Home >Companies >News >India's Covaxin safe, 'immunogenic with no serious side effects', finds Lancet study

Covaxin, an India-made coronavirus vaccine, has been declared "safe, immunogenic with no serious side effects" by Lancet that has published its phase 2 results.

Lancet has said that efficacy cannot be deduced by phase 2 trials but the vaccine made by Hyderabad-based Bharat Biotech is "safe/immunogenic".

"In the phase 1 trial, BBV152 induced high neutralising antibody responses that remained elevated in all participants at 3 months after the second vaccination," Lancet said in the study published Tuesday.

"In the phase 2 trial, BBV152 showed better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses compared with the phase 1 trial. The 6 μg with Algel-IMDG formulation has been selected for the phase 3 efficacy trial," Lancet said.

The phase 3 results of Covaxin, developed by Indian Council of Medical Research (ICMR) in partnership with Bharat Biotech International Limited (BBIL), had shown an interim vaccine efficacy of 81 per cent in preventing COVID-19. The phase 3 efficacy rate is yet to be published in a scientific journal.

The phase 3 trial, jointly initiated by ICMR and BBIL in mid-November 2020, was conducted on a total of 25,800 individuals across 21 sites.

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