COVAXIN Phase-II trial interim data shows better reactogenicity, safety: Lancet
COVAXIN, the COVID-19 vaccine developed by Hyderabad-based Bharat Biotech, has shown better reactogenicity and safety, Phase II trial interim data published in The Lancet journal showed. COVAXIN, along with Covishield, is already being used in India's vaccination drive, which was launched on January 16. Recently, preliminary Phase III trial results announced by Bharat Biotech had shown COVAXIN to have an efficacy of 81%.
Findings from double-blind, randomized, multi-center Phase II reported
COVAXIN, codenamed BBV152, is a whole virion inactivated vaccine for SARS-CoV-2, the virus that causes COVID-19. The Phase II trial was a double-blind, randomized, multi-center study to evaluate the immunogenicity and safety of the vaccine. It was conducted among healthy adults and adolescents (aged 12-65 years) at nine hospitals in India. Two intramuscular doses of vaccine were administered on day 0 and day 28.
Phase II trial 'showed better reactogenicity, safety outcomes'
The report stated in the Phase I trial, COVAXIN induced high neutralizing antibody responses that remained elevated in all participants three months after the second vaccination. The Phase II trial "showed better reactogenicity and safety outcomes" and "enhanced humoral and cell-mediated immune responses" compared with the Phase I trial. The 6 μg with Algel-IMDG formulation has been selected for the Phase III efficacy trial.
'Further corroboration with Phase III safety results required'
The report said, "The results reported in this study do not permit efficacy assessments. The evaluation of safety outcomes requires extensive Phase III clinical trials." "Further corroboration with Phase III safety results is required. This study enrolled a small number of participants aged 12-18 years and 55-65 years. Follow-on studies are required to establish immunogenicity in children and those aged 65 years and older."
Earlier this month, Bharat Biotech announced 81% efficacy for COVAXIN
Earlier this month, Bharat Biotech had announced that COVAXIN has 81% interim efficacy in preventing COVID-19 in those without prior infection after the second dose. Severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups, the company had said. The results are yet to be published in a scientific journal.
2.3 crore vaccinated in India so far
India had launched the first phase of its vaccination drive on January 16 with an aim to inoculate three crore health and frontline workers for free. Starting March 1, the second phase was launched to inoculate those who are above 60 years of age or are above 45 years with co-morbidities. As of Tuesday morning, 2,30,08,733 people had been vaccinated in India.