Over 250 applications for the Covid-19 ‘Covaxin’ vaccine trial have been received at the Jawaharlal Nehru Medical College Hospital of the Muslim University of Aligarh.
According to Professor Mohd Shameem, Principal Investigator, all applications will be reviewed according to the protocol and procedure established by the Indian Council for Medical Research (ICMR) prior to inclusion in the study / trial. Shameem reported that registration is progressing satisfactorily, but there is an exclusion as well as inclusion criteria and other detailed procedural / protocol formalities for the Covaxin trial, including written consent and other related formalities that will be completed in due course.
He also reported that the Vice Chancellor, Professor Tariq Mansoor, had volunteered for the phase 3 trial of Covaxin. After reading his recent medical history by the principal investigator, it has come to light that a few days ago, the rector was administered the influenza vaccine (Fluarex-Tetra), which is administered annually. Since your case falls within the exclusion criteria as per the protocol for the vaccine trial, you may not be able to participate in the trials and therefore your name will not be included in the initial study period of the trial.
Read more | AMU VC Registers Itself as First Volunteer for the Covaxin Phase-3 Trial
Bharat Biotech specialists will visit AMU in the next few days to train staff for vaccine trials. According to the trial protocol, “the person participating in the trial should not have taken any licensed / experimental vaccines in the four weeks prior to enrollment in the study.”
In addition, Jawaharlal Nehru Medical College Hospital (JNMCH) plans to gradually open the “Outpatient Department (OPD)”. The director of the JNMCH, Professor Shahid Ali Siddiqui will consult with the authorities and the presidents of the university and a decision may be made in the coming days depending on the situation of Covid-19, the position of the staff and the availability of resources. Until now, the various OPDs worked through online mode. The director informed that OPDs will be opened with the proper mandatory precautions, such as social distancing, hygiene, sanitation, wearing of masks, etc. The opening of the OPDs will also aid in the registration of subjects for the Covid-19 trial.
On November 15, India’s Covid-19 count reached 88,14,579 as the country reported an increase of 41,100 new cases, while 447 succumbed to the disease.
(with contributions from the agency)
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