HYDERABAD: A billion hopes may be riding on Bharat Biotech’s COVID-19 vaccine, but the statement put out by the top contender on Sunday smacks of cautious optimism.
As per the firm’s statement, trials conducted thus far suggest its vaccine candidate 'Covaxin' will be at least 60% effective. With the minimum criteria set, the company was now attempting to reach an even higher success rate. “Chances of the vaccine being less than 50% effective are remote," it added.
That may not sound too inspiring when one considers the Pfizer claim that their vaccine candidate was 95 per cent effective in preventing COVID-19; Moderna, another top contender in the race, has claimed that its vaccine was found to have an efficacy of nearly 94.5 per cent.
The president of Quality Operations at Bharat Biotech Sai D Prasad told media sources that the World Health Organisation, the United States Food and Drug Administration, and India's Central Drugs Standard Control Organisation approve a respiratory disease vaccine if it is at least 50% effective. ‘‘For Covaxin, we aim to achieve at least 60 percent but, it could also be more,” Prasad added in an exclusive interview to India Today TV.
However, there was scepticism in some quarters. AIDAN co-convenor Malini Aisola said in a tweet - "He has not shared Phase 1 and 2 results. Doesn’t come clean on adverse events. Detailed protocols for Phases 1/2 and Phase 3 are not in public domain."
But Dr VK Paul, a member of the Centre's expert group on vaccines, told News18 the data from trials would be available only after completion of Phase-III trials, dismissing the allegation that there was anything unusual about the data being kept from the public for now.
The company further stated that they will launch the vaccine in Q2 of 2021.
The Phase 3 trials, which involve 26,000 volunteers across 25 centres in India, are being conducted in partnership with the ICMR. It is the largest clinical trial being conducted in the country.
Covaxin is an inactivated vaccine derived from a strain of SARS-CoV-2 virus, isolated at the NIV, Pune.
Besides production, the other challenges for COVID-19 vaccine distribution were logistics and supply. At present, there is no adult vaccination programme in the country except tetanus for pregnant women.
Covaxin is not the only vaccine on the horizon. The Serum Institute of India is conducting phase-3 trial of the Oxford vaccine. Dr Reddy's Laboratories would shortly conduct the phase 2/3 human clinical trials of the Russian COVID-19 vaccine, Sputnik V. Also, the Biological E Ltd has started Phase I/II clinical trial of its COVID-19 subunit vaccine candidate.