In setback that could potentially delay the launch of Bharat Biotech's COVID-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes 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.
BLA is a "full approval" mechanism by the FDA for drugs and vaccines.
The development may delay the Covaxin launch in the US, Ocugen said.
"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.
Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission.
The company anticipates that data from an additional clinical trial will be required to support the submission.
"Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US," Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said.
"This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term," he added.
Reacting to the FDA's "recommendation", Bharat Biotech said with good herd immunity and significant percentage of the population vaccinated, the pandemic is reducing in the United States, the US regulator had earlier communicated that no new EUAs will be approved for COVID-19 vaccines.
"All applications have to follow the biological license application process, which is the standard process for vaccines. Data from an additional clinical trial will be required to support the marketing application submission for Covaxin," the vaccine maker said.
No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA.
When approved, it will be a "great leap forward" for vaccines' innovation and manufacturing from India, Bharat Biotech added.
Ocugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval.
The company will pursue expedited authorisation for the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.