Hyderabad: Bharat Biotech on Saturday announced that the Covaxin booster dose is safe and highly immunogenic against all variants citing the results of the trial studying the immunogenicity and safety of its booster dose. The announcement comes at a time when Omicron is driving the surge in Covid cases across the country.
"Neutralising antibodies against homologous and heterologous SARS-CoV-2 variants increased 19- to 265- fold after a third vaccination. Booster BBV152 vaccination is safe and may be necessary to ensure persistent immunity to prevent breakthrough infections," the company said in a statement.
Quoting the trials, it said the analysis showed, six months after a two-dose Covaxin series cell-mediated immunity and neutralising antibodies to both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, and Delta plus) persisted above baseline, although the magnitude of the responses had declined.
This update provides a comprehensive vaccine booster strategy and that Covaxin is the first vaccine (in India) to report safety and immunogenicity results from a booster clinical trial, the firm asserted.
Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “these trial results provide a strong foundation towards our goal to provide COVAXIN® as a booster dose. Our goals of developing a global vaccine against COVID-19 have been achieved with Covaxin indicated for adults, children, 2 dose primary and booster dose. This enables the use of Covaxin as a universal vaccine."
"We found the vaccine induces both memory B and T cells with a distinct CD4 and CD8 phenotype. Further, reactogenicity after vaccine and placebo was minimal and comparable, and no serious adverse events were reported. While protection against the severe disease remains high across the full 6 months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected," he added.
Bharat Biotech said that based on emerging data it believes that a third dose may be beneficial to maintain the highest levels of protection.
Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike. Covaxin is ready-to-use a liquid vaccine, stored at 2- 8°C, with 12 months shelf life and a multi-dose vial policy. The same vaccine can also be used for 2 doses of primary immunization and for booster dose vaccinations, making it truly a universal vaccine, the statement added.
Also read: Received several reports of other COVID-19 vaccines being administered to children: Bharat Biotech
