Senior Congress leader and former Union minister Shashi Tharoor has come down heavily on the Centre for granting approval to Bharat Biotech’s Covid19 vaccine, Covaxin, without Phase-3 trials.

Drug Controller General of India (DCGI) VG Somani on Sunday announced that Bharat Biotech’s ‘Covaxin’ has been approved for “restricted use in emergency situations”.

Also read: DCGI finally approves Serum Institute, Bharat Biotech’s COVID19 vaccines for emergency use

Prime Minister Narendra Modi also said: “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”

The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) met on January 1-2, 2021 and made recommendations in respect of proposal for restricted emergency approval of COVID19 virus vaccine of SII and Bharat Biotech.

However, Congress leader Tharoor said approval of the vaccine before its Phase 3 clinical trials “is a violation of every scientific protocol & unheard of in the world”.

“This is all we are saying. Of course we will be proud if the vaccine turns out to work effectively. But offering it before Phase3 clinical trials have proven efficacy is a violation of every scientific protocol &unheard of in the world. Jingoism is no substitute for common sense,” Tharoor tweeted.

Tharoor added that Union health minister Dr Harsh Vardhan is saying “it’s more likely to work” and “it’s likely to have similar protective efficacy reported for others” which is not “reassuring”.

“Likely” can only be “certain” after Phase 3 clinical trials, Tharoor said.

The DCGI has granted permission to Bharat Biotech to manufacture ‘Covaxin’ for sale and distribution, after the indigenous coronavirus vaccine received regulatory approval for emergency use.

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