A roller-coaster ride: Introduction of pentavalent vaccine in India

I ntroduction of Haemophilus influenzae type B (HiB) containing pentavalent vaccines (a combination vaccine which protects against five killer diseases-diphtheria , pertussis, tetanus, hepatitis B and Haemophilus in-fluenzae type B) in the Universal Immunization Program (UIP) was a far sighted decision taken in 2009 by the Ministry of Health and Family Welfare, Government of India. This decision was based on the recommendations of National Technical Advisory Group on Immunization (NTAGI) and was aimed at reducing the burden of HiB related infections (1). The decision was supported by the GAVI Alliance (formerly known as the Global Alliance for Vaccines and Immunizations) and in August 2009 they decided to provide funding worth US$ 165 million to the Government of India to support the introduction of pentavalent vaccine (2). The vaccine was to be introduced in a phased manner. In the first phase, the vaccine would have been rolled-out in 10 states and an estimated 18 million infants were expected to receive the vaccine. The decision of the Indian Government to introduce HiB vaccination into its UIP was hailed internationally by public health practitioners as India constitutes 34% of the birth cohort in GAVI-eligible countries (3) and even in the absence of population-based data, the country is estimated to have the highest number of deaths due to HiB in children under 5 years of age (4). However, the plans to introduce the vaccine were stalled following the filing of a Public Interest Litigation (PIL) in the Delhi High Court in December 2010, which questioned rationale for introducing the vaccine as well as its efficacy (5). The petitioners, comprising of a mixed group of medical practitioners including paediatricians, policy advisors to the Government of India, and a former civil servant (who also oppose the introduction of Hepatitis B vaccine into the UIP) claimed inter alia that the NTAGI had based its recommendation without considering data from studies which reveal that the burden of meningitis caused by HiB in In-dian children is much lower than in other parts of the world (6, 7). Moreover, the petitioners claimed that recent evidence from countries which have used pen-tavalent vaccine for several years revealed that there was no real benefit to children (8). They also claimed that the vaccine had been withdrawn from neighbouring Bhutan and Sri Lanka after reports of adverse effects following immunization with the vaccine. The Delhi High court sought a reply from the Indian …