According to Prof Mohd Shameem, principal investigator, all applications will be screened as per the protocol and procedure laid down by ICMR before inclusion in the study/trial. There is an exclusion, as well as inclusion criteria, and other detailed procedural/protocol formalities for the Covaxin trial which includes written consent and other related formalities that will be completed in due course of time.(Reuters)
According to Prof Mohd Shameem, principal investigator, all applications will be screened as per the protocol and procedure laid down by ICMR before inclusion in the study/trial. There is an exclusion, as well as inclusion criteria, and other detailed procedural/protocol formalities for the Covaxin trial which includes written consent and other related formalities that will be completed in due course of time.(Reuters)

250 register for Covid vaccine trial at AMU

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.
Hindustan Times, New Delhi | By hindustantimes.com | Edited by Mallika Soni
UPDATED ON NOV 15, 2020 01:35 PM IST

More than 250 applications have been received for the trial of Covid-19 vaccine ‘Covaxin’ at the Jawaharlal Nehru Medical College Hospital of the Aligarh Muslim University.

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. 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 which includes written consent and other related formalities that 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. 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.

Read more | AMU VC registers himself as first volunteer of Covaxin Phase-3 trial

The resource persons from Bharat Biotech will visit AMU in the coming days for training of staff for the vaccine trials. 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”.

 

Also, 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. The principal informed that OPDs will open with proper mandatory precautions such as social distancing, hygiene, sanitation, wearing of masks etc. Opening of OPDs will also help in enrolment of subjects for the Covid-19 trial.

On November 15, India’s Covid-19 tally reached 88,14,579 as the country reported a spike of 41,100 new cases while 447 succumbed to the disease.

(with agency inputs)

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