Emergency vaccine use proposals by Serum Institute, Bharat Biotech rejected; ministry denies report

The proposals made by Serum Institute and Bharat Biotech to the government for emergency vaccine use have not been cleared over inadequate safety and efficacy data, and they have been asked to provide more data.

This was decided in the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee meeting on Wednesday, which reviewed the applications of Pfizer, Serum Institute of India and Bharat Biotech, according to an NDTV report.

The Pune-based Serum Institute, the world's largest vaccine-maker, requested approval for the Oxford vaccine, Covishield, on December 6.

Pharma giant Pfizer sought Indian approval after securing clearances in the UK and Bahrain.

"It is standard practice for the government to hold several meetings. The process is expected to go on for one or two weeks," sources in Serum Institute told NDTV, reacting to the development.

Meanwhile, minutes after NDTV carried the report, the Ministry of Health and Family Welfare rejected the development and called it “fake news.” “The media report about the rejection of Serum Institute and Bharat Biotech's emergency use authorisation of vaccine is fake,” the ministry said, at a press conference.