India Biotech’s partner Ocugen Inc. for the United States and Canada for the COVID-19 vaccine Covaxin. said on Friday it has submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of the jab for pediatric use.
Covaxin (BBV152) is a full-virulence, inactivated vaccine manufactured using the Vero cell manufacturing platform, as has been used for the past 35 years in the production of inactivated polio vaccines, as well as other conventional childhood vaccines. There are also comments.
The presentation is based on the results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech with 526 children aged 2-18 years, which demonstrated a large, Phase 3 safety and efficacy clinical trial in approximately 25,800 adults. The immunogenicity data for the test has been bridged. in India.
About the data to support the EUA
A Phase 2/3, open-label, multicenter study was conducted in India from May 2021 to July 2021 to evaluate the safety, reactogenicity and immunogenicity of whole-virus inactivated SARS-CoV-2 vaccine (Covaxin BBV152) had gone. Volunteers aged 2-18 years.
Covaxin (BBV152) was evaluated in three age groups: 2–6 years, 6–12 years, and 12–18 years. All participants received two doses of complete virion inactivated SARS-CoV-2 virus vaccine 28 days apart.
Neutralizing antibody responses against the wild-type strain in the pediatric age group of 2-18 years were comparable to adults 18+ years of age in Bharat Biotech’s large Phase 3 efficacy and safety trial. A seroconversion rate greater than 90 percent was observed for antibody titers against S1, RBD, N proteins and wild-type neutralizing antibodies. These results suggest similar protection in children aged 2–18 years as demonstrated in adults over 18 years of age.
In 526 study subjects in a pediatric clinical trial, no serious adverse effects, such as death, hospitalization, myocarditis, pericarditis, Guillain-Barré syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions, were reported in the study .
These were also not observed in surveillance data collected in India after administration of more than 59 million doses of Covaxin (BBV152) in adults. All other adverse events were mild or moderate in nature and generally resolved within 24 hours.
The Board’s Chief Executive Officer, Dr. Shankar Musunuri said, “Filing for Emergency Use Authorization for Pediatric Use in the US is a step towards our hope of making our vaccine candidate available here and helping combat the COVID-19 pandemic.” An important step.” , and co-founder of Ocugen. “Our research shows that people are exploring more options when choosing a vaccine specifically for their children. Having a new type of vaccine available will enable people to discuss with their child’s doctor what their What is the best way to reduce the risk of their child contracting COVID-19. The inactivated virus platform has been used in vaccines for the pediatric population for decades and, if authorized, we are less than 2 years old We hope to offer another vaccine option to protect children of older age.”
About Covaxin:
Covaxin (BBV152) is an investigational vaccine candidate product in the US. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine manufactured using the Vero Cell manufacturing platform.
With more than 100 million doses administered to adults outside the US, Covaxin is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) has recently added Covaxin to its list of authorized vaccines for emergency use. The trade name Covaxin has not been evaluated by the FDA.
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