Vaccines for pandemic H1N1 2009: lessons learned and ensuring global access

Vaccines for pandemic H1N1 2009: lessons learned and ensuring

global access

David Wood

http://www.sciencephoto.com/images/download_wm_image.html/M715546-Flu_vaccine-SPL.jpg?id=777150546

2 |Vaccines for pandemic H1H17 September 2010

Outline

What went well

What didn't go so well

Towards ensuring global access


Lessons 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


What went well


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)


Vaccines were immunogenicManufacturer

(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


Vaccines appear to have been effective

Effectiveness data being reported at present

Uniformly high effectiveness results to date


• 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


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


Extensive and unprecedented data sharing


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


What didn't go so well


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 M1,296 M

June 2009 estimateJanuary 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


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


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


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


Equity 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

Num

ber o

f cou

ntrie

s(c

umul

ativ

e)

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


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


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.


Towards ensuring global access


Vaccine capacity development


Access 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.


The "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


Concluding 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

Date post:	10-Feb-2016
Category:	Documents
Upload:	efia
View:	42 times
Download:	0 times

Vaccines for pandemic H1N1 2009: lessons learned and ensuring global access

Documents