HYDERABAD: In what comes as a big relief to all awaiting the results of COVAXIN booster dose study play outs, the vaccine has shown equal efficacy against the latest strains, namely Delta and Omicron.
Earlier studies demonstrated the neutralising potential of COVAXIN against SARS-CoV-2 Variants of Concern Alpha, Beta, Delta, Zeta, and Kappa.
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 neutralisation responses against the Omicron and Delta variants validate 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.”
The study has been conducted at Emory University and demonstrates sera from subjects who received a booster dose of COVAXIN six months after getting a primary two-dose series of COVAXIN.
The findings administered by the study include: Booster dose of vaccine, COVAXIN, generated robust neutralizing antibody responses against both Omicron and Delta 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, is a viable option in this continuously evolving pandemic
“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 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.”
COVAXIN is formulated uniquely such that the same dosage can be administered to adults and children alike. COVAXIN 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.
In order to evaluate the effectiveness of COVAXIN against the Omicron variant, Ocugen contracted with the Emory Vaccine Center in Atlanta, GA to test human immune sera obtained from participants in an ongoing Phase 2 clinical trial. Sera were collected 28-days post booster — six months following the primary two-dose series. Each sera was tested in a neutralization assay.
This study was sponsored by Ocugen, Inc., and Ocugen’s partner, Bharat Biotech, provided the sera of the subjects from the Phase 2 study.
With more than 200 million doses having been administered to adults and children outside the U.S., COVAXIN is currently authorized under emergency use in more than 20 countries, and emergency use authorization is in process in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN.