New Delhi: India’s first indigenous vaccine against Covid-19, Covaxin, is safe and generates immune response without any serious side effects, according to the interim results of the phase 2 trials published in The Lancet Infectious Diseases journal.
The authors of the study noted that the phase 2 results did not assess the efficacy of the vaccine codenamed BBV152. Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, the vaccine has been granted emergency use authorisation in clinical trial mode by the Union government.
Covaxin had initially raised concerns among experts over its emergency approval by India’s drug regulator. The latest study comes a week after Bharat Biotech announced that the vaccine has shown 81 per cent efficacy in the third phase of clinical trials, the results of which are yet to be published.
The phase 2 trial to evaluate the immunogenicity and safety of BBV152 vaccine was conducted in healthy adults and adolescents aged 12-65 years at nine hospitals across nine States in India. Two intramuscular doses of vaccine were administered on day 0 and day 28. The primary outcome was assessed in all participants who had received both doses of the vaccine. Safety was assessed in participants who received at least one dose of the vaccine.
Between September 5 and 12, last year, 921 potential participants were screened, 380 of whom were enrolled. “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 authors of the study said.
In the phase 1 trial, published in the same journal last month, BBV152 induced high neutralising antibody responses that remained elevated in all participants three months after the second vaccination. In the phase 2 trial, BBV152 showed better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses — two main mechanisms within the adaptive immune system — compared with the phase 1 trial. Adaptive immunity occurs after exposure to an antigen either from a pathogen or a vaccination. Reactogenicity refers to the property of a vaccine of being able to produce common, adverse reactions, especially excessive immunological responses and associated signs and symptoms, including fever and sore arm at the injection site.
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