June 21, 2021

Lok Shakti.in

Nationalism Always Empower People

FDA rejects EUA for Covaxin, ‘suggests’ biologics license application route for US approval

In a jolt to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Food and Drug Administration has “recommended” the Indian vaccine maker’s US partner Ocugen Inc to go for the Biologics License Application (BLA) route with additional data, Nixinghopes Emergency use authorization. Ocugen announced in a statement Thursday that it will attempt to submit a Biologics License Application (BLA) for Covaxin, as recommended by the FDA. BLA is the “full approval” mechanism by the FDA for drugs and vaccines. “The Company will no longer pursue Emergency Use Authorization (EUA) for Covaxin. FDA provided feedback to Ocugen regarding the master file. The company previously submitted and recommended that Ocugen pursue a BLA submission rather than an EUA application for its vaccine candidate and requested additional information and data, Ocugen said. Ocugen said the development could delay the Covaxin launch in the US. OcuGen is in discussions with the FDA to understand the additional information needed to support BLA submissions. The company anticipates that data from an additional clinical trial will be needed to support the submission. “While we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue the BLA path. While this will extend our timeline, we remain committed to bringing Covaxin to the US,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of OcuGen. “This differentiated vaccine is an important tool to add to our national arsenal, which has the potential to address SARS-CoV-2 variants, including the delta variant, And given the unknown what will be necessary to protect the American population in the long term,” he added. Ocugen recently announced that it has acquired exclusive rights to commercialize Covaxin in Canada and has begun discussions with Health Canada for regulatory approval. The company will pursue an expedited authorization for a vaccine under an interim order regarding the import, sale and advertising of drugs for use in connection with COVID-19 in Canada. .

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