Amid reports that the government is planning to conduct a study to assess the pentavalent vaccine and the Supreme Court seeking comments of the Centre on discontinuing it, Indian Academy of Paediatrics (IAP) has strongly come out in support of the safety of the vaccine.

“IAP reassures all those concerned with the administration of pentavalent vaccines about the safety of the available pentavalent vaccine ((DTwP-HepB-Hib) formulations in the country,” the doctors' body stated, while claiming that the `misinformation campaign’ by the critics has re-surged.

In the wake of 21 infants dying after receiving pentavalent vaccine in the country, government is in the process of holding a study on the safety of the vaccine by the national-level Adverse Events Following Immunisation (AEFI) Committee of the Ministry of Health and Family Welfare.

Meanwhile, the Supreme Court has also sought the comments from the government on stopping the manufacture, use and sale of the pentavalent vaccine.  The court also sent notices to the Drug Controller General of India and the Christian Medical College at Vellore, on a PIL filed by some organisations.

“The IAP denounces the attempts to distort the facts and create confusion regarding the safety of the vaccine. It also condemns the approach of selectively referring to only a part of the studies or technical reports often neglecting the overall conclusion, and manipulating it to create doubts regarding the safety and utility of newly introduced pentavalent vaccine in the country. The academy fully endorses, and also commends the government’s decision on introduction of pentavalent vaccines in six states of the country,” the IAP statement said.

The pentavalent vaccine was introduced in Tamil Nadu and Kerala in December of 2011, and later the vaccine was introduced in phases in Haryana, Puducherry, Goa, Gujarat, and Jammu and Kashmir after an evaluation of the two states in August 2012.

The serious Adverse Events Following Immunization (AEFIs) including deaths, after pentavalent vaccination have been reported in Sri Lanka, Bhutan, India, and Vietnam.  However, investigations by local governments and WHO have demonstrated no causal link between pentavalent vaccination and reported infant deaths, the association said.

“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. In fact, IAP had conducted a scientific study amongst around 1000 pediatricians and found that more than 80 per cent of them are using this 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),” IAP said.

“IAP maintains that pentavalent vaccines provide tremendous public health benefits related to the ability to protect against five major health problems in a single shot. This vaccine has been given to tens of millions of children in more than 180 countries around the world and its safety profile has been well documented in India and elsewhere through clinical studies,” it said.