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SEC recommends Covaxin, Covishield for full market authorisation

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SEC recommends Covaxin, Covishield for full market authorisation
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New Delhi: The Drugs Controller General of India's (DCGI) Subject Expert Committee (SEC) on Wednesday recommended regular market usage of Covaxin and Covishield vaccines, in a bid to accelerate India's fight against coronavirus.

"SEC of CDSCO has recommended for the 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 tweeted.

As per reports, the vaccines are now expected to be widely available soon at hospitals and clinics registered with the government portal CoWIN.

A few days earlier, the SEC had sought more data from the COVID vaccine manufacturers- Serum Institute of India and Bharat Biotech for granting them full market approval for their vaccines.

The development now comes as the government deliberates over the booster dose policy. Precautionary third doses of vaccines -- announced by Prime Minister Narendra Modi last month -- are now being given to health and frontline workers and adults above 60 years of age, dealing with illnesses. The recommended period, however, between the second and the third dose is currently nine months.

The expert panel of the Central Drugs Standard Control Organisation (CDSCO)'s recommendation has been sent to the top drug regulator DCGI.

The vaccines won't be available over the counter and registration on CoWIN will be necessary, sources say.

With over 158 crore doses given so far in India, a market approval means that booster shots would soon be available for those in need, apart from the frontline workers and senior citizens, which may lead to big changes in the centre's policy.

However, there has not been any clarity regarding whether the interval between the second and third dose can be brought down to six months - the usual interval period being followed in many parts of the world as the antibody count starts depleting after that.

Also, as per the government policy, a mix-and-match of vaccines is not an option for now.

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TAGS:Subject expert committee DCGI 
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