Ocugen, Inc. (NASDAQ: OCGN), 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.
Ocugen today announced that its co-development partner, Bharat Biotech, shared positive results of the second interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease alone of 100%.
“We continue to be excited by the compelling second interim results of Bharat Biotech’s Phase 3 clinical trial. We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date. We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market. Based on a traditional vaccine platform that has a long-established safety profile, we believe COVAXIN is an important tool to add to our national arsenal in ending the pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.
“The safety and efficacy demonstrated by COVAXIN is remarkable because of the prevalence of several variants of the coronavirus circulating at the time of the trial. This vaccine is based on a proven technology platform and the company plans to consider clinical development in special populations such as children,” said Dr. Bruce Forrest, member of the vaccine scientific advisory board of Ocugen.
Second Interim Phase 3 Results as Reported by Bharat Biotech
Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age in India, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. However, due to the recent surge in cases in India, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The trial will be continuing to its pre-planned conclusion.
The efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test.
Note: COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (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 track record of more than 300 million doses supplied.
In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8⁰C.