Bharat Biotech's US partner Ocugen seeks Covaxin approval for kids
"The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children two-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India," it said in a statement. Covaxin uses the same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine.
A Phase 2/3, open-label, multicentre study was conducted in India from May 2021 to July 2021, to evaluate the safety, reactogenicity and immunogenicity, of the whole-virion inactivated SARS-CoV-2 Vaccine in healthy volunteers in the above mentioned age group.
Covaxin was evaluated in three age groups: two-six years, six-12 years and 12-18 years. All participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine 28 days apart, added the statement from Ocugen. The neutralising antibody responses against wild-type strain in the paediatric age group of two-18 years were equivalent to those seen in adults, aged 18 and above, in Bharat Biotech's large Phase 3 efficacy and safety trial.
"Filing for EUA in the US for pediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the Covid-19 pandemic," said Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen. Among the 526 study subjects in the pediatric clinical trial, no serious adverse effects, such as deaths, hospitalisations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study, the statement added.
