In a much needed relief for drugmaker Bharat Biotech, Covaxin, whose efficacy has remained under scanner, has been declared safe by the reputed medical journal the Lancet Infectious Diseases on Friday. The vaccine produces tolerable safety outcomes and enhances immune reposes in its Phase 2 trials, the Lancet said.
“BBV152 (Covaxin) led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted,” the results said.
With the development, Covaxin becomes India’s first vaccine against covid-19 to have data published in the Lancet. The data for the 375-participant phase 1 trials shows that Covaxin developed binding and neutralizing antibody response against the deadly virus.
“BBV152 (codename for Covaxin) induced binding and neutralising antibody responses and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-COV-2 vaccine that has been reported to induce a Th1-biased response,” said the general.
Covaxin follows the two dose regimen and in the first trials the two shots of the vaccine and placebo were given 14 days apart and the interim analysis was carried out after 42 days of first shot being administered. However, the vaccine is now advised to be administered 28 days apart.
Meanwhile, in an another article, the Lancet lauded India’s indigenous vaccine and said it was a “welcome addition to the covid-19 vaccine landscape.”
Bharat Biotech is currently conducting phase 3 trial across the country and announced on Friday that around 15,000 volunteers have successfully administered the second dose.
Covaxin has been approved by Drug Controller General of India for emergency use and is currently being administered by healthcare and frontline workers under country’s nationwide vaccination drive.