The company is also conducting phase-4 trials to see how successful the vaccine is in the real world.
The comprehensive analysis of the phase-3 clinical trial results for Bharat Biotech’s Covid-19 vaccine would be made public by July, according to the company. According to reports, the corporation is also conducting phase-4 trials to determine vaccine effectiveness in the real world.
Raches Ella, project lead, Covid19 vaccines at Bharat Biotech, announced in a series of tweets that the phase-3 clinical trial’s last participant (sample size 25,800) was vaccinated in mid-March. “The two-month safety follow-up required by CDSCO/FDA for all volunteers landed us in mid-May,” Ella explained. This, he claimed, was the largest efficacy trial ever done in a developing country. The corporation stated in mid-May that it has enough data for quality inspections and analysis.
Ella also went over the data that had been collected thus far, noting that each of the 25,800 participants had completed 30 different forms. The total number of data points is 7 million. According to Ella, “courageous investigators and field employees (350) ensuring compliance in the midst of the second wave” have conducted almost 210,000 quality checks.
Bharat Biotech and the Indian Institute of Medical Research collaborated on the development of Covaxin (ICMR). As a result, Ella continued, “Bharat/ICMR cannot access any data in order to stay unbiased.” IQVIA, our service provider, has begun the statistical analysis. It is scheduled to reach a pre-print server immediately after submitting efficacy and 2-months of safety to CDSCO (July).
The efficacy data paper will be Bharat Biotech’s tenth on Covaxin, according to the company.
The World Health Organization’s (WHO) Emergency Use List does not currently include covaxin (EUL). The company is now submitting data to the WHO in order to obtain an EUL. According to Bharat Biotech, the WHO approval is expected between July and September.
Meanwhile, according to ANI, the business is conducting a phase 4 trial to determine the vaccinations’ real-world effectiveness. Manufacturers often perform post-marketing studies to analyse real-world data for all authorised vaccinations.