Covishield and Covaxin approved for emergency use as COVID vaccines

Covishield and Covaxin approved for emergency use as COVID vaccines

The Central Drugs and Standards Committee (CDSCO) formally approved the COVID-19 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 crore such personnel, considered at the highest risk for COVID-19, would be given the vaccine for free.
Neither Covishield nor Covaxin has completed the crucial Phase-3 trial, under which a vaccine candidate is administered to volunteers at multiple locations across the country.
Both approvals accorded are for “restricted use in 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.

The Central Drugs Standard Control Organisation (CDSCO)

CDSCO under Directorate General of Health Services, Ministry of Health and Family Welfare is the National Regulatory Authority (NRA) of India.
Functions: Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice.
CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

Source: TH

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