
India has approved the Oxford-AstraZeneca vaccine, Covishield, for emergency use in India, Union Minister for Information and Broadcasting Prakash Javadekar said on Saturday. The minister was outlining how India has managed to tackle COVID-19 when he said that India is the only country where four vaccines are being prepared, and that on Friday, Covishield, which is being manufactured by Pune-based Serum Institute of India, was authorized for emergency use.
This makes it the first confirmation from the Union government about the vaccine being granted approval for emergency use in India.India has the highest number of coronavirus infections after the United States and is presently doing dry runs for vaccine drives in various places in the country.
Javadekar said that apart from Covishield, which is the first vaccine to get the approval for emergency use in India, the three others awaiting approval are Bharat Biotech’s COVAXIN, Zydus Cadila’s ZyCoV-D and Russia’s Sputnik V.
The AstraZeneca-Oxford vaccine has also been granted approval in the UK. In India, the Central Drugs Standard Control Organization (CDSCO) will announce the dosage of the same later. SII, which produces the most vaccines globally, has already stocked around 50 million doses of Covishield, which will be sold to the government at around Rs 250, and privately for Rs 1,000.
While the expert panel of CDSCO had recommended that Covishield be approved for emergency use, Bharat Biotech has been asked to provide more data before its candidate Covaxin is approved. Official sources told PTI that the Subject Expert Committee (SEC) on COVID-19 asked Bharat Biotech to expedite volunteer recruitment for the ongoing phase 3 clinical trial and recommended that it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for the vaccine.
The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from the Serum Institute of India (SII) and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter.
"After detailed deliberation, the committee recommended for grant of permission for restricted emergency use of the vaccine (Oxford COVID-19) subject to various regulatory provisions," a source said.
With PTI inputs