An expert panel from India’s top drug regulator on Saturday recommended restricted emergency approval for Covaxin, Bharat Biotech’s Covid-19 candidate vaccine currently being tested in the country.
The panel of experts now recommended a restricted authorization for two candidate vaccines in as many days; on Friday, it recommended similar approval for Covishield, the variant of the Oxford-AstraZeneca vaccine that is being manufactured under license in India by the Pune-based Serum Institute of Pune. India.
The recommendations in favor of Covishield and Covaxin pave the way for the Controller General of Drugs of India (DCGI), Dr. VG Somani, to authorize the two candidates for use in the country’s impending mass vaccination program.
The DCGI is scheduled to make a statement to the media about the Covid-19 vaccine at 11am on Sunday.
Since the start of the pandemic in February, the new coronavirus has sickened more than 1 crore and killed nearly 1.5 lakh people in India.
The Subject Matter Expert Committee (SEC) recommendation for “restricted use in emergencies” of Covaxin came in light of “infection by mutant strains” of the virus that have emerged in the UK and several other countries in the last weeks.
The decision was made after the committee, which had previously requested additional information from Bharat Biotech, met again on Saturday to consider the Hyderabad-based company’s request for marketing approval, despite the vaccine not yet. has completed late stage human clinical trials in India.
After deliberations, the SEC made its recommendation to the Central Drug Standard Control Organization (CDSCO) “in the public interest as an abundant precaution, in clinical trial mode,” the Ministry of Health and Family Welfare in a statement issued on Saturday night.
The ministry statement said the SEC also recommended that Zydus Cadila, which has been testing its own candidate, ZyCoV-D, should be allowed to begin late-stage human testing in the country.
The SEC had asked Bharat Biotech on Friday to expedite the recruitment of volunteers for the ongoing phase 3 trials of Covaxin and, in the meantime, present an interim analysis of data on the vaccine’s efficacy – that is, its ability to reduce the number of symptomatic symptoms. COVID-19 cases.
It was not immediately clear if this data was submitted to the SEC within the last 24 hours, or if the panel had made its recommendation after examining this information.
Bharat Biotech did not respond to inquiries about what information it had submitted to the SEC, and the number of participants it had recruited and dosed in its phase 3 trials thus far.
The company had previously received the green light from the regulator to conduct large-scale phase 3 clinical trials of Covaxin on around 26,000 participants across the country. On December 22, it announced that it had successfully recruited some 23,000 of these volunteers.
It is not clear how many participants received at least two doses of the vaccine. The phase 3 trial began on November 16 and the two doses will be administered 28 days apart.
Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
Sources had previously told The Indian Express that, upon requesting marketing approval for Covaxin in early December, Bharat Biotech had submitted interim data related to the safety and immunogenicity of its vaccine from phase 1 and 2 trials, that were carried out in around 1,000 participants.
Phase 3 trials are expected to provide greater clarity on the vaccine’s efficacy, and on Dec. 9, the SEC had asked the company to provide updated information from this phase of its trial, the sources said.
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