The indigenous vaccine against the coronavirus disease Covaxin has said to be completed with its final phase 3 analysis as mentioned by Hyderabad based vaccine maker Bharat Biotech on Friday. Against symptomatic COVID-19 patients, the pharmaceutical company has claimed that an overall efficacy of 77.8% has been found in Covaxin, citing preprint data from India’s largest efficacy trial.
Against severe symptomatic COVID-19 cases, Bharat Biotech mentions that 93.4% effectiveness has been demonstrated by its indigenous vaccine, elaborating on its findings from the efficacy analysis. While against the B.1.617.2 (Delta) strain which is currently the most predominant variant of COVID-19 in India, Covaxin provides around 65.2% protection, it said.
After its phase 3 efficacy trial, Bharat Biotech said that Covaxin provides an efficacy of 63.6% against asymptomatic COVID-19 patients.
As trial sites across 25 hospitals in India, the Covaxin faced 3 analyses was reportedly conducted. Using a sponsor supplied randomization scheme in which the volunteers received two intramuscular doses of either the COVID-19 vaccine or a placebo 4 weeks apart, a double-blind, randomized, multicenter clinical trial was deployed by the large scale final analysis, according to the report. From the age group of 18 to 98 years, it consisted of around 25,800 volunteers.
Mentioning that it would release phase 3 data by March, the indigenous vaccine made by the Hyderabad-based company was approved for emergency use in the Indian population in January. Although data regarding the multiple analysis has not yet been released, the data was earlier shared with the Indian drug regulators.