The latest development may delay the Covaxin launch in the U.S. (Photo for representation)
| Photo Credit:
In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the U.S. Food and Drug Administration has “ recommended” Ocugen Inc, the U.S. 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.
“The company will no longer pursue an Emergency Use Authorisation (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 U.S.,” 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 U.S. population in the long term,” he 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.
The new names would only be to aid public discussion using labels that were « non stigmatising » to the countries where they were first identified
– Covaxin's launch in US to be delayed after FDA requests additional data
– US FDA Denies Covaxin Emergency Use Approval
– Why was Bharat Biotech's Covaxin not approved in US? Here's what we know so far
– Coronavirus: US drug regulator rejects emergency use approval for Bharat Biotech's Covaxin
– FDA rejects EUA for Covaxin, 'suggests' Biologics Licence Application route for approval in US
– Coronavirus News LIVE: US FDA delays EUA of Covaxin in country, seeks more data through BLA route
– Covaxin's US approval delayed as FDA asks for more data
– Here's Why FDA Rejected Covaxin's Emergency Use in America
– US FDA rejects emergency use approval for Bharat Biotech's Covaxin
– US FDA rejects emergency authorisation for Covaxin, 'recommends' to take full approval route
Vaccine,Emergency Use Authorization,Food and Drug Administration,Vaccine, Emergency Use Authorization, Food and Drug Administration,,covaxin,coronavirus,covid 19,vaccine,Biologics Licence Application,Bharat Biotech,bharat biotech covaxin approval,