Even as the Supreme Court is examining a writ petition seeking to discontinue the manufacture, use and sale of the pentavalent vaccine due to its adverse effects, the union health ministry for the first time has admitted at least three deaths have occurred due to the immunisation of pentavalent vaccine.

According to the latest causality assessment report of the national adverse events following immunisation (AEFI) committee, at least three deaths were related to pentavalent immunisation among the 20 such cases investigated by the government. As per the new causality report, only one death has happened due to SIDS (sudden infant death syndrome)”. There are three deaths with causal association with immunisation and seven reported as 'unclassifiable'.  Incidentally, all the three deaths due to 'A consistent causal association to immunisation' have been reported from Tamil Nadu.

In six of the total 20 cases, the committee has classified the cause of death as unrelated, and the three remaining deaths have been classified as 'classification not done', 'underlying or emerging conditions' and 'coincidental underlying or emerging conditions or conditions caused by exposure to something other than vaccine'.

The committee has investigated three cases in Haryana, four cases in Tamil Nadu and 13 cases in Kerala.

Pentavalent vaccines were first introduced in Kerala and Tamil Nadu in 2011 on a pilot basis. Since then it has been introduced in seven other states Karnataka, Puducherry, Goa, Gujarat, Haryana, Jammu & Kashmir and Delhi.

The introduction of five-in-one or pentavalent vaccine under the national immunisation programme was a controversial issue in the country till an expert panel, headed by Indian Council of Medical Research (ICMR) director general Dr V M Katoch, recommended to the government early 2011 that the vaccine merits introduction in the country's immunisation programme in phases after studying the impact assessment in each phase.

The diseases covered by the five-in-one vaccine are diphtheria, tetanus, pertussis (whooping cough), hepatitis B and haemophilus influenzae Type B (often known as Hib) which causes some severe forms of pneumonia and meningitis.

The union health ministry set up the expert committee under Dr Katoch after the National Technical Advisory Group on Immunisation (NTAGI)'s recommendation to introduce pentavalent vaccine under the government’s immunisation drive became controversial with the experts in the field airing doubts over the need for universal vaccination for some of the diseases covered by the vaccine.

There was widespread criticism in the country against the introduction of pentavalent vaccine under the government’s immunisation programme. The critics were of the opinion that the vaccines, which are of questionable utility, expensive and also carry possible side-effects, are sought to be introduced at the cost of public exchequer at the behest of World Health Organization (WHO) and vaccine manufacturers.