Full Press Release Details
OCUGEN PARTNER, BHARAT BIOTECH, ANNOUNCES POSITIVE
IMMUNOGENICITY AND SAFETY DATA FROM COVAXIN (BBV152), COVID-19 CANDIDATE VACCINE, IN CHILDREN 2 - 18 YEARS
MALVERN, Pa, December 30, 2021: Ocugen, Inc. (Nasdaq:
OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced
today that its partner, Bharat Biotech, posted results from a Phase 2/3 trial conducted in India of candidate vaccine, COVAXIN
(BBV152), in children, aged 2 - 18 years, demonstrating a robust neutralizing antibody response and favorable safety profile on
the pre-print server, medRXiv. Using a two-dose regimen administered 28-days apart, antibody responses
in subjects were comparable to adult data from a previous phase 3 study. Those results demonstrated a greater than 93% reduction in severe
disease. These pediatric data were the basis of Ocugen's pediatric Emergency Use Authorization (EUA) submission in the United States
for children 2-18 on November 5, 2021.
"These data represent the first positive vaccine data in children
as young as two years of age and come at an important time as COVID-19 infections are seeing a spike across the globe," said Shankar
Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen. "The results suggest that COVAXIN ,
which is made on the same platform used in traditional polio pediatric vaccines for decades, when administered in a two-dose series to
children between 2-18, may offer an option that is safe while delivering a robust immune response."
In the study, immunogenicity against key COVID-19 proteins was measured
using geometric mean titer (GMT), a test that measures the amount of antibodies in the blood in response to the presence of the virus.
GMT was measured across three age groups and demonstrated strong immune response after the second dose. There were no serious adverse
events such as myocarditis, pericarditis, or blood clots, reported in any of the three age groups.
This immunobridging trial was intended to determine if COVAXIN
generates the same protective immunity in children as it does in adults. To be considered equivalent, pediatric participants needed to
achieve comparable GMT's to those generated by adults in a large phase 3 clinical trial. At Day 56, across all ages, the mean SARS-CoV-2
antibody GMT was more than 30% higher in children aged 2-18 than the mean GMT from Phase 3 clinical trial involving 25,800 adult subjects
aged 18+. These data demonstrate children 2-18 generate antibody response comparable to adults fully vaccinated with COVAXIN
The study also showed increased antibody titers against 3 viral antigens
(Spike - S1, Receptor Binding Domain - RBD and Nucleocapsid - NP) providing a broad immune response to COVID-19. In each case a
more than 4-fold increase in neutralizing antibody titers versus baseline (titers measured in the same participants before being vaccinated)
was seen in all age groups after the second dose.
Participants were not reported to have experienced any severe adverse
events. The majority of adverse events noted (49%, n=374) were mild (e.g., injection site pain) and a small proportion (19%, n=6) were
moderate (e.g., fever, headache). Mild to moderate adverse events resolved within 24 hours.
The data were also submitted to the Drugs Controller General of India
(DCGI) to support a pediatric indication as recommended by an independent committee, known as the Subject Expert Committee (SEC), that
advises the Indian regulatory agency. Bharat Biotech intends to submit data from the full Phase 3 trial to a peer-reviewed scientific
About the Phase 2/3 Trial in Children (BBIL/BBV152/2021)
The seven-month Phase 2/3 open label, multicenter, study enrolled 525
children ages 2 years to 18 from 6 clinical trial sites across India. Conducted between May and July 2021, it was designed to
evaluate the safety, reactogenicity and immunogenicity of COVAXIN (BBV152) on a two-dose schedule (28 days apart) in three age
groups: ages 12-18, ages 6-12, and ages 2-6. Children with prior infection of SARS-CoV-2 were not excluded from the trial.
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 (BBV152) is a highly purified and inactivated vaccine that is manufactured
using a vero cell manufacturing platform.
With more than 125 million doses having been
administered to adults outside the U.S., COVAXIN (BBV152) 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
(BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19
vaccination certificates with India that includes vaccination using COVAXIN (BBV152). 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. We are co-developing Bharat Biotech's COVAXIN vaccine candidate for COVID-19 in the U.S. and Canadian markets. For
more information, please visit www.ocugen.com.
About Bharat Biotech
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of
more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications.
Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine &
bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.
Having delivered more than 4 billion
doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese
Encephalitis, Rabies, Chikungunya, Zika, and the world's first tetanus-toxoid conjugated vaccine for Typhoid. Bharat's commitment
to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines
BIOPOLIO , ROTAVAC , and Typbar TCV combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the
rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world's largest rabies vaccine
manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.
Cautionary Note on Forward-Looking
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 "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 statements about data published on the preprint
server, medRxiv, by Bharat Biotech, which found that COVAXIN generated a potentially robust neutralizing antibody
response and favorable safety profile in its Phase 2/3 study in pediatric patients, and the potential for this data to support our application
to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of COVAXIN
in pediatric patients. 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; the risk that
we may not resolve the current clinical hold on COVAXIN in the near term or at all, or that the FDA could make other decisions
that adversely impact our ability to advance the development of COVAXIN in the United States, and the implications that this clinical
hold may have for our request for emergency use authorization for COVAXIN for pediatric use, including the timing and scope of any such
authorization; 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 biologics license application (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