Ocugen Inc said on Monday the Covid-19 vaccine developed by its Indian partner Bharat Biotech International Ltd met the main goals of a trial in the United States.
The vaccine, sold under brand name Covaxin, showed an immune response in individuals who had not received a Covid vaccine previously as well as those vaccinated with mRNA vaccines by Pfizer Inc and Moderna Inc, meeting its main goals, Ocugen said.
The traditional form of vaccine, which uses killed virus particles to trigger an immune response, was also found to be well-tolerated in both sets of participants in the trial comprising 419 patients, the company said.
Shares of Ocugen were up 14.6% to $1.49 in premarket trade.
Covaxin is not cleared for use in any age group in the United States, but is one of the two most widely used Covid vaccines in India and has received emergency use listing from the World Health Organization (WHO).
Ocugen did not provide details about its submission to the U.S. FDA for the vaccine. The company is responsible for conducting trials and commercialization of the shot in the United States under a partnership with Bharat Biotech.
Covaxin has struggled in the United States, after the WHO suspended supply of the shot in April last year to allow time to the manufacturer to upgrade facilities and address deficiencies found in an inspection.
The U.S. Food and Drug Administration had also paused trials of the shot after WHO’s inspection of Bharat Biotech’s facility. The hold was lifted in May.
The vaccine, sold under brand name Covaxin, showed an immune response in individuals who had not received a Covid vaccine previously as well as those vaccinated with mRNA vaccines by Pfizer Inc and Moderna Inc, meeting its main goals, Ocugen said.
The traditional form of vaccine, which uses killed virus particles to trigger an immune response, was also found to be well-tolerated in both sets of participants in the trial comprising 419 patients, the company said.
Shares of Ocugen were up 14.6% to $1.49 in premarket trade.
Covaxin is not cleared for use in any age group in the United States, but is one of the two most widely used Covid vaccines in India and has received emergency use listing from the World Health Organization (WHO).
Ocugen did not provide details about its submission to the U.S. FDA for the vaccine. The company is responsible for conducting trials and commercialization of the shot in the United States under a partnership with Bharat Biotech.
Covaxin has struggled in the United States, after the WHO suspended supply of the shot in April last year to allow time to the manufacturer to upgrade facilities and address deficiencies found in an inspection.
The U.S. Food and Drug Administration had also paused trials of the shot after WHO’s inspection of Bharat Biotech’s facility. The hold was lifted in May.
