An expert panel under India’s top drug regulator on Saturday recommended restricted emergency approval for Covaxin, Bharat Biotech’s Covid-19 vaccine candidate that is currently under testing in the country.
The expert panel has now recommended restricted clearance for two vaccine candidates in as many days — on Friday, it recommended similar approval for Covishield, the variant of the Oxford-AstraZeneca vaccine that is being manufactured under licence in India by Pune-based Serum Institute of India.
The recommendations in favour of Covishield and Covaxin pave the way for Drug Controller General of India (DCGI) Dr V G Somani to clear the two candidates for use in the country’s imminent mass vaccination programme.
The DCGI is scheduled to make a statement to the media on the Covid-19 vaccine at 11 am on Sunday.
The Subject Expert Committee’s (SEC’s) recommendation for “restricted use in emergency situation” of Covaxin came in light of “infection by mutant strains” of the virus that have emerged in the United Kingdom and several other countries in recent weeks.
The decision was taken after the committee, which had earlier sought additional information from Bharat Biotech, reconvened on Saturday to consider the Hyderabad-headquartered company’s request for marketing approval, even though the vaccine is yet to complete late-stage human clinical trials in India.
After the deliberations, the SEC made its recommendation to the Central Drugs Standard Control Organisation (CDSCO) “in public interest as an abundant precaution, in clinical trial mode”, the Ministry of Health and Family Welfare in a statement issued on Saturday evening.
The Ministry statement said the SEC had also recommended that Zydus Cadila, which has been testing its own candidate, ZyCoV-D, should be allowed to begin late-stage human trials in the country.
The SEC had on Friday asked Bharat Biotech to expedite recruitment of volunteers for the ongoing phase 3 trials of Covaxin and, in the meantime, submit an interim analysis of data on the vaccine’s efficacy, that is, its ability to bring down the number of symptomatic Covid-19 cases.
It was not immediately clear whether this data was submitted to the SEC over the past 24 hours, or whether the panel had made its recommendation after perusing this information.
Bharat Biotech did not respond to queries about what information it had submitted to the SEC, and the number of participants it had recruited and dosed in its phase 3 trials so far.
The company had earlier received the regulator’s green light to conduct large-scale phase 3 clinical trials of Covaxin on around 26,000 participants across the country. It announced on December 22 that it had successfully recruited around 23,000 of these volunteers.
It is unclear how many participants received at least two doses of the vaccine. The phase 3 trial commenced on November 16, and the two doses are to be given 28 days apart.
Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Sources had told The Indian Express earlier that, in applying for 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, which were conducted on around 1,000 participants.
The phase 3 trials are expected to give greater clarity on the vaccine’s efficacy and, on December 9, the SEC had asked the company to submit updated information from this phase of its trial, the sources had said.
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