Pune: Five of the seven hospitals in Maharashtra were chosen as sites for Corbevax Phase III Clinical Studies E’s biologically missed on that occasion, authorities told TII.
Officials from the selected hospital in Pune, Mumbai and Nagpur told the Toi that the trial investigators recently sent emails to reach the trial volunteers before these sites could obtain the required documentation and also the approval of the ethical committee.
When Tii contacted a hyderabad biological pharmaceutical company e, an official from the company refused to share comments about this issue citing confidentiality.
According to information about the registry clinical trials – India (CTRI), clinical studies of phase III to evaluate the immunogenicity and security of the Corbevax E vaccine from biologically for protection against Covid must be carried out at 30 sites, including seven in Maharashtra.
Only two hospitals in the state – Grant Medical College and Sir JJ Hospital in Mumbai and the Mahatma Gandhi Institute of Medical Sciences in Wardha – can participate in phase III trials for adults.
This is the first time in Maharashtra tried for Corbevax, India’s third custom vaccine against Covid-19, must be done for adults.
Phase I and II tests from vaccines are carried out in locations in other states.
The previous hospital was chosen from Pune was a YCM Hospital and BR J J J Govt Medical College and Sassoon General Hospital College.
In Mumbai, three hospitals were selected – Grant Medical College & Sir J J Hospital; TN Medical College & BYL Nair Hospital; and Memorial Center.
An official from the Selected Hospital in Nagpur told TII, “Before we can complete the required documents and get approval from the ethical committee, the sample size is achieved on other sites.
We accept communication in October not to advance further processes.” The official was say registration is the first step of the clinical trial.
“Different sites entered the study at different times during the trial period.
Sample size simultaneously calculated as and when volunteers registered.
There are no specific volunteer sites.
If the sample size is 3,000, it is not necessary that all sites must register the same amount of volunteers .
Therefore, after the sample size was achieved in this case, other selected sites were asked not to continue the process, “he said.
The source of Pune Hospital was previously selected for Corbevax Phase III trials said, “Recruitment for trial volunteers has been completed before we get approval from the Ethics Committee.
Therefore, the trial cannot be done.
Sponsors send us communication in this matter.” Other officials From city-based hospitals intended to be the trial site said, “The company only accepts our approval of our willingness to conduct a trial at our center.
We agree, but we cannot get some official documents to start the trial.
So, it cannot be done .
“The principal investigator for the trial at Mumbai hospital said,” We are in the process of getting the approval of the ethics committee, when we were told that the volunteer registration process has been completed.
It was the first week of October.
our site is therefore not required to carry out the trial.
“