V3P: Region Fact Sheet AMR

Highlights The AMR1 region market is 15% of the global market in volume and 63% in This regional fact sheet is intended value. The regional procurement habits are different from the rest for use by MoH and vaccine procurement staff. The regional fact of the world in several ways, which may serve to inform sustainable supply sheet provides information on all strategies: procured by AMR including • one vaccine type exclusive to the region; analyses of: • the presentations used in AMR • considerably higher use of single- vs. multi-dose presentations than in compared to the rest of the the rest of the world; world; • slightly lower use of pre-filled syringes than in the rest of the world; • the procurement methods used in AMR compared to the rest of • a higher proportion of countries are pool-procuring; the world; • HPV, Influenza (adult), Varicella, and Meningococcal vaccines have a • value to the market of the most higher relative value than in the non-AMR market; frequently reported vaccines to the V3P from AMR and the rest • three vaccines analysed for price suggest that: of the world; »» WAPs in non-Gavi, non-PAHO MICs may be slightly higher in AMR than in • prices paid by AMR, compared the rest of the world. to rest of the world. Increased knowledge about several Vaccine Market aspects of vaccine market and purchasing may help to inform the For the data in the V3P database, the size of the vaccine market in AMR is development of policies related to approximately 15% of the global market by volume, and about 63% by value. market shaping and vaccine access. However, a majority of HICs from Western Europe do not report price data to the V3P, so the relative size of the global market is higher than reported. The Vaccine Product Price & Procurement (V3P) initiative was launched to provide all countries The global top 10 vaccines by value are PCV, HPV, Rota, Influenza (seasonal - with a platform for greater vaccine adult), Varicella, DTP-HepB-Hib, MenA,C,Y,W-135 conj, MenC, DTaP-HepB-Hib- price & procurement transparency. IPV, and BCG, and these 10 account for about 71% of the value of the market The initiative collects data through in AMR. The relative value of each vaccine type, in each market, is shown in the WHO and UNICEF Joint Reporting Form, and analyses and Chart 1 (see page 2). distributes information to relevant stakeholders to inform policy Chart 1 also shows that the primary differences between the AMR and the making and procurement processes. non-AMR markets are the greater relative values of HPV, Influenza (adult), As of July 2017, the database Varicella, and Meningococcal vaccines in the AMR market. The value of contained data from 142 countries. each vaccine is more evenly distributed in the AMR market. The pertussis The fact sheet is exclusively combination vaccines, PCV, and BCG account for 52% of the non-AMR market based on the data reported compared to only 21% of the AMR market. through the JRF & V3P initiative, as of July 2017. Pool-procurement refers to vaccines procured through UNICEF SD and the PAHO Revolving Fund. Readers may access additional vaccine price and procurement information from reporting countries and procurement agencies (UNICEF and PAHO) on the V3P website (http://www.who.int/immunization/ v3p) or by contacting v3p-project@ who.int.

1AMR countries contributing to the V3P: Argentina, Brazil, Chile, Costa Rica, Cuba, Dominican Republic, Ecuador, Grenada, Guyana, Jamaica, Mexico, Nicaragua, Paraguay, Peru, Saint Lucia, Suriname, Trinidad and Tobago, United States of America, Uruguay. AMR countries not contributing to the V3P: Antigua and Barbuda, Bahamas, Barbados, Belize, Bolivia, Canada, Colombia, Dominica, El Salvador, Guatemala, Haiti, Honduras, Panama, Saint Kitts and Nevis, Saint Vincent and the Grenadines, Venezuela.

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Chart 1. The relative value of the global top 10 vaccines in the AMR and non-AMR markets.

AMR non-AMR

Products and Presentations AMR uses 35 vaccine types out of 57 reported by non-AMR of prefilled syringes and ampoules in AMR than in non- countries. One vaccine type (DTaP-HepB-IPV) is exclusive to AMR countries (16% versus 17%, and 3% versus 8%, AMR. respectively).

AMR uses five out of seven of the presentations used in Chart 2 shows a considerably greater predominance of non-AMR countries (Uniject and an intranasal sprayer are single-dose presentations in AMR compared to non-AMR reported from non-AMR but at a frequency of <1% - not countries (63% versus 47%), and a lower prevalence of 20- shown). There is, however, a slightly lower prevalence dose presentations (7%) than in non-AMR countries (17%).

Chart 2. Prevalence of presentation sizes in AMR and non-AMR countries.

AMR non-AMR

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Procurement Method Chart 3. Prevalence of procurement method in AMR and non-AMR countries. AMR has a higher predominance of AMR non-AMR pool-procurement (68%), compared to non-AMR regions (52%) (see Chart 3). Self-procurement in AMR is about half as prevalent as in non-AMR countries (16% versus 34%). The higher proportion of pool- procurement in AMR is a consequence of the PAHO Revolving Fund which a majority of AMR countries use for vaccine procurement.

Vaccine Prices There is very limited data for non-Gavi, non- PAHO MICs in AMR, but for three vaccines Chart 4. WAPs for three select single-dose vaccines in self-procuring non-Gavi, non- analysed, WAPs in AMR were 2 to 19% higher PAHO MICs in AMR and non-AMR, in 20162. than for the same single-dose vaccines in the non-AMR market (see Chart 4).

Minimum, maximum, and median prices for vaccines procured in AMR are shown in Table 1 (see page 4).

Vaccine Availability Reported manufacturers from AMR and globally, for each vaccine type, are shown in Table 2 (see page 5).

2Vaccines were selected on the basis of sufficient data for analyses – data for single-dose presentations from at least two countries in both AMR and non-AMR.

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Table 1. Proportion of countries self-procuring, minimum, median, and maximum prices, number of products, and number of manufacturers for each vaccine type reported from at least five AMR countries, in 2016.

AMR price (all procurement methods, all income Vaccine type (ranked by groups): lowest (presentation size) / highest

frequency of use) AMR (presentation size) / median in AMR N different N different % of countries % of self-procuring in self-procuring products products in AMR N manufacturers N manufacturers N manufacturers reported globally reported

MMR 22 $0.60 (10-dose) / $40.00 (1-dose) / $2.37 5 3 5

IPV 6 $1.73 (5-dose) / $12.72 (1-dose) / $2.80 4 2 7

Influenza (seasonal – adult) 29 $1.97 (10-dose) / $25.07 (1-dose) / $4.30 8 6 11

BCG 20 $0.14 (20-dose) / $0.94 (10-dose) / $0.16 5 4 16

bOPV1,3 7 $0.12 (20-dose) / $0.25 (20-dose) / $0.13 4 3 10

YF 7 $1.05 (10-dose) / $35.46 (1-dose) / $1.20 3 2 4

DTP-HepB-Hib 8 $2.00 (1-dose) / $4.00 (1-dose) / $2.25 5 4 11

Td 31 $0.10 (10-dose) / $19.69 (1-dose) / $0.15 7 6 13

HepB (adult) 23 $0.19 (10-dose) / $28.55 (1-dose) / $0.42 9 5 10

DTP 15 $0.20 (10-dose) / $1.20 (10-dose) / $0.24 5 5 8

PCV 17 $3.30 (1-dose) / $120.39 (1-dose) / $15.33 4 2 2

HPV 42 $3.74 (1-dose) / $133.15 (1-dose) / $10.37 5 4 4

Varicella 27 $14.10 (1-dose) / $88.34 (1-dose) / $15.99 3 3 4

Rota 20 $2.50 (1-dose) / $86.75 (1-dose) / $6.50 2 2 3

DT 0 $0.08 (10-dose) / $0.98 (10-dose) / $0.13 4 4 11

Rabies 20 $6.30 (1-dose) / $16.13 (1-dose) / $11.98 3 3 7

Pneumo ps 33 $6.14 (1-dose) / $46.40 (1-dose) / $8.48 2 2 2

HepB (ped) 25 $0.20 (1-dose) / $12.30 (1-dose) / $0.35 5 3 13

Influenza (seasonal – ped) 25 $1.35 (20-dose) / $19.14 (1-dose) / $1.48 5 4 6

Hib 14 $1.95 (1-dose) / $12.48 (1-dose) / $2.05 3 3 4

DTa P 29 $10.85 (1-dose) / $16.85 (1-dose) / $12.27 4 2 3

HepA (ped) 50 $6.70 (1-dose) / $18.23 (1-dose) / $9.47 6 4 9

MR 20 $0.63 (10-dose) / $2.25 (1-dose) / $1.24 2 1 3

MenA,C,Y,W-135 conj 40 $20.30 (1-dose) / $89.16 (1-dose) / $48.13 3 3 4

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Table 2. Vaccine manufacturers reported by AMR countries, and additional manufacturers reported from other regions but not from AMR.

Vaccine type Manufacturers reported by AMR countries Additional manufacturers not reported by AMR BCG FAP (Fundação Ataulpho de Paiva); InterVax; Japan BCG AJ Vaccines A/S; BB-NCIPD; Biomed Lublin; China CNBG; GreenSignal Bio Laboratory; Serum Institute of Pharma Limited; Institut Pasteur Iran; Institut Pasteur Tunis; IVAC (Institute of Vaccines and Medical Biologicals); Mikrogen; PT Bio Farma (Persero); Thai Red Cross Society; Torlak Institute of Virology, Vaccines and Sera bOPV1,3 ; Birmex; Serum Institute of India Boryung Biopharma; China CNBG; GSK; Haffkine Bio; PT Bio Farma (Persero); Razi Institute Iran; Sanofi Pasteur DT BB-NCIPD; Biological E; InterVax; Serum Institute of India Arabio; China CNBG; Mikrogen; PT Bio Farma (Persero); Razi Institute Iran; Sanofi Pasteur; Torlak Institute of Virology, Vaccines and Sera DTa P GSK; Sanofi Pasteur China CNBG DTP Biological E; Boryung Biopharma; Butantan; PT Bio Farma IVAC (Institute of Vaccines and Medical Biologicals); Mikrogen; Torlak Institute of (Persero); Serum Institute of India Virology, Vaccines and Sera DTP-HepB-Hib Biological E; Centro de Ingeniería Genética y Biotecnología; Arabio; Bharat Biotech; GSK; Janssen; LG Life Sciences; PT Bio Farma (Persero); Panacea Biotec; Serum Institute of India Shantha Biotechnics Private Limited HepA (ped) Butantan; GSK; Merck Vaccines; Sanofi Pasteur Changchun Changsheng Life Sciences Ltd.; China CNBG; Institute of Medical Biology – Chinese Academy of Medical Sciences; Sinovac; Zhejiang Pukang HepB (adult) Centro de Ingeniería Genética y Biotecnología; GSK; LG Life Berna Biotech Korea; Institut Pasteur Iran; Janssen; Mikrogen; Shantha Sciences; Merck Vaccines; Serum Institute of India Biotechnics Private Limited HepB (ped) GSK; Merck Vaccines; Serum Institute of India Biokangtai; China CNBG; Dalian Hissen; Janssen; LG Life Sciences; Mikrogen; NCPC GeneTech; PT Bio Farma (Persero); Sanofi Pasteur MSD; VABIOTECH Hib Merck Vaccines; Sanofi Pasteur; Serum Institute of India GSK HPV Butantan; GSK; Merck Vaccines; Sinergium None Influenza (adult) Abbott Biologicals B.V.; Butantan; Green Cross Corporation; GPO-MBP Co., Ltd.; GSK; Hualan Biological Bacterin Co., Ltd; Mikrogen; Npo Sanofi Pasteur; Seqirus; Sinergium Petrovaks Influenza (ped) Green Cross Corporation; Sanofi Pasteur; Seqirus; Sinergium Mikrogen; Npo Petrovaks IPV Bilthoven Biologicals; Sanofi Pasteur GSK; Institute of Medical Biology – Chinese Academy of Medical Sciences; PT Bio Farma (Persero); Serum Institute of India; Shantha Biotechnics Private Limited MenACYW-135 conj GSK; Pfizer; Sanofi Pasteur Arabio MMR Merck Vaccines; Sanofi Pasteur; Serum Institute of India China CNBG; GSK MR Serum Institute of India Beijing Minhai Biotech; China CNBG PCV GSK; Pfizer None Pneumo ps Merck Vaccines; Sanofi Pasteur None Bharat Biotech; Butantan; Sanofi Pasteur Chiron Behring Vaccines Private Ltd.; FSUE Chumakov; GSK; Novartis Rotavirus GSK; Merck Vaccines Bharat Biotech Td BB-NCIPD; Biological E; Butantan; InterVax; Sanofi Pasteur; AJ Vaccines A/S; Boryung Biopharma; GSK; Mikrogen; PT Bio Farma (Persero); Serum Institute of India Razi Institute Iran; Torlak Institute of Virology, Vaccines and Sera Varicella Green Cross Corporation; Merck Vaccines; Sinergium GSK YF Bio-Manguinhos; Sanofi Pasteur FSUE Chumakov; Institut Pasteur Dakar

DISCLAIMER Information contained in the V3P database is provided by participating countries and/or organizations procuring on behalf of countries that have agreed to share vaccine price and procurement data with V3P. Participating countries are solely responsible for the accuracy of the data provided. The information contained in the V3P database does not in any way imply an endorsement, certification, warranty of fitness or recommendation by WHO of any company or product for any purpose, and does not imply preference over products of a similar nature that are not mentioned. WHO furthermore does not warrant that: (1) the information is complete and/or error free; and/or that (2) the products listed are of acceptable quality, have obtained regulatory approval in any country, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws. Inclusion of products in the database does not furthermore imply any approval by WHO of the products in question (which is the sole prerogative of national authorities). WHO will not accept any liability or responsibility whatsoever for any injury, death, loss, damage, or other prejudice of any kind that may arise as a result of, or in connection with the procurement, distribution and use of any product listed in the V3P database.

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