ࣁ۞ߨڠBpi France Banque Publique d'Investissement France ϓϧϱηޮ ˛ೖຌ ֋൅ؽߑڂ֋൅๑ਕೖຌҫྏݜڂAMED Japan Agency for Medical Research and Development ࠅཱིݜ

ؽߑڷ֋൅๑ਕ Ռָٗढ़৾ڂJST Japan Science and Technology Agency ࠅཱིݜ

ιϱνʖڂNCGM National Center for Global Health and Medicine ࠅཱིࠅࡏҫྏݜ

ॶڂ൭ʀ݊߃ʀӭ཈ݜخ֋൅๑ਕҫ༂ڂNIBIOHN National Institutes of Biomedical Innovation, Health and Nutrition ࠅཱིݜ

ॶڂNIHS National Institute for Health Sciences ࠅཱིҫ༂඾ৱ඾Ӷਫ਼ݜ

ॶڂNISTEP National Institute of Science and Technology Policy ช෨Ռָ঴ Ռָٗढ़ʀָढ़੕ࡨݜ

߻ؽߑ૱حPMDA Pharmaceuticals and Medical Devices Agency ಢཱིߨ੕๑ਕ ҫ༂඾ҫྏؽ

ॶڂRIKEN RIKEN ཀྵԿָݜ ॶڂઝݜ״ॶ ࠅཱིڂઝݜ״ઝݜ ࠅཱི״ ੏౵؜΋ʥوखΕૌΊʤ๑ ௪ڠ˛

COVAX COVID-19 Vaccine Global Access Facility COVAXϓΟεϨτΡ

MER Market Entry Rewards ੣ଆ൤ജট೟खಚๅও੏ౕ

135 ྲྀޢʤ5/7ʥ ຌๅࠄॽͲ࢘༽͠Ηͱ͏ΖྲྀޢͺҐԾ͹௪Ε

੏౵؜΋ʥوखΕૌΊʤ๑ ˛ธࠅ ACA Affordable Care Act ҫྏฯݧ੏ౕրַ๑ʙΨώϜίΠ

ACTIV Accelerating COVID-19 Therapeutic Interventions and Vaccines ACTIV

ADEPTϕϫήϧϞ Autonomous Diagnostics to Enable Prevention and Therapeutics ADEPTϕϫήϧϞ

CTAP Coronavirus Treatment Acceleration Program αϫψΤ΢ϩη࣑ྏ༂ਟଐԿϕϫήϧϞ

DPA Defense Production Act ࠅ๹ਫ਼ࢊ๑

FFMN Fill and Finish Manufacturing Network ैల͕Γ;࢕৏͝੣ଆϋρφϭʖέ

GAIN๑ The Generating Antibiotic Incentives Now Act of 2011 Gain๑

MLSMR Molecular Libraries Small Molecule Repository ෾ࢢϧ΢ϔϧϨʖఁ෾ࢢϪϛζφϨ

NPC NCATS Pharmaceutical Collection Կָ෼࣯ΰόϞָιϱνʖʤNCGCʥ͹੣༂αϪέεϥϱ

OWS Operation Warp Speed ϭʖϕʀηϒʖχࡠક

PASTEUR๑Ҍ Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act PASTEUR๑Ҍ

PREP๑ Public Readiness and Emergency Preparedness Act PREP๑

RADx Rapid Acceleration of Diagnostics RADx΢ωεΠοϔ

VTEU Vaccine and Treatment Evaluation Units ϭέοϱ͕Γ;࣑ྏ඲ՃϤωρφ ˛ӵࠅ ACTT-EU/UK Adaptive COVID-19 Treatment Trial in the EU & UK ACTTࢾݩ

CO-CONNECT COVID – Curated and Open aNalysis aNd rEsearCh platform CO-CONNECT

CONDOR COVID-19 National Diagnostic Research and Evaluation CONDOR

RECOVERY Randomized Evaluation of COVID-19 Therapy RECOVERYࢾݩ ˛ೖຌ ൭ϕϧρφϓΧʖϞخBINDS Basis for Supporting Innovative Drug Discovery and Life Science Research ૓༂౵઎୼ٗढ़ࢩԋ

SIP Cross-ministerial Strategic Innovation Promotion Program કྲྀద΢όϗʖεϥϱ૓ଆϕϫήϧϞ

ྲྀޢʤ6/7ʥ ຌๅࠄॽͲ࢘༽͠Ηͱ͏ΖྲྀޢͺҐԾ͹௪Ε

໌׳࣮ ௪ڠ˛

AIDS Acquired immunodeficiency syndrome ޛళ੓໖Ӻ෈સ঳ޫ܊

AMR Antimicrobial resistance ༂ࡐଳ੓

ԎΤ΢ϩη،ܗHBV Hepatitis B virus B

ԎΤ΢ϩη،ܗHCV Hepatitis C virus C

ԎΤ΢ϩη،ܗHDV Hepatitis D virus D

HIV Human immunodeficiency viruses ϐφ໖Ӻ෈સΤ΢ϩη

HTLV Human T-lymphotropic virus ϐφTࡋ๖പ݄බΤ΢ϩη

܊঳ޫحٷMERS Middle East respiratory syndrome ஦౨ݼ

NTDs Neglected Tropical Diseases ޒΊΔΗ͵͏೦ଵබ

܊঳ޫحٷ੓ݼٺSARS Severe acute respiratory syndrome ॑঳

֫݃ TB Tuberculosis ޢ༽ҫྏؖ࿊ ௪ڠ˛

ABSL Animal Biosafety level ࣰݩಊ෼ࢬઅώ΢ΨιʖϓτΡϪϗϩ

BSL Biosafety level ώ΢ΨιʖϓτΡϪϗϩ

CDMO contract development and manufacturing organization ҫ༂඾ण୙੣ଆ֋൅ؽؖ

CEϜʖέ Conformitè Europëenne CEϜʖέ

ແण୙ؽؖۂCRO Contract Research Organization ֋൅

DB Database υʖνϗʖη

Dx Diagnosis ਏஇ๑

Նڒ༽࢘ٺە EUA Emergency Use Authorization

࢘༽Ϩηφٺە EUL Emergency Use List

136 ྲྀޢʤ7/7ʥ ຌๅࠄॽͲ࢘༽͠Ηͱ͏ΖྲྀޢͺҐԾ͹௪Ε

ޢ༽ҫྏؖ࿊ ௪ڠ˛

६خGDP Good distribution practice ҫ༂඾͹నਜ਼ླྀ௪

६خGLP Good Laboratory Practice ҫ༂඾͹҈સ੓ࢾݩ͹ࣰࢬͶؖͤΖ

൥وGMP Good manufacturing practice ҫ༂඾͹੣ଆ͕Γ;඾࣯؇ཀྵͶؖͤΖࣰભ

੏͹૱সوGxP Good x practice GCPɼGMP౵ɼ੣඾͹҈સ੓Ώ৶བ੓Ν୴ฯͤΖͪΌ͹

HEOR Health economics and outcomes research ҫྏʀܨࡃΠΤφΩϞϨγʖο

High throughput Screening ύ΢ηϩʖϕρφʀηέϨʖωϱή حHTSؽ

LS/MS Liquid Chromatography Mass Spectrometry ӹରέϫϜφήϧϓΡʖ࣯ྖ෾ੵ๑

MCMs Medical Counter Measures ҫָదଲࡨ

mRNA messenger Ribonucleic Acid ϟριϱζϡʖRNA

໒ڠـNMR Nuclear Magnetic Resonance ֫ࣕ

POCT Point-of-care testing ྡজݳ৖ଊ࣎ݗࠬ

۫ޤPPE Personal Protective Equipment ݺਕ๹

RWD Real world data ϨΠϩϭʖϩχυʖν

Rx Prescription drug ࣑ྏ๑

Vx Vaccination ϭέοϱ

137