"The Company will no longer pursue an Emergency Use Authorization for Covaxin (developed by Bharat Biotech & ICMR)," said Ocugen in a statement.
Rejecting its proposal, the FDA asked the company to launch an additional trial so that the company can file for BLA.
Following this, Ocugen said it is in discussions with the FDA to understand the additional information required to support a BLA submission.
“While this will extend our timelines, we are committed to bringing Covaxin to the US," said Shankar Musuniri, chief executive of Ocugen.
The development comes at a time when Bharat Biotech is under criticism in India for not sharing data from its phase 3 clinical trials almost six months after the company’s vaccine was included in the immunization programme.
In a statement to news agency ANI, the company said that it will release results from its phase 3 data in July (the earlier timeline was June).
The phase 3 data is crucial to seek emergency approval from the World Health Organisation, which will allow the company to export its vaccines, besides granting the much-needed validation that is required for the vaccine to be considered as part of a “vaccine passport".
Vaccine passport or immunity passports are becoming a reality as countries open their borders for non-essential travel to fully vaccinated individuals.
At present, several countries do not recognize Covaxin and those administered both doses of the vaccines are also considered unvaccinated.
According to a recent report, several US colleges are asking those students who have received Covaxin or the Russian-made Sputnik V to re-vaccinate.
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