Earlier studies had demonstrated the neutralizing potential of Covaxin against the identified SARS-CoV-2 Variants of Concern- Alpha, Beta, Delta, Zeta and Kappa.
The study was conducted by Ocugen, Inc. along with Bharat Biotech which provided the sera of the subjects from the Phase 2 study.
Sera was collected 28-days post booster and six months after the primary two-dose series. Each sera was tested in a neutralization assay which were observed to be effective in countering Omicron and Delta variants on a live virus neutralization assay. The neutralization activity of COVAXIN®-boosted sera was comparable to what has been observed in mRNA vaccine-boosted sera against the Omicron variant.
More than 90 percent of all individuals boosted with Covaxin (BBV152) showed neutralizing antibodies. All participants had received an initial two-dose schedule of Covaxin (BBV152) at day 0 and day 28.
Elaborating on the neutralization effect observed in Covaxin booster, Dr Mehul Suthar, Ph.D., Assistant Professor, Emory Vaccine Center who led the laboratory analysis said, “As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern. 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.”
Speaking on achieving the targets set for Covaxin, Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech said, “We are in a continuous state of innovation and product development for Covaxin. 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 as a universal vaccine for adults and children.”
Commenting on the findings, Dr Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc said, “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 as a primary and booster vaccine. 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.”
Covaxin is a ready-to-use, liquid vaccine which can be stored at 2 – 8°C in contrast to other vaccines that require extremely low temperatures. The shelf life was expanded to 12 months with a multi-dose vial policy set for the vaccine. The same doses of vaccines have been approved in India for two-dose primary immunization in adults and children and for booster dose vaccinations.