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”.
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 “significant step toward our hope to make our vaccine candidate available here [in the United States] and help combat the COVID-19 pandemic”.
“Our research suggests that people are seeking more choices when selecting a vaccine, especially for their children,” Musunuri said. “Having a new type of vaccine available will enable people to discuss with their child’s physician the best approach for them to lower their child’s risk of contracting Covid-19.”
On November 3, Bharat Biotech received the World Health Organization’s emergency use listing for Covaxin.
It took more than three months for Covaxin to get the WHO’s clearance. Prime Minister Narendra Modi had pushed for the vaccine’s approval at the G20 summit held earlier this month.
The Drugs Controller General of India had granted approval for restricted emergency use to Covaxin in January. Covaxin and Oxford-AstraZeneca’s Covishield were the first Covid-19 vaccines to be approved in India.
According to the CoWin dashboard, a total of 12,18,10,480 doses of Covaxin have been administered in India till October 6.