Bharat Biotech releases statement amid Covishield blood clot row: ‘Covaxin was developed with…’

Bharat Biotech on Thursday released a statement highlighting the safety measures taken during the development of its COVID-19 vaccine amid debate over the side effects of Covishield. The assertion comes mere days after AstraZeneca admitted in court that its vaccine could “in very rare cases” cause Thrombosis Thrombocytopenia Syndrome or TTS.

“Covaxin was developed with a single-minded focus on safety first, followed by efficacy…It was the only COVID-19 vaccine in the government's immunisation programme to have conducted efficacy trials in India. It was evaluated in more than 27,000 subjects as part of its licensure process,” the company asserted. 

Bharat Biotech added that all studies and 'safety follow-up activities' indicated that Covaxin was not associated with “incidents of blood clots, thrombocytopenia, TTS, VITT, pericarditis, myocarditis and more”. COVID-19 vaccines have once again become part of the political discourse after AstraZeneca admitted to the ‘extremely rare’ side effect.

The details were reportedly shared in court documents as the vaccine maker takes on a case linking its jab to death and serious injury in dozens of cases. Documents quoted by British media add that the causal link between the vaccines and the blood clot-related side effect remains unknown. Serum Institute of India had produced its version of the Vaxzevria vaccine (called Covishield) by using the viral vector platform.

“TTS is a serious and life-threatening adverse event. WHO has issued this interim emergency guidance to increase awareness about TTS in the context of COVID-19 vaccination and help healthcare providers in the assessment and management of potential TTS cases,” the World Health Organisation had said last year.

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A plea was filed in the Supreme Court on Wednesday seeking the constitution of a medical expert panel under the supervision of a retired apex court judge to examine any possible side effects and risk factors of the Covishield vaccine.

(With inputs from agencies)