The stage is set for the biggest vaccine rollout in India’s history with the Drugs Controller General of India formally approving two vaccines for restricted use under emergency conditions: Covishield by the Serum Institute of India (SII), and Covaxin by Bharat Biotech. Though other vaccine candidates are in the fray too, these two set a precedent for how future COVID-19 vaccines will be evaluated and administered. India has been long known as a manufacturer of vaccines but less so as one that can develop from scratch, test and then provide it to the world. The pandemic offers an unprecedented opportunity to establish those credentials, but already a key step — of establishing the vaccine’s efficacy in the Indian population before rollout — has been side-stepped. A double-blinded phase-3 trial — where some volunteers get the vaccine and some do not and the rate of disease in both arms is compared to determine the vaccine’s ability — is among the foundations of evidence-based medicine. The SII because of its agreement with AstraZeneca has furnished data from a phase-3 trial in the U.K. and Brazil, but nothing publicly on how protective the vaccine was in 1,600 Indian volunteers. All of the leading vaccine candidates — Pfizer, Moderna and AstraZeneca itself — made public at least partial results of the vaccine’s abilities in their own populations before these were given a go-ahead by the respective regulators. Bharat Biotech, which is conducting such a phase-3 trial in India, is yet to furnish similar data because it has not been able to finish recruiting the required number of volunteers. The Indian data furnished by the companies only attest to the vaccine’s safety and its evoking some immune response. However, this pandemic has revealed multiple instances of therapies and interventions — from convalescent plasma therapy to a slew of antivirals — that seemed to work well under idealised lab conditions but did not measurably protect in real-world hospital conditions.
The concern from approving an untested vaccine is that it makes it nearly impossible to conduct a proper phase-3 trial. It will be unethical to expect volunteers to participate in a trial where there is only a 50% chance of being administered the actual vaccine, when they have the option of the real dose elsewhere. Both SII and Bharat Biotech, given the pace of recruitment and potential pool of volunteers, would have been able to generate much more data within mere weeks. So, it is hard to imagine why an emergency use authorisation of these vaccines was hurried through. Opacity marks the government’s communication strategy in a country where distrust of vaccines remains in spite of years of vaccination programmes and elimination of grave diseases. The government neglects this at the country’s peril.