Four children have died in Kerala after they were administered pentavalent vaccine, which was introduced by Kerala government in its Universal Immunization Programme (UIP) on December 14, 2011. However, whether the administration of pentavalent vaccine is the reason for the death of these children is yet to be established.

According to sources, a Public Interest Litigation (PIL) has been filed by an NGO called Human Rights Law Network (HRLN) in the Kerala High Court at Ernakulam on behalf of parents of a female baby Ancy who died after receiving pentavalent vaccine on December 15, 2011. In the PIL, the HRLN has prayed to the court to stop vaccinating pentavalent vaccine to the other  children as there is risk of death due to the vaccine. The PIL was filed on February 16 this year.

Advocate Sandhya Raju, who is representing the HRLN in the case, said that the untoward incident involving the 56-day old female baby Ancy happened on December 15 a day after she was administered the first dose of pentavalent vaccine at the community health center at Vithura in Thiruvananathapuram district on December 14, 2011. On the same day of vaccination, the baby developed fever and the next day she died.

Sources said that in the second case at Kattakkada, Thiruvananathapuram, another baby died after administering the pentavalent vaccine. In this case, the child had reaction on way home from government hospital after vaccination. They went back to same government hospital. But the child died there. The hospital asked to do post-mortem which the parents declined.

Experts argue that if the reaction occurred after the injection and there was no other cause for the reaction it must probably be due to the vaccine.

In two other cases involving two children, who were administered the pentavalent vaccine, said to be died of co-morbid condition. But, the authorities so far could neither explain what the co-morbid condition was nor why the doctors gave pentavalent vaccine to two children who were so sick.

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 last year 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.

Sanofi-aventis, Shantha Biotech, Serum Institute of India, Bharat Biotech and Panacea Biotec are among the major companies that had introduced pentavalent vaccines in the domestic market.