Serum’s Adar Poonawalla seeks full approval for Covishield

Serum Institute of India (SII) has applied to Central Drugs Standard Control Organisation (CDSCO) seeking full approval for Covishield, its COVID-19 vaccine.

Taking to Twitter, Serum CEO Adar Poonawalla said the government has enough data for full market authorisation now and the supplies of the COVID-19 jab in the country have exceeded 1.25 billion and therefore the company has applied to the CDSCO for permission.

Serum Institute manufactures AstraZeneca’s COVID-19 vaccine under the name Covishield. The Pune-based firm has supplied more than 1.25 billion doses of the shot in India.

SII, the world’s biggest vaccine manufacturer, got the DCGI nod for emergency use of Covishield in India in January this year.

Also read: SII to launch COVID-19 vaccine for children in 6 months: Poonawalla

Serum’s Covishield and Hyderabad-based Bharat Biotech’s Covaxin have been the main stay of India’s inoculation drive so far. The company had earlier this month sought Indian drug regulator’s approval for Covishield as a booster dose citing adequate stock of the vaccine in the country.

In an application to the Drugs Controller General of India (DCGI), Prakash Kumar Singh, the Director, Government and Regulatory Affairs at Serum Institute of India (SII) cited that the UK’s Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine, sources told PTI.

The world’s largest vaccine maker has so far produced 240 million doses of Covishield and is gearing up to hike export exponentially from January next year. However, the Government of India has substantially cut down its orders for Covishield, prompting the Serum Institute to slash its monthly production of vaccines by at least 50 per cent.