India's 1st Covid-19 vaccines: DCGI approves Serum, Bharat B
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Two COVID-19 vaccines, Covishield and COVAXIN, have been granted emergency approval for use in India, the Drugs Controller General of India (DCGI) Dr. VG Somani said on 3 January.

Covishield has been developed by AstraZeneca and Oxford University, and manufactured by Pune-based Serum Institute of India (SII), while COVAXIN has been developed indigenously by the Hyderabad-based Bharat Biotech.

Here are more details:

• 2 vaccines approved for 'restricted use in emergency situation'

While addressing a press conference, Dr. Somani said, "After adequate examination, the CDCSO has decided to accept the recommendations of the expert committee, and accordingly, the vaccines of Serum Institute of India and Bharat Biotech are being approved for restricted use in an emergency situation. Permission is being granted to Cadila Healthcare for the conduct of Phase III clinical trials in India," he added.

• Earlier, concerns were raised about nod to vaccines

Earlier on 2 January, the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) had recommended the grant of emergency approval to COVAXIN. A day earlier, the same panel had recommended emergency approval for Covishield.

The nod to COVAXIN was deemed controversial as the recommendation came despite a lack of Phase III trial data indicating the vaccine's efficacy.

• Covishield 95% effective if doses given 3 months apart: SII

Both Covishield and COVAXIN are two-dose vaccines. SII CEO Adar Poonawalla had said last week that Covishield is "90-95% effective" if the two doses are given two-three months apart. Earlier, he had said that India has 40-50 million doses already stockpiled.

• 'Vaccines are 110% safe,' says DCGI

Addressing criticism over vaccine approval, the DCGI told reporters, "We would never approve (a vaccine) if there are any safety concerns... The vaccines are 110% safe."

"There are some mild side-effects, such as pain on the injection site, mild fever, and allergy. But these are common for every vaccine," he said, declaring the claims of impotency being a side-effect "absolute rubbish."

• PM Modi's statement

"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," said PM Modi.

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