Bharat Biotech Seeks Emergency Use Authorization for Covid-19 Vaccine
Following Pfizer and the Serum Institute, Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator for an emergency use authorization for its COVID-19 vaccine, Covaxin, official sources said.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
On December 4, Prime Minister Narendra Modi at an all-party meeting had expressed hope that a COVID-19 vaccine could be ready in a few weeks.
That same night, the Indian branch of the US pharmaceutical giant Pfizer applied to the central drug regulator for emergency use approval for its vaccine, after the firm obtained such authorization in the United Kingdom and Bahrain.
The Serum Institute sought that go-ahead for the COVID-19 vaccine from Oxford, Covishield, on December 6.
Applications from Bharat Biotech, Serum Institute of India and Pfizer will be reviewed by the subject matter expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organization (CDSCO) in the coming days.
“However, none of the applications have been sent to the committee so far and no date has been set on when the SEC will meet to evaluate and evaluate the applications,” the official source said.