India Approves 2 COVID­19 Vaccines For Emergency Use

The Central Drugs and Standards Committee (CDSCO) on Sunday formally approved the COVID­19 vaccines by Bharat Biotech and the Serum Institute of India (SII). This allows the vaccines — Covishield by SII and based on the Oxford AstraZeneca vaccine, and Covaxin by Bharat Biotech — to be offered to healthcare workers and frontline workers in India. The Health Ministry had said that 3 crores such personnel, considered at the highest risk for COVID­19, would be given the vaccine for free. It isn’t yet known which vaccine will be made available to this personnel though officials said rollouts could begin in less than a fortnight. Yet to complete trials Neither Covishield nor Covaxin has completed the crucial Phase­3 trial, under which a vaccine candidate is administered to volunteers at multiple locations across the country.


The approval was based on a recommendation by a Subject Expert Committee which deliberated for two days on granting approvals to the vaccines.  The minutes of the SEC meeting aren’t yet available However, a Health Ministry statement said the vaccine’s efficacy in Indian volunteers was “comparable” to that tested in overseas trials. Both approvals accorded are for “restricted use in an emergency situation” and in the case of Bharat Biotech, the approval wording notes that it is in “...public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains''. These conditions were not specified. 


Bharat Biotech, whose vaccine candidate is being tested in large Phase­3 trials in India, has provided safety and immunogenicity data India should be able to roll out its COVID­19 vaccination programme in the “near future” as the preparations are ready and robust, NITI Aayog member (health) V.K. Paul said in an exclusive interview to The Hindu. He added that at least 12 countries had expressed interest in the indigenous vaccine, Covexin. Dr. Paul said all preparations had been made to reach the last mile to dispense vaccines to beneficiaries. Stating that all vaccines currently available across the world work even with the mutation of the virus, Dr. Paul said, “ICMR­Bharat Biotech’s Covexin is a whole virion  vaccine approved for restricted use in an emergency by the Drugs Controller General of India and since this vaccine works on the whole of the virus, this is our additional weapon against it.




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