Covaxin US launch delayed as USFDA recommends Biologics License Applications route

Bharat Biotech's US and Canada partner Ocugen said the FDA is asking the vaccine to take a route other than the emergency authorisation

The launch of Bharat Biotech's Covaxin in the US market will be delayed as the US Food and Drug Administration (USFDA) has asked Ocugen Inc to apply for the Biologics License Applications (BLA) instead of the Emergency Use Authorization (EUA).

Ocugen is Bharat Biotech's partner in the US and Canada.

The Pennsylvania-based company, responsible for clinical development and regulatory approvals in the US, stated last week that it is in the process of submitting the emergency use application for Covaxin in the US market.

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Unlike the EUA, BLA is FDA's standard approval process for drugs, vaccines. Data from an additional clinical trial will be required to support the marketing application submission for Covaxin under the BLA.

"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, CEO and co-founder, Ocugen said, according to reports.

Ocugen and Bharat Biotech had in February declared “a definitive agreement” to co-develop, manufacture, supply, and commercialise Covaxin in the US and share the profits from the sale in a 45:55 ratio. The two firms have recently announced an extension of their pact to include Canada.

Bharat Biotech reacted to the development stating that the BLA process would extend the company's US roll-out time.

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“With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the US. On the sidelines of this, the USFDA had communicated that no new EUA would be approved for new Covid-19 vaccines,” the biotech firm said on Friday.

“Our US partner, Ocugen, has received a recommendation from the FDA to pursue the BLA path for Covaxin, which is full approval. All applications have to follow the BLA which is the standard process for vaccines,” the company stated while adding that Covaxin has received EUAs from 14 countries.

“No vaccine manufactured or developed from India has ever received EUA or full license from the USFDA. So, when Covaxin gets approved, it will be a great leap forward for vaccine innovation and manufacturing from India,” Bharat Biotech said.