Congress seeks Centre's clarification on SEC recommending Bharat Biotech's Covaxin

A day after the Special Experts Committee (SEC) gave the Emergency Use Authorization (EUA) nod to Bharat Biotech's vaccine -Covaxin, Congress' Jairam Ramesh has asked as to why the internationally accepted protocol is being modified for approving Covaxin. In a tweet on Sunday, just ahead of DCGI media briefing at 11 am, Ramesh said that Phase 3 trials protocol have been modified for the Bharat Biotech vaccine candidate. He urged Health Minister Harshvardhan to clarify on the same. 

The Special Experts Committee (SEC) on Saturday evening gave its nod to Covaxin and submitted its recommendations to the Drugs Controller General of India (DCGI). The Hyderabad-based pharma firm has partnered with the ICMR to develop India's indigenous COVID-19 vaccine. The drugs regulator is likely to give its decision on the applications for the COVID-19 vaccine candidates tomorrow. This comes after the SEC had recommended Serum Insititute's 'Covishield' for use against COVID-19 and had sought additional efficacy reports from Bharat Biotech. Meanwhile, the DGCI on Sunday will be briefing the media at 11 AM, at the National Media Centre regarding the vaccine.

READ | Health Minister reviews COVID vaccine dry run preparations even as SEC meets on approvals

However, serious questions have been raised about the Covaxin as its Third Phase trials are still ongoing, and the company has published the findings of the first two rounds. The vaccine also faced controversy after Haryana minister Anil Vij tested positive after receiving one dose of the vaccine during the trial. However, the company clarified that the efficacy of the vaccine can be determined only after 14 days post the second dose. Bharat Biotech has said that it is an inactivated vaccine, that destroys the pathogen’s ability to replicate, but keeps it intact so that the immune system can still recognise it and produce an immune response. 

READ | Bharat Biotech's Covaxin Gets SEC's Nod, DCGI Decision On Vaccine Likely Tomorrow: Sources

SEC recommends Covishield 

With the SEC giving a green signal to the Serum Institute's COVID vaccine candidate, the firm remains only a step away from making Covishield India's first approved COVID vaccine. Serum Institute, in partnership with Oxford-AstraZeneca has developed  Covishield, and now it awaits the confirmation from Drug Controller General of India (DCGI). Notably, the United Kingdom government had authorized the use of the Oxford-AstraZeneca COVID-19 vaccine couple of days ago, pushing its approval case inches ahead in India. Pertinently, the Serum Institute of India has already produced around 50 million dosages of the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' and plans to scale it up to 100 million by March next year even as it awaits app

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All about COVISHIELD here - Know all about the Oxford vaccine