SII and Bharat Biotech gifts India the most-awaited Covid vaccine, but here's where the problem starts

The global standard for vaccine approval hinges on three factors: safety, immunogenicity — the ability of the vaccine to generate immune response — and efficacy.

Synopsis
Even though clinical trials take several years, WHO allows companies and regulators to skip the usual process to grant emergency approval if certain minimum efficacy criteria are met. In case of Covid-19 vaccines, the minimum efficacy requirement is 50%. Efficacy does not mean effectiveness.

On Sunday, after the Drugs Controller General of India (DCGI) announced the emergency restricted use of vaccines by Serum Institute of India (SII) and Bharat Biotech, India’s scientific community should have been euphoric. It wasn’t. The lack of transparency regarding the approval process was further muddied by a ‘press briefing’ where reporters were not allowed to ask any questions. The contentious issue is to do with the emergency-use approval

Divya Rajagopal

ET Bureau

5 mins read

Jan 3, 2021, 11:26 PM IST

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