Covid-19: After Oxford vaccine, expert panel recommends conditional nod to Bharat Biotech’s Covaxin

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Updated: Jan 02, 2021 8:04 PM

According to sources, the panel recommends granting approval for restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India

CovaxinThe panel on Friday recommended that the Serum Institute of India’s Covishield vaccine be given the Emergency Use Authorisation (EUA) by the Drug Controller General of India with conditions.

Coronavirus vaccine update: After giving its approval to Oxford-AstraZeneca Covid-19 vaccine, the subject expert committee (SEC) of the Central Drugs Standard Control Organisation(CDSCO) on Saturday gave its nod to Bharat Biotech’s Covaxin for emergency use.

The panel has recommended granting approval for restricted use in an emergency situation in public interest as abundant precaution, in clinical trial mode, especially in the context of mutant strain infection, to Bharat Biotech and Serum Institute of India. The panel has also recommended the conduct of PhaseIII Clinical Trial Protocol to Cadila Healthcare, according to a release issued by the Ministry of Health and Family Welfare. It also granted permission to Serum Institute for the emergency use of the Oxford-AstraZeneca Covid-19 vaccine, subject to multiple regulatory approvals, the release said.

The panel on Friday recommended that the Serum Institute of India’s Covishield vaccine be given the Emergency Use Authorisation (EUA) by the Drug Controller General of India with conditions.

The DCGI will take the final decision on emergency approval to Covaxin and Covishield.

In India, there are four Covid-19 vaccines that are currently seeking approval. In the wake of the new Covid-19 strain in the UK, the SEC on Wednesday held a meeting to consider the emergency use approval request of Pfizer, Serum Institute of India (SII), and Bharat Biotech Pvt Ltd; Pfizer had asked for more time, according to the Union Health Ministry. Both Serum Institute, which is producing Oxford-AstraZeneca’s Covid-19 vaccine in India, and Bharat Biotech had submitted additional data regarding the vaccine to SEC for its analysis.

The panel further met on Friday (January 1), where they recommended the Oxford Covid vaccine to the Central Drugs Standard Control Organisation for emergency use approval. On Saturday, the SEC again held a meeting to decide on the emergency use authorisation for Bharat Biotech’s Covaxin after it submitted additional data, facts, and analysis subsequent to Friday’s review meeting, a source said, as reported by PTI.

On December 7, Hyderabad-based pharmaceutical firm Bharat Biotech had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for its Covid-19vaccine Covaxin. Bharat Biotech has developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR).

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