- COVAXIN ™ (BBV152) recently obtained the Emergency Use List from the World Health Organization
- Submission of pediatric EUA based on an immuno-bridge clinical trial in children, aged 2 to 18 years, demonstrating a neutralizing antibody response comparable to that observed in a large phase 3 clinical trial in adults conducted in India
- COVAXIN ™ (BBV152) uses the same Vero cell manufacturing platform as other childhood vaccines, including inactivated polio vaccine
- COVAXIN ™ (BBV152) elicited antibody titers against several antigens (S1, RBD and N); and provided lasting immunity against COVID-19 in phase 3 adult trial in India
- No serious adverse events or hospitalizations were observed in the phase 2/3 pediatric study of COVAXIN ™ (BBV152), including no events of particular interest such asGuillain-Barré syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia.
MALVERN, Pa., November 5, 2021 (GLOBE NEWSWIRE) – Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics and vaccines, today announced that it has submitted an application to the US Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) of Ocugen BBV152’s COVID-19 vaccine candidate, known as COVAXIN ™ outside of the United States, for pediatric use. The candidate vaccine was developed by the company’s partner, Bharat Biotech, and has been studied in an immunologic transition clinical trial conducted in India in children aged 2 to 18 years.
COVAXIN ™ (BBV152) is an inactivated whole virion vaccine, manufactured using a Vero Cell manufacturing platform, which has been used in the production of inactivated polio vaccine for the past 35 years, as well as ‘other traditional childhood vaccines.
Submission is based on the results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children aged 2-18 years, which linked immunogenicity data to a large clinical trial of Phase 3 safety and efficacy in nearly 25,800 adults. in India.
About data to support EUA
An open-label, phase 2/3 multicenter study was conducted in India from May 2021 to July 2021, to assess the safety, reactogenicity and immunogenicity of inactivated whole virion SARS-CoV-2 vaccine (COVAXIN ™ BBV152) in volunteers. healthy aged 2 to 18 years.
COVAXIN ™ (BBV152) has been evaluated in three age groups: 2 to 6 years old, 6 to 12 years old and 12 to 18 years old. All participants received two doses of the whole virion inactivated SARS-CoV-2 vaccine 28 days apart.
Neutralizing antibody responses to the wild-type strain in the pediatric age group 2 to 18 years were equivalent to those seen in adults, aged 18 years and older, in the large efficacy and safety trial of phase 3 of Bharat Biotech. More than 90% of seroconversion rates were observed for antibody titers against S1, RBD, N proteins and wild type neutralizing antibodies. These results suggest similar protection in children, aged 2 to 18, to that shown in adults over 18.
Among the 526 subjects in the pediatric clinical trial, no serious adverse reactions, such as death, hospitalization, myocarditis, pericarditis, Guillain-Barré syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reaction were reported in the study. . These have also not been observed in surveillance data collected in India following 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 filing of an emergency use authorization in the United States for pediatric use is an important step towards our hope to make our vaccine candidate available here and to help fight 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 looking for more choices when selecting a vaccine, especially for their children. Having a new type of vaccine will allow people to discuss with their child’s doctor the best approach for them to reduce 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 approved, we hope to provide another vaccine option to protect children as young as 2 years old.
About COVAXIN ™ (BBV152)
COVAXIN ™ (BBV152) is an investigational vaccine candidate in the United States. It was developed by Bharat Biotech in collaboration with the Indian Council for 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 administered to adults outside the United States, COVAXIN ™ is currently authorized for emergency use in 17 countries, and emergency use authorization applications are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN ™ to its list of authorized emergency vaccines. The trade name COVAXIN ™ has not been evaluated by the FDA.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of gene therapies to cure diseases of blindness and the development of a vaccine to save lives against COVID-19. Our revolutionary modifying gene therapy platform has the potential to treat multiple retinal diseases with a single drug – “one to many” – and our new biologic candidate aims to provide better therapy for patients with underserved diseases such as macular degeneration. wet age-related, diabetics. macular edema and diabetic retinopathy. For more information, please visit www.ocugen.com
Caution regarding forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predict”, “believe”, “possible”, “proposed”, “continue”, “” may “,” could “,” could “,” will “,” should ”or other words that reflect the uncertainty of future events or results to identify such forward-looking statements. These forward-looking statements include information about the qualitative evaluations of the available data, the potential benefits, expectations for clinical trials and the expected timing of clinical trial readings and regulatory submissions, including with respect to our expectation that COVAXIN ™, if authorized under the EUA, be accessible to children from the age of two. This information involves risks and uncertainties which could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among others, uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, start and / or completion dates of clinical trials, start dates and / or completion dates regulatory submission, regulatory approval dates and / or launch dates, including whether the FDA will allow COVAXIN ™ to be administered as a pediatric vaccine against COVID-19 in accordance with the EUA we have submitted to the FDA and the timing and scope of such authorization, as well as the risks associated with preliminary and interim data, including the possibility of new adverse clinical trial data and further analysis of existing clinical trial data ; the risk that the results of in vitro studies may not be duplicated in human clinical trials; the risk that clinical trial data will be subject to different interpretations and evaluations, including during the peer review / publication process, in the scientific community at large and by regulatory authorities; if and when Bharat Biotech clinical trial data will be published in scientific journals and, if so, when and with what modifications; whether the data and results from preclinical and clinical studies of COVAXIN ™, which were conducted by Bharat Biotech in India, will be accepted by the FDA or sufficient to support our EUA submission; the size, scope, timing and results of any additional trials or studies that we may need to conduct to support an EUA or BLA; any additional information on chemistry, manufacturing and controls that we may need to submit to the FDA; if and when a BLA for COVAXIN ™ will be submitted or approved by the FDA; whether developments regarding the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN ™ in the United States or Canada; FDA or Health Canada decisions affecting labeling, manufacturing processes, safety and / or other matters that could affect the availability or commercial potential of COVAXIN ™ in the United States or Canada , including the development of products or therapies by other companies. These and other risks and uncertainties are described in more detail in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the Quarterly Reports and annuals that we file with the SEC. All forward-looking statements we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, after the date of this press release. Press release.
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