In a setback that has the potential to delay the launch of Covid-19 Vaccine Covaxin Bharat Biotech in the United States, the food and drug administration there has been “recommended” Ocugen Inc., US partners from Indian vaccine makers, to go for biology license applications (BLA). Routes with additional data, Nixing Hopes authorization of emergency use.
Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue the submission of the Biological License Application (BLA) for Covaxin.
BLA is a “full approval” mechanism by the FDA for drugs and vaccines.
Development can delay the launch of Covaxin in the US, said Ocugen.
“The company will no longer pursue an emergency use authorization (EUA) for Covaxin. The FDA provides feedback to Ocugen about the master file. The company has previously sent and recommends that Ocugen pursue BLA filing for its vaccine candidates and request additional information and data,” Ocugen said.
Ocugen in discussions with the FDA to understand additional information needed to support BLA submission.
The company anticipates that data from additional clinical trials will be needed to support submissions.
“Even though we are close to completing our EUA application for submission, we accept recommendations from the FDA to pursue a blah line. Even though this will extend our schedule, we are committed to bringing Covaxin to the US,” Dr. Shankar Musunuri, Chair of the Board, Chief Executive Officer and Co-Founder of Ocugen said.
“This different vaccine is an important tool to be included in our national arsenal which is given its potential to overcome the SARS-COV-2 variant, including Delta variants, and remembering unknown things about what will protect the US population in the long run,” He added.
Reacting to the “Recommendation” FDA, Bharat Biotech said with a large flock of immunity and a significant percentage of the vaccinated population, the pandemic was reduced in the United States, the US regulator previously communicated that there was no new EUU to be approved for Covid -19 vaccines.
“All applications must follow the biological license application process, which is a standard process for vaccines. Data from additional clinical trials will be needed to support the submission of marketing applications for Covaxin,” the vaccine maker said.
There is no vaccine produced or developed from India that has ever received EUA or a full license from the USFda.
When approved, it will be a “big leap” for innovation and manufacturing vaccines from India, Bharat Biotech added.
Ocugen recently announced that he received exclusive rights to commercialize Covaxin in Canada and had begun discussion with Canadian health for regulatory approval.
The company will pursue accelerated authorization for vaccines under the temporary order that respects import, sales and drug advertising for use in connection with Covid-19 in Canada.
