BSS-47 Expert panel recommends emergency use of 2 Covid vaccines in India

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ZCZC

BSS-47

INDIA-VACCINE-RECOMMENDATION

Expert panel recommends emergency use of 2 Covid vaccines in India

NEW DELHI, Jan 2, 2021 (BSS) – The Indian government appointed
expert committee today 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 COVID19 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.

BSS/AIM/MRU/2309hrs