Julie Dunn said it was an easy choice to volunteer for the coronavirus vaccine trials run by Moderna.
“I used to work on clinical trials,” Dunn said in a video interview. “I’m an epidemiologist by training, and I understand how challenging it is to recruit for trials and get a decent cross-section of people. So to me, it was really a no brainer to volunteer. And plus, I had a 50-50 chance of getting the vaccine.”
The trials use a large number of volunteers to test the medication. Usually a certain number get the active medication, and a certain number a placebo — often half and half. In this case, it’s a high-profile event: The entire world is waiting for a working vaccine, so volunteers’ work is extremely valuable.
Such trials are all blinded — so she will not know for some time whether she received the actual vaccine or a placebo. But based on how she felt, she’s guessing it was the real thing.
She had her first shot in September. After it, her arm was sore for a couple of days, she said — maybe a little more sore than from a tetanus shot. The second shot was about a month later, in October. And she had a strong reaction the next day — extreme fatigue and a 100-degree fever. “I just felt kind of poleaxed and stayed in bed all day and slept a lot,” she said. “The fever was all gone by the next day. And I was a little more tired than usual the next day, and then that was it. And then I was happy because I figured, O.K., I think I got the real thing.”
A couple of weeks later, she said, her nose started running like crazy. “It was just really like a lot more than I would normally have at that time of year, which is why I reported it,” she said. “It only lasted for a day. And I’m just wondering if it was something that was trying to take hold, and I was able to fight it off?”
Follow-ups and an E-diary
Her two-month follow-up was in November, and she will have follow-up visits at 7 and 13 months after the first shot. The visits include an interview, taking vital signs and drawing blood to test for the presence of antibodies. She is recording her state of health in an E-diary questionnaire. She also heard semi-regularly from nurses and others checking in, because, she thinks, she had reported some side effects.
Dunn, who is a grant supervisor for the Massachusetts Department of Public Health, said she sought out the trial on the National Institutes of Health website, because she was interested in participating. She put her name into a questionnaire, and later heard from someone at Brigham and Women’s Hospital in Boston who was connected with the study. She went in for a screening, and normally if she passed the screening, she would have gotten her first shot that day. But she almost didn’t get in — she had had a pneumonia shot a few weeks earlier, which ruled her out. Then time passed, and she was admitted — perhaps one of the last people in the Phase 3 trial, she thinks. The Phase 3 one follows Phase 1 and Phase 2; Stage 3 is usually the last one before approval.
It’s listed as a two-year study, she said. “The general rule of thumb is if one treatment is found to be effective in a trial, you stop the trial, and then offer that to the folks who’ve gotten the placebo,” she said. “Now, I have no idea if they’re going to do that in this trial or not, they probably want to go further. I think they’re doing it slightly differently now, because it is more of an emergency situation.
“I did ask the clinicians when I went in, if it turns out that it’s effective, or another vaccine becomes available, will they let us know if we had the active vaccine or not? So we can make a decision as to whether we want to get another vaccine? And it was interesting, because the clinicians at the Brigham were saying, we don’t know, normally, that’s what they do, but the sponsors haven’t told us yet what they intend to do.”
Was she nervous about getting a shot for a fearsome disease that had not been approved by the government, and that might have downsides?
”No, because by the time things get to Phase 3 trials, which this was, I knew they’d already done a lot of safety checks in the Phase 1 and Phase 2 trials,” she said. “Again, I understand the process involved. I think I have more trust in that whole process than many people do, because I’ve been involved with it in the past. That’s partly why I think it’s important for people who do understand that to get out and participate, and share their experiences, because otherwise, there’s going to be all this misinformation floating around. People are understandably nervous, especially since politics was injected. And I’ll be honest, the fact that a lot of the vaccines didn’t really put in for approval until after the election helped a lot in my mind, because if they were rushing it, I would have felt very nervous.”
Dunn, 66, who lives in Watertown, Mass., also said the fact that she was in a trial for the Boston-based Moderna vaccine played a role — “they’re a hometown company,” she said.
Becky Schultz, who is a registered nurse at the University of Iowa hospitals in Iowa City, wrote to us on Facebook: “I’m in the Pfizer trial. We will be finding out any day now whether we received vaccine or placebo. I’m assuming I had vaccine because my arm was sore for a couple of days. Got an email today saying they’ll be unblinding the vaccine for those who want to be vaccinated. One of my visits was with Dr Winokur, the principal investigator. She is brilliant and I feel honored to be a part of historic research.”
She volunteered for the Pfizer trial
Ginny Frazer-Abel, 53 years old, of Aurora, Colo., also did a trial — this one for the Pfizer vaccine. She saw a local TV news spot announcing that the trials were open, and then discussed it with her wife, Ashley Frazer-Abel.
“She’s a scientist, so she knows a lot about the Covid vaccines and a lot about Covid,” said Ginny Frazer-Abel, who is a lawyer. “We talked about the mechanism of the one that they were trying. She said that, in her opinion, it was safe, and that there was no reason to think that it would cause any harm to try. So for me, it was really about trying to help. I figured I had an arm, I’m not scared of needles, and I’m not scared of blood draws. So I’ll just go ahead and sign up. And if they want my arm, they can have it.”
She went in for a screening visit in June, had an interview, a brief physical exam and a Covid nasal swab test, and then gave several vials of blood. At that same visit, she had the first of two shots, then got a second one several weeks later. She had no reaction, and so she guesses that she had the placebo.
“I didn’t have anything,” she said. “I assume that I’m probably on the placebo because my arm didn’t hurt. In fact, when it went in, it didn’t feel like anything,” she said, unlike flu shots or the shingles vaccine. “So, I kind of just assume I’m probably on the placebo. Because there’s been no effect at all.”
Ginny Frazer-Abel went back three months later to give blood for tests, and is scheduled again for March. Like Dunn, she’ll be followed for two years. The study managers also gave her a self-test nasal swab that she is to use if she gets Covid symptoms, and deliver it to the study managers so they can ascertain if she has the illness.
She is also getting paid, a modest sum: She was given two Visa cards for $120 each as part of her participation.
She volunteered for the AstraZeneca trial
Her wife, Ashley Frazer-Abel, also 53, is also in a trial, this one for the Astra-Zeneca vaccine. Ashley Frazer-Abel is director at Exsera Biolabs, part of the University of Colorado, and a board-certified immunologist who studies serological Covid testing, among other things.
Ashley Frazer-Abel said she wasn’t as quick as her wife to sign up, but then she began to see Facebook ads recruiting for both the AstraZeneca and Johnson & Johnson/Janssen trials.
The Astra-Zeneca one is a different modality, the adenovirus modality rather than the mRNA for both Moderna and Pfizer. “That gave me a little more pause,” she said. “But that’s also the one that’s only going to be $2.50 a dose versus $20. And they’re not reimbursing for travel or anything like that. So since I’m in the position to do that, it also felt like something I should do.”
Her first shot was Saturday, Dec. 5, and she doesn’t think she had a reaction — though she did get a runny nose, which she said is not uncommon for her at this time of year. Her next shot will be in several weeks.
She said she is doing Covid serology testing in her lab, “which felt good to be doing something, but it’s not quite the same.”
“So this was another piece that I could do,” she said. “And they’re not reimbursing. So I think they’re having more trouble recruiting.”
She also pointed out that AstraZeneca has SARS and MERS vaccines on the market, and that the mRNA modality used by Pfizer and Moderna is decades old, and has been used in several other medications.
Wasn’t she concerned that AstraZeneca had some adverse events in its trial? Because she has knowledge of trial protocols, she said, it wasn’t as frightening as it might be for a lay person.
“I know that trials get stopped because of adverse events, and then they get started again,” she said. “That’s just part of the process. Of course, I looked at it and looked at what they were thinking it was, but it didn’t give me the same pause as it might give someone who doesn’t read Phase 3 clinical trial protocols on a regular basis, like me.”