New Delhi: Hyderabad-based Bharat Biotech's US partner Ocugen has submitted a request to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Covaxin for children.
“Filing for Emergency Use Authorization in the U.S. 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 Dr Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen, in a statement.
Read: WHO grants emergency use listing to Bharat Biotech's Covaxin
“Our research suggests that people are seeking more choices when selecting a vaccine, especially for their children. 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. The inactivated virus platform has been used for decades in vaccines for the pediatric population and, if authorized, we hope to offer another vaccine option to protect children as young as 2 years," he said.
Covaxin was granted Emergency Use Listing by the World Health Organisation (WHO) recently. The approval was granted on the recommendation of the Technical Advisory Group (TAG) for Emergency Use Listing (TAG-EUL), an independent advisory panel that provides recommendations to WHO on whether a Covid19 vaccine can be listed for emergency use under the EUL procedure.
"The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children, 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India," the biopharmaceutical company said in a statement. "Covaxin uses the same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine," it said.
Read: Bharat Biotech expresses jubilation over WHO's approval
"A Phase 2/3, open-label, multicenter 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 (COVAXINTM BBV152). It was evaluated in three age groups: 2-6 years, 6-12 years and 12-18 years. All participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine 28 days apart," Ocugen said.
"No serious adverse events or hospitalizations were observed in Phase 2/3 pediatric study of COVAXINTM (BBV152), including no events of special interest such as Guillain-Barre Syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia," the company said.
