The subject expert committee recommended Covaxin for emergency use approval (EUA) on Saturday, a day after it advised EUA to the Serum Institute of India which is manufacturing Covishield. The DCGI process for formal licensure to both the companies will be complete by late Saturday night, sources said.
After extensive deliberations on Friday and Saturday, the SEC which comprises independent experts recommended grant of permission to Bharat Biotech for “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains”.
Explaining the official statement, a senior official said Covaxin has been developed on a platform with the whole virus or inactivated virus. “Such vaccines are generally active against any strain and are effective even if the virus mutates (such as the UK strain) because it targets the whole virus and not just any particular strain. Keeping this in mind, SEC has recommended EUA even as the candidate is in a clinical trial mode with Phase 3 trials going on,” he said.
The official added that the SEC has extensively evaluated the data to ensure safety and efficacy of the vaccine. Once approved, Bharat Biotech’s Covaxin, developed alongwith the Indian Council for Medical Research, will be India’s first locally developed and manufactured vaccine against the coronavirus.
“SII has offered a price of Rs 225-250 per dose for the first tranche, whereas Bharat Biotech has offered Rs 350. For the next lot, the prices may vary,” a source said.
The SEC had recommended EUA for SII’s Covishield on Friday with conditions like the company is required to give a factsheet to vaccine recipients before vaccination, and reporting of adverse events every 15 days.
The SEC has also advised the DCGI for grant of permission to conduct Phase 3 clinical trials to Cadila Healthcare for its plasmid DNA vaccine candidate against SARS-COV2. This may take longer to be ready for release to the market.
Covaxin is also a two-dose vaccine like Covishield and can be stored at 2 to 8 degrees.
Apart from marketing authorisation, DCGI will approve the label for vaccine vials. Once the label with requisite conditions or details are approved and printed, they will be stuck to the vials before dispatch.
Watch Bharat BioTech’s Covaxin gets expert panel’s nod for emergency use