COVID-19 : Serum, Bharat Biotech Vaccines Approved For Emergency Use

Subject Expert Committee of the Central Drugs Standards Control Organization met on January 1 and 2 to discuss the two vaccines.

Covishield and Covaxin, vaccines against Coronavius, have been given the go ahead for emergency use authorisation the Drugs Controller General of India, who is yet to announce when the vaccine will be rolled out in the country.

The recommendation for Covaxin and Covishield came from the Subject Expert Committee (SEC) of India's Central Drugs Standards Control Organisation (CDSCO). The panel permitted restricted emergency usage of both the vaccines, subject to unspecified multiple regulatory conditions.

Serum Institute of India is manufacturing Covishield, the adenoviral vector vaccine that is produced by Oxford-AstraZeneca. This vaccine which was undergoing Phase III trials in India received emergency approval in the United Kingdom on December 31. A reported effectiveness between 62-90 percent, this vaccine transfers the spike protein of SARS-CoV-2 and helps the body elicit an immune response.

Covaxin, India's indigenous vaccine candidate is prepared by Bharat Biotech with a strain isolated by the country's National Institute of Virology and uses the inactivated virus with adjuvants, to create antibodies against the virus. Still in the clinical trial phase, Covaxin, received the panel's nod in "public interest as an abundant precaution" with the statement adding, "in clinical trial mode, (e)specially in the context of infection by mutant strains". The Ministry and Bharat Biotech are yet to clarify the specifics of the caveats in Covaxin's approval. From the 25,800 people who participated in the trials, over 22,000 have received either the vaccine or a placebo. The efficacy data of this vaccine is still awaited.

The DCGI has also accepted the panel's recommendation to grant approval to Cadila Healthcare to conduct the third phase trials for its vaccine - ZyCov-D.

After a vaccine dry run in four states - Assam, Andhra Pradesh, Punjab and Gujarat, the Centre conducted a dry run for the vaccine in all states and union territories. The roll out checked the distribution methods, registration, administering of the vaccine.

India reported 18,177 cases in 24 hours, taking the total number 1,03,23,965 cases on Saturday. We also reported 217 deaths in a single day, with the death toll currently at 1,49,435. Of the reported 2,47,220 active cases, 29 cases are those positive for the new mutated coronavirus.

(Editor's Note: This story has been updated with after the DCGI's press conference)

Updated On: 2021-01-04T22:35:07+05:30
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