Study linking bivalent vaccines with stroke: Govt says no signals of concern seen in India

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Days after a study on bivalent vaccines signalled a potential linkage to brain strokes in the United States, government officials in India said the analysis of adverse events following immunisation through COVID-19 vaccines in the country has showed no signals of concern.

“We haven’t administered the mRNA vaccines in India. So, any link of this study with Indians would be vague. However, if you talk about the adverse event following immunisation (AEFI), analysis has shown no signals of concerns in the country,” a senior official from the National Technical Advisory Group on Immunisation (NTAGI) told Moneycontrol.

Last week, the US Centres for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) had flagged that Pfizer and BioNTech's updated (bivalent) COVID-19 vaccines could be linked to a type of brain (ischemic) stroke in people aged 65 and older.

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“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public,” the FDA said in a statement.

The FDA has said this preliminary signal has not been identified with Moderna’s bivalent COVID-19 vaccine. The CDC and FDA said it will continue to evaluate additional data from these and other vaccine safety systems.

Another key official from the AEFI committee also said the government’s signal review meeting has been looking at the international reports, but no such report linked to a type of brain stroke in India has been seen.

“We have largely seen minor adverse events like fever and headache and nausea being reported in India. Among the major events, the thrombocytopenia syndrome (TTS) has been seen in the country,” the official said.

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The official added that no alarming signals were identified in India after assessing the global data of adverse events.

“We had signal review meetings in December and January to assess the adverse events being seen at the global level,” the official part of AEFI said.

The official said that the adverse event committee was also looking at cases of deaths due to sudden heart attacks in India.

Noting that the mRNA vaccines have been linked with myocarditis, Rajeev Jayadevan, Co-Chairman, National IMA COVID Task Force, said it has not yet been translated into a significant number of deaths in peer-reviewed published studies.

“Unfortunately, such data are being used by anti-vaxxers to generate universal fear of COVID vaccines, and this eventually will affect other vaccinations too. The vaccines used in India are different. Myocarditis is not a concern with these vaccines,” he added.