India approves Serum, Bharat Biotech coronavirus vaccines for emergency use; DCGI assures 100% safety

India has officially got a vaccine against the coronavirus infection as the DCGI on Sunday announced the formal approval for the coronavirus vaccines of Oxford-AstraZeneca and Bharat Biotech, saying the vaccines will be administered in two dosages each.

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India approves Serum, Bharat Biotech coronavirus vaccines for emergency use; DCGI assures 100% safety
DCGI has approved Serum's Covishield and Bharat Biotech's Covaxin for emergency use (Photo: PTI)

India's central drug authority, Drugs Controller General of India (DCGI), on Sunday announced the formal approval for the coronavirus vaccines of Oxford-AstraZeneca, manufactured by the Serum Institute, and Bharat Biotech, saying they will be administered in two dosages each. VG Somani of DCGI said both firms submitted data on their trial runs of the coronavirus vaccines and both have been granted permission for "restricted use" in emergency situations.

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The approval by the DCGI was given on the basis of recommendations submitted by a coronavirus subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

Announcing approval to Serum Institute's 'Covishield' coronavirus vaccine, VG Somani said the vaccine trial was conducted on 23,745 participants and the overall efficacy of the vaccine was found to be more than 70 per cent. "The Indian data was also found to be comparable with overseas clinical studies," the DCGI said.

"Bharat Biotech's coronavirus vaccine 'Covaxin' is safe and gives a robust immune response," the DCGI said adding that Covaxin, too, has been approved for restricted use in emergency situations.

After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations," DCGI Dr V G Somani said.

Asserting that no vaccine with even the slightest safety concern would not be approved, the DCGI said the vaccines that have been approved for emergency use are 110 per cent safe. "We'll never approve anything if there's slightest of safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine," the DCGI said.

"The rumours [that people may get impotent] is absolute rubbish," VG Somani said.

On Saturday, Bharat Biotech's coronavirus vaccine, 'Covaxin', become the second vaccine to secure recommendations for restricted emergency use from a government-appointed expert panel in India. A day earlier, the panel made a similar recommendation for Oxford's 'Covishield'.

PM MODI CONGRATULATES INDIA

As the DCGI announced the formal approval to Serum's 'Covishield' and Bharat Biotech's 'Covaxin' vaccines, PM Narendra Modi congratulated India and said the approval has accelerated the road to a healthier and coronavirus-free nation.

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"A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of Serum Institue of India & Bharat Biotech accelerates the road to healthier and Covid-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators," PM Modi tweeted.

He 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."

Serum Institute of India’s CEO Adar Poonawalla tweeted, “Happy new year, everyone! All the risks Serum Institute of India took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”

The authority has also granted Cadila Healthcare the permission to conduct the Phase III clinical trial of its vaccine candidate in India, Somani said.