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India s First Covid-19 Vaccine Covaxin Has No Serious Side Effects by Hannah Joy on March 10, 2021 at 6:04 PM
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.
‘Bharat Biotech s phase 3 results show that Covaxin vaccine demonstrated 81% interim efficacy in preventing Covid-19, in those without prior infection, after the second dose.’ 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 ag
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.
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 .
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.