- Data from 25,800 participants in the Phase 3 study in India received vaccine or placebo in a 1: 1 ratio showed that the vaccine candidate was well tolerated and demonstrated an 81% efficacy in preventing COVID-19 in those without previous infection after the second dose.
- The clinical trial will continue until the final analysis in 130 confirmed cases to collect additional data and to evaluate the efficacy of COVAXIN in the additional final criteria of the secondary study.
MALVERN, Pa., March 3, 2021 (GLOBE NEWSWIRE) – Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on the discovery, development and commercialization of gene therapies to cure blindness and develop a vaccine to save the lives of COVID-19, announced today that its co-development partner, Bharat Biotech, announced the results of the first interim analysis of its phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN has been shown to be 81% effective in the vaccine.
“We are pleased with the interim results of the efficacy of the Phase 3 study of Bharat Biotech COVAXIN in India. These results, which in part suggest significant immunogenicity compared to the rapidly emerging variant in the United Kingdom, are a further step towards shaping the regulatory path for EUA and approval in the United States. COVAXIN, a candidate for virion-based vaccine, is designed to meet a significant unmet need in our national arsenal of COVID-19 vaccines, “said Dr. Shankar Musunuri, chairman of the board, executive director and co-founder of Ocugen.
Today’s results from Bharat Biotech’s COVAXIN phase 3 interim analysis mark an important milestone in the development of another critical vaccination option for the US market. COVAXIN has been shown to induce immune responses against several protein antigens of the virus, potentially reducing the possibility of the mutant virus escaping. This range of immune responses has been demonstrated by the ability of COVAXIN-induced antibodies to neutralize the British version of SARS-Cov-2, ”said Dr. Bruce Forrest, a member of the Ocugen Vaccine Scientific Advisory Committee.
Intermediate results of phase 3 reported by Bharat Biotech
The phase 3 clinical trial of Bharat Biotech enrolled 25,800 participants aged between 18 and 91 years, including 2,433 over 60 years and 4,500 with comorbidities. The primary objective of the Phase 3 clinical trial is based on the first symptomatic PCR-confirmed COVID-19 (mild, moderate, or severe) with onset at least 14 days after the second negative serology vaccination study. SARS-CoV- 2) adult participants at baseline.
The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the COVAXIN group, resulting in a point estimate of vaccine efficacy of 80.6%.
The interim analysis included a preliminary review of the safety database, which showed that severe, serious and medically adverse adverse events occurred at low levels and were balanced between the vaccine and placebo groups. The conduct and monitoring of the study are in accordance with good clinical practice guidelines and have been outsourced to IQVIA.
Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize strains of the UK variant and other heterologous strains, which has been published in bioRxiv.
Bharat Biotech expects to share further details about the results of the studies as more data becomes available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analysis will be shared via pre-publication servers, as well as sent to a peer-reviewed journal for publication.
About COVAXIN
COVAXIN, the India COVID-19 vaccine by Bharat Biotech, is being developed in collaboration with the Indian Medical Research Council (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety experience of over 300 million doses provided.
In addition to generating a strong immune response against multiple antigens, COVAXIN generates memory T cell responses for multiple epitopes, indicating longevity and a rapid response of antibodies to future infections. With published data demonstrating a higher safety profile than several other vaccines, COVAXIN is packaged in multiple dose vials that can be stored at 2-8C.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of gene therapies for the cure of blindness and the development of a vaccine to save the lives of COVID-19. Our discovery-modifying gene therapy platform has the potential to treat multiple retinal diseases with a single drug – “one to many”, and our new biologic candidate aims to provide better therapy for patients with underlying diseases, such as would be macular degeneration related to wet age, edema and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN vaccine candidate for COVID-19 in the US market. 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 patents worldwide, a broad product portfolio of over 16 vaccines, 4 bio-therapeutic products, registrations in over 123 countries and World Health Organization pre-qualifications ( WHO). Located in the Genome Valley of Hyderabad, India, a hub for the global biotechnology industry, Bharat Biotech has built a world-class and bio-therapeutic vaccine, product research and development, bio-security level 3 manufacturing and vaccine supply and distribution.
After delivering over 4 billion doses of vaccines worldwide, Bharat Biotech continues to drive innovation and has developed vaccines for H1N1 flu, Rotavirus, Japanese encephalitis, rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugate vaccine for typhoid.
Bharat’s commitment to global social innovation programs and public-private partnerships has led to the introduction of pre-qualified WHO BIOPOLIO®, ROTAVAC® and Typbar TCV® vaccines, which fight polio, rotavirus and typhoid infections. The recent acquisition of the rabies vaccination facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest producer of rabies vaccine in the world. To learn more about Bharat Biotech visit www.bharatbiotech.com.
Warning 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 “predict,” “believe,” “potential,” “proposed,” “continue,” “estimate,” “anticipate,” “expect,” “plan,” “intend,” “Maybe”, “could”, “could”, “will”, “should” or other words that convey uncertainty about future events or results to identify these forward-looking statements. Such forward-looking statements include information on qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readings and regulatory documents. This information implies risks and uncertainties that could cause the actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, including the ability to meet anticipated clinical objectives, start and / or end dates of clinical trials, regulatory submission data, regulatory approval data and / or launch, as well as the risks associated with preliminary and interim data (including phase 3 interim data covered by this Communication), including the possibility of new unfavorable clinical trial data and further analysis of existing clinical trial data; the risk of clinical trial data being subject to different interpretations and evaluations, including during the peer review / publication process, in the scientific community at large and by regulators; if and when data from Bharat Biotech clinical trials will be published in scientific publications and, if so, when and with what changes; whether the US Food and Drug Administration (FDA) will be satisfied with the design and results of preclinical and clinical studies of COVAXIN, which were conducted by Bharat Biotech in India; if and when any biological license and / or applications for emergency use authorization may be filed in the United States for COVAXIN; if and when such applications may be approved by the FDA; FDA decisions affecting labeling, manufacturing processes, safety, and / or other issues that could affect the availability or commercial potential of COVAXIN in the United States, including product development or therapies by other companies. These risks and other risks and uncertainties are described in more detail in our regular documents to the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports we submit to the SEC. Any forward-looking statements we make in this press release speak only as of the date of this press release. Except for the legal provisions, we do not assume any obligation to update the advance statements contained in this press release, either as a result of new information, future events or otherwise, after the date of this press release.
Contact Ocugen:
Ocugen, Inc.
Sanjay subramanian
Chief Financial Officer and Head of Corporate Development
[email protected]
Media contact:
For Ocugen:
LaVoieHealthScience
Emmie Twombly
[email protected]
+1 857-389-6042
Lisa DeScenza
[email protected]
+1 978-395-5970