New Delhi: After the Food and Administration, a governing medical body in the United States, sought more data and information from Bharat Biotech's partner for Covaxin, the pharma giant has said that it will no longer seek emergency use authorisation, and instead, file for a full approval.
Ocugen , which has partnered with Bharat Biotech to procure Covaxin in the US, said the decision to seek full time approval was based on a recommendation from the country's top public health regulator.
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"The FDA provided feedback to Ocugen regarding the Master File submitted previously and recommended that we pursue a BLA submission instead of an EUA application for the vaccine candidate and requested additional information and data," Ocugen, which has partnered with Bharat Biotech to produce Covaxin for the US market, said in a statement to the New York Stock Exchange (NYSE).
"While this will extend our timelines, we're committed to bringing Covaxin to the US," Ocugen chief executive officer (CEO) Dr Shankar Musunuri said.
Covaxin, India's only homegrown vaccine, is being administered in in the country after getting approval from Drug Controller General. While presenting the data for their vaccine, Bharat Biotech had stated that their vaccine was found to be 78% effective against the symptomatic disease, and 100% protection from serious illness, according to the interim analysis.
Bharat Biotech was expected to announce the results of phase three clinical trials in June but announced on Thursday that it would do so in July.