Bharat Biotech's partner for Covaxin in the US has said it will no longer seek an emergency use authorisation for its Covid-19 vaccine candidate and will file for a full approval of the shot after the Food and Drug Administration (FDA) asked for additional information and data. Ocugen, which has partnered with Bharat Biotech to produce Covaxin for the US market, said the decision was based on a recommendation from the country's top public health regulator.
"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).
As a result of this, Ocugen said, it would no longer pursue a EUA application and would instead aim to file for full approval of the shot and go for a Biological License Application (BLA)—the full approval for a vaccine shot. The firm added that it expects data from an additional clinical trial to be required for a full-use application.
"While this will extend our timelines, we're committed to bringing Covaxin to the US," Ocugen chief executive officer (CEO) Dr Shankar Musunuri said. In addition to the US, Ocugen has secured exclusive rights to market the vaccine in Canada as well and is in discussion with Health Canada for regulatory approval.
Covaxin is India's only homemade vaccine against the coronavirus disease and one among three to have been approved for use; Covishield and Sputnik V are the other two shots. Of these, Covaxin and Covishield have been used since India began its vaccination drive on January 16.
The shot was found to be 78% effective against the symptomatic disease, and 100% protection from serious illness, according to the interim analysis. Bharat Biotech was to announce the results of phase three clinical trials in June but said on June 10 it would do so only a month later, in July.