Prior to moving to New York, I was very afraid of getting COVID and suffering from long-term effects, namely reduced cardiovascular output. I did a lot of research into long COVID to try to understand the risks the best I could, but certainly anxiety surrounding the pandemic was tinting my lens a bit. In the end, I ended up volunteering for the Novavax vaccine trial and got my first shot on January 20th, 2021, about 30 minutes after Biden was sworn in. It was a good day.read more
Some of my friends and family were concerned about me joining a trial, for the same reasons many are still afraid to get the vaccine. My calculus was simple: I can get a vaccine that's already been tested on about 100 people in a phase I and phase II study which is also pharmacologically thought to be safe, or I could take a (rather large) risk of getting COVID which will fuck with the epithelial cells (the innermost layer of cells) in blood vessels all over the body: the brain, the heart, the lungs, etc. Put another way, we know we would never subject even 100 people to voluntarily get COVID due to how horrible the effects on the body are and because we'd know that between 1 and 2 of those 100 people would die as a result, but the rates of illness or death due to a vaccine are nowhere near that high. Even just looking at death rates, a vaccine that's gone through phase I and phase II would be safer. It's like: 100% chance of getting vaccine * maybe slim chance of something bad happening vs ~30% chance of getting COVID * decent chance of something bad happening. When you do the math, even joining a vaccine trial was the intelligent health decision to make.Novavax Phase 1-2 Trial Results
Novavax Trial Consent Form (with my highlights)
* https://www.youtube.com/watch?v=0gLmMPOHDwM * https://udayton.edu/news/articles/2020/12/messinger_covid.php * https://www.vox.com/22166236/long-term-side-effects-covid-19-symptoms-heart-fatigue * Our friends have started getting it. Li has long term effects. etc. * https://www.nytimes.com/2021/01/21/magazine/long-covid-nightmare.html * CDC: It’s possible for people to spread the virus for about 2 days before experiencing signs or symptoms and remain contagious for at least 10 days after signs or symptoms first appeared. If someone is asymptomatic or their symptoms go away, it’s possible to remain contagious for at least 10 days after testing positive for COVID-19. Results: * I think we should be as safe as possible if we move to New York, at least until the case counts go down, possibly until vaccination. * Definitely no seeing random people inside, under any circumstance. I'm realizing that this is reckless. I mentioned it to Eunice and she thought it was way too far. Think about it: nobody else we know is doing that. * We should work from home/a home office that Coursicle pays for. * We should see friends in outdoor settings, not indoors. A trusted pod could be discussed, but this would have a very high bar of trust, and the people in this pod would have to be very low risk. * Indoor shared spaces, unless they're very ventilated spaces like an indoor mall, are off limits. That means no gyms. The CDC says that you should limit gym activity indoors, if you have to be indoors, a window should be open. * We can enjoy New York outside. We can get settled in the city. But our expectation that our time in New York really won't be starting until later. Questions for friends I'd stay with until I found a place: * Are you working in-person or at home? If in person, how often (per week)? * Are you using a public transit system? If so, how often (per week)? * Are you eating at restaurants indoors? If so, how often (per month)? * Are you eating at restaurants outdoors? If so, how often (per month)? * Are you seeing friends in-person indoors? If so, how many and how often (per week)? * Do you go to an indoor gym? If so, how often? Question for Novavax study: * What is the placebo group given? Saline or anything with an active ingredient? * Saline. * Will everyone in the placebo group be given the vaccine if the vaccine is shown to be effective and the FDA grants it emergency use authorization? * Correct. * Can you tell me about Phase I and II of the study? Were human volunteers involved? What was measured/monitored in those phases? * Localized reactions. Healthy young people. with phase III, More comoribities, higher risk. Rabbits and marsupials, still localized. * They did up to 5 injections. * How many enrollees in Phase II? * 14,000 * 1,400 for the M1. * Are all patients in the treatment group being given the same dosage of protein and adjuvant? * All the same. * (Optional) If I happen to be traveling during one of the study visit times, would I be able to do the blood draw and swab at a partner hospital or a LabCorp? * Any idea if you'll do Fauci's suggestion; where you do injections at the "end" of the 4 months that give placebo to the treatment group and active ingredient to the control? * It says on page 14: * Unknown Risks * Because this study vaccine has only been given to 131 participants in other studies. there may be other risks that are unknown. * I thought it had been given to many more? * What kind of COVID tests are being done? Are they rapid tests or PCR? * How will you/I know if I contract COVID during the study, I'm asymptomatic, and I didn't happen to have a viral test during that time? The antibodies might look the same if I'm in the treatment group? (Shot 2) Questions for study members: * I forgot to enter in my survey one night the past 3 weeks. What are the repercussions? * Just don’t get compensated for that day. No other repercussions. * Do I have to take my temperature every day for 2 years? * Yes. * Was I chosen to give more blood as per one of the things I signed? * No. * Will trial participants be first in line to get the booster vaccine for the other variants, like the South African variant? * Not sure yet. * Any updates on when the study might end? * No, seems like maybe a month after EUA submission, which might be as soon as after we they fully enroll. This site will be fully enrolled by Saturday, that’s the last appointment. * [At the very end after getting second shot] I'm moving to NY, can you transfer me to a NYC location for future appointments? * Yes, gave address and they’ll contact me letting me choose which site. (Cornell) Questions for study members: * How many people have unblinded since the study started? * Over 5% for sure. About 6% and 10% guess, have been unblinded. * Are there any known effects of interactions between Pfizer and Novavax? Anybody had shots from both? * Nothing known. Mixing vaccines is not recommended. * What's the location of the site? * 1305 York Ave * Why did it take so long? * Safety issues with the metadata not being shared. Dr. Marks was concerned not enough much being shared. * There were not many follow-up emails coming from the intermediary (ICON). * Make sure that transfer and IRT (randomization system) happen. * My email sped things up with ICON. I emailed the CEO. * Transfer of the internal data. * They do apologize for the delay.