As an adult cystic fibrosis doctor, I have seen the importance of participating in clinical trials firsthand. Certainly, after seeing the positive impact that Trikafta® has had on our CF community, I am especially grateful to those who took a leap of faith and enrolled in the clinical trials that made it possible.
Like many, by September 2020, I was growing weary of COVID-19 and of 2020 in general. I was motivated to get access to a potential COVID-19 vaccine as soon as possible. When I heard that the infectious disease practice across from my hospital was a site for the Pfizer vaccine trial, I filled out the interest form right away. By the next business day, I was booked for my first study visit three days later.
I have been involved in clinical trials on the medical side, but never as a study participant myself. On Sept. 3, I showed up for my first study visit not knowing what to expect. I figured they would have me sign a consent form for the study and then do some basic tests to make sure I was eligible. I had no idea that I would get my first shot that day … so I didn't even have time to over-think it or really even be nervous.
After checking my vital signs, they did a COVID-19 nasal test, drew my blood, and then gave me the first dose. I had a 50-50 chance for either the real vaccine or a placebo. I was required to be observed for 30 minutes after the shot and then I went right back to work. As the day went on, I noticed my left upper arm hurt a little but, admittedly, I have skinny arms and I flinched when they gave me the shot.
I woke up that night with discomfort in my arm and took ibuprofen, which helped. I made note that I should probably ask for the next shot in my right (dominant) arm and avoid my left arm since I sleep on that side. And that was it. By the next night, the pain was gone.
Three weeks later, I went back for my second dose. By that time, I had read more about the vaccine design.
I felt reassured that the mRNA vaccine does not contain any actual virus, but instead the messenger RNA (the code that instructs the body to make a protein) for the spike protein on the outside of the virus.
Based on what I read in the Phase 1 study, it seemed like about 85% of people who got the real vaccine (rather than the placebo) in the first study had side effects after the second dose, so I figured that the second dose could be tougher.
At that point, I couldn't have told you if I was getting the vaccine or the placebo based on my experience with the first dose. A sore arm could happen with any injection (saline placebo or real thing), I thought. So I was a little bit nervous at my second visit on Sept. 24. On one hand, I was a little scared of the unknown and how I might feel after the shot. On the other hand, I really wanted to get the actual vaccine and I knew that side effects would be a good sign that my body was responding to the vaccine and building immunity.
At the second visit, they did another nasal swab and then gave me another shot. Having learned my lesson with the first dose, I asked for the shot to go in my right arm. I took ibuprofen right after the shot and went back to work. That night, I took another dose of ibuprofen before bed and slept well.
The next morning, I woke up with a mild headache and headed into the hospital for CF clinic. Around noon, I was starting to drag a little bit. I felt a chill, but no one else thought it was cold in clinic. As the afternoon went on, I felt more tired and was relieved when clinic was over so I could go home.
I couldn't wait to get into a hot bath to relax. My muscles felt sore and my neck was a little stiff. A bath, a cup of tea, and some ibuprofen helped a lot.
I went to bed early and woke up during the night with a low-grade fever of 100.5°F, which is very unusual for me as my temperature usually runs on the low side. The next day was Saturday and, fortunately, I didn't have to work. Other than getting up to get some breakfast, I listened to my body and stayed in bed and rested until 2 p.m. Around mid-afternoon, I felt better, got up and showered, and went to the grocery store. By the next morning, I felt essentially back to normal and did my normal Sunday-morning yoga. Never did I feel any respiratory symptoms like cough or shortness of breath.
A week later, my husband Rick, who was also enrolled in the vaccine study, had a similar experience, although milder. He felt more prepared for his second dose and knew what to expect based on what happened to me. He went to bed the night of his second shot saying, “Bring it on!” He was hopeful to get a chance at immunity, too.
Because of the symptoms that we both had; we were fairly sure that we had received the actual vaccine. Of course, we found out nothing through the study since it was blinded. Through a study on health care workers at the hospital, I found out that my COVID-19 antibody test was positive in early October, after testing negative since the beginning of the pandemic…which was a good sign.
But the real test came later in October when our live-in childcare provider (also enrolled in the study but had no side effects with her shots so presumably got the placebo) came down with a cold. As part of the study, she was asked to do a nasal swab on herself. Several days later, she was informed she had COVID-19. Amazingly, Rick and I didn't get sick (our daughters got cold-like symptoms) despite living under the same roof and having dinner with her every night.
This was extremely reassuring and pretty compelling evidence that the vaccine works, especially since my husband usually picks up every infection that comes his way.
We joked that our house was a microcosm of the Pfizer study. Rick and I dodged COVID-19 and, thankfully, our nanny and girls recovered quickly.
It has been a relief to have protection from the virus over the past few months, although I know better than to let down my guard. I consistently wear personal protection equipment and make safe decisions to minimize my exposure to the virus. But I don't worry about my family quite as much anymore. In mid-December, I found out officially from Pfizer that my husband and I received the vaccine and my childcare provider received the placebo. Deeply grateful for the opportunity to be involved in making history and getting the vaccine approved, I would do it all again.
In a year characterized by total of lack of control, I see choosing to get the vaccine as taking control…control of when your body is exposed to COVID-19 (or the vaccine “fake-out”).
As unpredictable as COVID-19 can be, a little predictability and planning is a welcome change. I would gladly take one to two days of feeling crappy to a wildly unpredictable and dangerous virus.
They say herd immunity is the only way we will move on from COVID-19, and I much prefer getting my immunity through the vaccine rather than the real deal. I realize that we are in the early days of vaccine rollout, and it will take a while for the process to pick up steam. But when the time comes, I encourage you to discuss it with your care team. I am recommending that my patients get the vaccine when it's available. People with CF are tough, and COVID-19 vaccination will likely be much easier than most CF flare-ups, and much shorter lived.
Choose wisely. Fight back against COVID-19. Take back control.
Some vaccine lessons learned:
- Expect the vaccine to have side effects (more with the second dose than the first.)
- If or when you feel side effects, this is not COVID-19 -- it is the “fake out” effect of the vaccine on your immune system.
- Be prepared to feel soreness in your arm -- consider taking ibuprofen or acetaminophen pre-medication and choose an arm you don't sleep on.J
- Side effects only last a limited amount of time -- much like flipping off a light switch; once a few days have passed you will be back to normal with no lasting symptoms.
- The virus itself can have effects that linger for weeks and even months.
- Plan ahead before you get the vaccine by getting it on a Friday or taking two days off of work afterwards (especially the second dose) to rest.
- Protection from COVID-19 may take at least a week after the second dose -- it's not immediate and different people may respond more completely than others.
- Physical distancing and mask use remain crucial after getting vaccinated. Continue to set a good example and feel proud that you are doing everything in your power to protect yourself and others from COVID-19!
Stay safe and consider vaccination at your first opportunity. Together, we can move forward.
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