Covid-19 vaccine: After UK findings, India to expand review of probable side effects of Covishield, Covaxin

As the concerns over the possible side effects of Oxford University-AstraZeneca Covid-19 vaccine surface in several countries, including the United Kingdom, authorities in India have decided to widen the scope of data to analyse the probable cases of side effects resulting among beneficiaries who have been vaccinated with AstraZeneca vaccine as well as Bharat Biotech’s Covaxin, The Indian Express reported. The decision by the Indian authorities comes in the wake of the European Medicines Authority (EMA) listing “unusual” blood clots (thrombosis) and abnormally low blood platelets (thrombocytopenia) as “extremely rare” side effects of the AstraZeneca vaccine. The EMA also found that these blood clots were found at places like veins inside the brain, abdomen, along with other arteries of the body.

The Oxford University-AstraZeneca Covid-19 vaccine is being manufactured by the Serum Institute of India (SII) in India and branded as Covishield and is one of the two Covid-19 vaccines currently being inoculated in the country. Reacting to the development related to Covishield vaccine, President of the Public Health Foundation of India Dr Srinath Reddy said that Indian drug regulators should now also provide data on similar adverse events which may have occurred in the country.

The Indian authorities including the National Committee for Adverse Event Following Immunization (AEFI) have now decided to expand the review of adverse reactions and will now analyse about 19,500 mild cases, the Indian Express reported. The review of data is expected to continue until the end of next week. A close source told The Indian Express that the authorities have taken a lead from what is being said about the vaccine by UK authorities. The source who wanted to remain anonymous also said that the review of data will exclusively focus on the blood clotting issue.

Whether India will follow the UK example and issue an advisory after the completion of the analysis remains to be seen. The source told the Indian Express that if there is a need to issue an updated advisory then the advisory will be issued through proper channels. However, the source further said that a tightrope will have to be walked as a not well-thought-out advisory could actually cause alarm about the Covishield vaccine which constitutes the largest amount of vaccine stocks in the country. The negative fallout could also cause more damage in India as there is only one alternative to Covishield in comparison to European countries which have alternatives like Pfizer, Moderna vaccines among others.

Malini Aisola, who is a co-convenor of patient activist group All India Drug Action Network (AIDAN) expressed concern about the lack of serious investigation and exchange of information about the probable adverse events resulting from the vaccine even as more AstraZeneca vaccines are being administered in India compared to any other country.