Ocugen has reported positive data from paediatric Phase II/III clinical trial of the Covid-19 vaccine, Covaxin (BBV152), in children of the age two to 18 years.
Developed and produced by Ocugen’s partner Bharat Biotech, Covaxin is a whole-virion inactivated vaccine candidate for Covid-19.
Covaxin is said to have low reactogenicity, which could make it a suitable option for paediatric populations.
The open-label, non-randomised trial was carried out by Bharat Biotech in six hospitals in India and enrolled 526 healthy children aged two to 18 years.
The trial subjects were given two doses of the vaccine at a gap of 28 days.
In the paediatric Phase II/III trial, the vaccine offered no serious adverse events or mortality.
In addition, no withdrawals due to an adverse event including cases of thromboembolic events, Guillain-Barré syndrome, myocarditis or pericarditis were reported.
Currently, follow-up trials to evaluate paediatric effectiveness are progressing.
Bharat Biotech chairman and managing director Dr Krishna Ella said: “Safety of the vaccine is critical for children, and we are glad to share that Covaxin has proven data for safety and immunogenicity in children.
“We have now achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children, for primary immunisation and booster doses, making Covaxin a universal vaccine.”
The vaccine is currently being analysed clinically by Ocugen in the US for usage in adults of the age 18 years and above.
It can be stored at standard vaccine storage conditions of 2-8°C.
Ocugen holds the commercial rights for the vaccine throughout North America and has obtained emergency use authorization for use of Covaxin for adults in Mexico.
The company is now exploring emergency use authorization for paediatric individuals in Mexico.
In February this year, the US Food and Drug Administration lifted a clinical hold placed on Ocugen’s Investigational New Drug application to assess the Covid-19 vaccine, BBV152.