Ocugen Inc., Bharat Biotech’s US partner for its Covid-19 vaccine, said it had filed with the US Food and Drug Administration (FDA) for an Emergency Authorization (EUA) for Covaxin for children of the age group 2 has put. 18 years.
The application for approval is based on the results of a phase 2/3 pediatric clinical study conducted by Bharat Biotech in India with 526 children aged 2 to 18 years, which produced a neutralizing antibody response comparable to that in a large phase 3 clinical study showed in adults living in India.
Covaxin recently received an award World Health Organization (WHO) emergency list.
COVAXIN FOR PEDIATRICS
Covaxin uses the same Vero Cell production platform as other childhood vaccines, including the inactivated polio vaccine.
It elicited antibody titers against several antigens (S1, RBD and N); and provided ongoing immunity to Covid-19 in a phase 3 adult study in India.
No serious adverse events or hospital admissions were observed in the Covaxin Phase 2/3 pediatric study.
ABOUT THE EEA SUPPORT DATA FOR CHILDREN
From May 2021 to July 2021, a phase 2/3, open-label, multicenter study was conducted in India to evaluate the safety, reactogenicity and immunogenicity of the inactivated SARS-CoV-2 whole virion vaccine Covaxin in healthy volunteers in age group 2 -18 years.
Covaxin has been studied in three age groups: 2-6 years, 6-12 years, and 12-18 years. All participants received two doses of the total virion-inactivated SARS-CoV-2 virus vaccine 28 days apart.
The neutralizing antibody responses against wild-type strains in the pediatric age group from 2 to 18 years of age were similar to those in adults aged 18 and over in Bharat Biotech’s large Phase 3 efficacy and safety study.
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More than 90 percent of the seroconversion rates were observed for antibody titers against S1, RBD, N proteins and neutralizing wild-type antibodies. These results suggest similar protection in children ages 2 to 18 as in adults over 18 years of age.
Among the 526 subjects in the pediatric clinical study, no serious adverse events such as death, hospital admissions, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia, or anaphylactic reactions were reported in the study.
These were also not seen in the surveillance data collected in India following administration of over 59 million doses of Covaxin in adults. All other adverse events were mild or moderate in nature and generally resolved within 24 hours.
“Applying for an emergency license in the US for pediatric use is an important step in our hope of making our vaccine candidate available here and helping to fight the Covid-19 pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen.
He added, “Our research suggests that people are looking for more choice when choosing a vaccine, especially for their children. The availability of a new vaccine will allow people to discuss with their child’s doctor how best to lower their child’s risk of developing Covid-19. The inactivated virus platform has been used in vaccines for the pediatric population for decades and, if approved, we hope to offer another vaccine option to protect children aged 2 years and over. “
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