Hyderabad-based Bharat Biotech said on Friday that it will be carrying out a clinical trial in the US to support the marketing application for Covaxin in that country. The company didn’t disclose details regarding the possible number of participants or whether it would be a local bridging trial, among other details.
On Thursday the US partner for Bharat Biotech’s Covid-19 vaccine, Ocugen, said that it would pursue submission of a Biologics License Application (BLA) for the jab, instead of seeking Emergency Use Authorisation (EUA) as originally planned.
Ocugen, a Pennsylvania-based eye disease company, had to change its application at the USFDA, following a recommendation from the regulator.
Analysts say this means that subject to regulatory approvals, it could take longer for Covaxin to be launched in the US. Submission of a BLA represents the pursuit of full approval for the vaccine, rather than a provisional approval under an EUA
“The USFDA had earlier communicated that no new EUAs will be approved for Covid vaccines,” Bharat Biotech said in a statement. “All applications have to follow the BLA process, which is the standard process for vaccines. No vaccine manufactured or developed in India has ever received EUA or full licensure from the USFDA.”
On Thursday the US partner for Bharat Biotech’s Covid-19 vaccine, Ocugen, said that it would pursue submission of a Biologics License Application (BLA) for the jab, instead of seeking Emergency Use Authorisation (EUA) as originally planned.
Ocugen, a Pennsylvania-based eye disease company, had to change its application at the USFDA, following a recommendation from the regulator.
Analysts say this means that subject to regulatory approvals, it could take longer for Covaxin to be launched in the US. Submission of a BLA represents the pursuit of full approval for the vaccine, rather than a provisional approval under an EUA
“The USFDA had earlier communicated that no new EUAs will be approved for Covid vaccines,” Bharat Biotech said in a statement. “All applications have to follow the BLA process, which is the standard process for vaccines. No vaccine manufactured or developed in India has ever received EUA or full licensure from the USFDA.”
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