To put it politely, Europe is struggling to get its population vaccinated. So, when the opportunity to participate in a vaccine study came along at the end of January, I thought it might be worth pursuing. If you had asked me six months before that to participate in such a study, I would had said “no way, Jose!” But with the success of the Pfizer-BioNTech and Moderna vaccines, I figured that this could be one way to get vaccinated before I might otherwise, and well, “for the science,” and all that.
I signed up for the trial and initially didn’t hear anything. It turns out that many people were willing to participate, and they had more than 1,500 volunteers for 1,000 spots here. In the end, everyone was invited to participate because enough people were disqualified or chose to not to enroll after all. The study will last for two years and requires five in-person appointments, plus three telephonic follow-up calls within the first year, and four more the following year. Participants who receive the placebo will be entitled to receive the vaccine if it is approved. I knew going in that the proposed vaccine is an mRNA project (like Pfizer and Moderna) by a German company called Curevac.
I was excited, and then I was a bit intimidated. First, because I had never done anything remotely similar, and second because I would be doing this all in Spanish. I admit I was nervous, but I was lucky that my friend Carol had her first appointment the day before mine, so her description of what would happen and where to be was super helpful. I carefully reviewed the 15-page informed consent and description of the study, which took a long time to review in Spanish!
At the first appointment (February 24), I checked in and was promptly asked to take a pregnancy test because pregnant women are excluded from the trial. While I explained that I knew with absolute certainty that I was not and could not be pregnant, I still had to take the test. It was negative. I then met with a doctor who reviewed the consent form with me, which we then signed. The next step was a blood draw. After that, a nurse took my vital signs, and I received an injection. As this is a “gold standard,” stage three, double-blind study, no one knew what I received. I then had to wait 30 minutes to see if I had any adverse reaction, after which I met with the nurse and had my vital signs taken again. While I was waiting, I was given instructions on how to use the study’s “app” and provided an oral thermometer as we need to monitor our temperature and report it, along with any symptoms, twice a week. After all that, which took about two hours, I was free to go.
I had no symptoms or adverse effects from my first shot, not even a sore arm. This was disappointing, but not unexpected since everyone had a 50% chance of receiving the placebo or vaccine. But since many people have no effects after a first vaccine shot, I could not be sure what I had received. I dutifully recorded my lack of symptoms and my temperature using the app twice a week. I have now taken my temperature more times in the past several weeks than I have in my lifetime. It is somewhat interesting how it varies from day to day.
The second appointment (March 25) was practically identical to the first, only there was no blood draw. The physician meeting focused on my lack of any reaction to the injection and lack of any COVID symptoms. I received my second injection, dutifully waited, and went home hoping I would soon feel like I got hit by a truck – a sure sign that I got the vaccine. Only I felt fine – perfectly fine. Again, not even a sore arm. Thus, I’m nearly certain that I am on “Team Placebo.” How disappointing. But that was obviously possible and is part of the process.
My third appointment (April 8) was a quick and easy follow up in which a nurse took my vitals, I again explained to a doctor that I had no adverse effects after the second shot and no COVID symptoms, and had my blood drawn. The next follow-ups will be in June and September. In the interim, I’ll keep monitoring for symptoms and taking my temperature twice a week.
Since my first appointment I’ve done a bit of research on Curevac and am keeping track of its progress in the approval process as much as possible. The good news is that so far things are looking promising and that the company has been submitting data on a rolling basis to the European approval authorities to speed things up. It is unclear when the approval process will finish, but this week they confirmed that they hope to be approved by May or June. If you’re curious about the company, which happens to be the one that Trump supposedly wanted to buy, here’s a link to the best article I’ve read so far: https://www.irishtimes.com/
While it is possible that we could be “eligible” to be vaccinated before the vaccine is approved, perhaps at the earliest late May (although there seem to be new delays on a daily basis), my plan is to stick with the study. Because we are not part of the Spanish national health system, getting vaccinated is going to be one of those “fun” challenges as the regional health services are responsible for administering the entire vaccination program and we are not on their radar. I’ve checked with our private insurance carrier, which is a Spanish company, who confirmed that are not involved and have no control over the vaccination process. We’ll be figuring it out for Jeff when the time comes. I’m sure it will make for an interesting future blog post.
Hasta luego,
Shana
No comments:
Post a Comment