Ocugen Inc. said on May 23 the U.S. drug regulator has lifted the clinical hold on a mid-to-late stage trial of the COVID-19 vaccine being developed by the company’s Indian partner Bharat Biotech.
The global vaccine alliance Gavi has secured $4.8 billion in funding pledges for the vaccine-sharing scheme COVAX, an official said on Friday, falling just shy of its target.
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.
The world’s leading COVID-19 vaccine and therapeutic manufacturers continue to develop treatments for the waves of variants as well as life-changing therapies for disease areas outside the world of coronaviruses. The world’s efforts to combat the global pandemic continue to evolve, as does Coronavirus Disease 2019 as variants and subvariants constantly toss volleys of grenades at the battlefront lines.
India’s Bharat Biotech said on January 12 a booster shot of the company’s Covaxin COVID-19 vaccine administered six months after the last of two doses neutralizes both the Omicron and Delta variants of the coronavirus.
Ocugen Inc. announced Nov. 5 that the biopharmaceutical company submitted a request to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) of the Covid-19 vaccine candidate BBV152, known as Covaxin outside of the United States, for pediatric use.
Europe registered a 55 percent rise in Covid-19 cases in the last four weeks, despite the availability of vaccines, which should serve as a “warning shot” to other regions, World Health Organization (WHO) officials said on November 4.
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).
British health authorities, as well as global experts, are closely watching a subtype of the Delta variant that appears to be rising in the UK.