United States-based biopharmaceutical company Ocugen announced on Friday that it has sought emergency use authorisation from the country’s Food and Drug Administration to administer Covaxin to children.
Ocugen is Bharat Biotech’s partner in the United States for the Covid-19 vaccine. It has sought approval to administer the vaccine to children from 2 to 18 years of age.
The US-based firm has applied for the authorisation based on the results of phase 2 and 3 clinical trials conducted on 526 children aged between 2 and 18 years of age in India. The study had shown that the vaccine induced antibody responses equivalent to those seen in adults, and no adverse effects of the vaccine were reported.
Raches Ella, the clinical lead for Covid-19 vaccines at Bharat Biotech, said on Twitter that Covaxin is ideally placed for children because of its “tolerable safety profile”.
Due to a tolerable safety profile, COVAXIN is ideally placed for children. We are pleased to announce our EUA filing to the US-FDA through our partners- Ocugen. https://t.co/xu6CyLds8H
— Dr. Raches Ella (@RachesElla) November 5, 2021
Ocugen’s press release noted that Covaxin uses the same vero cell manufacturing platform as other vaccines for children, including the inactivated polio vaccine.
The company’s co-founder Shankar Musunuri said that the application for emergency use authorisation is a…