Covid-19: Covaxin, Covishield vaccines recommended for full market approval
The regular approval recommendation comes after deliberation on the side effects observed due to the vaccines in the last one year.
India’s primary vaccines being used against COVID-19, Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield have been recommended for regular market approval after a meeting of the government panel SEC (Subject Expert Committee) of CDSCO (Central Drugs Standard Control Organisation) on Wednesday (January 19).
Experts reviewed documents related to vaccine trials. The regular approval comes after deliberation on the side effects observed due to the vaccines in the last one year. Both vaccines now have regular market approval rather than approvals for emergency use.
Applications by Bharat Biotech and SII were submitted to drug regulator DCGI for regular market authorisation.On January 3, Covaxin and Covishield were granted Emergency Use Authorisation (EUA).
More than 100 crore doses of Covishield have been administered in India, under the government’s Covid-19 vaccination drive, and around the world.
"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech's application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions,” an official source was quoted by news agency PTI.
(With inputs from agencies)