As researchers collaborate to develop a vaccine to halt the spreading of the Coronavirus, thousands of people across the globe are encouraged to offer their bodies to the study. The participants have volunteered in clinical trials of COVID-19 vaccines that are currently in development. Subject to regulatory approvals, the doses of these vaccines could be available to the public.
What follows is a snapshot of a volunteer who participated in the Phase III trial of Covaxin, conducted in AIIMS Delhi, India. The indigenous vaccine is manufactured by Bharat Biotech.
Why did you decide to volunteer for the Coronavirus vaccine?
I had gone to AIIMS Delhi, one of the centers for the Bharat Biotech phase III trial, with a Doctor friend who was an advisor to the committee. It was the last day of the trial, and since I also work in the healthcare analytics segment, with a keen interest in clinical trials and data, he asked me to join him. As they were discussing their business, someone mentioned the requirement of candidates for the trial. My doctor friend decided to volunteer and asked me, whether I would be interested in participating. The decision, as such, was not difficult, as my friend was volunteering and also safety was not an issue.
What was the enrollment process?
It was quite smooth actually, since I went in with a person who knew the process. A detailed consent form was given, which included essential questions concerning medical history, including any prolonging sickness or current intake of a particular medicine, etc. A physical instructor checked my sugar and blood pressure, took my blood sample, and nasal swab for the anti-body test. Both of which came negative. They explained the symptoms and side effects like fever and injection site pain, Nausea, Diarrhea, etc. I was also informed of life insurance, in case of any mortalities. In addition, I do not suffer from any combability, so the coast was quite clear for me.
Were there specific criteria followed for volunteer approval?
There did not seem to be any exclusion criteria for approval. However, there was for termination; if the candidate had a history with COVID-19. It cannot participate in the trial due to the presence of anti-bodies.
What specific documents were required during the registration process?
Aadhar Card and declaration of information were the only required documents. While video consent was mentioned in the form, no video was taken.
Did you do any research? If yes, what kind?
Not really. It was all a bit last minute. My friend did tell me that this vaccine is different in terms of mechanism of action. Instead of modified RNA, this is from inactive vaccines.
Were your doubts related to the vaccine answered by the authorities?
Yes, the PI there briefed everyone on the process. There were two dosages taken in an interval of 28 days. It was a double-blind study, wherein the sample was prepared and given a serial number. The details of whether the sample is a placebo or a vaccine were listed out and sealed. This information is revealed only at the end stage while analyzing the data. So, neither the authorities nor I was aware of whether I received the vaccine or a placebo.
Which vaccine trial were you part of?
Covaxin, by Bharat BioTech, phase III trial, which was conducted at AIIMS Delhi.
What was your experience with the vaccine?
It was an outpatient trial. I was given an injection in my forearm. No hospitalization was required. The research associates of the trial from the AIIMS called me regularly for five days for an update on my health. After that, I did not receive any call, so I am assuming that the first five days are when a person is vulnerable to any reaction. I was also told that I am allowed to opt-out anytime during the process, even after the first shot or before the process begins at all. I felt no adverse effects. No pain or any other issues. It felt like a flu shot or any other injection.
Did you have any apprehensions?
Not on the safety aspect. Given that I did not experience even minimal side effects like elevated body temperature, I am afraid I might have received a placebo. In the worst-case scenario, if someone felt unwell, we were given contact numbers of the doctors. We were told that the treatment for any adverse effects would be covered by their insurance.
Were you made aware of any risks or potential side effects? Did you experience any?
Yes, basic ones like injection site reaction and fever. I did not experience any. The whole process was explained in detail: the idea behind the vaccine and the risks. He also listed the dos and don’ts, such as not donating blood for the following three months or not drinking.
He also explained that since this was a trial, the participants are not to let their guard down about COVID-19. All participants must continue to follow all precautions and guidelines, such as masking and social distancing.
Kartik is an Entrepreneur, based in Gurgaon, India. He runs a successful data analytics organization Medeva.io, with a focus on the Healthcare sector. He firmly believes in the power of data and the positive change that it can bring to an individual and society.