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DCGI approves two Covid-19 vaccines for emergency use

TV Jayan New Delhi | Updated on January 03, 2021

Serum antidote may be rolled out by mid-January; confusion as Bharat Bio yet to submit efficacy data

Two Covid-19 vaccines, including an indigenous one developed by Bharat Biotech together with Indian scientists, received emergency use authorisation (EUA) on Sunday amid criticism that the drugs regulator failed to answer some key questions.

The final approval given by the Central Drugs Standard Control Organisation (CDSCO) to AstraZeneca-Oxford University candidate Covishield, produced by Pune-based Serum Institute of India, and Hyderabad-based Bharat Biotech’s Covaxin, was based on recommendations given by the Subject Expert Committee (SEC) on Saturday.

Addressing a press conference on Sunday morning, Drugs Controller General of India (DCGI), VG Somani said: “After adequate examination, CDSCO has decided to accept the recommendations of the SEC and, accordingly, the vaccines of Serum and Bharat Biotech are being approved for restricted use in emergency situations.”

 

Though the EUA will lead to early (likely mid-January) rollout of Covid-19 vaccines in the country, experts are worried about an alleged lack of transparency in the approval process. Besides, there are some inconsistencies, too, they say.

While Somani claimed that Covishield has an efficacy of 70.42 per cent, the two-dose regimen that India is planning to follow has only an efficacy of 62 per cent, per studies carried out by AstraZeneca elsewhere, based on which the approval was given here.

Similarly, the statement that Covaxin will be approved for use in “emergency situation in public interest” has also created a lot of confusion considering Bharat Biotech has not submitted efficacy data. Adding to the confusion, All India Institute of Medical Sciences (AIIMS) Director and national task force member Randeep Guleria has said Covaxin will be a backup in cases where Covishield is found not efficacious.

‘Back-up’ vaccine

A widely circulated video message by Guleria also claimed that the vaccines getting approved in India are as efficacious as those cleared elsewhere, which certainly does not seem to be the case.

For instance, the vaccines developed by both Moderna and Pfizer were found to have an efficacy of around 95 per cent in clinical trials.

India plans to inoculate 30 crore people in the first phase, beginning with 1 crore healthcare personnel, followed by 2 crore frontline corona warriors such as police and sanitation workers. The balance 27 crore will be people above the age of 50 and those with co-morbidities.

Prime Minister Narendra Modi, in a tweet, called the development “a decisive turning point to strengthen a spirited fight.”

“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 Atmanirbhar Bharat, at the root of which is care and compassion,” he tweeted.

 

 

Published on January 03, 2021

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