The past few weeks have been uneventful. I spend a few minutes each day filling out a questionnaire on the Patient Cloud app I installed during my first visit. The study is interested in reactions to the injection itself: redness, swelling, pain, etc. around the injection site, and the first section of the questionnaire checks for these symptoms. The next part is a self-screen for Covid-19 itself. Using the thermometer the nurses gave me, I take and report my temperature. There’s a checklist of symptoms to look out for: malaise, nausea, fatigue, etc. I’ve had nothing interesting to report, which I’m sure is a delight to the researchers.
I have my next injection appointment in about a week - I planned to write this second update sometime after that, since I would have a better idea of whether or not I received the placebo treatment. However, I got a very interesting email today (image below):
Dear PREVENT-19 Study Participant:
Novavax is happy to announce that thanks to many volunteers like you, we have completed enrollment in the PREVENT-19 study. We want to thank you for your commitment to participation as without it, we would not be able to progress this very important research into a new COVID-19 vaccine.
We also want to take the opportunity to notify you that the Institutional Review Board (IRB) has approved Novavax's plan for a blinded crossover. What this means is that all participants will eventually receive the real vaccine. For this to happen, we first need to demonstrate that the vaccine is safe and does prevent COVID-19 disease. Participants who choose to remain in the study on their blinded treatment (sic). We anticipate that between one to two more months of follow-up will be required to reach that goal. Crossover vaccinations will be planned to follow thereafter.
We thank you for the extremely valuable contribution you are making to research and to society during these trying and challenging times.
The Novavax Team
My first response was a sense of relief that, worst case, I would likely receive the real vaccine within a few months. But then my critical thinking booted up. We are still experiencing a national (and global) shortage of vaccines - If the Novavax vaccines are believed safe and effective, shouldn’t they be going into the same supply of vaccines that everyone else is being served out of? I came up with two possible answers to this question. (Spoiler: both of them suck)
- I am getting special priority because I volunteered to participate. If that is true, is that kind of kickback scheme remotely ethical? To participate in the trial, I needed to have the time, energy, and ability to sign up online, transport myself to the site, and then spend part of my day answering questions and letting the nurses poke and prod me a bit - all of which was made considerably easier by ability to speak English, access to a car, resources and free time, etc., in other words, exactly NOT the kinds of things according to which we should be allocating vaccines.
- Novavax and the experimental team think it’s safe and effective enough to do the cross-over and give the control group the real vaccine, but the Very Serious People in charge of US vaccine approvals don’t. In that case, we’re just back to the regular story of an abundance of caution causing senseless morbidity and mortality; blah blah blah FDA Delenda Est.
Of course this is all occurring with the backdrop of the Novavax vaccine already having been tested with great results overseas, and oh my god why haven’t we been distributing this thing since last month?
If it turns out that I was randomized into the placebo group and they offer me the real treatment sometime in the future, I plan to take it despite not being particularly vulnerable - I don’t think me refusing on principle would result in someone else getting the dose any faster, but it might result in a lot of wasted effort contacting me repeatedly while the dose meant for me sits in a freezer unused.
I think as well as what others have said, an ethical consideration with placebos is that they are treating someone with something that they know doesn't work. Like, basically, on some level, it's ethically dubious to make you go to all the effort you outlined, interact with medical staff, receive an actual injection, etc, and deliberately not treat you. That's why many many trials have "stopping rules", where if it turns out the treatment is working really well, the placebo group gets it, too.
You absolutely have taken a small risk to your life here. It is not guaranteed that a new vaccine like this will be safe. The manufacturing process is extremely complex and there are many kinds of errors that could cause it to do terrible things, be contaminated with pathogens, give you anaphylaxis, and so on. So they are compensating you for some of the lifespan they have statistically taken away from you with a slightly earlier vaccine dose.
As I understand it the main ethical problem with rewarding trial participation is that people may sign up for the reward without adequately considering the risk. However this becomes a moot point when the "reward" is just the trial vaccine itself along with any associated risks.