The Drugs Controller General of India (DGCI) gave emergency approval to two vaccines. Both Covishield and Covaxin have gained approval after a recommendation by the expert panel of DGCI. Covishield is the Oxford-AstraZeneca vaccine being produced by the pharmaceutical company Serum Institute of India. Covaxin is India’s indigenous COVID-19 vaccine by Bharat Biotech developed in collaboration with the Indian Council of Medical Research (ICMR).
“After adequate examination, the CDSCO (Central Drugs Standard Control Organisation) has decided to accept the recommendations of the expert committee” the DCGI said. However, both vaccines “have been approved for restricted use in emergency situation…” and “subject to multiple regulatory conditionalities”. The Serum Institute of India (SII), which is making Covishield 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 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.
A similar restricted permission, “in clinical trial mode” has been given 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. While it is not known if the firm has submitted efficacy data the recommendation was “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.
As leaders in the opposition and some experts raised concerns over the approval given to Covaxin, without its efficacy trials being over, Health Minister Harsh Vardhan said that Bharat Biotech’s vaccine is more likely to work against newer variants of the virus, including the UK variant, and that 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.
Clinical trials for both the drugs will however continue. The firms are required to submit safety data every 15 days for the first two months and monthly thereafter.
After both vaccines got approval from the DCGI a competition war between the two pharmaceutical companies became more visible with the heads of both companies raising questions over the efficacy of each other’s vaccines.
While Poonawalla had told a television channel that there were only three vaccines in the world with proven efficacy (Pfizer, Moderna, and Oxford-AstraZeneca) and everything else had been proven safe “just like water”, Ella of Bharat Biotech said if his firm had done trials like AstraZeneca, the drug regulator would have “shut down the company”.
For now the Prime Minister is happy that both vaccines have been “made in India”. “A decisive turning point to strengthen a spirited fight!” he tweeted. He said that the vaccines showed “the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”
The emergency use of the vaccine is an approval given during an emergency situation to certain vaccines when all evidence to establish their effectiveness and safety is not available but there is some evidence that suggests that patients have benefitted from their use.