No approval for emergency use of covaccine in the US, FDA said – more data needed


Hyderabad: Bharat Biotech’s Kovid-19 vaccine has not received emergency use approval in the US. The US Food and Drug Administration (FDA) has recommended the Indian vaccine maker’s US partner Ocugen Inc. to apply through the Biologics License Application (BLA) route with additional data.

OcuGen announced in a statement on Thursday that the US will endeavor to submit a Biologics License Application (BLA) for Covaccine as recommended by the FDA. Biologics License Application, or BLA, is a full approval mechanism by the FDA for drugs and vaccines.

There may be a delay in the US launch of Covaccine
OcuGen stated that “the company will no longer seek an Emergency Use Authorization (EUA) for Covaccine. The FDA has provided feedback to Ocugen regarding the master file. The company has recommended that Ocugen apply instead of an EUA for this vaccine.” Focus on BLA submission. Along with this, additional information and data have been requested.

OcuGen said that this could delay the launch of Covaccine in the US. The company is in discussions with the FDA regarding additional documents required for application of the vaccine for BLA submission.

Negotiations on for Covaccine Approval in Canada
OcuGen recently announced that it has obtained exclusive rights to commercialize the vaccine in Canada and has started discussions with Canadian health authorities for approval. The company will pursue authorization for the vaccine under an interim order regarding the import, sale and advertising of drugs for use in connection with COVID-19 in Canada.

In a statement issued by Bharat Biotech, the company said that “The USFDA has previously stated that no new emergency use authorization will be approved for the Kovid vaccine. All applications will have to follow the Biologics License Application Process which is the standard for vaccines.” process.”

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