Ocugen, Bharat Biotech’s US partner, has stated that it has requested emergency use authorisation for the Covid-19 vaccine Covaxin in the United States (US) for children aged 2 to 18 years.
Bharat Biotech’s clinical lead for Covid-19 vaccines, Dr Raches Ella, says on his Twitter handle, “We are thrilled to announce our EUA filing to the US-FDA through our partners- Ocugen,” when discussing the benefits of employing Covaxin as a covid-19 vaccination for children.
According to an Ocugen press release, the vaccine candidates were produced by Bharat Biotech and tested in an immuno-bridging clinical trial with children aged 2 to 18 in India. It further stated that the covid-19 vaccine had been used under emergency use authorization in 17 nations.
“Covaxin™ (BBV152) is a whole-virion, inactivated vaccine created using a Vero Cell manufacturing platform, which has been used in the production of the inactivated polio vaccine and other traditional childhood vaccines for the past 35 years,” according to a recent report.
A Phase 2/3 multicenter study, as well as a paediatric clinical trial, were undertaken in India from May to July 2021 to examine the “safety, reactogenicity, and immunogenicity.” The study included three age groups: 2-6 years, 6-12 years, and 12-18 years. The volunteers were given two doses of Covaxin, separated by 28 days.
The study included 526 volunteers aged 2 to 18 years old, and no adverse effects such as “deaths, hospitalizations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia, or allergic reactions” were detected.
“Filing for Emergency Use Authorization in the United States for paediatric use is a significant step toward our hope of making our vaccine candidate available here and helping in the fight against the COVID-19 pandemic,” Dr. Shankar Musunuri, Chairman of the Board, CEO, and Co-Founder of Ocugen, said in a press release.
“Our results suggest that consumers want more options when choosing a vaccine, particularly for their children.” The availability of a new type of vaccine will allow parents to discuss with their child’s doctor the best way to reduce their child’s risk of developing COVID-19. The inactivated virus platform has been utilised in paediatric vaccinations for decades, and if approved, we aim to offer another vaccine option to protect youngsters as young as 2 years old,” he says.