India’s top drug regulator Sunday approved Covishield and Covaxin vaccines for restricted use against Covid-19 in the country, paving the way for mass vaccination against the virus that has so far infected more than a crore people and killed nearly 1.5 lakh.
The approvals to the two vaccines, both to be given in two doses, follow a recommendation regarding the same by the Drugs Controller General of India’s (DCGI) expert panel. In the case of Covaxin, for whose Phase 3 trials limited data is available, informed consent would have to be sought from those receiving the vaccine, which will be administered according to a protocol that is still in the process of being decided, according to a senior government official close to the development.
Announcing the clearance to Covishield and Covaxin at a media briefing on Sunday morning, DCGI Dr V K Somani said clinical trials regarding both the drugs would have to continue. The firms are required to submit safety data every 15 days for the first two months and monthly thereafter.
“After adequate examination, the CDSCO (Central Drugs Standard Control Organisation) has decided to accept the recommendations of the expert committee and, accordingly, vaccines of M/s Serum and Bharat Biotech are being approved for restricted use in emergency situation…,” Somani said.
“A decisive turning point to strengthen a spirited fight!” tweeted Prime Minister Narendra Modi following the announcement. “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,” he added.
With some experts and Opposition leaders raising concerns over the grant of approval to Covaxin, without its efficacy trials being over, Health Minister Harsh Vardhan tweeted that Bharat Biotech’s vaccine is more likely to work against newer variants of the virus, including the UK variant, “as it contains immunogens (epitopes) from other genes in addition to those from Spike protein”.
Vardhan also underlined that the emergency use approval for Covaxin was “differently conditional” from Covishield and was in clinical trial mode. “All Covaxin recipients to be tracked, monitored as if they’re in trial,” the minister tweeted. “This approval ensures India has an additional vaccine shield in its arsenal (especially) against potential mutant strains in a dynamic pandemic situation — A strategic decision for our vaccine security.”
Vardhan added that no “seroconversion” — from the point of viral infection to when antibodies become present in the blood — had been observed in those given Covaxin, an inactivated vaccine, in Phase 1 and 2 of its clinical trials. “Our experience with inactivated vaccines not having serious adverse events was also observed in Phase II done… No serious adverse events seen. Only 7 per cent persons receiving 6 microgram dose had mild symptoms,” Vardhan said in another tweet.
A Subject Expert Committee (SEC) looking into applications by the two firms for marketing authorisation had recommended that the Serum Institute of India (SII), which is making Covishield, be granted restricted emergency use permission “subject to multiple regulatory conditionalities”, the Ministry of Health and Family Welfare said on Saturday.
The SII had submitted safety, immunogenicity and efficacy data generated from 23,745 participants aged 18 years and older from overseas clinical studies, as well as interim safety and immunogenicity data from its ongoing Phase 2/3 clinical trials on 1,600 participants in India. The SEC had found the data submitted from the Indian trial to be “comparable” with data from its overseas studies, said Dr Somani.
The immunogenicity of a vaccine is its ability to prompt an immune response, while the efficacy, in this case, is a measure of its ability to bring down the number of symptomatic Covid-19 cases.
The SEC had also recommended similar restricted permission, “in clinical trial mode”, to Bharat Biotech, which has submitted safety and immunogenicity data from pre-clinical studies on animals as well as results from Phase 1 and 2 human trials in approximately 800 volunteers of Covaxin.
The SEC’s recommendation came after it reviewed this safety and immunogenicity data, according to Dr Somani. While he did not mention whether the firm had submitted any efficacy data on the vaccine, he said that the recommendation was also “in public interest as an abundant precaution… to have more options for vaccinations, especially in case of infection by a mutant strain”.
Bharat Biotech is currently in the process of recruiting and vaccinating 25,800 volunteers for the Phase 3 trials of Covaxin and, till date, 22,500 participants have received at least one dose of the vaccine.
Covishield is a version of the vaccine developed by the University of Oxford in collaboration with Swedish-British drugmaker AstraZeneca, that has already got emergency use approval in the UK. Its first batches arrived in UK hospitals over the weekend.
Covaxin, India’s only indigenous Covid-19 vaccine, has been developed by Hyderabad-headquartered Bharat Biotech in collaboration with the Indian Council of Medical Research’s National Institute of Virology, Pune.
Covishield would be ready to roll out “in the coming weeks,” tweeted SII CEO Adar Poonawalla. “All the risks SII took with stockpiling the vaccine (have) paid off.”
The approval to Covaxin is a “giant leap for innovation and novel product development in India,” said Bharat Biotech Chairman and Managing Director Dr Krishna Ella.
With inputs from ENS, Pune
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