Amid an increasing rush to find a coronavirus vaccine after a new strain of virus has experts and public worried, Drug Controller General of India may give Serum Institute of India' Covishield vaccine for emergency use authorisation even before the UK, as the British medicine regulator continues to examine data from the trials.
“Serum Institute has submitted the additional data as sought by the subject expert committee in the last review (on 9 December) " a goverment official in the know told Mint officials. The DCGI may clear Covishield for use by next week if clinical data furnished by Serum Institute is found to be satisfactory, a Reuters report said.
“The review here is happening in parallel with the one in the UK. The same data that the UK regulator is reviewing we are also reviewing (along with Serum’s bridging study data)," an official told Mint.
The world's largest vaccine producer, Serum Institute, will manufacture AstraZeneca Plc's Covishield, developed by Oxford University and British drugmaker AstraZeneca Plc. An expert panel had asked Serum Institute in December to present the outcome of the assessment of the UK regulator for grant of emergency use licence.
This could be an important event in India's vaccination effort, globally, as the UK’s regulatory approval was deemed important. SII made the request for emergency use based on clinical trials data from the UK and Brazil, but the firm is also conducting trials in India, the final results of which are expected to take some more time.
"Serum Institute submitted its revised data on the vaccine on Monday, and the expert panel will be considering the proposal, along with that from Pfizer, by the end of the month," Mint quoted another official as saying.
Earlier, Dr V K Paul, a member of the NITI Aayog, during the weekly briefing on Tuesday said that the examination of additional data has begun. He explained that there are three applications before the DCGI- Pfizer, Serum Institute and Bharat Biotech. Pfizer is yet to submit data while the other two applicants had presented the data, for which the regulator sought additional data.