Bharat Biotech’s bid for an emergency use authorisation(EUA) for Covaxin has been rejected by the US Food and Drug Administration (US-FDA). The US FDA has now asked Ocugen, Bharat Biotech’s partner in the US, to conduct an additional trial in the country and then apply for a full approval known as ‘Biologics Licence Application’. Covaxin is an inactivated virus-based COVID-19 vaccine developed indigenously by Indian pharma company Bharat Biotech.
The US FDA’s rejection of an interim approval will delay Bharat Biotech’s plan to export its vaccine to the United States. According to a statement made by Ocugen to the NYSE, the FDA has asked the company to submit additional information & data and then apply for a BLA submission instead of a EUA. “While this will extend our timelines, we are committed to bringing Covaxin to the US,” CEO of Ocugen Shankar Musuniri said.
The FDA rejected the application for Covaxin as Ocugen had submitted only partial data from the vaccine’s trial in March this year. The US regulator had recently released a new set of guidelines and announced that it would not grant emergency use authorisation to any new applications.
Meanwhile, Bharat Biotech is facing the heat in India as well for its delay in releasing the complete data from Covaxin’s phase 3 trials. The pharma company recently told news agency ANI that it would release the phase 3 data in July. The data is crucial for getting Covaxin authorised by the World Health Organization (WHO). WHO’s and US FDA’s approval would allow Bharat Biotech to easily export vaccines to countries across the world. It would also ensure that Covaxin gets recognised as a ‘vaccine passport’, which may be needed in future for travelling to other countries.