Covaxin is the first fully locally developed candidate vaccine against Covid-19 to be considered for emergency use authorization in the country. The vaccine was developed from a SARS-CoV-2 strain isolated by ICMR-National Institute of Virology, Pune.
Bharat Biotech is conducting the largest phase 3 clinical trials in India on 26,000 subjects at 25 sites. Currently, 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 effectiveness is determined 14 days after the second dose.
While US drug maker Pfizer has offered its vaccine, developed in conjunction with German firm BioNTech, SII has sought approval from Covishield, which has been developed by the University of Oxford and AstraZeneca in the UK. IBS has only done bridging studies in India, but is manufacturing the injections.
The Central Drugs Standard Control Organization (CDSCO) has already initiated an internal review of applications submitted by SII and Pfizer, seeking emergency authorization of their respective candidate vaccines in India.
The regulatory authority will review applications based on three parameters – safety, quality and efficacy – before providing its recommendations to the Subject Matter Expert Committee (SEC). The SEC, which is likely to meet this week, will evaluate the suggestions and advise the drug regulator, the Comptroller General of Drugs of India (DCGI), on whether or not the emergency authorization should be granted. It can also recommend conditions that may apply to companies that manufacture or market vaccines in India. Generally, the SEC recommendation, which includes domain experts, is accepted by the DCGI, which grants final approval.
“This is a very important matter and we would not like to make a hasty decision. It is essential to evaluate the safety, efficacy and immunogenicity of the data before reaching a conclusion, ”said an official.
The SEC will also decide whether Pfizer would need to conduct bridging studies here. “It is also possible that Pfizer will obtain emergency authorization here as it has already been approved in the UK and is continuing with bridging studies before obtaining final approval,” the official said.
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