India’s drug regulatory expert panel on Saturday recommended conditional and restricted emergency use of a home-grown vaccine against the coronavirus disease without direct evidence for its protective efficacy.
Earlier on Friday, the AstraZeneca-Oxford vaccine had been recommended. The recommendations from the Subject Expert Committee (SEC) to the Central Drugs Standard Control Organisation, the apex regulatory authority for drugs and vaccines, imply India could use two vaccines for its planned campaign to initially vaccinate around 300 million people.
The Union health ministry said on Saturday the SEC had granted the permissions under multiple conditions, but some medical experts said the committee appeared to have yielded to a desire to launch an Indian-made vaccine alongside a foreign one.
Expert Panel Clears Bharat Biotech’s Covaxin Amid UK Virus Strain: What You Need to Know
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An expert panel of India s central drug authority has recommended granting permission for restricted use of Bharat Biotech-developed indigenous COVID-19 vaccine Covaxin in emergency situation, especially in the context of infection by mutant strains, officials said on Saturday.
The recommendation for Bharat Biotech s vaccine came a day after the panel cleared the Serum Institute of India s emergency use authorisation application for the Oxford-AstraZeneca vaccine Covishield, paving the way for the roll-out of COVID-19 shots in the country in the next few days.
Coronavirus vaccine India | Bharat Biotech successfully recruits 23,000 volunteers across India
The company will now look to towards achieving the goal of 26,000 participants for Phase-3 clinical trial of COVAXIN across multiple sites in India. January 02, 2021 / 10:22 PM IST
Hyderabad-based Bharat Biotech, which is developing an indigenous COVID-19 vaccine candidate said it has successfully recruited 23,000 volunteers on January 2.
It will now look to towards achieving the goal of 26,000 participants for Phase-3 clinical trial of COVAXIN across multiple sites in India.
What is COVAXIN?
COVAXIN is a highly purified and inactivated 2 dose SARS-CoV2 vaccine. It is manufactured in a Vero cell manufacturing platform and currently has a safety track record of more than 300 million doses, according to a release.
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Expert panel recommends granting restricted emergency use approval for COVAXIN.
A day after a government panel recommended to grant emergency use approval for the Oxford-AstraZeneca s Covishield vaccine for coronavirus, an expert panel on Saturday recommended granting permission for restricted emergency use authorisation for Bharat Biotech s indigenously developed COVID-19 vaccine â Covaxin, ANI reported quoting government sources.
The Subject Expert Committee of Central Drug Standard Control Organization on Saturday recommended Bharat Biotech s Covaxin for emergency use in India. The
final decision on its approval will, however, be taken by the Drug Controller General of India (DCGI).
The committee of experts assessing Coronavirus vaccines had called Hyderabad-based Bharat Biotech for a meeting in the afternoon today, a day after the firm was asked to present more data to get a nod, a top source said on Saturday.