Hyderabad: Bharat Biotech’s Covid-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 Covaxine as recommended by the FDA. Biologics License Application, or BLA, is a full approval mechanism by the FDA for drugs and vaccines.

Covaxine’s US launch may be delayed
OcuGen stated that “the company will no longer seek an emergency use authorization (EUA) for Covaxine. 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 Covaxine 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 approval of Covaxine 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 Covid vaccine. All applications will have to follow the Biologics License Application Process which is the standard for vaccines process.”


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By Roddur

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