Bharat Biotech based in Hyderabad said early on Saturday that it had concluded the final analysis for the efficacy of the Kovagin as part of the phase 3 clinical trial.
Sharing the final phase pre-3 data about Medrxiv, the company has claimed that the vaccine shows an overall efficacy of 77.8% of symptomatic infections.
Furthermore, said that Covaxin has shown a 93.4% efficacy of severe infection and provides 65.2% protection against a variant of B.1.617.2 (DELTA), which is currently dominant in India.
In the so-called Bharat Biotech “Indian largest efficacy test”, more than 25,798 participants aged between 18 and 98 years were recruited from November 16 to January 7, 2021.
Final analysis mobilized clinical test blind, random, multi-center, using a randomizing scheme provided by sponsors. Of the total, 24,419 received two doses of vaccines or plasebo for four weeks.
The company said that 130 symptomatic cases of Covid-19 infection were reported at 16,973 (0.77%) of participants at least two weeks after the second dose occurred in the vaccine group and 106 at the placebo recipient which provided a total vaccine efficacy of 77.8%.
In addition, 16 cases, one vaccine and 15 placebo recipients fulfill the definition of Covid-19 cases severe symptoms provide a vaccine efficacy of 93.4%.
The efficacy of the Asimptomatic Covid-19 was 63.6%.
“BBV152 is well tolerated without a clinically significant difference or statistically in the distribution of the requested, unsolicited side effects, or serious between vaccine groups and placebo. There are no cases of anaphylaxis or mortality related to the vaccine reported,” Read the Statement of Analysis.
“The vaccine is immunogenic and is very effective against the variant of the variant and asymptomatic associations, especially against severe diseases in adults,” he added.
Phase-3 trial data
The country’s central drug authority panel is reviewing and receiving data-3 trial data from the Covid-19 Vaccine Covaxin Bharat Biotech last month.
Covaxin is one of three vaccines approved by DGCI for emergency use and is being deployed in the Covid-19 vaccination program. The absence of its 3-phase data has become a topic of old conflict.
The company has developed a vaccine in relation to the Indian Medical Research Council (ICMR).
