On Friday, the Central Drugs Quality Control Organization (CDSCO) expert panel on COVID-19 recommended granting emergency use authorization for the Oxford COVID-19 Covishield vaccine developed by the Serum Institute of India, sources said on Friday.
The Central Drugs Standard Control Organisation (CDSCO) Subject Expert Committee (SEC) on COVID-19 has recommended granting emergency use authorization for the ‘Covishield’ Oxford COVID-19 vaccine, which is manufactured by the Serum Institute of India, reports said.
According to a CNBC-TV18 report, the recommendation comes with some requirements but has not been comprehensive.
A report in India Today reported that India’s Drug Controller General will take a final call on whether or not to authorize an emergency use authorization vaccine.
A formal clearance from the Drugs Controller General of India (DCGI) V.G. Somani is likely to follow soon, the source said.
Serum Institute of India (SII), the world’s largest vaccine manufacturer has teamed up with AstraZeneca to produce the Covishield vaccine developed by Oxford University scientists. The SEC recommendation came days after the UK Regulatory Agency for Medicines and Healthcare Products (MHRA) approved the Oxford vaccine developed for human use by AstraZeneca in the UK.
The Serum Institute had submitted its emergency licensing proposal for the vaccine at the beginning of December, but the SEC had requested the company to return the updated data, and after approval was given by the UK MHRA to AstraZeneca for the original version.
AstraZeneca and the University of Oxford, with AstraZeneca having the commercial rights, co-developed the original version.
Any purchasing agreement for the vaccine has yet to be concluded between the Serum Institute and the government, although the world’s largest vaccine manufacturer has announced that it will give priority to its domestic market. Exports, mainly to South Asian and African nations, will come later.
The company has developed some 50 million doses of the Oxford-AstraZeneca vaccine and plans to roll out at least 100 million shots by March, SII Chief Executive Adar Poonawalla said.
The UK has also approved the Oxford vaccine, the second vaccine cleared in Britain after the Pfizer-BioNTech jabs, where a highly infectious strain of the coronavirus was found.
At present, there was no clarity as to the decision of the SEC on the proposal by Bharat Biotech and Pfizer, which is also under consideration for emergency licensing.