HYDERABAD: Amid the row over Bharat Biotech not making its Covaxin phase-3 data public in June, as promised earlier, the company said processing of the data is underway and it will apply for full licensure after the final analysis data is available by July.
Covaxin is the only vaccine to have conducted and completed one of the largest ever Phase-3 efficacy trials in India with 25,800 subjects, most other Covid-19 vaccines have only conducted immunogenicity studies and not efficacy studies in the Indian population, it said.
Elaborating on the reasons for delays in revealing the final data, Raches Ella, head of business development and advocacy, Bharat Biotech, said in a tweet: “Ph-3 timelines and reasons to trust the process: the largest efficacy trial conducted in the developing world (sample size=25,800) with the last volunteer being vaccinated in mid-March, add two months (based on CDSCO/ FDA requirement for 2-months post dose-2 safety follow-up) and we are in mid-May with sufficient data for quality checks and analysis.” “Data captured thus far: each participant has 30 separate forms and with 25,800 participants, individual data points = 70.4 lakh.
Quality (query) checks completed = 2.1 lakh.
Thanks to the courageous investigators and field staff (350) ensuring compliance in the midst of the second wave,” he said.
Ella also pointed out 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,” he said.
Ella, who is also the project lead for SARS-CoV-2 vaccines at Bharat Biotech, said that the nine publications on Covaxin are a testament to Bharat Biotech and ICMR’s scientific prowess.
“The efficacy paper will be our 10th.
If you are looking for Covid vaccine data generated in India, rest assured you will find only Covaxin…,” he said.
The row was triggered by a Twitter spat between Raches Ella and Kolkata-based endocrinologist Dr Awadhesh Kumar Singh over the latter’s study comparing immune responses of Covaxin and Covishield.
Bharat Biotech went on to slam the comparative study as flawed.
“This is not a peer reviewed publication, nor statistically and scientifically designed study, the study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis,” it had said.
“Further, the study was not registered on CTRI website, nor approved by CDSCO and SEC…Factually studies involving human clinical trials and human subjects should obtain their approvals,” it added.