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Explained: Reading data on post-vaccination effects and deaths in India

Since January 16 this year, 95.43 million doses of Covid-19 vaccines have been administered, with around 11.27 million people receiving both doses of either Covishield or Covaxin.

AEFI refers to untoward medical occurrences in people after being vaccinated against a certain disease. (File photo)

Around 180 people have died following vaccination against Covid-19 in India as of March 29, according to excerpts of a presentation made to India’s top Adverse Events Following Immunisation (AEFI) committee. AEFI refers to untoward medical occurrences in people after being vaccinated against a certain disease; these reactions are not necessarily always due to the vaccine. National and state AEFI committees are in place in India.

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So, how many AEFIs have been reported?

Since January 16 this year, 95.43 million doses of Covid-19 vaccines have been administered, with around 11.27 million people receiving both doses of either Covishield or Covaxin.

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Updated information on AEFIs as of April 9 is not available. However, a senior government official involved in the process of reviewing AEFIs has said that side-effects have been observed in over 20,000 people after they received a dose of either vaccine. Around 97% of them reported mild or moderate AEFIs that do not require hospitalisation. There have also been severe and serious adverse events (SAEs), but the government has not provided an update on it for nearly a month.

The presentation to the National AEFI Committee sheds some light on this aspect. As of March 31, there were 617 SAEs, including 180 deaths, according to it. Around 305 people with AEFIs had to be hospitalised, with around 276 hospitalisations occurring less than three days after the vaccination. In a categorisation of 124 of the deaths, again, a large proportion occurred less than three days after the vaccination, with the number of deaths tapering off as the days went by.

Top five categories of death following vaccination

Do the deaths mean the vaccines are unsafe?

It is not necessary that the vaccines would cause these adverse effects and deaths. While there have been instances around the world when AEFI surveillance and investigations have found some drugs and vaccines unsafe in specific or general populations, the Covid-19 vaccines being used in India and elsewhere have so far not been found unsafe. Reviews worldwide are being done by various committees, including India’s National AEFI committee.

For now, the government says both Covishield and Covaxin are safe and all those in the priority groups should be vaccinated.

What are the implications of the deaths, then?

The National AEFI committee is expected to review all these SAEs, including the deaths, to assess whether they are linked to the vaccines being used. So far, the committee has received complete documentation of only 236 (38.3%) of the over 600 SAEs reported across the country.

The committee is expected to study the documentation, including the person’s medical history and/or post-mortem reports, verbal autopsy, hospital reports and documents from investigations of the immunisation site. It is crucial for this information to be properly gathered at district level

For instance, in a report of investigations on eight serious AEFIs, the death of at least one person in Bihar was unclassifiable. There was “little clinical information” and “no diagnosis” mentioned in the available treatment records.

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