1. You Are At:
  2. English News
  3. India
  4. Covaxin manufacturer Bharat Biotech to carry out clinical trials in US

Covaxin manufacturer Bharat Biotech to carry out clinical trials in US

In a setback to Bharat Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation.

India TV News Desk India TV News Desk
New Delhi Updated on: June 12, 2021 17:30 IST
Ocugen in a statement on Thursday announced that as
Image Source : PTI

Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin.

 

Covid-19 vaccine major Bharat Biotech said that it will be carrying out clinical trials in the United States to support the marketing application for Covaxin.

ALSO READ: Covaxin protects against Delta, Beta variants of COVID-19, says study

“Currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analysed and compiled. The company will make Phase III trials data from the final analysis public soon," Bharat Biotech added.

In a setback to Bharat Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin.

ALSO READ: We respect US's decision: Centre on Covaxin EUA rejection

BLA is a "full approval" mechanism by the FDA for drugs and vaccines. "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 an EUA application for its vaccine candidate and requested additional information and data," Ocugen said.

Latest India News

Write a comment

X