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The Drugs Controller General of India’s grant of emergency use authorisation to Serum Institute’s Covishield and Bharat Biotech’s Covaxin marks the last regulatory hurdle before commencement of anti-Covid vaccination in India. Opacity surrounding data from trials, fast-tracking of data scrutiny and doubts over vaccine dosage and mutations have raised concerns. But India is no exception here; each country is adopting different approaches. The US is reserving stocks for those needing the second Pfizer/ Moderna doses 3-4 weeks later, but this has slowed the rollout. The UK, in contrast, has proposed up to 12 weeks gap between two doses and is inoculating as many people as possible with the first dose.
The UK’s idea is to replenish stocks in time for the second dose, or more controversially, allow people to take a different vaccine for the second dose. Russia raised eyebrows by beginning mass vaccination while Sputnik V Phase 3 trials were still in early stages. Bharat Biotech began Phase 3 trials in mid-November and needs to inoculate more volunteers. But the government appointed Subject Expert Committee was convinced that Covaxin’s inactivated virus may be more effective against mutations. DCGI has placed conditions on Covaxin like continuous follow-up with vaccine recipients, more reminiscent of trials than a commercial release.
Globally, many view the uncharacteristic responsiveness of hitherto bureaucratic regulators in approving “experimental” drugs and vaccines to combat the Covid pandemic as inordinate haste. The ranks of the former include opposition politicians, scientists, health activists, ordinary citizens and the usual vaccine sceptics. In India, former UP chief minister Akhilesh Yadav has needlessly injected partisanship by refusing to receive a “BJP vaccine”, yet promising a free vaccine “when he forms the government next year”.
India is guided by high goals like national pride in developing indigeneous vaccines, supplying them at low cost to poor countries, having more vaccines to choose from and thereby inoculating citizens faster. Building trust will give wings to these imperatives. Authorities in key institutions like DCGI, ICMR and AIIMS have spoken in different voices on Covaxin and Covishield. Experts are also struggling to offer informed opinion as a lot of empirical trial data is being held back. DCGI must make a clean breast of submitted data and continue rolling reviews of Phase 3 trials. Vaccines will test the government’s knack for answering inconvenient questions. It mustn’t duck the public scrutiny.
This piece appeared as an editorial opinion in the print edition of The Times of India.