Serum institute and Bharat Biotech’s proposals for emergency vaccine use have not been cleared over inadequate safety and efficacy data, sources said on Wednesday.
“Both proposals are not approved due to inadequate safety and efficacy data available currently. Both have been asked for more data,” the sources told NDTV.
This was reportedly decided in the meeting of the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) today.
The committee reviewed the applications of Pfizer, Serum Institute of India and Bharat Biotech.
“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, reacting to the development.
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.
On Monday, Hyderabad-based Bharat Biotech became the third vaccine-maker to apply to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed COVID-19 vaccine Covaxin.
At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a Covid vaccine may be ready in a few weeks.