Serum Institute, Bharat Biotech Vaccines Not Cleared: “Inadequate Data”


Serum institute and Bharat Biotech’s proposals for emergency vaccine use were not cleared today over inadequate safety and efficacy data, sources said on Wednesday. The two have been asked by a panel of experts to provide more data.

“Both proposals are not approved due to inadequate safety and efficacy data available currently. Both have been asked for more data,” the sources

The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) met today to review the applications of Pfizer, Serum Institute of India and Bharat Biotech. Approvals are a long process and this is only the start, sources said.

The committee can only recommend, but the decision to approve vaccines is with the Drugs Controller General of India (DCGI), the health ministry said.

“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 said on the development.

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