Bharat Biotech will be conducting phase-4 clinical trials of indigenously developed Covaxin to check its real-world effectiveness. It will also apply for full licensure for Covaxin only after it gets final analysis data of phase-3 studies, the company said on Wednesday.
According to the company, the phase-4 trials will not just help check the real-world effectiveness but also ensure that “its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA)”.
“It is important to note, the inoculation which began in mid-January and with several million doses administered, will have credible and sizable data soon,” it said.
The Hyderabad-based vaccine maker also said that the full data of Covaxin’s phase-3 trials will first be submitted to the Central Drugs Standard Control Organisation (CDSCO), followed by peer reviewed journals and will be made public during July.
“Once data from final analysis of phase-3 studies are available, Bharat Biotech will apply for full licensure for Covaxin,” it said, adding that “Covaxin has undergone and will continue to undergo the most intensive safety and efficacy monitoring in Indian vaccines history.”
As per interim data announced by Bharat Biotech and Indian Council of Medical Research (ICMR), Covaxin, which was given EUA in early January while phase-3 trials were underway, reported an overall efficacy of 78% and a 100% efficacy against hospitalisations.
The statements come in the wake of a Twitter spat between Bharat Biotech’s business development and advocacy head Raches Ella and Kolkata-based endocrinologist Dr Awadhesh Kumar Singh over the latter’s study comparing immune responses of Covaxin and Covishield, which also led to Singh and some Twitterati demanding that Bharat Biotech make Covaxin Phase-3 trials data public.
Bharat Biotech also slammed 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 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.
Surjitt Sahani
