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01 Apr 2014

The introduction of the pentavalent vaccine in India in December 2011 as part of the immunization programme of the Government has had a chequered history. The pentavalent vaccine (a combination vaccine for protection against five childhood diseases- diphtheria, pertussis (whooping cough), tetanus, hepatitis B and pneumonia and meningitis (caused by Haemophilus influenza type B (Hib)), seeks to replace the  traditional DPT vaccine given to infants at 6, 10 and 14 weeks of age. At present the vaccines are procured from WHO pre-qualified manufacturers, by the UNICEF, through part funding from the Global Alliance for Vaccines and Immunizations, more commonly known as the GAVI alliance (GAVI is a public private initiative that provides financial support to developing country governments to purchase vaccines for their immunization programmes). The use of the vaccine has been associated with adverse events following immunization (AEFI) and deaths. The fact that globally at least 63 deaths of infants have been recorded post-pentavalent inoculation, and that even in India the number of recorded deaths have climbed to 54 since 2011, calls for some serious re-assessment of the decision to introduce pentavalent vaccine in the universal immunization programme in India.  Between September and October 2013, news reports from Kashmir reported 8 cases of deaths of infants at the G.B. Pant Hospital in Srinagar. Information obtained under RTI showed that there had been several deaths between June and December, specifically, 1 death in June; 1 in September; 11 in October and 1 in December 2013. Roughly between 1-3 months of age, all these infants had received the pentavalent vaccine 12-36 hours prior to their death.It was in this context that PUDR put together a team comprising public health experts, and clinicians, to look into these deaths.This report should not be interpreted as being critical of all immunizations per se.  Rather it is an attempt to place in the public domain, to the extent possible, all the information and all sides of the discourse on adverse events following immunization and safety of vaccines.

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