Is India adequately assessing the deaths reported after Covid-19 vaccines?

Wait and watch.
Wait and watch.
Image: REUTERS/Adnan Abidi
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India has administered 36.4 million shots of the Covid-19 vaccine to its people. But healthcare experts now worry that these numbers are incomplete without looking at vaccine side-effects.

A group of 29 doctors, researchers, and healthcare professionals have written to India’s health minister and those on the committee for the Covid-19 vaccines expressing their worry over the lack of data on adverse events after immunisation (AEFIs) and deaths related to the vaccine.

This letter comes in the context of various European nations stopping the use of the AstraZeneca vaccine after reported AEFIs included incidents of clotting. In India, Covishield, manufactured by Serum Institute of India, is made from the master seed of the AstraZeneca vaccine. A large majority of India’s Covid-19 vaccine initiative depends on Covishield.

The group which wrote the letter is particularly concerned about the government withholding data on vaccine-related deaths. “We understand that at least 65 deaths have occurred following vaccination for Covid-19 since the vaccination campaign started on Jan. 16. However, the National AEFI committee’s investigation findings of only two of these deaths have been made public. Till now, no case of serious AEFI including death has been attributed to the vaccine,” it wrote in its letter on March 16.

Currently, the UK has been able to collect robust data on self-reported vaccine AEFIs—though some of them bizarre—which it had analysed and released (pdf) on March 8. The prevalence of blood clots was found to be one in 167,000 people who self-reported the symptom, which is at par with the occurrence of clotting incidents in the general population.

That is one of the reasons India’s vaccine committee remains cautiously optimistic.

Keeping an eye on vaccine AEFIs

India has a statutory body called the National AEFI Committee that currently monitors all mild and severe reactions to the vaccines. It is also meant to parse through the data and analysis on deaths.

NK Arora, the head of this committee, believes that there is no direct link between the deaths and Covid-19 vaccines from the data assessed so far. “Currently, whatever we are investigating, there is no causal linkage. All the events we have found so far are coincidental,” he told The Indian Express newspaper yesterday (March 17).

But the letter alerts to possible “gaps” in how AEFIs are being reported to the national committee. “There are gaps in AEFI investigations at the local level, affecting the quality of evidence submitted to state and national AEFI committees who depend on these findings for making causality assessments,” it said.

For now, though, India is going by the World Health Organization’s guidance on the safety of AstraZeneca vaccines and has no plans to pause its fast escalating vaccine drive.