FDA Declines to Issue Emergency Authorization of India-Made COVAXIN for 2 to 18 Year-Olds

Ocugen, Inc., an American biopharmaceutical company focused on innovative therapies including the Covid-19 vaccine, provided an update on Friday that the Food and Drug Administration had declined its application for Emergency Use Authorization request for its Covid-19 vaccine for children ages 2 to 18 years old.

According to its news release, COVAXIN (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines.

This new vaccine was partnered and developed with India’s Bharat Biotech.

More from their news release here and below:

The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults 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 the whole-virion inactivated SARS-CoV-2 Vaccine (COVAXIN BBV152) in healthy volunteers 2-18 years of age.

COVAXIN (BBV152) was evaluated in three age groups: 2-6 years, 6-12 years and 12-18 years. All participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine 28 days apart.

The neutralizing antibody responses against wild-type strain in the pediatric age group of 2-18 years were equivalent to those seen in adults, ages 18+ years, in Bharat Biotech’s large Phase 3 efficacy and safety trial. More than 90 percent of the seroconversion rates were observed for antibody titers against S1, RBD, N proteins and wild-type neutralizing antibodies. These results suggest similar protection in children, ages 2-18, to that demonstrated in adults older than 18 years.

Among the 526 study subjects in the pediatric clinical trial, no serious adverse effects, such as deaths, hospitalizations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study. These were also not observed in the surveillance data collected in India following the administration of over 59 million doses of COVAXIN (BBV152) in adults. All other adverse events were mild or moderate in nature and were generally resolved within 24 hours.

“Filing for Emergency Use Authorization in the U.S. for pediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the COVID-19 pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen. “Our research suggests that people are seeking more choices when selecting a vaccine, especially for their children. Having a new type of vaccine available will enable people to discuss with their child’s physician the best approach for them to lower their child’s risk of contracting COVID-19. The inactivated virus platform has been used for decades in vaccines for the pediatric population and, if authorized, we hope to offer another vaccine option to protect children as young as 2 years.”

About COVAXIN (BBV152)
COVAXIN (BBV152) is an investigational vaccine candidate product in the U.S. 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 that is manufactured using a vero cell manufacturing platform.

With more than 100 million doses having been administered to adults outside the U.S., 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) recently added COVAXIN to its list of vaccines authorized for emergency use. The trade name COVAXIN has not been evaluated by the FDA.

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