Here are the important things to know about COVAXIN Phase 3 trials.
1 ) COVAXIN™ clinical trials are based on a 2 dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose.
COVAXIN™ has been designed to be efficacious when subjects receive both doses and post the 14 day period after the 2nd dose.
The phase 3 trials are double blinded and randomized, where 50% of subjects will receive vaccine and 50% of subjects will receive placebo
2 ) Adverse event reporting process as per CDSCO-DCGI guidelines,
o Patient contacts the site PI, or during active follow up
o PI determines the severity of the AE
o Reports are submitted to site Ethics Committees, CDSCO-DCGI, Data Safety Monitoring Board and Sponsor
3) COVAXIN™ is an fully indigenously developed COVID-19 vaccine, with the largest Phase 3 clinical trial conducted in India, in ~ 26,000 subjects across ~ 25 sites. The goal is evaluate the efficacy of COVAXIN™ across India.
o The phase 3 trials of COVAXIN™ is the only efficacy trial being conducted in India for COVID-19 vaccines, to determine its suitability to the diverse Indian population,
COVAXINᵀᴹ trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 2 weeks after the 2nd dose. pic.twitter.com/ZKmGuKbBMf
— BharatBiotech (@BharatBiotech) December 5, 2020
4 ) Bharat Biotech is an innovator, vaccine developer and manufacturer, safety of vaccines is our primary objective, followed by efficacy,
5) Bharat Biotech in its 20 year history, has conducted more than 80 clinical trials, across 18 countries, in ~ 600,000 subjects,
o The same reporting procedure is followed for all clinical trials,
o All clinical trials are conducted in compliance with Good clinical practices,
o Bharat Biotech is one of the few companies to conduct human challenge studies at Oxford University, United Kingdom,
o Bharat Biotech is also conducting other clinical trials USA and UK,
More…. Bharat Biotech has supplied more than 4 billion doses, to more than 80 countries, with an excellent track report of safety,
o Safety is our primary criteria in vaccine development,
o Inactivated vaccines technology has delivered the safest form of vaccines for the past several decades, as apposed other new and unproven technologies,
o The vero cell manufacturing platform used for COVAXIN™ has delivered more than 300 million doses till date, with an excellent safety track record
Here is an interesting report that tells you more things about the vaccine.
