According to Prof Mohd Shameem, principal investigator, all applications will be screened as per the protocol and procedure laid down by the Indian Council of Medical Research (ICMR) before inclusion in the study/trial.
The resource persons from Bharat Biotech will visit AMU in the coming days for training of staff for the vaccine trials.
Shameem informed that the registration is moving satisfactory but there is an exclusion, as well as inclusion criteria, and other detailed procedural/protocol formalities for the COVAXIN trial.
He said that written consent and other related formalities will be completed in due course of time.
He further informed that the Vice-Chancellor Prof Tariq Mansoor had volunteered himself for Phase-3 trial of the Covaxin.
According to the protocol for the trial, “person participating in the trial should not have taken any licensed/experimental vaccine within four weeks before enrolment in the study”.
On perusal of his recent medical history by the Principal Investigator, it has come to light that a few days back, the Vice-Chancellor was administered influenza vaccine (Fluarex-Tetra), which is administered to him annually.
Since his case falls in the exclusionary criteria according to the protocol for the vaccine trial, he may not be able to participate in the trials, and hence his name will not be included in the initial study period of the trial.
The Jawaharlal Nehru Medical College Hospital (JNMCH) is planning to open ‘Out-Patient Department (OPD)’ in a phased manner.
The Principal JNMCH, Professor Shahid Ali Siddiqui will consult the university authorities and chairpersons and decision may be taken in the next few days depending upon the Covid-19 situation, staff position and availability of resources. Till now the various OPDs were working through on-line mode (telemedicine).
The Principal informed that OPD’s will open with proper mandatory precautions such as social distancing, hygiene, sanitation, wearing of masks etc.
Opening of OPD’s will also help in enrolment of subjects for the Covid-19 trial.