Hyderabad: In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Food and Drug Administration has “recommended” Ocugen Inc, the US associate of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with further information, nixinghopes of Emergency Use Authorisation.
Ocugen in a assertion on Thursday introduced that as really helpful by the FDA, it can pursue submission of a biologics licence software (BLA) for Covaxin. BLA, is a “full approval” mechanism by the FDA for medicine 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 mentioned.
The improvement could delay the Covaxin launch in the US, Ocugen mentioned. Ocugen is in discussions with the FDA to grasp the extra data required to assist a BLA submission.
The firm anticipates that information from an extra medical trial will likely be required to assist 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 mentioned.
“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.
Ocugen not too long ago introduced that it secured unique rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval.
The firm will pursue expedited authorisation for the vaccine below the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.