USFDA asks Bharat Biotech partner Ocugen to take BLA route, provide more data, instead of seeking EUA
In a development bound to extend timelines for Covaxin to get approval in the U.S., vaccine maker Bharat Biotech’s partner Ocugen Inc has been advised by US Food and Drug Administration to seek a Biologics License Application (BLA) instead of Emergency Use Authorisation, for the vaccine.
“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.,” said Shankar Musunuri, CEO and co-founder of Ocugen.
The US firm, which is co-developing Bharat Biotech’s Covaxin vaccine candidate for COVID-19 in the U.S. and Canadian markets, said it will no longer pursue an EUA for Covaxin.
This follows the regulator’s feedback regarding the master file it had previously submitted, the firm said. USFDA “recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.” Stating this, the firm said it is in discussions with the regulator 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, it said. Separately, Bharat Biotech, which has developed Covaxin in collaboration with the ICMR-National Institute of Virology (NIV), said “with good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the U.S.
On the sidelines of this, the USFDA had earlier communicated that no new EUA would be approved for new COVID-19 vaccines.”
Stating that its US partner Ocugen has received a recommendation from the FDA to pursue BLA path for Covaxin, which is "full approval,” the Hyderabad-based firm said all applications have to follow the BLA process, the standard process for vaccines.
“Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for Covaxin. This process will extend our timelines,” it also said.
In the same statement, Ocugen, which had recently announced securing exclusive rights to commercialise Covaxin in Canada, said it has initiated discussions with Health Canada for regulatory approval. The company will pursue expedited authorisation for Covaxin under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.
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