Hyderabad-based pharma major Bharat Biotech's US partner Ocugen has sought the Emergency Use Authorisation (EUA) from the US FDA for Covaxin to be administered in children aged two to 18 years.
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"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.