Hyderabad, March 9 : Covaxin, India’s first indigenous vaccine for Covid-19, is “safe, immunogenic with no serious side effects”, says leading medical journal The Lancet in its interim efficacy analysis.
The Lancet – Infectious Diseases Journal, published phase 2 results of the vaccine developed by Hyderabad-based Bharat Biotech.
However, the report made it clear that efficacy cannot be determined by phase 2 trials and this required further corroboration with phase 3 safety results.
“The results reported in this study do not permit efficacy assessments. The evaluation of safety outcomes requires extensive phase 3 clinical trials. We were unable to assess other immune responses (ie, binding antibody and cell-mediated responses) in convalescent serum samples due to the low quantity. Furthermore, no additional data on the age of the participant or the severity of disease from symptomatic individuals were obtained,” says the report.
It also pointed out that comparisons between phase 1 and 2 trials were not done in a randomised set of participants, and no adjustments on baseline parameters were made.
“Conclusions are to be considered as post-hoc analyses. Even though direct comparisons between the phase 1 and 2 trials cannot be made, the reactogenicity assessments reported in this study were substantially better in the phase 2 trial than the phase 1 trial and other trials with a placebo group,” it added.
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