Intended for healthcare professionals


Ten years of the Global Alliance for Vaccines and Immunisation

BMJ 2010; 340 doi: (Published 20 April 2010) Cite this as: BMJ 2010;340:c2004

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

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. accessed 23/4/2010.

3. The Hib Initiative. Hib vaccine: A critical ally in Asia's
effort to reduce child deaths. (Press release) accessed on 23/4/2010.

4. WHO. Hib vaccine: A critical ally in Asia’s effort to reduce
child deaths.
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:

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:

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

Competing interests: No competing interests

25 April 2010
Jacob M. Puliyel
Head of Department of Pediatrics
St Stephens Hospital, Delhi 110054 India