Covid-19: Serum, Bharat Biotech vaccines approved for emergency use: DCGI

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The India Drugs Regulator has approved the emergency use of Serum Institute of India’s ‘Covishield’ vaccine and Bharat Biotech’s ‘Covaxin’ for emergency use.

The Drugs Controller General of India Dr. VG Somani has said that the cocaine vaccine has been found to be 70.42% effective. It has been made by Bharat Biotech in association with the Indian Council of Medical Research.

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DCGI director Dr. VG Somani said We’ll never approve anything if there is slightest of safety concern. The vaccines are 100% safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It (people may get impotent) is absolute rubbish,”.

He said that the Subject Expert Committee on Corona had on Saturday recommended Bharat Biotech’s conditional approval for emergency use of Covaxin.

Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University, statement of Health ministry said.

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The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42%.

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Further, Serum was granted permission to conduct Phase-II/III clinical trial on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.

After detailed deliberations Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.

Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally.

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Statement further reads, the firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response.

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The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.

Prime Minister Narendra Modi tweeted on the important decision of DCGI, “DCGI has approved the Serum Institute of India and Bharat Biotech Vaccine. This will help the country to become corona free. Congratulations India. ”

“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 & COVID-free nation. Congratulations India. Congratulations to our hardworking scientists & innovators,” tweeted PM Modi.

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In a series of tweets, PM Modi wrote, “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.

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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,” wrote the PM.

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