The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) on Saturday recommended granting approval for restricted emergency use of Bharat Biotech's indigenous COVID-19 vaccine Covaxin in India.
The move came a day after the panel recommended granting permission for restricted emergency use of Oxford-AstraZeneca vaccine Covishield, being manufactured by the Serum Institute of India, paving the way for the roll-out of the first COVID-19 shot in the country.
According to a Union health ministry statement, the key decisions of the expert panel, which met on January 1 and 2, included “grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to M/s Serum Institute of India, Pune” and “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 M/s Bharat Biotech International Ltd., Hyderabad”.
The final decision of the Drugs Controller General of India (DCGI) on both Covishield and Covaxin is likely on Sunday.
The SEC on Saturday also decided to grant permission for conduct of phase 3 clinical trials to Ahmedabad-based Cadila Healthcare for its COVID-19 vaccine candidate.
The panel had earlier asked Bharat Biotech to expedite volunteer recruitment for the ongoing phase 3 clinical trial and recommended that it might conduct interim efficacy analysis for further consideration of restricted emergency use approval for the vaccine.
The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from the Serum Institute of India and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter.
Considering Bharat Biotech's application, the SEC had noted that the ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated.
Bharat Biotech is developing Covaxin in collaboration with the Indian Council of Medical Research (ICMR).
While granting the restricted emergency use approval for the Oxford COVID-19 vaccine, the panel had imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of four to six weeks.
Union Health Minister Harsh Vardhan appealed to people on Saturday not to be misguided by "rumours" regarding the safety and efficacy of the coronavirus vaccine, and said the most prioritised beneficiaries would be vaccinated for free.
Vardhan stressed that there would be no compromise on any protocol while approving the vaccine.
The minister, who visited two mock vaccination sites in Delhi to review the drill, said free vaccines would be provided in the first phase of the inoculation drive to the most prioritised beneficiaries, including one crore healthcare and two crore frontline workers.
With inputs from PTI
