India clears Covaxin, ‘certain conditions’ follow
Covaxin, the anti-coronavirus vaccine developed indigenously by India’s Hyderabad-based Bharat Biotech, has received restricted emergency use permission, with certain conditions, from an expert panel of India's central drug authority on Saturday, sources said.
Covaxin has been developed by the Hyderabad-based company in collaboration with the Indian Council of Medical Research (ICMR).
The Union Health Ministry on Saturday also confirmed that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to the Serum Institute of Institute (SII) for restricted emergency use of Covishield in India, subject to multiple regulatory conditionalities.
“The SEC of CDSCO met on January 1 and 2 and made the recommendations for the consideration and final decision of the Drugs Controller General of India (DCGI),” the ministry said.
The committee on Covid-19 on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday's review meeting, a source said.
The panel recommended “grant of permission 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, to Bharat Biotech,” the health ministry said.
According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available.
The committee noted that the vaccine is an inactivated whole virion, coronavirus vaccine, having potential to target mutated coronavirus strains, a source said. The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation.
According to sources, the recommendations stated that the vaccine should be supplied along with a fact-sheet and separate leaflet for the guidance of the healthcare provider.
Bharat Biotech had applied to the Drugs Controller General Of India (DCGI) seeking emergency use authorisation for its Covaxin on December 7.
On Friday, the SEC had recommended granting permission for restricted emergency use of Oxford-AstraZeneca vaccine Covishield, being manufactured by the Serum Institute of India.
India wants to start administering the vaccine soon, most likely by Wednesday, one source told Reuters on Friday.
Pfizer has not presented all its data to the regulatory panel yet, an expert, who is not a panel member, told The Telegraph.
“The home-grown vaccine has shown very promising immunogenicity data. It might be approved once some efficacy data comes in,” the expert had said on Friday.
After detailed deliberations, the SEC has also recommended for grant of permission to Cadila Healthcare Ltd in Ahmedabad for conduct of phase-3 clinical trial protocol for its vaccine candidate.