The pentavalent vaccine (PV), that was introduced into India's immunization programme six years ago, has doubled the deaths of children soon after vaccination compared to DPT (Diphtheria-Pertussis- Tetanus) vaccine, according to a study that calls for a 'rigorous review of the deaths following vaccination with PV'. According to government records, there were 10,612 deaths following vaccination in the last 10 years.

PV is a combination of DPT vaccine and two more vaccines against Haemophilus influenza type B (Hib) and hepatitis B.  Starting December 2011, PV was introduced into India's immunization programme to replace DPT vaccine in a staged manner with a view to adding protection against Hib and hepatitis B without increasing the number of injections given to infants.

The conducted study by Dr Jacob Puliyel, Head of Pediatrics at St Stephens Hospital and Dr V Sreenivas, Professor of Biostatistics at the All India Institute of Medical Sciences (AIIMS), both in New Delhi, has been published in the peer-reviewed Wolters Kluwer Health’s journal, Medical Journal of Dr D Y Patel University.

The sporadic reports of unexplained deaths following immunization with PV had been a matter of concern. Dr Puliyel, Dr Sreenivas, and their colleagues undertook the study to find out if these deaths were merely coincidental or vaccine induced.  The authors obtained data of all deaths reported from April 2012 to May 2016 under the Right to Information Act. Data on deaths within 72 hours of administering DPT and PV from different states were used.

For their study, the authors assumed that all deaths within 72 hours of receiving DPT are natural deaths. Using this figure as the baseline, they presumed that any increase in the number of deaths above this baseline among children receiving PV must be caused by this vaccine.

If a state introduced PV in 2014, then data on DPT doses PV doses and deaths following vaccination were noted from that year on. This ensured that the deaths were all reported from the state using the same surveillance system.

According to their analysis of the data provided by the government, there were 237 deaths within 72 hours of administering the PV -- twice the death rate among infants who received DPT vaccine.  Extrapolating the data, the authors have estimated that vaccination of 26 million children each year in India would result in 122 additional deaths within 72 hours, due to the switch from DPT to PV.

"There is likely to be 7,020 to 8,190 deaths from PV each year if data from states with the better reporting namely Manipur and Chandigarh are projected nationwide," the report says.

The authors note that while the study looks at the short-term increase in deaths (within three days of vaccination) it does not calculate the potential benefits of PV on infant mortality, for example by protection against lethal diseases like haemophilus influenza.

In spite of the data presented in this paper from a large cohort, the authors point out that the evidence is merely circumstantial and not conclusive. "These findings of differential death rates between DPT and PV do call for further rigorous prospective population-based investigations," the study concludes.

The health ministry has promised to study the huge increase in 2017. The present analysis could be a starting point in the quest to reduce the numbers of such deaths.