Centre confirms three pentavalent vaccine deaths

Union health ministry says 17 other deaths of infants reported in Haryana, Kerala and Tamil Nadu were not linked to five-in-one vaccine

By Jyotsna Singh
Published: Monday 16 December 2013

The pentavalent vaccine has replaced DPT vaccine and combines H influenza B and Hepatitis-B with the older trivalent vaccine

The Union Ministry of Health and Family Welfare has admitted that the pentavalent vaccine has caused at least three infant deaths in Tamil Nadu since December 2011 when the vaccine was launched in the state. The admission follows a Right To Information query after vaccine-related deaths were reported in Tamil Nadu, Kerala and Haryana.   

Pentavalent vaccine, which has replaced DPT (diphtheria, pertussis, and tetanus) vaccine and combines H influenza B and Hepatitis-B with the older trivalent vaccine, has been mired in controversy ever since it was introduced, with health experts continuously raising questions of its relevance in India.

The RTI, filed by Delhi-based RTI activist Sanjai Sharma, had sought official data on causality assessment of alleged vaccine-related deaths by local and national committees in October. The reply was given over a month later. This is the first time that any data by the government confirming deaths caused pentavalent vaccine has is out in the public domain. Activists have been trying to bring this to the government's notice, but the authorities did not accept the deaths as being related beyond doubt to the vaccine.

The RTI query also gives details of three reported deaths in Haryana and 13 in Kerala, apart from four in Tamil Nadu. The deaths reported in Kerala and Haryana, the ministry says, were either coincidental or caused by unknown reasons.

Discrepancies in reports

The reply to RTI also shows discrepancies between reports of local Adverse Effect Following Immunisation (AEFI) committees and the national committee.

The district and state AEFI committees had confirmed only one vaccine-related death in Tamil Nadu. The National AEFI Committee found that three out of four deaths it investigated were caused by the vaccine. The national body concluded that it found "a consistent causal association" of death to immunisation.

"This should raise concern. Local committees should be in a better position to investigate because they can reach fast and get better information. Instead, we see national committee finding the reasons of death in more details," said Amitav Banerjee, professor of community medicine at D Y Patil Medical College, Pune. Banerjee has written a letter to the Union health secretary to look into the matter of deaths as well as the discrepancy.

The RTI reply reveals that the local committees found one death to be vaccine-related, which coincides with the national committee's findings. Of the remaining two, one was judged to be caused by unknown reasons, and other coincidental with administration of the vaccine. There was no discrepancy in the reported of the national and local committees on conclusions about the deaths of infants administered the vaccine in Haryana and Kerala.

"It shows we need a proper monitoring system. We should know what is the rate of catching diseases after the vaccine. It is a cost intensive programme. Pentavalent vaccine costs six to seven times more than the age old DPT vaccine. The coverage of DPT is still 50-60 per cent in a given year. First that should be sorted out," said Banerjee.

He said the government should invest in sanitation and proper drinking water too to control diseases among children.

AEFI and the pentavalent vaccine: looking for a composite picture

Introduction of pentavalent vaccine in India

Introducing pentavalent vaccine in the EPI in India: A counsel for caution

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