The panel reviewed the applications of Pfizer, Serum Institute and Bharat Biotech (Representational)
New Delhi:
Proposals from the Serum Institute and Bharat Biotech for the use of emergency vaccines have not been approved because of inadequate safety and efficacy data, sources said Wednesday.
“Both proposals are not approved due to inadequate safety and efficacy data currently available. Both have been asked for more data,” the sources told NDTV.
This was reportedly decided today at the meeting of the Subject Matter Expert Committee of the Central Medicines Standards Control Organization (CDSCO).
The committee reviewed applications from Pfizer, Serum Institute of India, and Bharat Biotech.
“It is standard practice for the government to hold several meetings. The process is expected to last for a week or two,” said sources at the Serum Institute, reacting to the development.
The Pune-based Serum Institute, the world’s largest vaccine manufacturer, applied for approval for the vaccine from Oxford, Covishield, on December 6.
The pharmaceutical giant Pfizer sought approval from India after obtaining authorizations in the UK and Bahrain.
On Monday, Hyderabad-based Bharat Biotech became the third vaccine manufacturer to apply to the Controller General of Medicines of India (DCGI) for an emergency use authorization for its COVID-19 vaccine, developed in the country, Covaxin.
At an all-party meeting on December 4, Prime Minister Narendra Modi expressed his hope that a Covid vaccine will be ready in a few weeks.
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