Panel recommends granting permission for restricted emergency use of Covaxin
New Delhi: A day after granting conditional approval to Oxford-AstraZeneca vaccine Covishield, the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) on Saturday recommended granting permission for restricted emergency use of the indigenously developed Covid-19 vaccine Covaxin with certain conditions.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
While making it official, Union Health Ministry said in its statement that the SEC of CDSCO met on January 1 and January 2 and recommended to grant of permission for restricted emergency use of vaccines manufactured by Serum Institute of India and Bharat Biotech with multiple regulatory 'conditionalities'.
However, the ministry has not yet cleared that what are the 'conditionalities' that have been imposed on SII for its vaccine roll-out. The SEC has also recommended for grant of permission for conduct of Phase-III clinical trial protocol to Cadila Healthcare. After the SEC recommendation for consideration to Drugs Controller General of India, the final decision would be taken by the apex drug control authority.
As per the Health Ministry, the Hyderabad-based Bharat Biotech's vaccine Covaxin has been granted permission for 'restricted' use in emergency situation in public interest as an abundant precaution in 'clinical trial mode'. The permission has been granted to Covaxin especially in the context of infection by mutant strains, the ministry said. The decision in this regard was taken during the second round of SEC meeting on Saturday after the Hyderabad-based vaccine manufacturing firm submitted additional data, facts and analysis that was sought in the Friday's review meeting.
Bharat Biotech had applied to the DCGI seeking emergency use authorisation for its Covaxin on December 7.
Meanwhile, Bharat Biotech announced the successful completion of clinical trial on 23,000 volunteers against its target of 26,000 participants for Phase-3 clinical trial of Covaxin across multiple sites in India.
Suchitra Ella, who is joint Managing Director of Bharat Biotech said, "We thank every volunteer who has taken the time to participate in this trial. Their volunteering spirit is a great morale boost for India and the world."