Ocugen announces positive results for COVID-19 vaccine trial for children aged two-18 years

Ocugen today announced the publication of positive paediatric phase-II/III study results in children aged two-18 years for the COVID-19 vaccine Covaxin in The Lancet Infectious Diseases. Covaxin is developed and manufactured by Ocugen’s partner Bharat Biotech, and is under clinical investigation by Ocugen in the US for use in adults aged 18 years and older, Ocugen notified in a statement.

The Lancet article, entitled “Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged two-18 years: interim data from an open-label, non-randomised, age de-escalation phase-II/III study,” which was authored by Dr Krishna Mohan Vadrevu, Siddharth Reddy, MSc, and others, was published on 16th June, 2022, said the statement.

It also mentioned that Ocugen has commercial rights for Covaxin throughout North America, and it has an Emergency Use Authorisation (EUA) in Mexico for adults. Ocugen is continuing to explore paediatric EUA in Mexico. This data demonstrates that the same dose is effective in both paediatrics and adults (aged two years and older) and would be an ideal option as the majority of Americans are looking for traditional vaccine options. Ocugen is continuing its effort to bring this vaccine to the North American Market.

“We congratulate Bharat Biotech on the publication of the Covaxin paediatric data in this prestigious peer-reviewed medical journal,” said Dr Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen, in the statement. “Not only is this a strong validation of the work they are doing, but it is a very encouraging development in the effort to contain this pandemic, which needs a greater variety of vaccine options to combat the multiple COVID-19 variants. We believe the distinct features of Covaxin offer benefits that could help improve public health,” he added.

The low reactogenicity might make Covaxin more acceptable in paediatric populations than the more reactogenic mRNA vaccines as Bharat Biotech’s paediatric phase-II/III study had no serious adverse events, deaths or withdrawals due to an adverse event, including no cases of Guillain-Barré syndrome, thromboembolic events, myocarditis, or pericarditis, or other adverse events of special interest being observed to date, the statement added.

Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, also said in the statement, “We are glad to have Ocugen as a valuable partner to help bring Covaxin to North America. 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. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India.”