New Delhi: Bharat Biotech’s US partner Ocugen has said that it had asked the United States (US) authorities for emergency use authorization for the Covid-19 vaccine Covaxin in the US, for children in the age group of 2-18 years, ANI reported.
While talking about the merits of using Covaxin as a covid-19 vaccination for children, Bharat Biotech’s clinical lead for Covid-19 vaccines, Dr Raches Ella on his Twitter handle writes, “We are pleased to announce our EUA filing to the US-FDA through our partners- Ocugen.”
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. https://t.co/xu6CyLds8H
— Dr. Raches Ella (@RachesElla) November 5, 2021
According to a press statement issued by Ocugen, the vaccine candidates was developed by Bharat Biotech and was studied in an immuno-bridging clinical trial conducted in India with children between 2-18 years of age. It further claimed that the covid-19 vaccine has been used in 17 countries under emergency use authorization.
“Covaxin™ (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines,” reads the press statement.
In order to evaluate the “safety, reactogenicity and immunogenicity,” a Phase 2/3 multicenter study along with a paediatric clinical trial was conducted in India from May to July 2021. The study was conducted under three age groups i.e. 2-6 years, 6-12 years and 12-18 years. The volunteers received two doses of Covaxin with a gap of 28 days between the doses.
In the pedantic clinical trials, 526 volunteers between 2 to 18 years old participated and it was observed that no adverse effects such as “deaths, hospitalizations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions” was found in the study.
“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,” Dr. Shankar Musunuri, Chairman of the Board, CEO, and Co-Founder of Ocugen said in the press statement.
“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 adds.
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