Hyderabad-based pharmaceutical major Bharat Biotech will be carrying out clinical trials of its COVID-19 vaccine in the United States. The company announced that the trials will be conducted to support marketing applications in the US, reported ANI. The announcement from Bharat Biotech comes just a day after the emergency use authorisation for Covaxin was rejected in the US.
The US Food and Drugs Administration (FDA) yesterday "recommended" that Ocugen, Bharat Biotech’s US partner, will apply for the Biologics Licence Application (BLA) with additional data on the Covaxin vaccine. The recommendation by the FDA meant that Covaxin wouldn’t be approved for use in the country under the grant of the EUA.
The US drug regulator had announced changes in its guidelines for COVID-19 vaccine approvals and had announced that it would no longer be granting EUAs.
Bharat Biotech currently is the only manufacturer of India’s indigenously developed COVID-19 vaccine, Covaxin. However, the pharmaceutical company has yet to release its Phase III trial results regarding the vaccine’s efficacy. The company also announced that it was in the process of compiling and analysing the data from the Phase III trials and would release them soon.
"The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of a EUA application for its vaccine candidate and requested additional information and data,” Ocugen said.
Ocugen is currently in talks with the FDA to better understand the requirements and data needed to obtain the BLA. Bharat Biotech’s announcement to conduct trials in the US comes just a few days after the company announced that it would conduct Phase IV clinical trials to test the real-world effectiveness of Covaxin.