Bharat Biotech to Conduct Phase 4 Trials of Covaxin to Verify Real-World Efficacy | India News

Bharat Biotech to Conduct Phase 4 Trials of Covaxin to Verify Real-World Efficacy |  India News

HYDERABAD: Bharat Biotech will carry out phase 4 clinical trials of indigenous development Covaxin to check its effectiveness in the real world. It will also apply for the full license for Covaxin only after obtaining the final analysis data from the phase 3 studies, the company said Wednesday.
According to the company, phase 4 trials will not only help verify real-world effectiveness, but will also ensure that “your vaccine meets all rigorous scientific standards for safety, effectiveness, and manufacturing quality necessary to support licensing of emergency use (USA) “. .
“It is important to note that the inoculation that began in mid-January and with several million doses administered, will soon have credible and considerable data,” he said.
The Hyderabad-based vaccine maker also said that full data from the phase 3 trials of Covaxin will be sent first to the Central Drug Control Organization (CDSCO), followed by peer-reviewed journals and made public during July. .
“Once the data from the final analysis of the phase 3 studies are available, Bharat Biotech will apply for the full license for Covaxin,” he said, adding that “Covaxin has undergone and will continue to undergo the most intensive safety and efficacy monitoring in the history of Indian vaccines.. ”
According to interim data announced by Bharat Biotech and the Indian Council for Medical Research (ICMR), Covaxin, which received USA in early January while Phase 3 trials were in progress, reported an overall efficacy of 78% and an efficacy of 100 % against hospitalizations.
The remarks come in the wake of a Twitter dispute between Bharat Biotech’s head of business development and promotion, Raches Ella, and Kolkata-based endocrinologist Dr. Awadhesh Kumar Singh, over the latter’s study comparing the Covaxin immune responses and Covishield, which also led Singh and some Twitterati to demand that Bharat Biotech release the Covaxin Phase-3 trial data.
Bharat Biotech also criticized the comparative study as flawed. “This is not a peer-reviewed publication, nor is it a statistically and scientifically designed study, the design and conduct of the study reflect an ad hoc analysis, rather than a predetermined hypothesis,” he said.
“Furthermore, the study was not registered on the CTRI website, nor was it approved by CDSCO and SEC … In fact, studies involving clinical trials in humans and human subjects must obtain their approvals,” he added.


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