Full Press Release Details
COVAXIN (BBV152) Booster Dose Study Demonstrates
Robust Immune Responses and Long-Term Safety
MALVERN, Pa., January 8, 2022 - Ocugen, Inc. (NASDAQ:
OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced
that its partner, Bharat Biotech, posted positive results from a Phase 2 analysis of the vaccine candidate, COVAXIN (BBV152),
in participants ages 12-64, receiving a booster dose six months following a second dose on the pre-print server, medRxiv.
The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor
of vaccine efficacy.
"As the COVID-19 virus continues to evolve, so does our understanding
of the efficacy of vaccines and the critical role they play in protecting people from serious disease, hospitalization and death,"
said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. "These booster data provide critical information
about how COVAXIN can be used in the ongoing battle against COVID-19. We are encouraged by these results which continue to suggest
that COVAXIN remains an important, broad-spectrum vaccine candidate with durability."
Additional data from the analysis found that more than 75 percent of
all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN . After
receiving the booster, participants also saw an increase in antibody titers (at day 28) that were higher than those achieved after the
two-dose primary series. Wild-type neutralizing antibodies (PRNT50) GMTs at one month after a booster dose against Alpha, Beta,
Delta and Delta plus variants were increased 10 9, 161 0, 264 7, and 174 2 fold from baseline at six months
post second dose, respectively.
"Although protection against severe disease remains high six
months following the second dose, a decline in efficacy against symptomatic disease over time and the continued emergence of variants
are expected and consistent with what we are seeing with other vaccines. Based on emerging data, a third dose may be beneficial to maintain
the highest levels of protection," said Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.
The booster dose analysis also found no serious adverse events, including
hospitalization or death, were reported.
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 (BBV152) is a highly purified
and inactivated vaccine that is manufactured using a vero cell manufacturing platform.
With more than 180 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 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 "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 , when administered as a booster dose, generated a five-fold increase
in neutralizing titers, an important predictor of vaccine efficacy, 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 or our planned biologics
license application (BLA), assuming the clinical hold is lifted, for approval of COVAXIN for use in adult patients, as well as
statements regarding the potential short and long-term benefits of receiving a booster dose of COVAXIN . 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 EUA of 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 or planned BLA submission, assuming the clinical hold is lifted; 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