When Jennifer Haller heard that researchers were looking for volunteers to be injected with an experimental coronavirus vaccine, the Seattle mother of two rolled up her sleeve.
Well, not literally. Haller, 43, the first person to receive the vaccine, was wearing a tank top when a pharmacist, sheathed in gloves, a mask and protective eye gear, injected her with an experimental vaccine named mRNA-1273. It made her arm a bit sore, "but besides that, no, no side effects," she says.
With the outbreak rapidly spreading across the nation, Haller says she was excited to enroll in the Phase 1 trial, which started Monday.
"I wanted to do something because there's so many millions of Americans that don't have the same privileges that I've been given," says Haller, who now works from home for a small tech company. "They're losing their jobs. They are concerned about paying bills, feeding their family."
Vaccines typically take years to develop and bring to market. They go through extensive animal trials to ensure they are not only effective, but safe. But as the coronavirus death toll rapidly climbed — reaching 11,147 on Friday — researchers felt they couldn't wait.
The injection Haller received was developed by the National Institutes of Health and the Massachusetts-based biotechnology firm Moderna Inc. It does not use any form of a live or weakened virus, so Haller can't contract the coronavirus from the vaccine.
That doesn't mean there aren't risks. She had to sign a 45-page waiver just to enroll in the trial.
Despite the uncertainty, Haller says she was moved to volunteer out of a feeling of helplessness. She felt uniquely positioned to contribute, given that her children are older, she has friends and family nearby and a job that allows her maximum flexibility of when and how she works.
"This was just something that I could do and that I wanted to do."
A sprint to Phase 1 trials
The vaccine given to Haller was developed in record time, according to Dr. Tal Zaks, the chief medical officer for Moderna. "We've been able to do that based on the fact that our technology starts with the digital information. So we did not need to have the physical virus, just the information."
Instead of using parts of a killed virus to provoke an immune system, Moderna, working with the NIH, created a synthetic RNA molecule once the virus behind the outbreak in Wuhan, China was identified.
In early January, just days after the virus was identified, researchers had designed synthetic virus particles that they hope will convince the body to produce antibodies against the coronavirus. On March 16, Haller and three other study participants were the first to be vaccinated. Zaks says 45 patients in all will participate in the trial, each at three different dose levels.
Moderna is one of at least 20 drug manufacturers around the world working on potential coronavirus vaccines and treatments. President Trump has reportedly told pharmaceutical executives that he wants to see a vaccine developed in the United States to ensure it controls supplies.
"This should work"
The subjects in the NIH-Moderna trial will receive a two-dose vaccination schedule, 28 days apart. Haller keeps a log of her temperature and any symptoms she might be experiencing. So far, she says, there have been none.
All of the participants will be monitored for a total of 14 months. Regular blood tests will show whether the vaccine is activating their immune systems. Participants in the study will receive $100 for each lab visit for a total of $1100.
Zaks says he is confident in the trial. "This should work," he says, adding, "we've already begun the scale-up activity in our manufacturing site to be able to scale up and produce the vaccine."
Still, even if this first human trial is successful, public health officials don't expect a vaccine to be ready for widespread use for at least 18 months.
SCOTT SIMON, HOST:
Researchers are racing to find a vaccine that can prevent the coronavirus. At least 20 are reportedly in development around the world. Vaccine trials typically involve extensive animal studies to make certain the vaccines are effective and, of course, safe. But with more than 200,000 people now infected around the world, the research and testing is being fast-tracked.
The first human trials got underway this week, using a vaccine developed by the biotechnology company Moderna, in partnership with the National Institutes of Health. And the first person to get that shot was Jennifer Haller of Seattle, who joins us now. Thanks so much for being with us.
JENNIFER HALLER: Thank you. I'm happy to be here.
SIMON: How are you feeling?
HALLER: I'm feeling great. I mean, as far as the vaccine goes, I'm feeling great. My arm was a little bit sore the next day, but besides that, no side effects that I'm experiencing.
SIMON: This vaccine didn't go through the usual phase of animal testing. Did the doctors involved tell you that there were possible risks?
HALLER: Yeah, absolutely. You know, there was a 45-page waiver that I signed (laughter). And, you know, there's the usual vaccination risks - you know, soreness at site of injection and body aches and nausea, things like that. And then there's the complete unknown - you know, the big one. This one has not been tested in humans before.
SIMON: Unlike some other vaccines - the traditional way, if you please - the vaccine you've been given has no derivative from coronavirus, right?
HALLER: That is correct. So there's no risk to me throughout any part of this study to contract coronavirus. Of course, you know, I could contract it in real life. But as being part of the study, I will never be exposed to the virus.
SIMON: I gather you're the mother of two teenagers.
HALLER: That's correct. Yes.
SIMON: What made you decide to volunteer for this?
HALLER: Well, you know, we all feel so helpless right now. And I have so much privilege being healthy. You know, my kids are older. I have friends and family nearby. I have a great job in the tech sector in Seattle, you know, that provides me a lot of flexibility to work from home or work - you know, flexibility in when and how I work. I'm going to maintain a salary through all this.
I wanted to do something because there's so many millions of Americans that don't have the same privilege that I've been given. This was just something that I could do and that I wanted to do.
SIMON: I guess - what? - you'll get two shots, 28 days apart.
HALLER: That is correct, yeah.
SIMON: And they're going to keep checking on you?
HALLER: Yeah. After the first shot on Monday, I'll go back in for a blood draw a week from Monday, and then another week following that. And then, yeah, 28 days after the first shot, I'll get a second one. We'll do the same follow-ups. And then throughout the next 14 months, I'll have a handful of follow-ups for blood draws. But that's all.
SIMON: Well, I hope, for a lot of different reasons and a lot of different people, that this works out.
HALLER: Me, too. You know, this is just the first of many, many studies that are coming. You know, the chances of this being the right one - the exact, right one - I don't know what the chances are. But there's a lot happening, a lot of people working on this. And this is just, you know, the first tiny step of many, many steps that are going to get us to the right place.
SIMON: The Jennifer isn't a bad name for a vaccine. I don't know if that's occurred to you.
HALLER: (Laughter) No, I have nothing to do with it. I just got lucky that I got selected. There's nothing there.
SIMON: Jennifer Haller, thanks so much for being with us.
HALLER: Thank you so much. It was my pleasure.
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