An expert panel will tomorrow review the request by three pharmaceutical firms – the Serum Institute of India, Pfizer and Bharat Biotech – to approve emergency use of their coronavirus vaccines in India, sources told NDTV.
On Monday, Hyderabad-based firm Bharat Biotech became the third firm, say sources, to put a request for approval of its vaccine – Covaxin, India’s first indigenous candidate for the highly infectious virus.
American firm Pfizer was the first to submit its application last week to the the DCGI (Drugs Controller General of India), followed by Pune-based Serum Institute of India.
After review, the expert panel will share its observations with the drug regulator, as per sources. An emergency use approval of a drug can be granted after there is sufficient evidence to suggest that the medical product is safe and effective. Final approval is granted only after completion of the trials and analysis of full data.
Serum Institute of India, the world’s largest vaccine maker by number of doses produced, is developing its vaccine – Covishield – with the University of Oxford and British drugmaker AstraZeneca. Last month, AstraZeneca had said an interim analysis of clinical trials of its COVID-19 vaccine in the UK and Brazil showed that it was 70 per cent effective on average, adding it is up to 90 per cent effective.
Last week, the United Kingdom became the first country to clear the Covid-19 shot developed jointly by Pfizer and German biotechnology partner BioNTech, which has reported an efficiency of 95 per cent in the third stage of trials.
Experts have voiced concerns about logistical challenges linked to Pfizer vacine, which needs to be stored and transported at -70 degrees Celcius. However, the pharma firm has asserted it’s prepared to overcome these hurdles.
Adar Poonawala’s SII was mired into controversy after a Chennai volunteer’s allegation of serious adverse effects. But the government last week said it had found no reason to stop the Oxford vaccine trials in India. The vaccine was “safe and immunogenic” and the Data and Safety Monitoring Board and the Ethics Committee had “independently cleared” the trials after examining the complaint, the Pune-based firm asserted.
Yesterday, he tweeted: “As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.”
Haryana Health Minister Anil Vij, who took a single dose of Bharat Biotech’s Covaxin in the third state of trials, said on Saturday he had tested positive for coronavirus. However, the vaccine maker later clarified that Covaxin has been designed to be effective if a person takes two doses. “Covaxin clinical trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose,” the Hyderabad firm said in an official statement.
The emergency use authorisation by the DCGI will allow the vaccine to be administered to people under certain conditions – for a limited period of time or on specific groups.
India has logged 96.7 lakh Covid infections so far, the second highest in the world after the United States, and 1.4 lakh deaths linked to the disease.