Rapid Responses to:

Kelley Lee and Andrew Harmer
Ten years of the Global Alliance for Vaccines and Immunisation
BMJ 2010; 340: c2004 [Full text]
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Rapid Responses published:

Rapid Response] Gates Foundation commitment
Melissa Covelli   (25 April 2010)
Rapid Response] Demanding Accountability from GAVI and WHO
Jacob M. Puliyel   (25 April 2010)
Rapid Response] Vaccination is not enough
Andrew D. Lynk   (26 April 2010)
Rapid Response] Robust health systems are critical
Julian Lob-Levyt   (3 May 2010)

Gates Foundation commitment 25 April 2010
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Melissa Covelli,
Program Officer, Global Health Policy & Advocacy
Bill & Melinda Gates Foundation, Seattle, WA 98119

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Re: Gates Foundation commitment

�Ten years of the Global Alliance for Vaccines and Immunisation� incorrectly states that the Bill & Melinda Gates Foundation�s $10 billion, ten-year commitment to vaccines, announced in January 2010, will be directed to GAVI. In fact, that commitment covers all of the foundation�s support for vaccine research, development, and delivery. The foundation has not announced specific grants or organizations that would receive funding.

I would be grateful if this error could be corrected.

Competing interests: None declared

Demanding Accountability from GAVI and WHO 25 April 2010
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Jacob M. Puliyel,
Head of Department of Pediatrics
St Stephens Hospital, Delhi 110054 India

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Re: Demanding Accountability from GAVI and WHO

Lee and Harmer have highlighted the achievements of GAVI but they have also cited the criticisms leveled against it (1). Their article however would have gone to press before the recent controversy over WHO and GAVI functioning, started in India.

This week, the Indian Journal of Medical Research published an article entitled: "Incomplete reporting of research in press releases: Et tu, WHO" (2). The article relates to a press release issued by WHO jointly with GAVI, USAID, and Johns Hopkins among others (3,4), after the Bangladesh case-control study on effectiveness of Hib vaccination (5). The press release suggested that the vaccine is useful, whereas the study itself showed no benefit. No statistical difference was seen in the vaccination status of those with pneumonia or meningitis compared to controls. A post-hoc analysis presented without proper multiple testing was used to bolster the erroneous claim. Contrary to the subtle suggestion in the press release, analysis of data from an earlier Indonesian probe study also found no benefit (6).

This misleading press release is seen as the smoking gun.

After the Bangladesh study (2006) the WHO issued a position paper recommending the inclusion of Hib vaccine in all routine immunization programs, regardless of national burden (7) replacing the earlier 1998 position paper which suggested countries should consider Hib burden before introducing the vaccine (8). GAVI (which includes representatives of vaccine manufacturers on its Board,) "encouraged" developing countries in Asia to avail of the vaccine at a highly subsidized rate. The subsidy of course came from money given by donor countries and the Bill and Melinda Gates foundation, for achievement of the MDGs.

Given that the probe studies in Asia had failed to confirm benefit from the vaccine, it would appear that millions of dollars from the MGD Fund were spent wastefully. A possible argument that the vaccine was/is/maybe highly efficacious in other parts of the world hence should be used in Asia, is unscientific because the very basis of the research studies was that the situation in Asia was/is different.

A collective of civil society organizations have written to the Director General of the WHO to investigate how the misleading press release came to be put out and the events surrounding the Bangladesh study. It is hoped that widespread reporting of these events, will bring about changes in the way decisions are taken for/in developing countries.

Jacob M Puliyel MD

References 1. Lee K, Harmer A. Ten years of the Global Alliance for Vaccines and Immunization BMJ 2010;340:c2004.

2. Puliyel JM, Mathew JL, Priya R. Incomplete reporting of research in press releases: Et tu, WHO. Indian J Med Res 2010;131:588-589. http://www.icmr.nic.in/ijmr/2010/april/0418.pdf accessed 23/4/2010.

3. The Hib Initiative. Hib vaccine: A critical ally in Asia's effort to reduce child deaths. (Press release) http://www.hibaction.org/news/2007/20070627.pdf accessed on 23/4/2010.

4. WHO. Hib vaccine: A critical ally in Asia’s effort to reduce child deaths. http://www.who.int/immunization/newsroom/Hib_vaccine/en/ accessed on 23/4/2010.

5. Baqui AH, El Arifeen S, Saha SK, Persson L, Zaman K, Gessner BD, Moulton LH, Black RE, Santosham M. Effectiveness of Haemophilus influenzae type B conjugate vaccine on prevention of pneumonia and meningitis in Bangladesh children: a case control study. Pedaitr Infect Dis J. 2007;26: 565-571.

6. Gessner BD, Sutanto A, Linehan M, Djelantik IG, Fletcher T, Gerudug IK, Ingerani, Mercer D, Moniaga V, Moulton LH, Moulton LH, Mulholland K, Nelson C, Soemohardjo S, Steinhoff M, Widjaya A, Stoeckel P, Maynard J, Arjoso S. Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet- randomised vaccine-probe trial. Lancet 2005; 365: 43-52.

7. World Health Organization. WHO Position Paper on Haemophilus influenzae type b conjugate vaccines. Wkly Epidemiol Rec 2006;81: 445-452.

8. [Anonymous] Global programme for vaccines and immunization (GPV). The WHO position paper on Haemophilus influenzae type b conjugate vaccines. Wkly Epidemiol Rec 1998;73: 64-68.

Competing interests: None declared

Vaccination is not enough 26 April 2010
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Andrew D. Lynk,
Consultant Pediatrician
Sydney, Nova Scotia Canada B1P1P3

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Re: Vaccination is not enough

There is no vaccine for poverty.

Competing interests: None declared

Robust health systems are critical 3 May 2010
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Julian Lob-Levyt,
CEO, GAVI Alliance
GAVI Alliance, chemin des Mines 2, CH-1202 Geneva, Switzerland

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Re: Robust health systems are critical

Thank you for your editorial �Ten years of the Global Alliance for Vaccines and Immunisation� (23 April 2010). We welcome your analysis of the challenges we face in trying to accelerate immunisation and strengthen health systems in developing countries.

To maintain and increase our successes in reaching children with life -saving vaccines, we have indeed recognized that robust health systems are critical. Like others we have moved on from the sterile, �horizontal versus vertical� debate, choosing instead to focus on the strengthening of integrated delivery platforms to tackle MDGs 4, 5 and 6. We have already made US$800 million available to poor countries to strengthen their health systems, with a deliberate focus on downstream delivery and on 20 April 2010, the GAVI Alliance Board backed the development of a joint Health System Funding Platform which aims to make better use of new and existing funds for health systems and leverage additional funding.

This performance- and results-based platform, which GAVI is currently developing with the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Bank and the World Health Organization, aims to ensure a more coordinated effort and clarify partners� roles to support the improvement of health systems. It will not only reduce transaction costs and make it simpler for countries to apply for funding but will also focus on country results and value for money.

This new flexible funding channel provides an opportunity to reduce the fragmented efforts to tackle health system strengthening and help better tackle MDGs 4 and 5,for example ensuring the integrated delivery of new vaccines against pneumonia and diarrhoea which can protect children�s lives and avert up to a million deaths a year. It will also help ensure women can deliver healthy children and live to see them thrive and ensure more people who need antiretroviral or TB medicines do in fact receive them.

Please also note that while the GAVI Alliance needs to raise an additional US$ 2.6 billion over the next six years in order to help roll out these new vaccines against the two biggest child killers, we have not received any of the US$10 billion announced by The Bill & Melinda Gates Foundation in January.

Yours sincerely,

Julian Lob-Levyt

CEO, GAVI Alliance

Competing interests: None declared