Malvern Co. Developing Vax That May Be Effective On COVID Variant

MALVERN, PA — A Malvern-based biopharmaceutical company announced today that studies show one of its products, Covaxin, to be potentially effective against three COVID-19 variants —including the variant found in Brazil.

Ocugen is now developing Covaxin, Bharat Biotech's COVID-19 vaccine candidate, for the U.S. market after studies that showed the vaccine used widely in India is potentially effective against three key variants of SARS-CoV-2; Covaxin was shown to effectively neutralize the Brazil variant along with the UK variant and India double-mutant variants. The company said the research suggests potential effectiveness against multiple variants.

Ocugen (OCGN) shares were climbing on Monday after the biopharma announced the findings of its study. According to a Monday report on TheStreet, shares of the Malvern company were up 17 percent at $14.85 just before noon.

In the study results of the Phase 3 clinical trial, Covaxin demonstrated 78 percent overall efficacy and 100 percent in severe COVID-19 disease, including hospitalization, the company reported.

Covaxin has been developed in collaboration with the Indian Council of Medical Research (ICMR)/National Institute of Virology (NIV). It 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, the company's report said.

Scientists at ICMR/NIV found that Covaxin demonstrated potential effectiveness against the Brazil variant of SARS-CoV-2, B.1.128.2. It is notable, the Ocugen news release said, that the Brazilian variant, B1.128.2, contains the E484K mutation that was found in New York.

In addition to generating a strong immune response against multiple antigens, Covaxin has been shown to generate memory T-cell responses, for its multiple epitopes, indicating longevity and 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, according to Ocugen's news release.

"We are pleased to see the results of this study as it demonstrates the potential effectiveness of Covaxin against multiple variants, further strengthening our belief that this vaccine can potentially eliminate the possibility of mutant virus escape,” said Dr. Satish Chandran, chair of the vaccine scientific advisory board of Ocugen.

"Covaxin continues to show strong results in all the studies conducted to date. We continue to believe this vaccine is a critical tool to include in our national arsenal to fight this pandemic. The Ocugen team submitted a comprehensive drug master file with the FDA and is currently diligently preparing the EUA application," said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and co-founder of Ocugen.