In the latest update, the Hyderabad-based pharma major Bharat Biotech’s US partner Ocugen is seeking approval for Emergency Use Authorisation from the US FDA for Covaxin to be given for children from the age of 2 years to 18 years.
Submission Based On Trial Conducted With 526 Children
The company said in a statement that they have submitted a request seeking the approval. They said that the submission is based on the results of a Phase ⅔ pediatric clinical trial conducted by the Bharat Biotech in India with 526 children. The participants were of the age 2 years old to 18 years old.
The statement further said that the data collected bridged the immunogenicity data to a large. Covaxin uses the same Vero Cell manufacturing platform as the other childhood vaccines including the anti-polio vaccine.
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A Phase2/3, open-label multicentre study was conducted in India from May 2021 to July 2021. The aim was to evaluate the safety, reactogenicity and immunogenicity of the whole -virion inactivated SARS-CoV-2 vaccine in healthy volunteers in the mentioned age group.
Following this, the Covaxin evaluated three groups; 2-6 years old, 6-12 years old and 12-18 years old. All the participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine within 28 days of the doses.
Antibody Response Similar To The One In Adults
The neutralising antibody responses against the strain in the paediatric age group is similar to the ones ntoed in the adults in the Bharat Biotech’s large Phase 3 efficacy and safety trials.
Shankar Musunuri, Chairman of the Board, Chief Execute officer and Co-Founder of Ocugen said that the filling for the EUA in the uS for pediatric use is an important step towards their hope to make the vaccine candidate available and help combat the Covid 19 pandemic.
