DCGI grants emergency-use approval to Serum Institute’s Covishield and Bharat Biotech’s Covaxin

In a series of tweets, Prime Minister Narendra Modi congratulated the frontline workers and the scientific community for their efforts
DCGI grants emergency-use approval to Serum Institute’s Covishield and Bharat Biotech’s Covaxin

On Sunday, Drug Controller General of India VG Somani approved Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin for emergency use, following the expert committee’s recommendations on January 1 and 2. “After adequate examination, Central Drugs Standard Control Organisation (CDSCO) has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of SII and Bharat Biotech are being approved for restricted use in an emergency,” a press release said.

Regarding the Bharat Biotech’s vaccine, the officials said, “The Subject Expert Committee (SEC) has reviewed data on safety and immunogenicity of Covaxin. They recommended it for grant of permission for restricted use in an emergency in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by Bharat Biotech will continue.”

Concerning the safety and efficacy of the vaccines, Somani told reporters that they wouldn’t approve anything if there were a slight concern. “We'll never approve anything if there is the slightest of safety concern. The vaccines are completely safe. Some side effects like mild fever, pain, and allergy are common for every vaccine. The rumour that the vaccine may cause impotency is absolute rubbish,” he said.

Following the announcement, the Prime Minister took to Twitter to congratulate frontline workers as well as to emphasise ‘make in India’. “This is a decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to a healthier and Covid-free nation. Congratulations India! Congratulations to our hardworking scientists and innovators,” he said on Twitter.

He said that 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,” he added.

“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,” he tweeted.

Moreover, the DCGI has granted permission to another pharmaceutical company, Cadila Healthcare, allowing its vaccine to move to Phase III. “The firm initiated Phase I/II clinical trial in India in more than 1,000 participants, which is ongoing. Interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, the firm has sought permission to conduct a Phase III clinical trial in 26,000 Indian participants, which has been recommended by the Subject Expert Committee.”

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