One hundred percent of test serum samples showed neutralization of the delta variant, and more than ninety percent of serum samples showed neutralization of the Omicron variant.
On Wednesday, partners Ocugen and Bharat Biotech said data from the preliminary analysis of the Covaxin booster shot had been found to neutralize both Omicron and Delta variants of SARS-CoV-2 successfully.
Ocugen Inc., a biopharmaceutical company developing gene therapies to cure blindness diseases and a vaccine to save lives from COVID-19, and partner Bharat Biotech, a multidimensional biotechnology company making vaccines and biotherapeutics, announced promising results of the Covaxin (BBV152) study conducted at the Emory Vaccine Center.
The study conducted using a live virus neutralization assay showed the booster dose generated robust neutralizing antibody responses against both Omicron and Delta variants. Earlier trials have indicated the neutralizing potential of Covaxin against SARS-CoV-2 variants of concern Alpha, Beta, Delta, Zeta, and Kappa.
The analysis demonstrated blood serum collected from the Phase II study subjects who received Covaxin booster shots six months after getting a primary two-dose series of Covaxin neutralized both Omicron and Delta variants. One hundred percent of test serum samples showed neutralization of the delta variant, and more than ninety percent of serum samples showed neutralization of the Omicron variant.
To evaluate Covaxin’s efficacy against Omicron, Bharat Biotech’s partner Ocugen Inc. sponsored the study and tested human immune sera obtained from 13 individuals 28 days after their booster shot. Each serum was tested in a neutralization assay. Following three doses, the FRNT50 geometric mean titers (GMTs) of neutralizing antibodies against the Omicron variant measured in the samples was 75, compared to 480 against the Delta variant and 706 against the vaccine strain, D614G.
Shankar Musunuri, Ph.D., chairman of the board, CEO, and co-founder of Ocugen Inc., looks forward to the significant progress of Covaxin for primary and booster vaccine as the global fight against COVID-19 continues. “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,” said Musunuri.
Mehul Suthar, Ph.D., assistant professor at Emory University, said, “Data from this preliminary analysis show individuals receiving a booster dose of Covaxin 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.”
Scientist Krishna Ella, chairman and managing director of Bharat Biotech, said the company is in a continuous state of innovation and product development of Covaxin. The study’s positive results against Omicron and Delta validate the company’s hypothesis of a multi-epitope vaccine developing 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 as a universal vaccine for adults and children,” Ella added.
These data show that Covaxin booster dose can reduce disease severity and hospitalizations and be a viable option in this continuously evolving pandemic. The study will be published on the pre-print server, medRXiv, in the coming days.
