Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on
discovering, developing, and commercializing novel gene and cell
therapies, biologicals, and vaccines, today announced the
publication of positive pediatric Phase 2/3 study results in
children aged 2–18 years for the COVID-19 vaccine
COVAXIN™ (BBV152) in The Lancet Infectious Diseases (“The
Lancet”). COVAXIN™ is developed and manufactured by Ocugen’s
partner Bharat Biotech International Limited (“Bharat Biotech”), a
global leader in vaccine innovation based in Hyderabad, India, and
is under clinical investigation by Ocugen in the United States for
use in adults aged 18 years and older.
The Lancet article, entitled “Immunogenicity and reactogenicity
of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2–18
years: interim data from an open-label, non-randomised, age
de-escalation phase 2/3 study,” which was authored by Dr. Krishna
Mohan Vadrevu, Siddharth Reddy, MSc, and others, was published on
June 16, 2022.
Ocugen has commercial rights for COVAXIN™ throughout North
America and COVAXIN™ has emergency use authorization in Mexico
for adults. Ocugen is continuing to explore pediatric emergency use
authorization in Mexico. This data demonstrates that the same dose
is effective in both pediatrics and adults (ages two and older) and
would be an ideal option as the majority of Americans are looking
for traditional vaccine options. Ocugen is continuing its effort to
bring this vaccine to the North American Market.
“We congratulate Bharat Biotech on the publication of the
COVAXIN™ pediatric data in this prestigious peer-reviewed
medical journal,” said Dr. Shankar Musunuri, Chairman, CEO, and
Co-Founder of Ocugen. “Not only is this a strong validation of the
work they are doing, but it is a very encouraging development in
the effort to contain this pandemic, which needs a greater variety
of vaccine options to combat the multiple COVID-19 variants. We
believe the distinct features of COVAXIN™ offer benefits that
could help improve public health.”
Dr. Krishna Ella, Chairman and Managing Director of Bharat
Biotech, said, “We are glad to have Ocugen as a valuable partner to
help bring COVAXIN™ to North America. Safety of the vaccine is
critical for children, and we are glad to share that
COVAXIN™ has proven data for safety and immunogenicity in
children. We have now achieved our goal of developing a safe and
efficacious COVID-19 vaccine for adults and children, for primary
immunization and booster doses, making COVAXIN™ a universal
vaccine. It has proven to be a highly safe vaccine based on data
from more than 50 million doses administered to children in
India.”
The low reactogenicity might make COVAXIN™ more acceptable
in pediatric populations than the more reactogenic mRNA vaccines as
Bharat Biotech’s pediatric Phase 2/3 study had no serious adverse
events, deaths, or withdrawals due to an adverse event including no
cases of Guillain-Barré syndrome, thromboembolic events,
myocarditis, or pericarditis, or other adverse events of special
interest being observed to date. We believe COVAXIN™ will be a
valuable tool in the global immunization effort as it can be stored
at 2–8°C, which is standard vaccine storage conditions. Follow-up
studies to assess pediatric effectiveness are underway, but this
study suggests that similar efficacy, measured by the ability of a
vaccine to prevent disease, might be anticipated in children based
on the observation of superior immunogenicity, measured by the
ability of a vaccine to produce an immune response, as compared to
adults.
The open-label, non-randomized study was conducted in six
hospitals in India and included 526 healthy children. Two doses of
COVAXIN™ were administered 28 days apart in three groups
according to their ages, two to six years, six to 12 years, and 12
to 18 years. The results were compared with those from adults who
participated in a previously reported Phase 2 study. The study is
registered with the Clinical Trials Registry, India
(CTRI/2021/05/033752) and ClinicalTrials.gov (NCT04918797).
About
COVAXIN™ (BBV152)The COVID-19
vaccine candidate BBV152, known as COVAXIN™ outside the United
States, is a whole-virion inactivated COVID-19 vaccine candidate
that applies the same Vero cell manufacturing platform, which has
been used in the production of polio vaccines for decades.
COVAXIN™ was co-developed with Ocugen’s partner, Bharat
Biotech, in collaboration with the Indian Council of Medical
Research – National Institute of Virology. COVAXIN™ has been
granted Emergency Use Listing by the World Health Organization
based on a submission by Bharat Biotech. COVAXIN™ is
formulated uniquely such that the same dosage can be administered
to adults and children alike, making it truly a universal vaccine.
COVAXIN™ is a ready to use liquid vaccine stored at 2-8°C with
a 12-month shelf life and multi dose vial policy.
About Ocugen, Inc.Ocugen, Inc. is a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies, biologicals, and
vaccines that improve health and offer hope for people and global
communities. We are making an impact through courageous innovation,
taking science in new directions in service of patients. Our
breakthrough modifier gene therapy platform has the potential to
treat multiple diseases with one drug and we are advancing research
in other therapeutic areas to offer new options for people with
unmet medical needs. Discover more at www.ocugen.com and follow us
on Twitter and LinkedIn.
Cautionary Note on Forward-Looking
StatementsThis 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 “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, but are not limited to,
statements about COVAXIN™ efficacy, safety, and immunogenicity
in children aged 2-18 years, Ocugen’s ability to expand emergency
use authorization for COVAXIN™ in Mexico to include children
aged 2-18 years, Ocugen’s intention to continue its effort to bring
COVAXIN™ to the North American Market, and the potential
advantages of COVAXIN™ over other vaccines. Such statements
are subject to numerous important factors, risks, and uncertainties
that may cause actual events or results to differ materially from
our current expectations. 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.
Contacts:Tiberend Strategic Advisors,
Inc.Jonathan Nugent / Daniel Kontoh-Boateng (Investor
Relations)jnugent@tiberend.comdboateng@tiberend.com
Bill Borden (Media)bborden@tiberend.com
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