Covaxin Bharat Biotech's US partner files request for paediatric use of Covaxin
New Delhi/UNI: Ocugen Inc, Bharat Biotech's partner in the US and Canada for Covaxin, has submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the Covid-19 jab for paediatric use.
Ocugen Inc, in a statement said, “The vaccine candidate was developed by the company’s partner, Bharat Biotech, and was studied in an immuno-bridging clinical trial conducted in India with children 2-18 years of age.”
It said 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”.
It said that “no serious adverse effects were seen among the 526 study subjects in the pediatric clinical trial” as well as 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”, it said.
“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 of the Board, CEO and Co-Founder of Ocugen.
“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 added.
“Due to a tolerable safety profile, COVAXIN is ideally placed for children. We are pleased to announce our EUA filing to the US-FDA through our partners- Ocugen,” said Dr Raches Ella, Project Lead: SARS-CoV-2 Vaccine Head of Bharat Biotech, in a tweet.
Currently, Pfizer's shot is the only one approved in the United States for children under the age of 18.
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