Shearer and colleagues use sophisticated modeling
techniques to try and explain why some countries take longer to adopt
Haemophilus influenza type b (Hib) vaccine in their national
immunization programs (1). A primary premise they make is that the
vaccine is beneficial to society. Published evidence of strain shifts
and side effects however contradict this assumption.
Data from
Canada and elsewhere suggests that Hib vaccine has nearly eliminated
Haemophilus influenza type b but there has been a proportional increase
in non-Hib strains including non-serotypable strains causing invasive H
influenza disease in the post Hib vaccine era (2-10). Studies from
Finland have shown an increase in type 1 diabetes after introduction of
the vaccine. The increase in incidence was 58/100000 (p=0.029) (11,12)
where the pre-Hib vaccine incidence of Hib in Europe was 12 to 54/
100000 (13)
We note that research by Shearer and colleagues did
not model the results of local studies – only their existence (1). The
authors state that knowing a study exists is not equivalent to knowing
the implication of their findings or their dissemination to decision
makers. Such patronization of decision makers does not serve the cause
of objective discourse. In India as also in other countries, evidence of
natural immunity to Hib, developed in infancy because of infection with
other bacteria (with cross-reactive antigens) (14-17) have been quoted
as the rationale negating need to vaccinate with Hib. The low incidence
of Hib disease has had a direct bearing on the non-introduction of the
vaccine in India.
A large multi-center study in India, funded by
GAVI (18) found that the incidence of all-cause pneumonia deaths was
fifty times less than what was projected previously (19, 20). The
incidence of pneumonia was so low that even with 10% mortality; the
deaths would not match the figures projected to make the vaccine appear
cost-effective. This study argues against the need for both the Hib
vaccine and the pneumococcal vaccine in India. Rather conveniently the
data from this study was not included in the National Technical Advisory
Group on Immunization (NTAGI) report recommending Hib (21). The data
from the study was obtained under the Right to Information Act. The
omission of this data from the recommendation of the NTAGI (to decision
makers) became the focus of a public interest petition in the Delhi High
Court and it has resulted in reevaluation of the NTAGI report by the
Government of India (22). This suggests that attempts ‘not to
disseminate findings to decision maker’ may not always serve the
purpose.
Another premise the authors start with (1), is that
‘democracy’ results in early introduction of vaccines. A previous study
(23) and their own results (not included in the abstract) (1) have
actually proved the opposite - that autocracy favors vaccine
introduction. The experience from India also suggests that a well
informed and active civil-society movement sometimes stands in the way
of the introduction of vaccines. It is not such bad news either.
One
is left to speculate what lessons the GAVI will take from this finding.
One hopes accelerated introduction of the other vaccines like human
papillomavirus, pneumococcal and rotavirus vaccines will not be
accompanied by an assault on democratic rights, institutions and systems
like the Right to Information Act in India.
Prashant Tyagi MBBS
Department
of Pediatrics
St Stephens Hospital
Delhi 110054 India
prash119@yahoo.com
Mira
Shiva MD
Initiative for Health , Equity and Society/Third World
Network
All India Drug Action Network
A-60, Hauz Khas
New
Delhi - 110 016
Tel: 91-11-26512385, Mob:91 9810582028
mirashiva@gmail.com
Jacob
Puliyel MD MPhil
Department of Pediatrics
St Stephens Hospital
Delhi
110054 India
Puliyel@gmail.com
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No competing interests declared.
