Bharat Biotech: DCGI Expert Group, asks SII to provide more protection and effectiveness data for COVID-19 vaccines
In the key background of the developments relating to Vaccine COVID-19, the Subject Expert Committee (SEC) of the Indian Drug Controller General DCGI has demanded further safety and efficacy statistics from the Serum Institute of India (SII) and the Bharat Biotech for their vaccines COVID-19.
Revised safety results from the country phase 2 and 3 clinical trials and clinical tests in the UK and India for immunogenicity have been sought from the Serum Institute of India. The SAC recommended that the pharma major apply safety and efficacy results from their ongoing phase 3 Indian trial for further review in the light of the application of Bharat Biotech company after a thorough assessment,” a source said.
The application submitted by Pfizer was not addressed during the SEC meeting, as the company has asked for more time for the presentation to be submitted.