With over 51 lakh cases and around 84,000 deaths so far, India is bearing the brunt of the novel coronavirus. The much-awaited Covid peak seems nowhere in sight, while herd immunity is also a distant dream. No wonder the country is desperate to have a potent vaccine at the earliest. The tie-up between Russian Direct Investment Fund and Indian pharma giant Dr Reddy’s Laboratories to conduct Phase 3 trials of the Sputnik V vaccine has raised hopes that, if all goes well, the all-important shot will be available in India later this year. Subject to successful trials and the Indian drug regulator’s approval, 10 crore doses will be supplied.
Phase 1 and Phase 2 clinical trials of Sputnik V have demonstrated ‘no serious adverse effects and a stable immune response in participants’, according to a research paper published earlier this month in The Lancet. However, these two phases had just 70-odd participants — too small a sample size to arrive at definitive conclusions. It’s the result of Phase 3, in which thousands of people are involved to ascertain the efficacy and safety of the vaccine over a period of a few months, that matters the most.
After the Indian Council of Medical Research caused a stir by setting an improbable deadline (August 15) for an indigenous vaccine, the government is understandably wary of jumping the gun. Union Health Minister Harsh Vardhan said in Rajya Sabha on Thursday that the coronavirus vaccine will be made available in the country by the start of next year. India is the manufacturing partner of Covishield, a vaccine candidate developed jointly by the University of Oxford’s Jenner Institute and AstraZeneca. British-Swedish pharma major AstraZeneca had to suspend global trials recently after a participant in the UK showed a serious side-effect. However, Oxford has stated that the trial illnesses may not be due to the vaccine shot, even as trials have resumed in Britain, Brazil and South Africa. Under the circumstances, the Russian vaccine could be India’s best bet to save millions of lives, provided the notorious Indian red tape is not allowed to impede the process.