Ted S. Warren/AP
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.