Serum Institute of India’s application for emergency use approval for the coronavirus vaccine developed by Oxford University and pharma major AstraZeneca will be considered by an expert panel today, sources have told NDTV, hours after the UK gave the same clearance.
Serum Institute’s chief Adar Poonawalla expressed happiness over the decision. “This is a great and encouraging news. We will wait for the final approval from Indian regulators,” he told NDTV.
Last month, Serum Institute, which makes the vaccine that has been named “Covishield”, said a positive late-state trial result would allow it to seek approval by year-end for emergency use of its candidate, before getting approval for full introduction by February or March.
The world’s largest vaccine maker has already produced around 50 million doses of the Oxford-AstraZeneca shot and plans to scale it up to 100 million by March next year, Mr Poonawalla had said on Monday.
Besides SII, Bharat Biotech and Pfizer had applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their COVID-19 vaccines this month.
The UK on Wednesday approved the Oxford University-AstraZeneca vaccine for human use, the second coronavirus vaccine to be cleared for rollout in Britain after the Pfizer-BioNTech jabs.
The Oxford vaccine was being evaluated by the British regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – after the final cut of data was submitted by the government last week.
The approval by the MHRA means the vaccine is both “safe and effective” and the UK government’s Department of Health and Social Care (DHSC) said that the National Health Service (NHS) will prioritise giving the first of the two-dose vaccine to those in the most high-risk groups quickly.
Like the Pfizer-BioNTech jabs, Covishield is similar in requiring two doses but is easier to deliver as it does not need extremely low temperatures for storage. It is also cheap and easy to mass-produce.
(With inputs from agencies)