An open-label Phase 2/3 study was conducted in India from May 2021 to July 2021 to assess the reactogenicity, immunogenicity, and safety of the whole-virion inactivated SARS-CoV-2 vaccine, Covaxin, in healthy volunteers between the age group of 2- 18 years.
Bharat Biotech’s partner for the USA for its Covid-19 vaccine Ocugen Inc. said it had submitted a request for Emergency Use Authorization (EUA) of Covaxin for children in the age group 2-18 years to the US Food and Drug Administration (FDA).
This approval request is referred to a paediatric clinical trial conducted by Bharat Biotech called phase 2/3 in India with 526 children aged 2-18 years, demonstrating comparable neutralizing antibody response as seen in a significant adult Phase three clinical trial conducted in India.
Covaxin has recently been awarded as Emergency Use Listing by the World Health Organisation (WHO).
Covaxin For Paediatric Use
Covaxin has the same Vero Cell manufacturing platform as other vaccines for childhood, including the inactivated polio vaccine.
It obtained antibody IgM against several antigens (RBD, N and S1); and was given considerable immunity against Covid-19 in Phase three adult trials in India.
No serious adverse events or hospitalization were observed in the Phase 2/3 paediatric study of Covaxin.
The Data to Support EUA for Children
An open-label Phase 2/3 study was conducted in India from May 2021 to July 2021 to assess the reactogenicity, immunogenicity, and safety of the whole-virion inactivated SARS-CoV-2 vaccine, Covaxin, in healthy volunteers between the age group of 2- 18 years.
Covaxin was assessed in three age groups of 2-6, 6-12 and 12-18. All the participants were given two doses of the whole virion inactivated SARS-CoV-2 virus vaccine with a gap of 28 days.
The responses of neutralizing antibodies against wild-type strain in the paediatric age group of 2-18 years were found to be equal to those seen in adults, ages 18 and above, in Bharat Biotech’s significant Phase 3 efficacy and safety trial.
Over 90 per cent of the seroconversion rates were observed for antibody titers against S1, RBD, N proteins and wild-type neutralizing antibodies.
These results suggest the same protection in children, ages 2-18, as demonstrated in adults older than 18 years.
Amidst the 526 study subjects in the paediatric clinical trial, no serious adverse effects, such as deaths, hospitalization, anaphylactic reactions or vaccine-induced thrombotic thrombocytopenia, were reported.
There was also no observation in the data collected in India following the administration of over 59 million doses of Covaxin in adults. All other adverse events were or moderate or mild and were resolved within 24 hours.
Dr Shankar Musunuri statted that “Applying for Emergency Use Authorization in the US for paediatric use is a remarkable step to our hope to make our vaccine available here and help fight the Covid-19 pandemic,” He’s the CEO and Co-Founder of Ocugen.
He further added, “Our research proposed that people are looking for more options when choosing a vaccine, especially for their children. Having a new version of vaccine available will help them to discuss with their child’s physician and choose the best for them to lower the risk of their child’s of Covid 19
This inactivated virus platform has been used for several decades in vaccines for the paediatrician population and, if approved, we hope to offer another vaccine option to protect children as young as two years.”
