Covaxin Safe, Phase 3 Results Needed To Assess Effectiveness, Says Lancet
Covaxin, the homegrown 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 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".
Faheem Younus, Chief of Infectious Diseases at the University of Maryland Upper Chesapeake Health, US, described the development as "good news" in a tweet.
Good News: Phase 2 Results of COVAXIN (Bharat Biotech) Published in Lancet
380 volunteers studied
Double-blind, RCT trial
2 shots - 28 days apart
No serious (level 4/5) side effects
Can't determine efficacy by phase 2 trials but it's safe/ immunogenic https://t.co/Ef2pdrzZ8cpic.twitter.com/AtXakkJyz6
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.