Provide more safety data on Covid-19 vaccine: SEC to Serum, Bharat Biotech

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 (SII) and 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.

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 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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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