DCGI expert panel asks SII, Bharat Biotech to provide more safety, efficacy data for COVID-19 vaccines
Dec 09, 2020
New Delhi[India], December 9 : In a major development related to COVID-19 vaccine, Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their COVID-19 vaccines.
According to government sources, an SEC meeting was held on Wednesday to review the application submitted by the pharma majors for emergency use authorisation (EUA) for their vaccine candidates.
"Serum Institute of India has been asked for an updated safety data of phase 2 and 3 clinical trial in the country and immunogenicity data from the clinical trial in the United Kingdom and India. While considering the application of Bharat Biotech company, the SEC after detailed evaluation recommended that the pharma major should submit the safety and efficacy data from its ongoing phase 3 clinical trial in India for more analysis," a source said.
The application submitted by the Pfizer was not discussed at the SEC meeting as the company has requested for more time for giving its presentation, sources said.
