Infant deaths have cast a shadow over the inclusion of the pentavalent vaccine in the country’s Universal Immunisation Programme (UIP).

Though the pentavalent vaccine has been rolled out in about six States and is poised for a scale-up – its safety continues to be called into question by a deeply divided scientific community.

The issue is expected to come up at the NTAGI (National Technical Advisory Group on Immunisation) meeting this week.

Coming out in an open endorsement of the 5-in-1 vaccine, the Indian Association of Pediatrics (IAP) recently “reassured” health-administrators on the safety of the pentavalent vaccine.

Referring to serious adverse events, including deaths reported after immunisation in India, Sri Lanka, Bhutan and Vietnam – the IAP said, “investigations by local governments and the WHO (World Health Organisation) have demonstrated no casual link between the pentavalent vaccine and reported infant deaths.”

But even as it endorses the vaccine, the IAP admits, “the causality (of death) could not be ascertained in all cases due to incomplete information”.

Vaccine deaths?

And this is precisely the cause for concern, say pro-health representatives.

Not being able to link infant deaths to the vaccine does not make the vaccine safe, says a representative familiar with the issue. Concerned that the number of infant deaths may be greater than what was being reported, a section of doctors has called for greater scrutiny of the vaccine and the adverse effects linked to it.

Immunisation needs to be followed-up by active monitoring, and the scaled-up vaccine roll-out should be deferred till the Government is confident the vaccine is safe, they point out.

A Public Interest Litigation questioning the safety of the pentavalent vaccine is at present in the Supreme Court. Though reports say 15 infants died following the immunisation in Kerala and Tamil Nadu in 2012 – the petition says that information revealed through the Right to Information Act found that there were five deaths in 40,000 doses administered to children in Kerala, in six months.

“If this is extrapolated to the 25 million babies born in India each year, 3,125 deaths can be expected. These deaths from the vaccine outweigh any benefit of immunisation,” the petition added.

Reinstated programmes

The IAP, however, says that Sri Lanka and Bhutan have reinstated the vaccination programme that was suspended following infant deaths. Elaborating on the uncertainty over the deaths, the IAP explains that children are at their greatest risk in the first year of life, where they succumb to conditions including diarrhoea, pneumonia and sudden infant death syndrome.

The first year of life is also the time most vaccines are administered.

Therefore, deaths among infants will be coincidentally associated with vaccination administration even though those deaths are not caused by the vaccines, the IAP explains.

Former chief of the Indian Council of Medical Research N.K. Ganguly, further adds, that much thought had gone into the administration of the pentavalent vaccines, including having standard operating procedures, training people who give the vaccine and setting up of surveillance mechanisms to observe children after the vaccination was done.

Several countries use vaccines made by Indian companies and “we owe it to our children,” he said, indicating that the vaccine was required if the country had to bring down its infant mortality rate.