New Delhi: Hyderabad-based Bharat Biotech filed an application seeking emergency use authorisation for Covaxin on Monday, becoming the third company to seek such regulatory approval in India after Pfizer and Serum Institute of India (SII).
Covaxin is the first fully locally developed vaccine candidate that will be considered for emergency use authorisation.
It was developed from a strain of SARS-CoV-2 isolated by ICMR-NIV, Pune.
Regulator starts review of Serum & Pfizer applications
Bharat Biotech is conducting the largest Phase-3 clinical trials in India on 26,000 subjects across 25 sites. At present, phase-3 clinical trials for Covaxin are ongoing in Delhi, UP, Bihar, Maharashtra, Punjab, Assam and other states. The vaccine is based on a two-dose schedule and its efficacy is determined 14 days after the second dosage.
While US drug maker Pfizer has offered its vaccine, developed along with German firm BioNTech, Serum Institute of India (SII) has sought the approval for Covishield, which has been developed by Oxford University and AstraZeneca in the UK. SII has conducted only bridging studies in India but is manufacturing the shots.
The Central Drugs Standard Control Organisation (CDSCO) has already started an internal review of applications submitted by SII and Pfizer, seeking emergency authorisation of their respective vaccine candidates in India.
The regulatory authority will examine the applications based on three parameters — safety, quality and efficacy — before providing its recommendations to the Subject Expert Committee (SEC). The SEC, likely to meet this week, will evaluate the suggestions and advise the drug regulator, Drugs Controller General of India (DCGI), on whether emergency authorisation should be granted or not. It may also recommend conditions that may apply to companies manufacturing or marketing the vaccines in India. Usually, the recommendation from the SEC — which comprises domain experts — is accepted by the DCGI, which grants final approval.
“This is an important matter and we wouldn’t like to take a decision in a hurry. It is essential to evaluate the data for safety, efficacy and immunogenicity before we arrive at any conclusion,” an official said. The SEC will also decide whether Pfizer would need to conduct bridging studies here.