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 extra knowledge, nixinghopes of Emergency Use Authorisation.
Ocugen in a assertion on Thursday introduced that as advisable by the FDA, it would pursue submission of a biologics licence utility (BLA) for Covaxin. BLA, is a “full approval” mechanism by the FDA for medication 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 stated.
The growth could delay the Covaxin launch in the US, Ocugen stated. Ocugen is in discussions with the FDA to know the extra info required to assist a BLA submission.
The firm anticipates that knowledge from an extra scientific trial will probably 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 stated.
“This differentiated vaccine is a important software to incorporate in our nationwide arsenal given its potential to address the SARS-CoV-2 variants, together with the delta variant, and given the unknowns about what will probably be wanted to guard US inhabitants in the long run,” 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.