In a fresh report, national AEFI panel confirms 55 severe adverse events after COVID-19 shots

NEW DELHI: The national Adverse Effects Following Covid-19 Immunization (AEFI) committee has approved reports for 60 more serious adverse events, ruling that 55 cases, the majority of which needed hospitalization, were associated with vaccination as per the causality assessment. 

A total of five cases, that included a death after administration of Covishield in a 57-year-old male in February, however, were found to be “coincidental”, not directly linked with vaccination.

The report is based on an assessment of 60 serious adverse events—three of which were recorded following Covaxin jabs while the rest were registered after administration of Covishield- by the national panel on May 27 and was submitted to the Union ministry of health and family welfare on July 8.

Before this, in June, releasing the first national report on causality assessment of 31 serious AEFI cases, the Centre had recorded India’s first Covid19 vaccine-related death since the start of the coronavirus vaccination campaign while seven other post-vaccination deaths were declared as “indeterminate" indicating there is no evidence to connect them to the vaccines.

The confirmed death due to the Covid-19 vaccine was reported in a 68-year-old male on March 21 and the reason was anaphylaxis or severe allergic reaction to the jab but it's not clear whether the person had received Covishield or Covaxin.

The latest report says that 36—out of 60- were anxiety-related reactions, and 18 were vaccine product-related reactions, and one was classified as both vaccine product-related and anxiety-related reaction.

However, five cases were found to have inconsistent causal association to vaccination, (coincidental - not linked to vaccination) of which one was a death case.

“Overall, the benefits of vaccination are overwhelmingly greater than the small risk of harm. However, as a measure of utmost precaution, all emerging signals of harm are being constantly tracked and reviewed periodically,” the report by the committee, headed by N K Arora said.

The report further explained that vaccine product-related reactions are expected reactions that can be attributed to vaccination based on current scientific evidence, examples of such reactions are allergic reactions and anaphylaxis.

Those watching the follow up of adverse events following Covid19 shots meanwhile said that while release of this bulletin is a positive step, the committee seems to be sitting on “difficult AEFI cases”.

“Majority of the cases assessed include anxiety reactions while the committee is not releasing its report on a huge pile of cases of deaths and hospitalisations,” said Malini Aisola of the All-India Drug Action Network. 

“I just wish that the AEFI assessment process is faster and more transparent.”

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