DCGI seeking more data for authorisation won t impact COVID-19 vaccine roll-out timeline: Govt
The applications are being examined on scientific basis, using the frameworks that are scientific, frameworks that are globally aligned and ensuring that the vaccine is safe, NITI Aayog member (health) Dr V K Paul said
PTI | December 16, 2020 | Updated 08:32 IST
Six vaccines are undergoing clinical trials in India.
The applications of Bharat Biotech, Serum Institute and Pfizer seeking emergency use authorisation for their COVID-19 vaccines are being examined, the Centre said on Tuesday asserting that drug regulator DCGI seeking more data from these companies will not impact the vaccine-roll out timeline.
DCGI seeking more data for authorisation won t impact vaccine roll-out: Govt
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Last Updated: Dec 15, 2020, 10:24 PM IST
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Synopsis This situation was factored-in from before as it is emergency use authorisation. There should be more than reasonable satisfaction about the safety, immunogenicity and effectiveness of the vaccine, NITI Aayog member (health) Dr V K Paul said.
PTI The applications are being examined on scientific basis, using the frameworks that are scientific, frameworks that are globally aligned and ensuring that the vaccine is safe, immunogenic adequately and effective in reducing the incidence of COVID-19 disease in people, NITI Aayog member (health) Dr V K Paul said.
DCGI Seeking More Data for Granting Emergency Use Authorisation Won t Impact Vaccine Rollout Timeline: Govt
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The applications of Bharat Biotech, Serum Institute and Pfizer seeking emergency use authorisation for their COVID-19 vaccines are being examined, the Centre said on Tuesday asserting that drug regulator DCGI seeking more data from these companies will not impact the vaccine-roll out timeline. These applications filed with the Drugs Controller General of India are being examined by the subject expert committee on COVID-19 of CDSCO for emergency use authorisation, NITI Aayog member (health) Dr V K Paul said. This situation was factored-in from before as it is emergency use authorisation. There should be more than reasonable satisfaction about the safety, immunogenicity and effectiveness of the vaccine, he told reporters when asked about DCGI seeking more information from the companies for grant of emergency use authorisation to their vaccines. The applicatio
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