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…
