To stop the coronavirus we need a vaccine fast—and volunteers willing to receive it.
Several vaccines are in development, but the first to be tested in humans is a novel type of shot developed by Moderna Therapeutics, a company whose technology has allowed what’s being called the fastest startup of a vaccine trial ever.
The first step, under way now, is a safety trial to make sure the vaccine isn’t dangerous and that it provokes an immune response. In March, 45 people were asked to volunteer at a Kaiser Permanente facility in Seattle. According to a 20-page consent form the volunteers are signing (shown below), they acknowledge that there could be risks and the vaccine isn’t likely to help them. They also agree to undergo a series of blood draws in the coming months, to share their genetic information, and to avoid having children during the study.
We spoke to Ian Haydon, a communications specialist at the University of Washington, who told us why he decided to volunteer and how he was chosen.
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You are going to be among the first 45 people to get a coronavirus vaccine in Seattle. Why did you decide to do it?
It’s a good question. I am a public information specialist at the University of Washington, in particular for the Institute for Protein Design, which is doing covid-19 research. There are 35 people in the lab doing vaccine work. The rest are staying home. I have never been a subject of one of these studies, but I have been around them, and the idea of being able to participate in a different way seemed like the right thing to do.
When will you get the vaccine?
April 8 at nine in the morning. And a second dose about a month after that.
How did you manage to get picked for this study?
Luck, mostly. I heard about the study from a lab mate who shared on Slack that they were recruiting. I submitted my health information; they wanted to know my health history and age. I didn’t expect to hear back; they had thousands of responses. But I did. I went in for a physical and bloodwork, and they explained the study to me. They asked if I was still interested, and I said yes and signed up.
Any second thoughts?
No. I had been looking forward to the call.
How old are you?
I am 29.
Did you tell your parents? What do they think?
I told my parents as I was going in to do the physical. That was about the same time I told my girlfriend. I think that my parents are proud. My mother is perhaps a little worried, understandably.
What are the risks, do you think?
I think there are few small buckets of risk. The first is the risk of anaphylactic shock—that can be a problem for a small number of people, and it’s not a risk unique to this study. Another small bucket of risk, and it’s not clear if it’s relevant to covid-19, is called antibody-dependent enhancement [when a vaccine makes a disease worse]. That is part of what they are evaluating, I suppose. And the third bucket of risk is the unanticipated. That exists for any vaccine, especially one based on new technology.
How does the vaccine work?
This is an mRNA vaccine. Part of the genetic code of the virus is in the vaccine, in a lipid nanoparticle, which is essentially a ball of fat. When it’s injected into a patient like me, it’s supposed to produce the protein—in this case the coronavirus spike protein. That is what is supposed to get my immune system to react and produce antibodies. The vaccine delivers the genetic material and not the protein directly.
How soon will you develop antibodies?
That will be monitored throughout the trial, for more than a year. Each of the visits will involve scrutinizing my antibodies and the immune cells.
Did you do some research on the technology?
Yeah, a little bit. My understanding is that this lipid nanoparticle vaccine platform has been through some phase 1 studies for infections other than coronavirus. Actually, what the clinicians said that stuck with me is that one in three patients who received an mRNA vaccine had severe pain that interfered with normal activity for the rest of the day. That is on my mind.
What’s your take on Moderna?
I think their technology is amazing, and I am glad it is being trialed. It could be an important platform not only for coronavirus but for many diseases. I think Moderna is really in the hot seat now. I think their decision to develop a coronavirus vaccine and try it out in humans in the midst of a pandemic is a remarkable thing for any company to do. They seem to be putting a lot on the line here, and I hope it works.
How much are you being paid to be a volunteer?
I think its’s $100 per visit, so about $1,000 if you do all of them.
Has covid-19 affected you personally?
I think like almost everyone else, this pandemic has turned my life upside down—working from home, being quarantined, and especially being a resident of Seattle. The whole experience has broken down some of the walls between my personal and professional life. A lot of people are experiencing that. I know a lot of scientists at the university have volunteered to process clinical samples coming in the lab. That is not their day job. People have shifted their work around. I have not been close to the infection itself, but I feel it all around me.
The trial document says the safety study lasts 14 months. Why so long? Don’t we need an answer before then?
I heard they might have a clear indication of safety by month three. If the safety data is clear by the third month, and coronavirus continues to be the problem that it is, I would expect phase 2 trials to begin early. But these clinical trials can only be sped up so much. This is already the fastest a new vaccine candidate has ever entered humans. I should say I haven’t felt rushed. Everyone I have interacted with has been calm and extremely professional.
Do you think there is a chance the vaccine will protect you?
I suppose it’s possible. But part of what they are doing is evaluating different doses, so I am not going into this assuming that I am on a fast track to immunity.
The consent form makes it pretty clear everyone in the trial is supposed to use birth control. What is that about?
I have been wondering about that too. I have some theories. I was specifically asked to make a promise to use protection. I wonder if, this being a genetic vaccine, someone wanted to guard against the possibility of a new generation of mRNA-vaccine children being born.
You mean the DNA could end up in the germline, in your sperm?
I’m speculating. I imagine either regulators or Moderna themselves thinking that is a possibility they don’t want to entertain. Whether or not there is a molecular mechanism that would make that possible, it seems responsible not to go down that path.
What’s it like to know you will help so directly?
I consider myself lucky to be in this position. I am lucky to be healthy enough to participate. I am lucky to have been selected from a large pool, and I hope that a lot of people in my position would also step up and participate.
We recently wrote a story about a proposal to speed up vaccine studies by “challenging” participants with the virus. That is, infecting them on purpose. Is that something that you would be willing to do as well?
It’s worth saying that is not happening in this trial, but it’s just about the most common question I am getting—are you going to be exposed to the virus? I think it’s an interesting conversation. I don’t know if it’s a responsible thing to do, but I have been thinking about it. If I was in a situation where tests indicated I had a robust immune response and there was a compelling case that an exposure challenge was medically useful, I would be interested in listening to that argument.
What would your mother think about that?
I think she would worry about that too.
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