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Ocugen Announces Publication of a Comprehensive Review of BBV152 in Frontiers in Immunology

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Ocugen, Inc. announced the publication of a comprehensive review on BBV152, commercialized as COVAXIN™, highlighting its effectiveness against COVID-19 and its variants, particularly Delta and Omicron. The review published in Frontiers in Immunology emphasizes the vaccine's immunogenicity, safety, and efficacy. BBV152 shows 77.8% protection from symptomatic COVID-19 and over 95% seroconversion in pediatric populations. COVAXIN™ has been authorized in 28 countries and accepted by over 85 for travel, enhancing its global accessibility. The company is investigating its use in adults in the U.S.

Positive
  • 77.8% protection against symptomatic COVID-19 and 93.4% against severe cases.
  • Superior immunogenicity in pediatric populations with >95% seroconversion.
  • Recognized and authorized in 28 countries and accepted for travel by 85+, enhancing market potential.
Negative
  • None.
  • Data include the persistence of immune responses and protection against variants of concern, especially Delta and Omicron
  • Ocugen has North American commercialization rights for BBV152, commercialized as COVAXIN™

MALVERN, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the publication “A comprehensive review of BBV152 vaccine development, effectiveness, safety, challenges, and prospects” appeared in Frontiers in Immunology. BBV152, commercialized as COVAXIN™, is developed and manufactured by Ocugen’s partner Bharat Biotech, a global leader in vaccine innovation based in Hyderabad, India. BBV152 is currently authorized by the World Health Organization, authorized under Emergency Use Authorization in 28 countries, and accepted as a COVID-19 vaccine to travel into over 85 countries. It is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older.

This review by Dotiwala and Upadhyay provides a detailed analysis of the immunogenicity, safety, and efficacy of BBV152—a whole virus inactivated vaccine and an important tool in the fight to control the COVID-19 pandemic. Additionally, BBV152 has a broader impact on public health, as it induces high neutralization efficacy against different SARS-CoV-2 variants of concern.

“Unfortunately, the COVID-19 pandemic is not yet over, despite the introduction of effective vaccines and a greater understanding of COVID-19 pathogenesis and transmission dynamics,” said David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Medicine, Translational Medicine & Human Genetics, University of Pennsylvania, and Ocugen Vaccine Scientific Advisory Board member. “This study demonstrates durability through immune memory and a broader immune response with BBV152 and provides further evidence that additional vaccine options—including those built on a traditional vaccine platform—are needed.”

Findings include:

  • 77.8% and 93.4% protection from symptomatic COVID-19 disease and severe symptomatic COVID-19 disease respectively.
  • Studies in pediatric populations show superior immunogenicity (geometric mean titer ratio of 1.76 compared to an adult) with a seroconversion rate of >95%.
  • Reactogenicity and safety profiles were comparable across all pediatric age groups between 2-18 yrs.

The study concludes that BBV152 is a suitable alternative to mRNA vaccines.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. 
Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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 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.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com

 


FAQ

What are the efficacy rates of COVAXIN™ according to the recent study?

The recent study indicates that COVAXIN™ provides 77.8% protection against symptomatic COVID-19 and 93.4% against severe symptomatic cases.

Where has COVAXIN™ been authorized for use?

COVAXIN™ has been authorized under Emergency Use Authorization in 28 countries and accepted for travel into over 85 countries.

What age group is Ocugen investigating for COVAXIN™ use in the U.S.?

Ocugen is conducting clinical investigations of COVAXIN™ for adults aged 18 years and older in the U.S.

How does COVAXIN™ compare with mRNA vaccines?

The study concludes that COVAXIN™ is a suitable alternative to mRNA vaccines, providing a broader immune response.

Ocugen, Inc.

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Biotechnology
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