Days after a doctor filed a public interest litigation (PIL) in the top court calling for a ban on the use of Pentavalent vaccine, a fine-in-one shot vaccine comprising of antigens of Deptheria, Pertussis, Tetanus and Hepatitis B and Haemophilus Influenza Type b (Hib), the Indian Academy of Paediatrics (IAP) assured that available vaccine was safe.
Endorsing the government governments decision to introduce the vaccine, it condemned the attempts of those distorting facts and create confusion regarding the safety of the vaccine. “The strong faith of the academy in the pentavalent vaccines has been reaffirmed by its membership, majority of whom are using these vaccines in their clinical practice for more than a decade,” it said.
In fact, in their recent study comprising around 1,000 paediatricians, it found that more than 80 per cent of them are using Hib-containing pentavalent vaccine in their clinical practice for more than last 5-15 years. “Majority of them had never encountered any serious AEFI, including death (under publication),” it added.
According to experts, like all injectable vaccines some adverse reactions do occur with pentavalent vaccines, the reactions are, however, they say, are mild and include fever and pain, swelling and redness at the site of injection. “The review of published literature on the safety of available pentavalent (DTwP-HepB-Hib) vaccines in India, including the currently employed PENTAVAC by Serum Institute of India (SII) in many states of the country is quite comforting. Within India, clinical trials of SII’s pentavalent vaccine found no serious AEFI in clinical trials amongst Indian children. Clinical trials of other manufacturers’ pentavalent vaccines (both multinationals and Indian manufacturers) in India also found just 1 serious AEFI determined to be vaccine-associated (excessive crying)”.
In 2009, India’s National Technical Advisory Group on Immunisation had advised the government to incorporate Hib via pentavalent into its national immunisation programme. The recommendation was endorsed by the Indian Academy of Paediatrics, a body of more than 19,000 paediatricians.
Since then, around 8.2 million doses have been administered to children in eight Indian states and the government is considering rolling out the vaccine nationwide.
The academy has welcomed the steps taken by government in setting up district, state and national-level AEFI committee for monitoring all serious AEFI.