Benzinga | Jan 12, 2022 06:44AM EST

Ocugen And Bharat Biotech Announce Results From Study Demonstrating A Booster Dose Of COVAXIN 'generated robust neutralizing antibody responses' Against Omicron And Delta



* Booster dose of candidate vaccine, COVAXIN(tm) (BBV152), generated robust neutralizing antibody responses against both Omicron (B.1.529) and Delta (B.1.617.2) using a live virus neutralization assay

* 100% of test serum samples showed neutralization of the Delta variant and more than 90% of serum samples showed neutralization of the Omicron variant

* These data add to the body of evidence that the broad-spectrum mechanism of action of a whole virus inactivated COVID-19 vaccine, like COVAXIN(tm) (BBV152), is a viable option in this continuously evolving pandemic

MALVERN, Pa., Jan. 12, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ:OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, and its partner, Bharat Biotech, a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced results from a study conducted at Emory University demonstrating that sera from subjects who received a booster dose of candidate vaccine COVAXIN(tm) (BBV152) six months after getting a primary two-dose series of COVAXIN(tm) (BBV152) neutralized the SARS-CoV-2 Omicron and Delta variants. Earlier studies demonstrated the neutralizing potential of COVAXIN(tm) (BBV152) against SARS-CoV-2 Variants of Concern Alpha, Beta, Delta, Zeta and Kappa.

The study will be published on the pre-print server, medRXiv, in the coming days.

Sera samples from individuals who received a booster of COVAXIN(tm) (BBV152) were observed to be effective in neutralizing Omicron and Delta variants on a live virus neutralization assay. The neutralization activity of COVAXIN(tm)-boosted sera was comparable to what has been observed in mRNA vaccine-boosted sera against the Omicron variant. More than 90% of all individuals boosted with COVAXIN(tm) (BBV152) showed neutralizing antibodies. All participants received an initial two-dose schedule of COVAXIN(tm) (BBV152) at Day 0 and Day 28.

"The global impact of Omicron shows us that the fight against COVID-19 continues, and we're encouraged that these data demonstrate the value of COVAXIN(tm) as a primary and booster vaccine," said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. "These results show how a broad-spectrum vaccine has the potential ability to address ever-shifting public health challenges such as new variants and mutations."

"As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern," said Mehul Suthar, Ph.D., Assistant Professor, Emory Vaccine Center and who led the laboratory analysis. "Data from this preliminary analysis show individuals receiving a booster dose of COVAXIN(tm) have a significant immune response to both the Omicron and Delta variants. These findings suggest that a booster dose has the potential to reduce disease severity and hospitalizations."

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said, "We are in a continuous state of innovation and product development for COVAXIN(tm). The positive neutralization responses against the Omicron and Delta variants, validates our hypothesis of a multi epitope vaccine generating both humoral and cell mediated immune responses. Our goals of developing a global vaccine against COVID-19 have been achieved with the use of COVAXIN(tm) as a universal vaccine for adults and children."

COVAXIN(tm) is formulated uniquely such that the same dosage can be administered to adults and children alike. COVAXIN(tm) is a ready-to-use, liquid vaccine, stored at 2 - 8?C, with 12 months shelf life and multi-dose vial policy. The same doses of vaccine can also be used for two-dose primary immunization in adults and children and for booster dose vaccinations, making it truly a universal vaccine. COVAXIN(tm) is not currently authorized or approved for use as a primary or booster dose in the United States.