Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin.
Covid-19 vaccine major Bharat Biotech said that it will be carrying out clinical trials in the United States to support the marketing application for Covaxin.
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“Currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analysed and compiled. The company will make Phase III trials data from the final analysis public soon," Bharat Biotech added.
In a setback to Bharat Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin.
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BLA is a "full approval" mechanism by the FDA for drugs 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 pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data," Ocugen said.
