India
oi-Vicky Nanjappa
New Delhi, June 11: Bharat Biotech’s partner for Covaxin the US has said it will no longer seek emergency use authorisation for its COVID-19 vaccine candidate. It said that it would file for a full approval of the shot after the FDA asked for additional information and data.
Ocugen which has partnered with Bharat Biotech to produce Covaxin for the US market said that the decision was based on a recommendation from the country’s regulator.
“The FDA provided feedback to Ocugen regarding the Master File submitted previously and recommended that we pursue a BLA submission instead of an EUA application for the vaccine candidate and requested additional information and data,” Ocugen said in a statement to the New York Stock Exchange.
The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The…