Full Press Release Details
Ocugen, Inc. Announces Submission of Emergency
Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN (BBV152) for Children Ages 2-18 Years
MALVERN, Pa., - November 5, 2021 - Ocugen, Inc. (NASDAQ:
OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced
today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Ocugen's
COVID-19 vaccine candidate BBV152, known as COVAXIN outside of the U.S., for pediatric use. The vaccine candidate was developed
by the company's partner, Bharat Biotech, and was studied in an immuno-bridging clinical trial conducted in India with children
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.
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
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)
(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.
Ocugen, Inc. is a biopharmaceutical company focused on discovering,
developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough
modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug - "one to many" -
and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular
degeneration, diabetic macular edema, and diabetic retinopathy. For more information, please visit www.ocugen.com
Cautionary Note on Forward-Looking Statements
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 "predicts," "believes," "potential,"
"proposed," "continue," "estimates," "anticipates," "expects," "plans,"
"intends," "may," "could," "might," "will," "should" or other
words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements
include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated
timing of clinical trial readouts and regulatory submissions, including with respect to our hope that COVAXIN , if authorized under
the EUA, would be available to children as young as two years of age. This information involves risks and uncertainties that could cause
actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, including whether
the FDA will authorize COVAXIN for administration as a vaccine for pediatric uses against COVID-19 pursuant to the EUA we submitted
with the FDA and the timing and scope of any such authorization, as well as risks associated with preliminary and interim data, including
the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results
of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations
and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities;
whether and when data from Bharat Biotech's clinical trials will be published in scientific journal publications and, if so, when
and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN , which have been
conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission; the size,
scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional
chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN
will be submitted to or approved by the FDA; whether developments with respect to 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; decisions by the FDA or Health Canada impacting 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 development of
products or therapies by other companies. These and other risks and uncertainties are more fully described 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 and annual reports that we file with the SEC. Any forward-looking statements that 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 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.
Head, Investor Relations & Communications
investor-related inquiries to: IR@ocugen.com