Call for Review of Adverse Reactions to COVID-19 Vaccines in India

In the wake of concerns raised in the UK High Court regarding the potential side effects of COVID-19 vaccines, medical experts in India are calling for a thorough evaluation of adverse reactions to these vaccines within the country. Dr. Sanjay Rai, a professor of community medicine at the All India Institute of Medical Sciences (AIIMS) and a key figure in India’s pandemic response, has emphasized the need for a comprehensive review by the health ministry’s Adverse Event Following Immunization (AEFI) committee to assess the safety of COVID-19 vaccines.

Dr. Rai’s statement comes after the British drugmaker AstraZeneca admitted in court that its COVID-19 vaccine, Covishield, which has been widely administered in India, can cause “rare side effects” such as thrombocytopenia syndrome (TTS), a condition involving blood clots and a low platelet count. In India, a plea has been filed in the Supreme Court seeking the establishment of an expert panel to evaluate the side effects of Covishield.

Dr. Rai, who played a key role as Principal Investigator of safety trials for Covaxin, another COVID-19 vaccine manufactured by Bharat Biotech, pointed out that while vaccines have been effective in controlling the severity of the virus, adverse events do occur, albeit rarely. He stressed the importance of conducting a risk-benefit analysis to weigh the potential benefits of vaccination against the risks of rare side effects.

As of May 1, 2023, India had recorded 856 active COVID-19 cases, and 23 people had received COVID-19 vaccinations on that day. Dr. Rai suggested that vaccination may no longer be necessary since the majority of the population has developed immunity against the infection, and that further vaccination could potentially do more harm than good.

In India, Covishield was manufactured by the Serum Institute of India and extensively administered to the population. While Covishield’s phase 2 and 3 trials were conducted in India in collaboration with the Indian Council of Medical Research (ICMR), efficacy trials were carried out in the UK, US, Brazil, and South Africa. Despite queries, the Serum Institute has yet to provide a response.

The Serum Institute’s website acknowledges the potential occurrence of adverse events after Covishield vaccination, including major blood clotting in combination with a low platelet count. However, the company maintains that the vaccine has an acceptable safety profile and that the benefits of vaccination outweigh the risks of extremely rare potential side effects.

A report published in 2022 by the reputable medical journal Pubmed cited short-term adverse events following two doses of Covishield but characterized them as mild and short-lived.

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