Even as the controversy over the reason for the death of four children after they were administered the pentavalent vaccine continues in Kerala, the state  government has informed the Kerala High Court that administration of pentavalent vaccine cannot be said to be the sole cause of these children's death.

In a counter affidavit filed by the Kerala government in the Kerala High Court against a case filed by the Human Rights Law Network (HRLN) on behalf of parents of Ancy who died after receiving pentavalent vaccine, the Kerala government has pleaded that  the postmortem report of the baby has only indicated that hypersensitivity reaction is a probable cause of death. It does not indicate any direct reaction of the vaccine to the death of the child. Apart from the vaccine any other foreign material including paracetamol could have caused hypersensitivity to the child which has resulted in death.

Since the date of introduction, the pentavalent vaccine is being routinely administered as part of the UIP. Out of the 4 adverse instances reported after the administration of the this vaccine, including that of the deceased Ancy, no case is reported having direct connection with the administration of the vaccine. While two children are reported dead due to co-morbidity, another case could not be investigated due to refusal of parents to have autopsy conducted on the dead child. The vaccine has been implemented in the private sector for a long time before introduction of the pentavalent vaccine in the government sector, the Kerala government's counter affidavit said.

Pentavalent vaccine is certified as safe by WHO also. The possibility of adverse reaction due to the use of pentavalent vaccine is no more than what is seen in other vaccines. Since hypersensitivity occurs through unique reaction between the recipients body and the allergen, administration of pentavalent vaccine cannot be said to be universally bad since the allergic reaction depends on the acceptability of the foreign element within the body of every and any individual. As the relationship between vaccine and hypersensitivity is not established and as almost 20 hours had elapsed between vaccination and death of the child no reactions were seen during the intervening period, administration of pentavalent vaccine cannot be said to be the sole cause of the child’s death, it said.

The Kerala government informed the Court that though an enquiry was conducted on the death of Ancy by a team constituted by the government of India, the linkage between the death of the child and the administration of pentavalent vaccine is not yet conclusively proven and appears to be only extremely remote. No other child who was vaccinated from the same container or from any other container on that day had adverse consequences.

Four children had 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. A public interest litigation (PIL) was filed by the NGO HRLN in the Kerala High Court at Ernakulam on behalf of parents of Ancy who died after receiving pentavalent vaccine on December 15, 2011.