On December 22nd, I watched along with the rest of the country as Dr. Anthony Fauci received the Moderna COVID-19 vaccine at the National Institutes of Health in Washington, DC. Years ago, I was an intern at the NIH, and as an Italian American in medicine, I have greatly admired Dr. Fauci’s intelligence, level-headedness and dedication to his work since my time there. Which is why I considered it such a privilege to have received the vaccine as part of a clinical trial and contribute to this incredible medical advance. (I even ended up getting the vaccine before he did.)
In the early fall of 2020, I participated in Phase 3 of Moderna’s Covid-19 Vaccine Trial. For reasons I’ll explain later, I had a hunch I had been given the actual vaccine rather than the placebo, and I found out late last week that my suspicions were correct. I was informed in the routine “unblinding” of the trial that I had been given the vaccine.
For the past 25 years as a doctor, I’ve been doing clinical research at institutions like Johns Hopkins and the University of Pennsylvania, and now in the private sector as the Executive Vice President of Research and Development and Chief Medical Officer at Jazz Pharmaceuticals. I’ve run countless clinical trials, but until this year, I had never been a participant in a clinical trial. When trials for the COVID-19 vaccines began, I realized it was my chance to be on the other side of a trial, and to contribute to the development of a successful vaccine. My motivation was altruistic, but obviously, I could also benefit from having the vaccine, and I felt that potential benefit balanced out any unknown risks.
The mRNA technology was a huge part of what got me interested. This delivery method— encasing messenger RNA in a protective fat particle to ensure it gets taken up by immune cells, and what it’s designed to do (encourage your immune cells to mount a protective response against the spike protein on the surface of the COVID-19 virus)—seemed to me to be ingenious, safe, and also serendipitous. Prior research on the use of this technology for cancer and therapeutic protein replacement, and on vaccines for other viruses, made it possible to quickly develop a vaccine against COVID-19.
How I got the vaccine so early
I actually did not become involved with the Moderna clinical trial through my job as a medical researcher. I had an interest, so I did a Google search, and signed up to be considered for the vaccine trials. I went through the screening process, first over the phone and then in person, so they could take a detailed medical history and do bloodwork. They counseled me on potential risks and I agreed to participate. At that time, they had already enrolled over 20,000 participants. In a double-blind, randomized trial, half of the participants get the vaccine, and half get a placebo. So, I knew at least 10,000 people had already gotten the actual vaccine and had follow-up to the extent that if there were major problems with the vaccine, they would have surfaced by that point, and I was reassured by that.
The first shot: September 11, 2020
On the day of my first injection, I was told the most common side effect of the first shot is swelling at the injection site. They set me up with an ingenious smartphone app that would send me notifications requesting that I report my symptoms. That evening, I did develop some tenderness at the injection site, which is in the deltoid muscle in the shoulder. They also ask you to check your armpit for swollen lymph nodes, and I did notice one small slight bit of swelling in a lymph node. However, it was pretty subtle, so I might have missed it if I weren’t looking for it. For some perspective on the soreness, we were permitted to get the flu shot on one specific day between the two COVID shots. When I did that, I made a mental note that the COVID shot was similar to what I experience with the influenza vaccine.
The second shot: October 9, 2020
I got my second shot four weeks after the first, on Friday, October 9th. I was told that after the second shot, people were reporting more symptoms of viral prodrome, which means you feel like you’re about to get sick with a viral infection. And indeed, within eight hours of the injection, I was feeling like something was up. I wasn’t feeling great, and I had a mild fever on Saturday morning. They had given me a thermometer to measure my temperature as part of the trial, and I was registering 100 to 100.5 for most of the weekend.
However, it didn’t get in the way of any of my normal activities. I went for a run both mornings and played pickleball with my wife in the afternoons, and by Monday, the fever was gone. This happens because the protein the mRNA instructs your body to make is foreign. That’s why you get the fever, and that’s a good thing. By reacting, my immune system is making antibodies to clear that foreign protein and those antibodies will remain, so if I ever get the virus, they will clear the infection. While the intent is to generate an immune response, you don’t get the actual virus, so there is no risk of any of the problems caused by COVID-19.
It was because of that viral prodrome that I suspected I got the real vaccine and not the placebo. But because the trial is blinded, neither the people who administered my shot, nor the staff at the University of Pennsylvania or at Moderna initially knew which one I got. They only decided to proceed with unblinding to give those who had been on the placebo arm of the trial a chance to get the real vaccine once the vaccine had been authorized by the FDA under Emergency Use Authorization (EUA).
The after-effects
I really have had no issues at all during the whole vaccination process, and it has had no effect on my ability to work out. I have continued to do all of my usual stuff, which includes running and biking outside, spinning inside, a lot of pickleball and some cross training with weights.
What I tell others
I hear people in the popular media saying, “We don’t know, we don’t know,” but the truth is, we know a lot now about these vaccines and the data are spectacular. It blocked infection in vitro, and the early results show a dramatic difference between whether you get an infection or not, and even those who did get infection tended to have much milder cases. Between the Moderna and Pfizer trials, around 70,000 patients have participated, so we now know a lot about the safety of this vaccine. I’m very thankful that we have it, and I’d encourage others to get it as soon as it’s available to them.
Source: Read Full Article