Not all 1,139 deaths post immunisation can be attributed to vaccines: officials

The Union Health Ministry is to study a reported rise in “adverse events” following vaccinations in 2017 as compared to the two previous years.

Between April and December last year, reports from across States recorded that 1,139 children had died following immunisation. By comparison, there were 176 and 111 such deaths during the same period in 2016 and 2015. The statistics have been compiled by a Health Ministry database.

Sources, however, stressed that along with children who may have died due to adverse reaction to a vaccine or improper administration or due to inherent defects in the vaccine itself, the numbers include children who were already seriously ill or had congenital diseases but had died during a specified period after vaccination.

A Health Ministry official told The Hindu that the 2017 numbers — termed deaths due to Adverse Events Following Immunisation (AEFI) — appeared “marginally higher” than the previous years, but the process of investigation was still on.

The database also records 21,450 AEFI cases that caused rashes and related skin reactions and abscess, as well as 2,66,879 ‘other’ AEFI cases for 2017.

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India’s AEFI data is compiled by district officers, and the Union Health Ministry’s national AEFI committee follows up on reports, sifting out deaths that may have a link with vaccine administration.

The National AEFI committee said that during 2012-2016, there were only 132 serious AEFI cases, in which 54 persons died while 78 were treated in hospital. About 50% of those who survived were classified as having had reactions. No deaths were attributed to vaccines alone.

Pradeep Haldar, who heads the Health Ministry division dedicated to tracking immunisation-related reactions, said data supplied by States on adverse events was not always accurate.

“This data is collated from States and there are quality issues. Only after we follow up on each and every adverse event can we reliably attribute the cause of death or other serious reactions,” he said. “Data reported in, say 2014, may sometimes take three years to verify. However there is a marginal increase in AEFI this year, according to preliminary reports.” The 2017 numbers emerged in response to Right To Information activist Chetan Kothari’s query to the Health Ministry. The Ministry said the data could be sourced from its public database, where The Hindu independently verified the numbers.

Gagandeep Kang, a member of the National Technical Advisory Group on Immunisation and a paediatrician involved in the development of India’s first homegrown rotavirus vaccine, said adverse events from vaccinations were under-reported in India so far because the AEFI panel met only four times a year and reviewed just 100 cases at a time.

The WHO has recommended the use of performance indicators for AEFI functionality assessment. Ms. Kang said it was important to note that all events were not deaths, nor was there any indication of a causal association with any vaccine, but they gave an indication that safety following immunisation was being monitored.

“It is estimated that for every 1,00,000 children immunised, there should be at least 10 serious adverse events (including deaths and hospitalisation). So if you take 26 million children getting three vaccines in their first year, you are talking about 2,600 such events,” she added.

India’s Universal Immunisation Programme has vaccines for 12 diseases. Vaccination coverage is about 65%, and the government aims to ensure 90% coverage by the end of the year.