It’s been a week of promising news on the various COVID-19vaccines under development. Moderna announced that it’s vaccine has been found to be 94.5% effective based on its trials. Pfizer followed with the news that it’s vaccine was found to be 95% effective. Closer to home, the Oxford-AstraZeneca vaccine being manufactured at the Serum Institute of India declared that its vaccine has 90% efficacy. Subject to regulatory approvals, the first doses of these could be available to the public at different parts of the world as early as December.
The collaborative effort to find a vaccine to halt COVID-19 has had many experts working tirelessly over months. But each of the vaccines is also the product of the participation of thousands of volunteers who signed up for the trials to determine their safety and efficacy. The volunteers waded into the unknown at a degree of personal risk in order to ensure that the cure for COVID-19 can be developed at the earliest.
One such volunteer is Kumara Prashandh, a 31-year old IT employee. He is one of the participants in the Phase 2 trial of Covaxin, the indigenous vaccine manufactured by Bharat Biotech. The trials were conducted at the SRM Medical College Hospital and Research Centre in Chennai.
Prashandh spoke to Citizen Matters about his personal motivation behind volunteering for the vaccine trial, the process behind it and what he hoped would happen in the coming months.
How did you find out about the trial in the first place?
I had been following news about vaccines right from June or July, when there discussions about it first gained steam. The first one I heard about was the AstraZeneca vaccine. Then I heard about the development of a vaccine by Bharat Biotech called Covaxin. Around this time, a doctor from SRM in Chennai had tweeted that the medical college hospital had been chosen as one of the centres for its human trials. He mentioned that those interested could come to SRM on a given date and enrol in the trial.
Why did you decide to enrol in the trial?
When I started reading about the Oxford-AstraZeneca vaccine trial I had come across a news report where it was mentioned that they were not getting enough volunteers. There they were, doing something that would benefit the entire world, but faced this situation. I was confident that such a thing would not happen when human trials started here, but wanted to do my own bit to ensure that. Hence I decided to volunteer for the trial.
How did your family and friends react to your decision?
I did not make it public at that point of time. Now I can see that the stigma has gone completely, but at that point we were also still learning new things about the virus. I have been working from home, so I was not really interacting with or meeting any of my friends or colleagues.
I just told my immediate family that I would like to participate in the trial. My father was supportive. We just had a baby boy earlier this year. My mom and wife said that they were okay with it as long as I felt confident that everything would be fine and safe for me and the family.
I told myself that if the trial was going to be successful, there was a good chance that my family would be getting the same vaccine in the coming months, so why don’t I try it out in advance?
What was the enrolment process like?
After the initial call for volunteers I saw that they had started Phase 1 trials. For Phase 1 the number of volunteers needed was not very high. I called the number that I had come across on social media. I was informed that they already had enough participants for Phase 1, but that I would be called when they began Phase 2 trials.
I kept track of its progress in the news and when I saw that the Phase 2 trials were to begin shortly, I called the number again. This time, they responded that preparatory work was underway. Then on September 7th, I got a call asking me to go to SRM to complete the screening process.
What does the screening process entail?
For screening, they tested participants for COVID-19 using the RT-PCR method. An antibody test is also carried out to make sure that the person has not already been infected by the virus. Those who test negative for both and do not have any health conditions such as diabetes, heart problems etc, and are within the prescribed age range, are eligible for the trial.
What happened after that?
After I gave the swab for COVID test and blood for antibodies, I returned home. The next evening I got a call saying that the tests were negative and I was eligible to take part in the trial. I was asked to go to SRM the next day to get the first shot.
How did the first shot go? What preparations did you have to go through prior to that?
Even before the swab test and blood test, there was a counseling session headed by a senior doctor there. He explained the whole process in great 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 having unprotected sex.
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. 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.
Once I decided to go ahead, I got the first shot on the 9th. I felt no adverse effects. No pain or any other issues. It felt like a flu shot or any other injection.
Did you read up about the risks on your own as well?
Yes, absolutely. Before going there I did my own research and was ready. I had trust in the team as well. From what I had read, I gathered that even if it goes wrong, it was not likely to have dangerous repercussions. You might have a fever for a day or feel sore for a couple of days, and then it should be okay.
What kind of follow-up took place after the first shot?
All the participants were given a log book. It had 30 pages. Whatever we felt, we had to note it down in the book. Even if it was temporary low-grade fever or some minor cramp, it had to be logged. We had to mention if we were taking any other medication as well.
In the worst case scenario, if someone really felt unwell, we were given contact numbers of the doctors and we were allowed to call them anytime, or come back to the same hospital anytime. We were told that the treatment for any adverse effects would be covered by their insurance.
What we know about Covaxin
Covaxin is the indigenous vaccine manufactured by Bharat Biotech in collaboration with the National Institute of Virology (NIV) in Pune.
It is an “inactivated vaccine” that is, it uses particles from the SARS-CoV-2 virus that have lost the ability to cause an infection, to activate an immune response in the body. After the NIV isolated the COVID-19 strain in March, Bharat Biotech began work on the vaccine.
Bharat Biotech has stated that the vaccine has proven to be 60% effective and could be ready for rollout by June of 2021. An adverse event was reported during Phase 1 of the clinical trial of Covaxin but the manufacturer reported that it was found to be unrelated to the vaccine.
Did you get to interact with the other trial volunteers? Did you exchange notes?
Not really, because we did not have time. There was a process to be followed. On the day of screening, after volunteers have gone through the counselling, they go to the room where the swab is taken, and then they proceed to give the blood samples.
The next day we were vaccinated and then we were kept under observation for a couple of hours. But everyone rushed back to work after the observation period. When we all convened again for the second shot on October 20th, no one seemed to have had any adverse effects and were fine.
Whoever I met at that time were all daily wage labourers, I think. They were aware of the process and the fact that this was not the final vaccine, but from my interaction, I was not sure they understood the magnitude of their actions and how they could be a part of history.
What are your thoughts on having been a part of this process?
Before COVID-19, we may not have been aware that India has such huge capacity to manufacture vaccines, but the world is now looking to us. I feel very proud of that.
If the Covaxin vaccine is proven effective, it would be nice to have something homegrown that has been worked upon by our scientists. And I feel very proud to have played a small part in the process.
There is a call for volunteers for the third phase, and from my experience of having seen people of all age groups participate in Phase 2, I would say people should sign up. I hope the vaccine trials are successful and we see an end to this pandemic soon.
COVID-19 vaccine: Three phases of human trials
Each individual trial sets its own criteria for various parameters but the broad aims of the various phases are as follows:
Phase 1 – Testing of the vaccine for safety and assessing the antibody response, usually conducted among a small pool of trial volunteers
Phase 2 – Studying the immune response and determining the size of the effective dose, conducted amongst an expanded pool of volunteers numbering in the 100s
Phase 3 – Studying the efficacy of the vaccine amongst thousands of volunteers to prove reduction in infection rates and overall safety
Each trial will see a relaxation in the age group of volunteers as well as an increase in the number of volunteers.
Volunteers for the COVID vaccine trials had to satisfy preconditions such as having a negative COVID-19 RT-PCR test and a negative antibodies test. In addition, the individuals should not have had any prior allergic reactions to any vaccine, diabetes, hypertension, heat conditions or any chronic illness including those related to the immune system. Pregnant women are also not allowed to take part in the trials.