I am in a COVID vaccine trial: My take on the testing experience
BioLogos’ President enrolled as a volunteer in a COVID vaccine trial. Here’s what it’s like, and what she learned.
My own experience is that no corners are being cut. The study was being done with full attention to detail and as consistently as possible.
This past summer I signed up to be a vaccine tester. Initially, my biggest motive was curiosity. For me as a scientist, this was a cool opportunity to see up close how a human medical trial was done. What I experienced is a trial that is meticulous, ethical, and protects the health of the participants as much as possible. It is double-blind studies like these that will bring us a safe and effective vaccine, a blessing from God to end the suffering and death of COVID-19.
In late October, I was contacted about a vaccine trial starting in my area. Then I had to make a choice. Could I commit the time? I learned that the first appointment would be over 6 hours, plus a 1-2 year commitment to several follow-up appointments. But it didn’t take me long to realize that this service was more important than the tasks crowding my calendar. I haven’t had to sacrifice much during this pandemic—I still have my job, I haven’t been sick, I haven’t had a family member die. Here was an opportunity to sacrifice a little of my time to help stop the spread of the disease and prevent others from getting sick.
It was only the day before the appointment that I started thinking about the health risks. I realized that for my whole life, I’ve benefited from a modern regulatory system that ensures food is safe, drugs are effective, and everything is clearly labeled. In this study, I could be ingesting something that wasn’t yet FDA approved!
Yet during my first day at the trial, I saw firsthand the many ways these studies are designed to protect the health of the volunteers. The vaccine is built so that it cannot possibly give you COVID, and volunteers are not deliberately exposed to COVID as part of the study. This particular vaccine (Johnson & Johnson’s Ad26) had already been given to over 800 people in the Phase 1 and Phase 2 trials. And very similar vaccines had been developed for other recent diseases (such as Ebola) and tested on over 10,000 people. Each of us volunteers met privately with a doctor to review medical history and ensure we didn’t have risky health conditions. After receiving the shot, we were monitored for 30 minutes with a doctor on site, to watch for any initial allergic or other negative reactions. There’s a 24-hour hotline to call if complications develop, an app to fill out twice a week, and checkups every 1-2 months. So if anything bad does happen, I feel I am in good hands. All in all, it feels safer than taking an unregulated herbal supplement on my own.
The ethics of the study were also well done. The “informed consent” document was long (30 pages!) but at an accessible reading level, and sent ahead of time with encouragement to discuss with friends and family. The information was reviewed again verbally when we arrived. Each participant met privately with a nurse to ask as many questions as we wanted before signing the consent form.
I expected there to be more inspirational calls to serve (like this video), or at least abundant thanks for our sacrifice, but these were left out, I think to eliminate any sort of pressure to volunteer. The study staff at my site represented a broad range of races and ethnicities, and the opportunity was widely advertised. We were paid at the end of the day, an amount appropriate for the hours of work lost, travel expenses, etc., but the payment wasn’t used as an incentive (It wasn’t even mentioned till over halfway through the document). We were told repeatedly that we would be accepting some risk, that the study might not benefit us, and that we could back out at any time. Once fully informed, everyone in my session agreed to serve.
What impressed me the most, however, was the consistency and thoroughness of the study. I am one of 60,000 volunteers at dozens of sites all over the globe. For the results to mean anything, all of us have to be treated the same way. On the first day, we all had to do several sessions around the building (group orientation, checking vitals, blood draws, meeting with the doctor, etc.), all while staying 6 feet apart. It could have been chaotic, but it was actually very well-organized. The staff were patient and diligent, checking every form, ensuring that all of our information was complete and correctly recorded. The key scientific step took place early in the afternoon, when a staff person gave each of us a card with a special code number that assigned us either to the placebo group or the vaccine group. Half of the participants are in each group, but I don’t know which group I’m in. The card was exchanged for a box with a syringe, and the person who gave me the shot didn’t know what was in the syringe either. That’s what “double-blind” means—neither the patient nor the medical staff know which shot was used. The researchers will now watch for cases of COVID among both groups as we live our lives in the coming months. If most of the cases are in the placebo group, they can conclude that the vaccine was effective in protecting the other group.
With the desperate rush for a vaccine and the conspiracy theories swirling around this issue, it is understandable that some people are concerned about the reliability of these studies. Last summer BioLogos posted a note from Francis Collins, Director of the National Institutes of Health, to someone with these concerns, emphasizing that the research findings will be transparent and available to all to review. My own experience is that no corners are being cut. The study was being done with full attention to detail and as consistently as possible. The “Warp Speed” aspect of the vaccine push refers not to any sacrifice in scientific quality, but to several other special measures being taken to speed up the timeline. The biggest is that the government is paying vaccine companies to produce millions of doses now, even knowing that the doses will have to be dumped if the studies show the vaccine isn’t safe and effective. Another special measure is using larger numbers of people in Phase 3 trials than is typically done—60,000 in the case of my trial. A large group means that the number of COVID cases among participants will stack up faster, giving the researchers an earlier opportunity to see how many cases are in the placebo group vs. the vaccine group. The study is still being done with all deliberate care. From all I could see, the researchers running the study are experienced and ethical, and I have no reason to doubt that they will apply the same integrity to reporting these findings as they have in previous trials they have run.
A big question on the minds of us volunteers was the recent announcement of the preliminary results for the Pfizer vaccine (followed a week later by Moderna and yesterday by AstraZeneca—see a current summary of all vaccines). Some of the headlines give the impression that the search is over—“a vaccine has been found!” The actual good news is that multiple vaccines might work, allowing more of the doses already produced to be used immediately in meeting the need. At our trial, the staff said that if another vaccine is approved for distribution while our trial is running, they will contact us to discuss our options; they repeatedly said we could drop out at any time. For me, I’d like to stay in the trial for several months. The other vaccines in the news are double-dose, while the Johnson & Johnson vaccine is single-dose. This vaccine would be much more practical to disseminate to large numbers of people, both in the U.S. and around the world. And I can be part of showing if it works.
Many other vaccine trials are just getting started, studying vaccines that may prove to have less side effects or be easier to produce and distribute than the ones already announced. The trials need to be done on a large number of people, with a range of health conditions, age, race, ethnicity, and life situation. Volunteers are still needed. If after prayerful consideration you would like to be part of testing a vaccine, visit preventcovid.org or call 1-866-288-1919.
COVID-19 has forced us into a grueling marathon. Many of us are exhausted from all the restrictions and sacrifices. The possibility of a safe and effective vaccine gives us cause for optimism, a glimpse of the finish line! But we have many hills to climb and miles to run before we reach it. And the virus is not getting tired. We need to stay strong, encouraging and supporting one another. See our statement for the names of thousands of Christians committed to following public health measures.
With Thanksgiving coming up, all of us will need to make sacrifices. One of the riskiest behaviors is talking and eating together without masks—this is a big spreader of COVID, even if done 6 feet apart. Please do not gather in large groups and instead share the meal only with those in your household. Use Zoom calls, chatting outside, or delivering meals and treats as safe ways to stay connected. We need to prevent spreading the disease to those we love the most. Yet we can thank God for the blessings we still have, and pray for those who have been hit hardest—the sick, the grieving, the healthcare workers, and those who have lost jobs. Let’s keep looking for ways to love and serve our families and neighbors through this crisis. May Christians be known as the people most wise in discerning science, most courageous in fighting for justice, and most compassionate in caring for the sick. We should be the ones most willing to make sacrifices for the sake of others, following in the footsteps of Jesus Christ.
On January 29, 2021, Johnson & Johnson announced that the vaccine was 85% effective in preventing severe cases of COVID-19 in just a single shot. On February 28, the Food and Drug Administration granted an Emergency Use Authorization for the vaccine. The study began “unblinding” participants, and on April 1, Deb Haarsma learned she had been in the placebo group and was given the vaccine. As of April 1, 16.4% of the U.S. population has been fully vaccinated.
About the author
