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 companion Ocugen Inc to go for the Biologics License Application (BLA) route with extra information, Nixinghopes Emergency use authorization. Ocugen introduced in an announcement Thursday that it’ll try and submit a Biologics License Application (BLA) for Covaxin, as beneficial by the FDA. BLA is the “full approval” mechanism by the FDA for medication and vaccines.
“The Company will no longer pursue an emergency use authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the master file. The company had previously submitted and recommended that Ocugen apply for an EUA application for its vaccine candidate. Instead the BLA pursued submissions and requested additional information and data,” Ocugen mentioned.
Ocugen mentioned the event may delay the Covaxin launch within the US. OcuGen is in discussions with the FDA to grasp the extra info wanted to help BLA submissions.
The firm anticipates that information from a further scientific trial can be wanted to help the submission. “While we had been near finalizing our EUA software for submission, we acquired a advice from the FDA to pursue the BLA path. Although this can prolong our deadline, we stay dedicated to bringing Covaxin to the US, Said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of OKUGEN.
“This differentiated vaccine is a vital instrument so as to add to our nationwide arsenal, with the potential to handle SARS-CoV-2 variants, together with the delta variant, and given the unknown the best way to defend the US inhabitants in the long run. What can be required,” he added.
Ocugen just lately introduced that it has acquired unique rights to commercialize Covaxin in Canada and has begun discussions with Health Canada for regulatory approval. The firm will pursue an expedited authorization for a vaccine underneath an interim order relating to the import, sale and promoting of medication to be used in reference to COVID-19 in Canada.
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With inputs from TheIndianEXPRESS
