Numerous vaccines are in development, but the first to be tested on the volunteer is a new type of coronavirus vaccine developed by Moderna Therapeutics. A company whose technology has enabled what is called “the fastest start-up of a vaccine study ever.”
The first phase, now underway, is a safety trial to make sure that the vaccine is not dangerous and that it causes an effective immune response. In March, 45 people were asked to volunteer at a facility in Seattle.
The 20-page consent form that volunteers are signing (you can download and read it in the box below), recognizes that there may be risks.
Volunteers also agree to undergo a series of blood samples in the coming months to share their genetic information. And they agree to give up having children during the study period.
Il MIT Technology Review Magazine interviewed Ian Haydon, a communications major at the University of Washington. Ian explained why he decided to volunteer for the coronavirus vaccine and how he was chosen. The following is the translation of the interview.
You will be among the first 45 people to receive a coronavirus vaccine. Why did you decide to do it?
Good question! I'm a public information specialist at the University of Washington, specifically for the Institute for Protein Design, which is doing research on covid-19. There are 35 people in the laboratory working on the vaccine. The rest stays at home. I have never been the subject of one of these studies, but I experience them closely and the idea of being able to participate in a different way seemed like the right thing to do.
When will you receive the vaccine?
April 8th at nine in the morning. And a second dose about a month later.
How were you chosen for this study?
Luck, above all. I heard about the study from a lab colleague who told me about the recruitment. I sent my health information: they wanted to know my health and age history. I did not expect to have news, because they had thousands of answers. But they chose me. I went for a physical and blood test, and they explained the study to me. They asked me if I was still interested in volunteering for this coronavirus vaccine. I said yes and I signed up.
Any fears?
No. I was looking forward to the call.
How old are you?
I'm 29.
Did you tell your parents? What do they think?
I got mine while I was going for my first physical exam. I also told my girlfriend at the time. I think my parents are proud: my mother is a little worried, understandably.
What do you think the risks are?
I think there are some small risks. The first is anaphylactic shock, which can be a problem for a small number of people and is not a unique risk in this study. Another small risk, and it's not clear whether it's relevant to covid-19, is called “antibody-dependent enhancement” (when a vaccine makes a disease worse).
That's part of what they're considering, I guess. The third level of risk is the unexpected. This exists for any vaccine, especially those based on new technologies.
How does the vaccine work?
This is an mRNA vaccine. Part of the virus's genetic code is found in the vaccine, in a lipid nanoparticle, which is essentially a pellet of fat. When it is injected into a volunteer like me, it is supposed to produce the protein, in this case the coronavirus spike protein. This is what should make my immune system react and produce antibodies. The vaccine delivers the genetic material directly and not the proteins.
How long should you develop antibodies?
This will be monitored throughout the trial period, for over a year. Each of the visits will check my antibodies and immune cells.
You did some research on technology?
Yes a little bit. My understanding is that this lipid nanoparticle vaccine platform has passed some phase 1 trials for infections other than coronavirus. In fact, what clinicians said was that one in three patients who received an mRNA vaccine had severe pain that interfered with normal activity for the rest of the day.
What is your opinion on Moderna?
I think their technology is extraordinary and I'm glad it's being tested. It could be an important platform not only for coronavirus but for many diseases. Their decision to develop a coronavirus vaccine and try it in humans in the midst of a pandemic is an extraordinary thing for any company. They are putting everything into play, I hope it works.
Do you receive a refund for your contribution?
I think it's $ 100 per visit, so about $ 1.000 in all.
The new coronavirus Did Covid-19 hit you personally?
I think like almost everyone else, this pandemic has turned my life upside down. Working from home, being quarantined, and most of all being a Seattle resident. The whole experience broke down some of the walls between my personal and professional life.
Many people are experiencing it. I know that many scientists at the university have volunteered to process clinical samples that come into the lab. This is not their day job. People moved their jobs. I haven't been near the infection itself, but I feel it around me.
The test document states that the safety study lasts 14 months. Why so long? Don't we need an answer first?
I heard they might have a clear indication of safety by the third month. If the safety data is clear by the third month and coronavirus continues to be the issue, I expect phase 2 trials to begin soon. But these clinical trials can't be sped up that much. This is already the fastest vaccine candidate to ever enter humans.
Do you think there is a chance that the vaccine will protect you?
I suppose it's possible. But part of what they're doing with the vaccine is evaluating different doses, so I'm not going to take for granted that we'll get immunity from the coronavirus.
The consent form makes it quite clear that everyone involved in the process should avoid new births. What is it about?
I wonder it too. I have theories. I have been specifically asked to use contraceptives. I wonder if, being a genetic vaccine, someone wanted to avoid the birth of a new generation of children vaccinated with mRNA.
Do you mean that DNA could end up in the germ line, in your sperm?
I guess scientists themselves think it's a possibility they don't want to explore. Whether or not there is a molecular mechanism that would make it possible, it seems responsible not to continue on that path.
What's it like knowing you'll be contributing so directly?
I consider myself lucky to be able to volunteer to fight the coronavirus. I am lucky to be healthy enough to participate. I am lucky to have been selected by a large pool, and I hope that many people in my position will also be able to participate.
