Hyderabad: Ocugen Inc., Bharat Biotech partner for the United States and Canada for Covid-19 Vaccine Covaxin, on Friday said it has sent a request to the US Food and Drug Administration (FDA) to authorize emergency use (EUA) from Jab for Pediatric using.
Submission is based on the results of the clinical trial phase 2/3 conducted by Bharat Biotech in India with 526 children aged 2-18 years, which bridges immunogenicity data in the clinical trial of safety and efficacy and efficacy at almost 25,800 adults in India, said Ocugen in submission of regulations.
“Submission for the use of emergency authorization in the US for pediatric use is an important step towards our expectations to make our vaccine candidates available here and help fight Pandemic Covid-19,” Shankar Musunuri, Chair of the Board, Chief Executive Officer and Co-founder of Ocugen said.
Some studies show that people are looking for more choices when choosing a vaccine, especially for their children.
Having a new type of vaccine available will allow people to discuss with their pediatricians to reduce their child’s risk.
Covid-19 contract, he further said.
“Inactive virus platforms have been used for decades in vaccines for children’s populations and, if permitted, we hope to offer other vaccine options to protect children as young as two years,” he added.
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Phase 2/3 studies, open labels, multi-centers are carried out in India from May 2021 to July 2021 to evaluate safety, reactogenicity and immunogenicity from all VA which is not active.
Ccine in healthy volunteers in the age group 2-18.
Covaxin was evaluated in three age groups: 2-6 years, 6-12 years and 12-18 years.
All participants received two doses of a separate 28 day vaccine, he said.
Covaxin has recently been awarded an emergency use list by the World Health Organization.