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Vaccines for pandemic H1N1 2009: lessons learned and ensuring
global access
David Wood
2 |Vaccines for pandemic H1H17 September 2010
OutlineOutline
What went well
What didn't go so well
Towards ensuring global access
3 |Vaccines for pandemic H1H17 September 2010
Lessons learned evaluationsLessons learned evaluations
A Review Committee of the International Health Regulations is conducting a "lessons learned" review
This will be a holistic review of all aspects of the response to the pandemic, and will report to the May 2011 World Health Assembly
The comments in this presentation are to be considered as "informal reflections" and do not constitute official conclusions on the pandemic
Disclaimer
4 |Vaccines for pandemic H1H17 September 2010
What went wellWhat went well
5 |Vaccines for pandemic H1H17 September 2010
More than 20 monovalent pandemic influenza A (H1N1) 2009 vaccines licensed
More than 20 monovalent pandemic influenza A (H1N1) 2009 vaccines licensed
(Source: IFPMA-IVS)
Baxter (Vero cell) (EMA)
Ommnivest (Hungary)
8 manufacturers, (China)
CSL (Australia; US)
Sanofi Pasteur (US; EMA)
SP + AFO3 (EMA)
Green Cross (Korea)
GSK + ASO3 (EMA, Canada)
Novartis (US)
Novartis+Mf59 (EMA)
Novartis (MDCK cell) + Mf59 (Germany)
MedImmune (US)
Microgen (Russia)
6 |Vaccines for pandemic H1H17 September 2010
Vaccines were immunogenicVaccines were immunogenic
Manufacturer (Licensing agency)
No. doses Number of regulatory criteria exceeded
CSL (Australia; US-FDA) Adults 1; children 2 3/3
GSK/ASO3 adjuvanted (Health Canada and EMA)
Adults and children 1 3/3
Sanofi Pasteur (US-FDA) Adults 1; children 2 3/3
Novartis/Mf59 adjuvanted (EMA)
Adults 1; children 2 3/3
Green Cross (Korea FDA) Adults 1; children 2 3/3
MedImmune (US-FDA) Adults 1; children 2 Not applicable to live vaccines
*Vaccines offered to WHO
7 |Vaccines for pandemic H1H17 September 2010
Vaccines appear to have been effectiveVaccines appear to have been effective
Effectiveness data being reported at present
Uniformly high effectiveness results to date
8 |Vaccines for pandemic H1H17 September 2010
• Local and systemic reactions were common pain and swelling at injection site, fever, chills, malaise, fatigue, headache, muscle pain
• Variety of allergic reactionshives, rash, angioedema, anaphylaxiswithin expected range
• Guillain Barré syndrome Observed frequency at or below seasonal influenza vaccine rates
• Gastrointestinal symptomatolgydiarrhoea, vomiting, nauseaSomewhat higher than expected rate, mild and self limited
• Neurological symptomsnacrolepsy? Very new observation with one vaccine; under investigation
Vaccines were safe
9 |Vaccines for pandemic H1H17 September 2010
Consensus on immunization policy recommendations
Consensus on immunization policy recommendations
7 July 2009 http://www.who.int/wer
Front-line HCWs (1-2% of population) to protect the health care system
Specific groups to reduce morbidity and mortality
– pregnant women,
– individuals aged of >6 months with one of several chronic medical conditions
– Healthy young adults (aged >15 years and <49 years)
– Healthy children.
– Healthy adults aged >49 years and <65 years
– Healthy adults aged >65 years
28 Oct 2009 http://www.who.int/wer
Number of doses :– Public health considerations support
the use of a single dose of vaccine in adults, adolescents from 10 years of age and above, provided this use is consistent with regulatory authorities' indications.
– In the context of limited vaccine supplies, priority should be given to provide one dose of vaccine to as many children as possible where priority has been assigned to this group by national authorities. A second dose can provided as further supplies become available, if recommended by regulatory authorities.
WHO Strategic Advisory Group of Experts
10 |Vaccines for pandemic H1H17 September 2010
Extensive and unprecedented data sharing
11 |Vaccines for pandemic H1H17 September 2010
Vaccines for H1N1 were available slightly ahead of plans (6 months after strain identified): Timeline for large-scale vaccine use - 2009
39 40 41 42 43 44 45 46 47 48 49 50 51 52 53
September October November December
China, Oman
Belgium, Italy, Sweden
Denmark, Ireland, Israel, Qatar, Saudi Arabia, Singapore, Turkey
Croatia, Cyprus, Romania
Albania, FYROM,
Iran,Monte-negro,Serbia
Greece, Jordan, Spain
Netherlands, Russian Federation, Switzerland, UAEUSA
Australia, Hungary
Austria, Canada, Germany, Kuwait, Luxemburg, Portugal, Republic of Korea, Slovenia
Finland, France, Japan, Monaco, Norway, United Kingdom
12 |Vaccines for pandemic H1H17 September 2010
What didn't go so wellWhat didn't go so well
13 |Vaccines for pandemic H1H17 September 2010
Global pandemic (H1N1) 2009 vaccine production was less than predicted
Global pandemic (H1N1) 2009 vaccine production was less than predicted
95 M
2,459 M
4,918 M
.0 B
1.0 B
2.0 B
3.0 B
4.0 B
5.0 B
6.0 B
Weekly 6 month Annual
28 M
Max 3B dosesOctober 2009
495 M
1,296 M
June 2009 estimate
January 2010
*As of 10 January 2010
June 2009 survey assumed- 1:1 H1N1 to seasonal yields- Most dose sparing formulation for each manufacturer-Use of full production capacity
In reality
- 1:3 H1N1 to seasonal yields- Not all manufacturers could use their most dose sparing formulation- some production capacity not immediately switched from seasonal vaccine production-Demand collapsed in 2010
14 |Vaccines for pandemic H1H17 September 2010
Varying uptake of 2009 H1N1 vaccines
• Over 570 million doses distributed, over 350 million doses administered
• Varying uptake >>> from shortages to surpluses
• High media coverage (positive and negative effects)
• Timeliness of scientifically credible information
• Barriers to vaccinations need to be better understood and addressed
15 |Vaccines for pandemic H1H17 September 2010
Vaccine was not available sufficiently quickly
Vaccine was not available sufficiently quickly
Reduce timelines for current procedures by 3-4 weeks
- alternative methods of vaccine potency evaluation to calibrate clinical trial lots
Reliable methods to produce high-yield candidate vaccine strains, through a comprehensive research programme
Development of new generation vaccine technologies (longer-term)
Development of new strategies based on current technologies to mitigate new pandemic risks in the medium term
16 |Vaccines for pandemic H1H17 September 2010
Equity in vaccine deployment was slow Equity in vaccine deployment was slow
WHO Director General and UN Secretary General called for international solidarity to meet donation target of 10% population coverage for countries in need
Access to vaccines for Low Income/Low-Middle income countries an international priority (target = 95 countries)
13 donor governments and 5 manufacturers pledged support (200 million doses of vaccine pledged; 70 million syringes; 48 million$ for operations)
WHO directed and coordinated the deployment of donations and provision of technical/operational support in collaboration with donors and others
17 |Vaccines for pandemic H1H17 September 2010
Equity in vaccine deployment was slowEquity in vaccine deployment was slow
0
5
10
15
20
25
30
35
Sept 16-30 Oct 1-15 Oct 16-31 Nov 1-15 Nov 16-27
Pandemic Vaccine Distribution
Nu
mb
er
of
co
un
trie
s
(cu
mu
lati
ve
)
High Income
Middle Income
Low Income
World economies1 1 World Bank classification 2009
• Initial available vaccines mostly to developed countries• Vaccine roll out to low income countries slower than hoped• First donated doses arrived in Azerbaijan & Mongolia in January 2010• As of 24 Aug 2010, 72 million doses distributed to 69 countries
18 |Vaccines for pandemic H1H17 September 2010
What were the complexities?What were the complexities?
Extreme logistical & legal issues– Need for standard approaches but multiple vaccines and countries– Need for new approaches such as liability agreements by
recipient countries
Balancing retention of vaccines for domestic use and donations to support to global solidarity
Limitations of an ad hoc approach– A framework for equitable access in future pandemics will be an
essential component of better preparedness
19 |Vaccines for pandemic H1H17 September 2010
Readiness of some countries to deploy donated vaccine
Readiness of some countries to deploy donated vaccine
When developing their plans countries did not know:
- What type of vaccine and how many doses will they receive? (Many countries do not use seasonal influenza vaccine)
- When will vaccine be delivered?
Inability of countries to secure sufficient resources to fund critical in-country operational deployment activities.
- Competing priority with other public health problems in many resource poor countries
Planning vaccination of cohorts not normally included in national immunization programme.
20 |Vaccines for pandemic H1H17 September 2010
Towards ensuring global accessTowards ensuring global access
21 |Vaccines for pandemic H1H17 September 2010
Vaccine capacity developmentVaccine capacity development
22 |Vaccines for pandemic H1H17 September 2010
Access to new technologyAccess to new technology
WHO provided three developing country vaccine manufacturers with a license on the Russian Live Attenuated Influenza Vaccines (LAIV) technology:
- Serum Institute of India (SII)
- Government Pharmaceutical Organization of Thailand (GPO Thailand)
- Zhejiang Tianyuan Bio-pharmaceutical Company, China
GPO Thailand and SII in clinical trials of influenza A(H1N1) 2009 LAIVs.
23 |Vaccines for pandemic H1H17 September 2010
The "Technology Hub" ConceptThe "Technology Hub" Concept
Major challenges encountered during attempts to increase production capacity
- Finding a technology provider proved very difficult
- Limited human resources at new manufacturer site
A possible solution: to create a "technology hub" to serve as technology provider
- A technology platform for transferring a robust production process with relevant documentation (SOPs, Batch Process Records, validation procedures, analytical methods and release criteria) established at the Netherlands Vaccine Institute
- A technology package transferable to interested developing country vaccine manufacturers, upon request (and possibly against fees), without IPR hurdles
- Selected technology: Inactivated whole virion influenza vaccine produced in embryonated eggs
Transfer of capacity for independent regulatory oversight equally important
24 |Vaccines for pandemic H1H17 September 2010
Concluding remarksConcluding remarks
Preparedness significantly improved the 2009 response overall compared with the past
– But it was incomplete with many gaps
Flexibility was and remains essential – No degree of planning fully anticipates reality
Complexities of improving access to vaccines demonstrates the limitations of an ad hoc approach
– A framework for future pandemics will be an essential component of better preparedness