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DCGI approves Covishield, Covaxin, says 110% safe, Congress raises concern

HealthDCGI approves Covishield, Covaxin, says 110% safe, Congress raises concern

India’s wait for Covid-19 vaccine is over with the DCGI giving emergency approval on two vaccines – Pune-based Serum Institute’s Covishield and Bharat Biotech’s Covaxin

New Delhi: The Drug Controller General of India VG Somani said Pune-based Serum Institute’s Covishield and Bharat Biotech’s Covaxin submitted data on their trial runs and both have been granted permission for “restricted use“.

VG Somani said, “We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 percent safe.”

Prime Minister congratulates

Describing the development as a “decisive turning point to strengthen a spirited fight”, Prime Minister Narendra Modi said that DCGI approval to the two vaccines accelerates the road to a healthier and COVID-free nation.”

Congratulating the hardworking scientists and innovators, the Prime Minister said, in a series of tweets, that it would make every Indian proud that the two vaccines that have been given emergency approval are made in India.

“This shows the eagerness of our scientific community to fulfill the dream of an Atmanirbhar Bharat, at the root of which is care and compassion,” he said.

Prime Minister said in a tweet, “We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers, and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives.”

The expert panel under the drug regulator recommended on Saturday restricted emergency approval for Covaxin of Bharat Biotech. The panel had granted approval to Covishield which being manufactured by Serum Institute of India, Pune under license from Oxford-AstraZeneca.

A day ago India completed a full dry run for a massive vaccination drive, involving 286 session sites spread across 125 districts.

Harshvardhan promises a free vaccine

Union Health and Family Welfare Minister Dr. Harshvardhan said a free vaccine would be provided in the first phase to the most prioritized beneficiaries, including one crore healthcare and two crore frontline workers. He said the details of the methodology of vaccinating 27 crore priority beneficiaries until July were being finalized.

Amit Shah hails scientists for Covid vaccine

Hailing the efforts of Indian scientists for Covid Vaccine, the Union Home Minister Amit Shah on Sunday said that the approval given by the Drug Controller General of India to Indian vaccines will prove to be a game-changer in boosting Prime Minister Narendra Modi’s vision of ‘Aatmanirbhar Bharat.’

Taking to Twitter he said “A momentous achievement for India! DCGI has granted approval to COVID vaccines of @SerumInstIndia and @BharatBiotech. I salute our very talented and hardworking scientists for making India proud. Congratulations to PM @narendramodiji for striving towards a COVID free India”.

DCGI chief says Covid vaccines 110 % safe

Venugopal G Somani on Sunday said that the two Covid vaccines that have been approved for emergency use are ‘hundred and ten percent’ safe.

Dr. Somani said, “Vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for the conduct of Phase III clinical trial. These vaccines have to be administered in two doses, and all the three vaccines have to be stored at 2 to 8 degrees C.”

Congress Party raises concern over approval

Meanwhile, minutes after the DCGI granted permission for the restricted emergency use of two vaccines, senior Congress leader Anand Sharma raised concern over the approval of Bharat Biotech’s Covaxin. He asked the government to explain why mandatory protocols and verification of data have been dispensed with.

Anand Sharma, who heads the Parliamentary panel on Home Affairs, said the issue of granting authorization to the vaccine use needs to be taken carefully as no country has dispensed with the mandatory Phase III trials and verification of data.

Mr. Sharma said, “As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement.”

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