With companies like Zydus Cadila, Bharat Biotech and Oxford stepping forth for clinical trials of vaccines developed for the novel Coronavirus, Indians can volunteer to be a part of these trials.
Coronavirus vaccine in India: With companies like Zydus Cadila, Bharat Biotech and Oxford stepping forth for clinical trials of vaccines developed for the novel Coronavirus, Indians can volunteer to be a part of these trials. It is to note that trials are conducted to find out about the safety and efficacy of any vaccines, thus building immunity in humans against a particular pathogen. For this, healthy people who have not been exposed to infection, can volunteer for clinical trials of vaccines. In the case of Coronavirus too, researchers are observing the safety of vaccines in humans. The participation in these trials, however, is completely dependent on the person.
According to a report by The Indian Express, each company working on the Coronavirus vaccine, has its own criteria for selecting vaccines. Usually these factors include illness and age of the volunteer. The criteria may be modified, depending on the progress of trials. With these factors and requirements of the clinical trial, a company decides eligibility for volunteers. In the first phase of clinical trials for Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D, volunteers between the age of 18 and 55 have been invited to participate. However, volunteers having high blood pressure, asthma or any other allergies have been excluded from the clinical trials.
In India, as the study on COVID-19 vaccine progresses, Oxford’s Covishield has set the minimum age for enrollment in clinical trials to 18 years while Bharat Biotech and Zydus Cadila have reduced the minimum age to 12 years and extended maximum to 65 years. This means that anyone healthy between the age of 12 years and 65 years, who have not been infected with the novel Coronavirus, can enroll for trials, the report said.
The report highlighted that volunteers can enroll after going through information provided by the Clinical Trial Registry of India and check locations for a specific trial. Meanwhile, the companies also advertise the invitation for volunteers. To be sure, the Institute of Medical Sciences and SUM Hospital-Odisha’s Department of Community Medicine have come up with different websites for prospective volunteers.
Before trials for any vaccine begins, the volunteers are required to give their consent (audio and visual format) after the complete procedure has been explained thoroughly. Notably, in Coronavirus vaccine trials, if any volunteer already encountered the infection, he/she will be termed as ineligible for the vaccine trial.
The report said that as per Indian regulations, no volunteers are paid for participating in clinical trials of any vaccine. A pre-approved standard has been set which compensate for food and travel expenses. Now, the question is what can be done if the trial goes wrong. To start with, the majority of trials are safe and do not lead to extreme and adverse reactions as vaccines are tested before on animals that have similar genetic coding. After approvals only, the company starts with clinical trials among humans. According to the report, a Data and Safety Monitoring Board (DSMB) has also been set up for every trial that will keep a tab on all processes. DSMB will also study the collected information. If there is a major concern, it can also recommend the trial to be stopped.
Meanwhile, if any volunteer goes through problems with trials including death, or other injuries, the trials rules of India ensures compensation. The compensation, the report said, can be between Rs 2 lakh to Rs 74 lakhs, depending on many conditions.