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Bharat Biotech’s US Partner Ocugen Seeks Approval On Covaxin’s Use For Children Below 18 Years

by TLAteam November 6, 2021November 6, 2021
written by TLAteam November 6, 2021November 6, 2021
Bharat Biotech’s US Partner Ocugen Seeks Approval On Covaxin’s Use For Children Below 18 Years

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.

Business News

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.

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