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Bharat Biotech's and Serum Institute Of India's Vaccines Have Been Approved For Emergency Use By DCGI

 The Drugs Controller General Of India (DCGI) on Sunday formally approved Oxford-AstraZeneca's Covishield and Bharat Biotech's Covaxin for use in India.

"Serum Institute and Bharat Biotech's vaccines have to be administered in two doses.All the vaccines have to be stored at 2-8° C.After adequate examination,CDSCO has decided to accept the recommendation of the Expert Committee and accordingly,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 conduct of the Phase III clinical trial",said DCGI in a press statement. 

Earlier on Saturday, the Subject Expert Committee(SEC) of the Central Drugs Standards Control Organization made recommendation to the DCGI to grant permission for restricted emergency use of the Serum Institute Of India (SII) and Bharat Biotech's vaccines.

Prime Minister Narendra Modi has welcomed the DCGI decision and said that approval of two vaccines is a decisive turning point to strengthen a spirited fight."DCGI granting approval to vaccines of Serum Institute and Bharat Biotech accelerates the road to healthier and Covid-free nation.Congratulations India.Congratulation to our hardworking scientists and innovators",he said.

 


 Serum Institute Of India SEO Adar Poonawalla said,"Happy new year everyone! All the risks @SerumInstIndia 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 DCGI said that the vaccine candidate presented by Serum Institute is Recombinant Chimpanzee Adenovirus vector vaccine."The firm submitted safety,immunogenicity  and efficacy data generated on 23,745 participants ages 18 years or older from overseas clinical studies.The overall vaccine efficacy was found to be 70.42 per cent.Further,M/s Serum was granted permission to conduct Phase II/III clinical trials on 1600 participants within the country.The firm also submitted the interim safety and immuneogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.After detailed deliberations the Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situations subject to certain regulatory conditions.The clinical trial ongoing within the country by the firm will continue",it said.

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

"We'll never approve any thing 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",said VG Somani,Drug Controller General Of India.

As of January 3,India had reported more than 1.03 crore confirmed Covid-19 cases.The death toll from the outbreak in the country stood at 1.49 lakh. While more than 99.27 lakh patients had recovered,and there are 2.49 lakh active cases. Globally,more than 8.4 crore individuals have been infected by the virus and over 18.3 lakh people have died so far.


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