Covaxin safe, can be stored at 2-8°C, says Lancet report
Bharat Biotech announced earlier this month that preliminary results show Covaxin has an efficacy of 81% in phase 3 clinical trial amid months of speculations to rest
Covaxin, made by Hyderabad-based Bharat Biotech International Limited, has been declared "safe, immunogenic with no serious side effects" by Lancet, which has published its phase 2 results.
Lancet also said that efficacy cannot be determined by phase 2 trials, reports the NDTV.
"We report interim findings of the phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose on day 28," the report published on Monday said.
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Covaxin induced high neutralising antibody responses that remained elevated in all participants at 3 months after the second vaccination in the Phase 1 trial, it said.
"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," it said.
