Covaxin, Covishield cleared for full market approval

Tribune News Service

New Delhi, January 19

Nearly a year after being granted emergency use authorisation for administration among the adult Indian population, subject experts of the Drug Controller General of India on Wednesday approved the two shots for full and regular market authorisation.

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

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 today, the majority are Covishield and the rest are Covaxin.

SII told the experts that the administration of nearly 100 crore shots to Indians and others worldwide is a testimony to population based efficacy and safety of the Covid vaccine.

An Emergency Use Authorisation (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current Covid-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

In the past many months, accelerated vaccine development to prevent or reduce the severity of coronavirus disease 2019 (Covid-19) 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-19 vaccine to Pfizer-BioNTech Covid-19 vaccine (Comirnaty) for individuals 16 years and older.

Full approval to Covishield and Covaxin marks a significant step forward to address concerns of people who were hesitant to get vaccinated due to only emergency use approvals to the shots.

With India keen to scale up vaccination and end hesitancy, the full approvals 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, hospitalizations and deaths.

The CDSCO said in a statement, “The Subject Expert Committee of the CDSCO has recommended for upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in adult population. The Drug Controller General of India will evaluate the recommendations and give its decision.”

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