Expert panel clears Covaxin, Covishield for market use

An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has cleared Covishield and Covaxin for regular market use. This means the vaccines can be used without conditions and will be available at hospitals and clinics registered on the CoWIN portal once the Drugs Controller General of India (DCGI) gives the final nod.

The recommendation of the expert panel has been sent to the DCGI for approval.

This comes a year after the drug regulatory authority gave emergency usage authorization to both the vaccines to enable the government to launch its mega COVID-19 vaccination drive. While Covaxin, India’s indigenous COVID vaccine has been jointly developed by Bharat Biotech and ICMR, the Oxford-AstraZeneca vaccine Covishield is being manufactured in India by Serum Institute of India.

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“SEC of 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 the adult population, DCGI will evaluate the recommendations and give its decision,” the regulatory body said in a tweet.

Both SII and Bharat Biotech had applied to the DCGI for regular market authorization of their vaccines.

While Serum’s director (government and regulatory affairs) Prakash Kumar Singh had submitted an application to the DCGI on October 25 last year, the latter had asked for more data and documents. Singh had recently submitted a response along with the additional data.

In his submission, Singh told the drug regulator that while the company has conducted the Phase 2 and 3 clinical trials of the vaccine in India, more than 100 crore doses of Covishield have been administered to people across India and other countries.

Reports say SII currently has around 300 million doses of the vaccine in stock.

In the application for Bharat Biotech, its director V Krishna Mohan gave complete details of the chemistry, manufacturing and controls and data of the clinical trials of the vaccine.

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The green signal by the expert panel comes when the government is preparing to administer booster shots of the vaccine to the population. Precautionary shots, announced by Prime Minister Narendra Modi, are already being administered to the vulnerable groups of healthcare workers, frontline workers and the elderly age 60 and above. The interval period between the second dose and the precautionary dose is nine months.

At least 156 crore vaccine doses have been administered in the country since the government rolled out its mega vaccination drive on January 16 last year. Of this 90 crore are first doses, 65 crore are second doses and 42 lakh are precautionary doses.