Ocugen Inc, Bharat Biotech’s partner for USA and Canada for coronavirus vaccine Covaxin on Friday said it has submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the jab for paediatric usage.
In a regulatory filing, Ocugen said, the submission is based on the results of a Phase 2/3 paediatric 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.
Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said, “Filing for Emergency Use Authorization in the US for paediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the COVID-19 pandemic.”
We’ve filed an EUA application with the @US_FDA to seek emergency use authorization of our investigational #COVID-19 vaccine candidate for children ages 2-18 in the US. It is being administered under emergency use authorization in 17 countries. Learn more: https://t.co/DjM7ORsppc pic.twitter.com/DOMKQ2P2YH
— Ocugen (@Ocugen) November 5, 2021
Some exploration suggests that people are seeking further choices when opting a vaccine, especially for their children. Having a new type of vaccine available will enable people to bandy with their child’s croaker the stylish approach for them to lower their child’s threat of constricting COVID-19, he further said.
“The inactivated virus platform has been used for decades in vaccines for the paediatric population and, if authorized, we hope to offer another vaccine option to protect children as young as two years,” he added.
A Phase2/3, open- marker,multi-center study was conducted in India from May 2021 to July 2021 to estimate the safety, reactogenicity and immunogenicity of the whole-virion inactivated Vaccine in healthy levies in the 2-18 age group. Covaxin was estimated in three age groups 2-6 times, 6-12 times and 12-18 times. All actors entered two boluses of the vaccine 28 days piecemeal, it said.