Covaxin, Covishield okayed for regular market approval

Tribune News Service

New Delhi, January 19

Nearly a year after being granted emergency use authorisation, Covid vaccines Covaxin and Covishield were on Wednesday approved for full and regular market authorisation by subject experts of the Drug Controller General of India.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Covid-19, which reviewed Serum Institute of India and Bharat Biotech’s applications, has recommended regular market approval to Covishield and Covaxin subject to certain conditions, sources said.

Will boost drive

• Move will address concerns of people hesitant to get vaccinated due to only emergency use nod
• With India keen on ramping up vaccinations, full approvals will aid the drive

This was the second review of the applications submitted by Pune-based SII and Hyderabad-based Bharat Biotech. Of the 158.54 crore doses of Covid-19 administered in India till date, the majority are Covishield. SII told experts that the administration of nearly 100 crore shots to Indians and others worldwide was a testimony to population-based efficacy and safety of the vaccine.

• Fresh cases 2,82,970
• Total deaths 4,87,202
• Active cases 18,31,000
• 441 deaths in 24 hours

In the past many months, accelerated vaccine development to prevent or reduce the severity of Covid has resulted in rapid global emergency regulatory approvals, including the US Food and Drug Administration (FDA) emergency use authorisation (EUA) approvals and similar approvals worldwide, including in India.

On August 23, 2021, the US FDA gave the first full regulatory approval for a Covid vaccine to Pfizer-BioNTech’s Comirnaty for individuals 16 years and older.

With India keen on scaling up vaccinations and end hesitancy, the full approval to the two shots will aid expansion by allaying the fears of skeptics by way of full DCGI confidence in the safety of the two shots and their capacity to prevent severe Covid, hospitalisations and deaths.

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