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Bharat Biotech's US partner Ocugen seeks FDA approval for Covaxin use for children below 18 years

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The approval request by Ocugen is based on result of Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children in the age group 2-18 years.

Ocugen Inc., Bharat Biotech’s partner for USA for its Covid-19 vaccine, said that it has submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of Covaxin for children in the age group 2-18 years.

The approval request 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 demonstrated comparable neutralising antibody response as seen in a large adult Phase 3 clinical trial conducted in India.

Covaxin uses same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine.

It elicited antibody titers against multiple antigens (S1, RBD, and N); and provided durable immunity against Covid-19 in Phase 3 adult trial in India.

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, Covaxin, in healthy volunteers in the age group 2-18 years.

Covaxin 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.

The neutralizing antibody responses against wild-type strain in the pediatric age group of 2-18 years were equivalent to those seen in adults, ages 18 and above, in Bharat Biotech’s large Phase 3 efficacy and safety trial.

More than 90 per cent of the seroconversion rates were observed for antibody titers against S1, RBD, N proteins and wild-type neutralizing antibodies. These results suggest similar protection in children, ages 2-18, to that demonstrated in adults older than 18 years.

Among the 526 study subjects in the pediatric clinical trial, no serious adverse effects, such as deaths, hospitalizations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study.

These were also not observed in the surveillance data collected in India following the administration of over 59 million doses of Covaxin in adults. All other adverse events were mild or moderate in nature and were generally resolved within 24 hours.

“Filing for Emergency Use Authorization 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 Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen.

He added,“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.”

India Today

Friday, November 12, 2021 – 09:50

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