Bharat Biotech Covaxin is safe: Lancet Study

Lancet interim findings of the phase 2 trial is found to be immunogenicity and safety

India’s first indigenous vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), has been found safe, generates immune response according to the interim results of the phase 2 trials published in The Lancet Infectious Diseases journal.

Lancet has also said that efficacy cannot be determined by phase 2 trials, Lancet says “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.” It also added “The evaluation of safety outcomes requires extensive phase 3 clinical trials. We were unable to assess other immune responses (i.e, binding antibody and cell-mediated responses) in convalescent serum samples due to the low quantity.”

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 in those aged 65 years and older. The study population has also lacked ethnic, racial, and gender diversity, further underscoring the importance of evaluating BBV152 in other populations. Longitudinal follow-up of additional post-vaccination visits (at months 3, 6, and 12) is also important for understanding the durability of immune responses, and is ongoing according to Lancet.

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