pandemic influenza vaccines: update on future availability
TRANSCRIPT
Pandemic influenza vaccines: update on future availability
Marie-Paule Kieny
SAGE, October 2009 2 |
Production and availability of pandemic (H1N1) 2009 vaccine
Vaccine supply through WHO: how much, when, where?
SAGE, October 2009 3 |
Assumptions / Methodology
Survey sent to 36 potential influenza vaccine manufacturers
– 100% response rate – All 21 current influenza vaccine
producers responded – 26 manufacturers that intend to
produce pandemic vaccines – Includes LAIV and one recombinant
vaccine capacity
Survey assumes – 1:1 H1N1 to seasonal yields – Most dose sparing formulation for
each manufacturer – Use of full production capacity
Global pandemic (H1N1) 2009 vaccine production capacity: less than 3B doses/year
H1N
1 do
ses
Estimated H1N1 Vaccine Capacity At 1:1 yields, most dose-sparing formulation, full capacity
Timeframe Source: WHO survey (Collin N. et al, Vaccine 2009. 27(38):5184-6 )
Max 3B doses (to be confirmed by new survey Nov 2009)
SAGE, October 2009 4 |
Impact on vaccine availability of seasonal vaccine options (hypothetical production)
300 M doses H1N1 vaccine without adjuvant (15 ug HA/dose)
OR >1,000 M doses H1N1 vaccine with
adjuvant (3.8 ug HA/dose) OR
100 M doses of seasonal trivalent vaccine (45 ug HA/dose)
OR
100 M doses of seasonal bivalent vaccine (H3N2; B, 30 ug HA/dose) + 400 M doses of monovalent H1N1 pandemic vaccine (3.8 ug HA/dose)
H1N1; H3N2; B
H3N2; B H1N1
H1N1
H1N1
H1N1
+ Adj
+ Adj + Adj
SAGE, October 2009 5 |
Production and availability of pandemic (H1N1) 2009 vaccine
Vaccine supply through WHO: how much, when, where?
SAGE, October 2009 6 |
Current status of pandemic (H1N1) 2009 vaccine donation to WHO
Donations from manufacturers: GSK, Sanofi Pasteur, CSL, MedImmune
156 million doses
Donation from 12 governments of up to 10% of domestic vaccine supply (or equivalent capacity, or cash, or mixture of the above): Australia, Brazil, France, Germany, Italy, Japan, New Zealand, Norway, Switzerland, Thailand, UK and USA
Up to 50 million doses?
Delivery schedule: starting end November 2009 over a 12 month period
Prequalification of H1N1 vaccines: expected October 2009 to early 2010 for vaccine donated to WHO
SAGE, October 2009 7 |
Types of pandemic Influenza Vaccines donated to WHO
(Source: IFPMA-IVS)
+ MF59 (Novartis) (MedImmune)
+ AS03 (GSK)
(Sanofi Pasteur)
+ AF03 (Sanofi Pasteur)
(CSL)
SAGE, October 2009 8 |
Scenario planning for deployment of pandemic vaccine (2009) in countries eligible for donation of vaccine
through WHO
Standard initial allocation: 2% population (for HCW, following SAGE recommendation)
WHO target: 10% population
Number of doses necessary for initial deployment (December 2009 – February 2010?): 36 million
Total number of doses needed: 200 to 300 million doses
SAGE, October 2009 9 |
Draft country eligibility list for H1N1 vaccine donation
SAGE, October 2009 10 |
Basket of principles for defining the sequence of distribution of WHO H1N1 pandemic influenza vaccine
(following SAGE advice, not in ranking order)
Vulnerability considerations – Geography: in the first 6 months (starting November): 2/3 of supplies
to the Northern hemisphere, 1/3 to SH, because number of cases in the decline currently in the SH, and rising in the North; after April 2010, 2/3 SH, 1/3 NH.
– Disease burden: in the same hemisphere, countries with highest ratio of death/inhabitant will be served first.
Readiness considerations – Programmatic aspects: i.e. readiness to vaccinate (plan, logistics,
priority groups identified etc). – Contractual arrangements: fulfillment of legal requirements (waiver
registration, assume liability, etc as per country letter of agreement)