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You are at:Home»Biotech News»Its Just for restricted use in an emergency situation! DCGI approval of Bharat Biotech & Serum Institute COVID-19 vaccines

Its Just for restricted use in an emergency situation! DCGI approval of Bharat Biotech & Serum Institute COVID-19 vaccines

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By Biotech Express on 05/01/2021 Biotech News, SARS- CoV2 & COVID-19 Updates

After passing by many hurdles finally Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin have received DCGI’s  approval for emergency use against coronavirus.

The approvals were given but faced questions after taking the step without publishing efficacy data for the homegrown coronavirus vaccine.

The vaccine manufactured by the Serum Institute of India is a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University.

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.

Serum Institute of India CEO Adar Poonawalla on Sunday revealed the prices of Covishield and disclosed that his company has fixed two different prices for the vaccine.Poonawalla announced that Covishield will be given at Rs 250 to the government and the vaccine will be available in the private market for Rs 1,000.

According to a post by the largest news agency the Reuters, Neither the company nor India’s Central Drugs Standards Control Organisation would reveal its efficacy results. A source with knowledge of the matter told Reuters its effectiveness could be more than 60% with two doses. China also did not publish detailed efficacy data for a vaccine it authorized on Thursday but its developer has shared interim data.

Bharat Biotech’s chairman Krishna Ella hit out at critics on Monday  saying his firm had carried out “200 per cent honest clinical trials”. Bharat Biotech’s response comes after Serum Institute of India’s CEO Adar Poonawalla reportedly termed Covid-19 vaccines other than that of Pfizer, Moderna and Oxford-AstraZeneca as “just like water”.

“On what basis was this approval given when Bharat Biotech has NOT shown enough data proving safety & efficacy?” transparency activist Saket Gokhale asked on Twitter. Gokhale has filed a request under India’s right-to-information law asking the government for safety and other data for the two vaccines approved on Sunday.

Ella said the US and Europe had refused to accept the AstraZeneca-Oxford vaccine trial data from the UK because it was not “clean”, but no one was questioning Oxford data.

“Approval was premature and could be dangerous,” said opposition lawmaker and former minister Shashi Tharoor, asking Health Minister Harsh Vardhan for an explanation.

Read More in next issue of Biotech Express Magazine

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ISSN: 2454-6968 | Biotech Express Magazine publishes articles in the field of biotechnology and allied sciences in a way that have never been presented earlier. It publishes Editorials, Guest Articles, Reports, Interviews, Current News of Govt. Academics and Business, Research Highlights and Notifications of Events, Jobs, Research Proposals in the field of Biotechnology, Biological Sciences, Life Sciences, Microbiology, Biochemistry, Neurosciences, Genetics, Medical Sciences, BioPharma etc.

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