The Indian government appointed expert committee on Saturday recommended Bharat Biotech’s coronavirus vaccine “Covaxin” and Serum Institute of India’s “Oxford-AstraZeneca’s vaccine” for “restricted use in emergency situation in public interest”.
The panel submitted its findings to the Drug Controller General of India (DCGI) on Saturday evening to take the final decision for “restricted emergency use of vaccine, subject to multiple regulatory conditionalities”, according to a statement issued by the Indian Health ministry this evening.
The DCGI will take the final call on approving of the vaccine. The national regulator is scheduled to address the media at 11 am Sunday.
The Subject Expert Committee of Central Drugs Standards Control Organization (CDSCO) after a two-day meeting concluded today made recommendations to DCGI for “grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to M/s Serum Institute of India, Pune”.
The committee also “granted permission” to Bharat Biotech International Ltd “for restricted use of “Covaxin” in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains”, statement added.
The expert panel, however, grant permission to Cadila Healthcare Ltd to conduct of Phase-III Clinical Trial Protocol.
Besides, India has started dry run drillat selected sites across the country for administering the Covid-19 vaccine.
This dry run of the vaccination drive spread across 125 districts is covering all States/UTs having adequate representation of urban and rural districts along with hard-to-reach areas, the ministry sources said.
Source: BSS
