New Delhi: Covaxin, the indigenous coronavirus vaccine that was authorized for use in January before full clinical trial data, has been declared “safe, immunogenic with no serious side effects” by a study in Lancet that has published its phase 2 results.
Lancet has said that efficacy cannot be determined by phase 2 trials, but the vaccine made by Hyderabad-based Bharat Biotech is “safe/immunogenic”.
The Lancet report says the results reported in the study of phase 2 results do not permit efficacy assessments and further corroboration with phase 3 safety results was required, NDTV reported.
“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,” it said.
It, however, added that though direct comparisons between phase 1 and 2 trials could not be made, the response to the vaccine reported in the study were “substantially better in the phase 2 trial” than the phase 1 trial.
Also, the proportion of participants reporting adverse events in the phase 2 trial were lower than those in phase 1, said Lancet.
Earlier on March 3, Bharat Biotech reported that Covaxin has demonstrated an interim efficacy of 81 per cent in Phase 3 clinical trials.
Also Read: Relief For Doubters: Covaxin Phase 3 Trials Show Interim Efficacy Of 81%
