The U.S. Food and Drug Administration turned down Malvern, Pa.-based Ocugen’s Emergency Use Authorization (EUA) request for Covaxin in children ages 2 to 18 years. Covaxin is a Covid-19 vaccine the clinical-stage biopharmaceutical company is co-developing with India’s Bharat Biotech.
More than one year after the first COVID-19 vaccination was administered in the United States and more than 545 million doses later, new data from a survey conducted online by The Harris Poll among over 2,000 U.S. adults on behalf of Ocugen Inc. show a majority of Americans want more COVID-19 vaccines options to choose from.
The World Health Organization (WHO) granted approval for Indian drugmaker Bharat Biotech’s home-grown Covid-19 vaccine for emergency use listing, paving the way for Covaxin to be accepted as a valid vaccine in many poor countries.
Malvern, Pa.-based Ocugen submitted an Investigational New Drug Application to the U.S. Food and Drug Administration to run a Phase III trial of India’s Covid-19 vaccine BBV152 (Covaxin).
According to a Wall Street Journal report, the preferred Covid-19 shot globally is the Pfizer-BioNTech vaccine.
Bharat Biotech’s intranasal Covid-19 vaccine candidate is expected to enter the Phase II portion of a Phase II/III study within the next few weeks. BBV154 marks the second vaccine against the novel coronavirus developed by the India-based company.