Covaxin Phase-3 efficacy analysis to be made public by July: Bharat Biotech

The company is also doing phase-4 trials for real world effectiveness of the jab

Covaxin manufacturer Bharat Biotech said that the detailed analysis of the phase-3 clinical trial data of its Covid-19 vaccine will be made public by July. The company is also doing phase-4 trials for real world effectiveness of vaccines, reports said.

In a series of tweets, Raches Ella, project lead, Covid19 vaccines at Bharat Biotech said that the last volunteer of their phase-3 clinical trial (sample size 25,800) was vaccinated in mid-March. “Mandatory CDSCO/FDA requirement of a two-month safety follow-up for all volunteers landed us in Mid May,” Ella said. He claimed that this was the largest efficacy trial conducted in the developing world. In mid-May, the company said it has sufficient data for quality checks and analysis.

Ella also elaborated on the data captured so far-–each of the 25,800 participants has 30 separate forms. The Individual data points are 7 million. Around 210,000 quality checks have been completed thanks to the ‘courageous investigators and field staff (350) ensuring compliance in the midst of second wave’, Ella said.

Covaxin has been co-developed by Bharat Biotech and the Indian Institute of Medical Research (ICMR). Therefore, Ella went on to add that “To remain unbiased, Bharat/ICMR cannot access any data. Our service provider, IQVIA, has started the final statistical analysis. After submitting efficacy and 2-months of safety to CDSCO (July), it is expected to instantly reach a pre-print server. Peer review takes 2-4 months.”

The paper on efficacy data will be Bharat Biotech’s tenth publication on Covaxin, it said.

Covaxin is not yet a part of the World Health Organisation (WHO) Emergency Use List (EUL). The company is in the process of submitting data to the WHO seeking EUL. Bharat Biotech has said it expects the WHO nod between July to September.

Meanwhile, news agency ANI reported that the company is also doing a phase 4 trial to check the real world effectiveness of the vaccines. For all approved vaccines, typically, the manufacturers conduct post marketing studies to analyse real-world data.