Sinovac Begins Phase II Clinical Trail on H5N1 Vaccine

Total Page:16

File Type:pdf, Size:1020Kb

Sinovac Begins Phase II Clinical Trail on H5N1 Vaccine [ Industry Watch ] CHINA Sinovac Begins Phase II Clinical Trial on H5N1 Vaccine inovac Biotech Ltd, a leading China-based biopharmaceutical company focusing on human vaccine development, has announced that it has Scommenced vaccination of volunteers for its Phase II clinical research study of its pandemic influenza H5N1 vaccine. The Phase II clinical trial is a randomized double-blind study to assess the safety and efficacy of the pandemic influenza H5N1 vaccine. The trial started with 400 adult volunteers vaccinated with pandemic influenza whole viron H5N1 Vaccine. The initial result from this study is expected to be available by the end of 2007. Phase II clinical trial for the H5N1 vaccine was approved in April 2007 by the China State Food and Drug Administration (SFDA). The SFDA approval covers Phase Ib and II trials of the whole viron vaccine and Phase I and II trials of the split vaccine. Phase Ib clinical trial with whole viron H5N1 vaccine and Phase I clinical trial with split H5N1 vaccine commenced in August 2007. The company is reported to be making good progress on these trials. About Sinovac Sinovac Biotech Ltd is a China-based biopharmaceutical company that Contact Details: focuses on the research, development, manufacture and commercialization Sinovac Biotech Ltd of vaccines that protect against human infectious diseases. Sinovac’s vaccines Address: 39 Shangdi Xi Road, Haidian District, include HealiveTM (hepatitis A), BiliveTM (combined hepatitis A and B) Beijing 100085 TM and Anflu (influenza). Sinovac is currently developing human vaccines Tel: +86 108 289 0088 against the H5N1 strain of pandemic influenza, Japanese encephalitis and Fax: +86 106 296 6910 SARS. ■ URL: www.sinovac.com www.asiabiotech.com Volume 11 > Number 19 > 2007 ■ 1281.
Recommended publications
  • Scientific Committee on Vaccine Preventable Diseases and Scientific Committee on Emerging and Zoonotic Diseases
    Scientific Committee on Emerging and Zoonotic Disease and Scientific Committee on Vaccine Preventable Diseases Consensus Interim Recommendations on the Use of COVID-19 Vaccines in Hong Kong (As of Jan 7, 2021) Introduction The ongoing COVID-19 pandemic causes a significant disease burden worldwide. In Hong Kong, cases and outbreaks continue to be reported. To reduce the impacts of COVID-19 on health and society, vaccines against COVID-19 is considered an important public health tool for containing the pandemic in the medium and long term. On 7 January 2021, the Scientific Committee on Emerging and Zoonotic Diseases (SCEZD), the Scientific Committee on Vaccine Preventable Diseases (SCVPD), and the Expert Advisory Panel to Chief Executive (EAP) reviewed the latest scientific evidence on the epidemiology and clinical features of COVID-19, published data on the COVID- 19 vaccines be procured by the Hong Kong SAR Government, local data as well as overseas recommendations/practices, and provides recommendations on the population groups and circumstances for the use of COVID-19 vaccines in Hong Kong. COVID-19 Vaccines 2. At the meeting held on 13 August 2020, the joint SCEZD and SCVPD together with the EAP reviewed the then scientific development of COVID 19 vaccines and prioritization of target groups for COVID 19 vaccines in Hong Kong. The meeting recommended that vaccine procurement would be aimed at the whole Hong Kong population in the long run. In anticipation of a limited supply at the early stage when vaccines are available, a phased approach has to be taken with certain priority groups of the local population identified to be vaccinated first, in order to reduce morbidity and mortality and maintain essential services.
    [Show full text]
  • Immunogenicity and Safety of a Third Dose, and Immune Persistence Of
    medRxiv preprint doi: https://doi.org/10.1101/2021.07.23.21261026; this version posted July 25, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. 1 Immunogenicity and safety of a third dose, and immune persistence of 2 CoronaVac vaccine in healthy adults aged 18-59 years: interim results 3 from a double-blind, randomized, placebo-controlled phase 2 clinical 4 trial 5 6 Hongxing Pan MSc1*, Qianhui Wu MPH2*, Gang Zeng Ph.D.3*, Juan Yang Ph.D.1, Deyu 7 Jiang MSc4, Xiaowei Deng MSc2, Kai Chu MSc1, Wen Zheng BSc2, Fengcai Zhu M.D.5†, 8 Hongjie Yu M.D. Ph.D.2,6,7†, Weidong Yin MBA8† 9 10 Affiliations 11 1. Vaccine Evaluation Institute, Jiangsu Provincial Center for Disease Control and 12 Prevention, Nanjing, China 13 2. School of Public Health, Fudan University, Key Laboratory of Public Health Safety, 14 Ministry of Education, Shanghai, China 15 3. Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing, China 16 4. Covid-19 Vaccine Department, Sinovac Life Sciences Co., Ltd., Beijing, China 17 5. Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China 18 6. Shanghai Institute of Infectious Disease and Biosecurity, Fudan University, 19 Shanghai, China 20 7. Department of Infectious Diseases, Huashan Hospital, Fudan University, 21 Shanghai, China 22 8. Sinovac Biotech Co., Ltd., Beijing, China NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
    [Show full text]
  • COVID-19: China Medical Supply Chains and Broader Trade Issues
    COVID-19: China Medical Supply Chains and Broader Trade Issues Updated December 23, 2020 Congressional Research Service https://crsreports.congress.gov R46304 SUMMARY R46304 COVID-19: China Medical Supply Chains and December 23, 2020 Broader Trade Issues Karen M. Sutter, The outbreak of Coronavirus Disease 2019 (COVID-19), first in China, and then Coordinator globally, including in the United States, has drawn attention to the ways in which the Specialist in Asian Trade U.S. economy depends on manufacturing and supply chains based in China. This report and Finance aims to assess current developments and identify immediate and longer range China trade issues for Congress. Andres B. Schwarzenberg Analyst in International An area of particular concern to Congress has been U.S. shortages in medical supplies— Trade and Finance including personal protective equipment (PPE) and pharmaceuticals—as the United States stepped up efforts to contain the COVID-19 pandemic with limited domestic Michael D. Sutherland stockpiles and insufficient U.S. industrial capacity. Because of China’s role as a global Analyst in International supplier of PPE, medical devices, antibiotics, and active pharmaceutical ingredients, Trade and Finance reduced exports from China led to shortages of critical medical supplies in the United States. Exacerbating the situation, in early February 2020, the Chinese government nationalized control of the production and distribution of medical supplies in China— directing all production for domestic use—and directed the bureaucracy and Chinese industry to secure supplies from the global market. Once past the initial peak of its COVID-19 outbreak, the Chinese government appears to have prioritized certain countries and selectively released some medical supplies for overseas delivery.
    [Show full text]
  • WHO Survey on the Sharing of Genetic Sequence Data Of
    WHO Survey on the Sharing of Genetic Sequence Data of Influenza Viruses with Human Pandemic Potential Results and Analysis of data received 27 April 2016 Table of Contents Acknowledgement .................................................................................................................................. 3 Acronyms ................................................................................................................................................ 4 Executive Summary ................................................................................................................................. 5 Background ............................................................................................................................................. 8 Methodology Summary .......................................................................................................................... 9 IVPP GSD Sharing in Numbers (as of October 2014)............................................................................. 10 Survey Results ....................................................................................................................................... 11 1. Mechanisms for sharing of IVPP GSD........................................................................................ 11 2. Ease of sharing .......................................................................................................................... 13 3. Systematic sharing ...................................................................................................................
    [Show full text]
  • Dentons Flashpoint Daily Global Situation Report
    Dentons Flashpoint Daily Global Situation Report December 14, 2020 Global Situation Update: December 14, 2020 KEY TAKEAWAYS The US orders First COVID-19 emergency action The UN calls on vaccines to be after huge cyber every country administered in the security breach to declare a US and Canada involving the “climate emergency.” today. SolarWinds’ Orion platform. Note: This report is based on sources and information deemed to be true and reliable, but Dentons makes no representations to same. Global Globally, confirmed coronavirus cases surpassed 72 million infections and 1.6 million deaths. • Secretary-General Guterres called on every • German biotech firm CureVac has enrolled the country to declare a “climate emergency” as first participant for a Phase 2b/3 clinical trial world leaders marking the fifth anniversary of of its COVID-19 vaccine candidate, expected the Paris climate accord made mostly to include more than 35,000 participants in incremental pledges relative to the scale of the Europe and Latin America. crisis. • Peru suspended clinical trials of a Chinese Sinopharm Covid-19 vaccine after one of the volunteers involved in the program suffered a “serious adverse event”. Note: This report is based on sources and information deemed to be true and reliable, but Dentons makes no representations to same. Global Over the past week, the global curve for new cases continued to flatten, while topping 72 million. One week ago, the count was 67 million. The US continues to be the global leader for new infections, reporting more than 200,000 new cases for most of last week. Turkey has become the new global hotspot, with new cases doubling in eight days to over 1.8 million.
    [Show full text]
  • Sops) Sinovac Vaccine (Coronavac
    Date: 21April 2021 Document Code: 63-01 Version: 01 Guidelines and Standard Operating Procedures (SOPs) Sinovac Vaccine (CoronaVac) 1 Target Audience • All the concerned national, provincial & district health authorities and health care workers who are involved in the COVID-19 vaccine operations, establishment, and management of COVID-19 Vaccination Counters both at public and private health facilities. Objective of this document • To provide guidance on Sinovac COVID-19 Vaccine (CoronaVac) storage, handling, administration and safe disposal along with recommendations for vaccine recipients. Vaccination should not be considered as an alternate for wearing a mask, physical distancing and observing other SOPs for COVID-19 prevention. Vaccine Basic Information • CoronaVac manufactured by Sinovac Biotech Ltd. is an inactivated virus COVID-19 vaccine. • Active ingredient: Inactivated SARS-CoV-2 Virus (CZ02 strain). • Adjuvant: Aluminum hydroxide. • Excipients: Disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride. • CoronaVac is a milky-white suspension. Stratified precipitate may form which can be dispersed by shaking. Vaccine Dose • Two doses should be administered by intramuscular injection in the deltoid region of the upper arm. • The second dose is preferably given 28 days after the first dose. • Each vial (syringe) contains 0.5 mL of single dose containing 600S8U of inactivated SARS-CoV-2 virus as antigen. Who should receive CoronaVac: • Individuals who are above 18 years of age. Who should NOT receive CoronaVac: • Individuals who are below 18 years of age. The safety and efficacy of CoronaVac in children and adolescents below 18 have yet to be established. • People with history of allergic reaction to CoronaVac or other inactivated vaccine, or any component of CoronaVac (active or inactive ingredients, or any material used in the process).
    [Show full text]
  • Monitoring Des Asiatisch-Pazifischen Forschungsraums (APRA) 2
    2. Bericht (2020) Monitoring des Asiatisch-Pazifischen Forschungsraums (APRA) 2 Inhaltsverzeichnis Einleitung 13 Querschnittskapitel 15 Querschnittskapitel 1: Zukunftstechnologien in Asien 15 Schwerpunkt Bioökonomie / erneuerbare Energietechnologien .................................................15 Relevanz der APRA-Länder in zentralen Schlüsseltechnologien ............................................................15 Wissenschaftliche Aktivitäten ....................................................................................................................15 Technologische Aktivitäten ........................................................................................................................16 Relevanz zentraler Schlüsseltechnologien für die APRA-Länder ...........................................................17 Wissenschaftliche Aktivitäten ....................................................................................................................17 Technologische Aktivitäten ........................................................................................................................18 Studierendenmobilität in thematischen Schlüsselbereichen .................................................................19 Schwerpunkt: Bioökonomie .............................................................................................................22 Forschungs- und innovationspolitische Schwerpunkte ausgewählter APRA-Länder im Bereich Bioökonomie ..................................................................................................................................24
    [Show full text]
  • COVID-19 Vaccines: Summary of Current State-Of-Play Prepared Under Urgency 21 May 2020 – Updated 16 July 2020
    Office of the Prime Minister’s Chief Science Advisor Kaitohutohu Mātanga Pūtaiao Matua ki te Pirimia COVID-19 vaccines: Summary of current state-of-play Prepared under urgency 21 May 2020 – updated 16 July 2020 The COVID-19 pandemic has spurred a global effort to find a vaccine to protect people from SARS- CoV-2 infection. This summary highlights selected candidates, explains the different types of vaccines being investigated and outlines some of the potential issues and risks that may arise during the clinical testing process and beyond. Key points • There are at least 22 vaccine candidates registered in clinical (human) trials, out of a total of at least 194 in various stages of active development. • It is too early to choose a particular frontrunner as we lack safety and efficacy information for these candidates. • It is difficult to predict when a vaccine will be widely available. The fastest turnaround from exploratory research to vaccine approval was previously 4–5 years (ebolavirus vaccine), although it is likely that current efforts will break this record. • There are a number of challenges associated with accelerated vaccine development, including ensuring safety, proving efficacy in a rapidly changing pandemic landscape, and scaling up manufacture. • The vaccine that is licensed first will not necessarily confer full or long-lasting protection. 1 Contents Key points .................................................................................................................................. 1 1. Types of vaccines ...............................................................................................................
    [Show full text]
  • 'Vero Cell' COVID-19 Vaccine Rollout in Nepal: What We Know About The
    Editorial Editorial The ‘Vero Cell’ COVID-19 vaccine rollout in Nepal: What we know about the Chinese vaccine development and access? Jay N Shah Chief editor, Journal of Patan Academy of Health Sciences (JPAHS), Patan Academy of Health Sciences (PAHS), Lalitpur, Kathmandu, Nepal ISSN: 2091-2749 (Print) 2091-2757 (Online) Correspondence The world has changed dramatically from the impact of the COVID-19. It Prof. Dr. Jay N Shah, Editor in has impacted the normality of daily life, highlighting the failure of rich and Chief, Journal of Patan poor nations alike, which is evident from the high number of human lives Academy of Health Sciences lost in rich and powerful countries like the USA with total deaths of (JPAHS), Patan Academy of Health Sciences (PAHS), 32,735,704 and Europe with 43,708,958 until April 24, 2021, as per 1 Lalitpur, Nepal. Worldometer. The COVID-19 pandemic has shown that all of us ‘have and Email: have-not’, no one can escape from the effects of the lockdowns, disruption [email protected] of normal life including education, businesses, etc. reminding all of us that [email protected] equitable access to vaccines is the best possible choice not to further [email protected] exacerbate the challenges because ‘no country is safe until every country [email protected] is safe’.2 It is a remarkable scientific achievement that within a year of the identification of the virus, we have COVID-19 vaccines, albeit available mostly in rich countries. The benefit of research is possible only with solidarity, by sharing the available resources, vaccine included, for the control of the ongoing COVID-19 pandemic.
    [Show full text]
  • Prnewswirebigbooken.Pdf
    TABLE OF CONTENTS INTRODUCTION....................................................................................................... 9 HOW TO WRITE THE PERFECT PRESS RELEASE ......................................... 10 SENDING A RELEASE TO PR NEWSWIRE ........................................................ 14 Accounting News, Issues ............................................................................................ 17 Acquisitions, Mergers, Takeovers ............................................................................... 18 Advertising ................................................................................................................. 20 Advocacy/Group Opinion ........................................................................................... 23 Aerospace/Defense ..................................................................................................... 25 Agriculture .................................................................................................................. 28 Air Freight .................................................................................................................. 31 Airlines/Aviation ........................................................................................................ 34 Alternative Energies .................................................................................................... 37 Amusement Parks and Tourist Attractions ................................................................... 39 Animal Welfare .........................................................................................................
    [Show full text]
  • Sinopharm Group: 2H14 NDR Takeaways: Margin Expansion To
    Sinopharm Group | March 25, 2015 MORGAN STANLEY RESEARCH March 25, 2015 MORGAN STANLEY ASIA LIMITED+ Yolanda Hu Sinopharm Group [email protected] +852 2848-5649 Bin Li 2H14 NDR Takeaways: Margin Expansion [email protected] +852 2239-7596 Isabella Zhao to Continue [email protected] +852 2848-5887 Industry View Stock Rating Price Target Attractive Overweight HK$34.00 Sinopharm Group ( 1099.HK , 1099 HK ) China Healthcare / China Stock Rating Overweight Sinopharm’s solid sales growth and operating leverage are likely to Industry View Attractive continue in 2015, despite the uncertain policy outlook for the Price target HK$34.00 Up/downside to price target (%) 15 Healthcare industry. We find the stock attractive at 18x our revised Shr price, close (Mar 24, 2015) HK$29.50 2015e EPS. Reiterate OW. 52-Week Range HK$34.50-19.72 Sh out, dil, curr (mn) 2,568 Healthy 2015 sales outlook: Given decelerating GDP growth expected in Mkt cap, curr (mn) Rmb60,695 EV, curr (mn) Rmb78,243 2015, mgmt looks for growth of the end-user market to slow to 12%, and for Avg daily trading value (mn) HK$133 the distribution industry to grow 14-15%. Management remains confident about achieving its sales target of 3-5% above the market average. Fiscal Year Ending 12/14 12/15e 12/16e 12/17e ModelWare EPS (Rmb) 1.11 1.32 1.51 1.70 Margin improvement to continue in 2015, ... This is the first quarter that Prior ModelWare EPS 1.10 1.29 1.44 1.58 (Rmb) Sinopharm has recorded faster profit growth than sales growth, mainly due to: Consensus EPS (Rmb)§ 1.10 1.30 1.55 1.50 1) internal integration; 2) economies of scale; 3) optimizing customer mix Revenue, net (Rmb 200,131 235,469 272,701 313,245 (more direct sales to hospitals), and 4) more focus on the quality of growth.
    [Show full text]
  • Brief Summary Update on Coronavac COVID-19 Vaccine (Vero Cell)
    On-going Review of Benefit and Risk of Authorized COVID-19 Vaccine in Hong Kong under the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K, Laws of Hong Kong) CoronaVac COVID-19 Vaccine (Vero Cell), Inactivated Background Under the Prevention and Control of Disease (Use of Vaccines) Regulation (“the Regulation”), Cap. 599K, Laws of Hong Kong, the Advisory Panel on COVID-19 Vaccines (“the Advisory Panel”) has been appointed by the Chief Executive to advise the Secretary for Food and Health (“SFH”) on (i) whether to authorize a vaccine for the purpose of carrying out a programme that is conducted by the Government to administer authorized vaccines to members of the public, or a section of the public, on an emergency basis, for preventing, protecting against, delaying or otherwise controlling the incidence or transmission of, or mitigating a serious or life-threatening condition arising from the specified disease (i.e. COVID-19) or other reasonable purpose specified by the SFH, by taking into consideration the safety, efficacy and quality of the vaccine; (ii) conditions to be attached to an authorization; and (iii) revocation of an authorization. 2. Since 18 February 2021, the COVID-19 vaccine, namely CoronaVac COVID-19 Vaccine (Vero Cell), Inactivated (“CoronaVac”) by Sinovac Biotech (Hong Kong) Limited (“Sinovac”), has been authorized under the Regulation. Review by Advisory Panel 3. For providing advice to the SFH regarding authorization, the Advisory Panel conducts on-going review of the benefits and risks of authorized vaccines in order to protect public health. The Advisory Panel will conduct regular meetings to review the latest available evidence and information related to the safety, efficacy and quality of authorized COVID-19 vaccines, and to offer appropriate advice to the SFH in a timely manner.
    [Show full text]