Covaxin well tolerated in those not yet vaccinated in US: Study

Bharat Biotech said on Monday it's Covid-19 vaccine-Covaxin has been found to be well-tolerated in those who had not received a vaccine and in individuals previously vaccinated with mRNA vaccines in the United States, with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis, it said.

The results of the study were revealed by its partner in the US, Ocugen, which said the study met both co-primary endpoints with robust immune responses.

"Phase II/III observer-blind, immuno-bridging and broadening study was done to generate a broader immune response against the whole virus covering important antigens such as S-protein, RBD, and N-protein," it said, adding that currently approved vaccines in the US target only S-protein antigen. "Additionally, in contrast to other inactivated vaccines, clinical trials have demonstrated that TLR7/8 agonist adjuvant in Covaxin generates a Th1-biased immune response that induces robust long-term memory B- and T-cell responses," it said.