What it’s like to be a participant in a COVID-19 vaccine trial
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Decatur, GA — In a pandemic as serious and widespread as the COVID-19 crisis, hope lies in a vaccine.
Experts have agreed for months that a vaccine is what will let us return to something resembling normalcy — full lockdown isn’t a sustainable way of living, but neither is reopening while it’s unsafe. For an emergency vaccine to be developed quickly, the scientific community requires something that may be hard to come by in such a scary situation: willing participants of clinical trials.
Shelly Groves, a 57-year-old Avondale Estates resident, heard about the Moderna vaccine trial from her neighbor who works at Emory’s Hope Clinic. Groves had also participated in previous clinical trials at Emory. She became one of 20 participants in the Hope Clinic’s Phase I of the trial in mid-April, and will be a participant for 14 months.
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When asked what motivated her to participate in the study, Groves simply replied, “Mass infection and death.”
“I knew that I was of the age group they needed and I’m a very healthy person, I didn’t see any downsides to it, honestly,” she said.
Groves told Decaturish that her experience in the trial went relatively smoothly. After giving a detailed medical history and undergoing blood tests to ensure it would be safe for her to participate, she signed a 23-page release and began the trial. Groves personally received a 25 microgram dose of the vaccine, although other participants were given doses of 100 micrograms or 250 micrograms. The next phase of the trial will focus on the 100 microgram dose.
There are few risks related to the trial because unlike some existing vaccines for other illnesses, the Moderna vaccine contains no live or deactivated SARS-CoV-2 virus. The vaccine instead relies on messenger RNA, or mRNA, a synthetic genetic material that encodes for the protein in the outer spikes of the coronavirus. The material triggers the immune system to develop neutralizing antibodies, which block infection, but the mRNA vaccine does not pose a risk of coronavirus infection.
Groves experienced very few side effects, which were not unlike those normally experienced from routine vaccines, such as pain at the injection site and joint pain. She said the pain wasn’t enough to need over-the-counter pain medication like Tylenol, and that the side effects went away within 24 to 36 hours.
Another participant of the Moderna vaccine trial is 29-year-old Seattle resident Ian Haydon, who received the dose of 250 micrograms. His experience was different: he developed a high fever and experienced fainting, but recovered within a few days. He says he doesn’t regret participating in the trial and told STAT that he hopes his negative experience “doesn’t fuel any sort of general antagonism towards vaccines in general or towards even this vaccine.”
The Moderna trial has since moved through Phase 2 and generated an immune response. Since it’s been deemed safe, it will now move on to the Phase 3 efficacy trial, with 30,000 participants. Participants in the trial shouldn’t assume that the trial vaccine will give them immunity: Phase 3 of the trial will contain 50% placebo vaccines and 50% real doses of the vaccine.
Because the demand for a safe and effective vaccine to be developed quickly is so high, scientists are ramping up the timeline of vaccine development. There are more than 140 potential vaccines currently in the pre-clinical trial stage, with Moderna being one of the contenders that are furthest along in the process of human trials for safety and efficacy. The Trump administration announced this week that it would invest an additional $472 million into the Moderna vaccine.
Stuart A. Thompson’s New York Times Opinion piece, “How Long Will A Vaccine Really Take?” illustrates the goal timeline of developing a COVID-19 vaccine in just 18 months, compared to the years or even decades it usually takes for vaccines to be developed. According to the projection, if scientists weren’t adjusting their methods, a vaccine wouldn’t be available until 2033. Efforts to shorten the timeline include putting many vaccine candidates through human trials at once, beginning to build factories before the human trials are through, and beginning manufacturing early.
The Trump administration’s plan to help scientists quickly develop and distribute a COVID-19 vaccine is, no joke, known as Operation Warp Speed. The plan “aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).”
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January 2021 might be too soon of a goal according to some, but Dr. Anthony Fauci has said he’s “cautiously optimistic” about Moderna’s progress specifically.
It might sound scary to the general public that a vaccine is being “rushed” in this way. But that’s the point of having so many clinical trials — the only vaccines that make it to the distribution phase will have been verified to be safe and effective by tens of thousands of trial participants.
According to Atlanta Magazine, Phase 3 of the Moderna vaccine trial is open to adults 18 and older, with some exceptions. You can’t participate if you have an immune deficiency, if you’ve ever had a SARS-CoV-2 infection (even if you were asymptomatic), if you’ve ever had an allergic reaction to a vaccine, or if you are pregnant or breastfeeding. Researchers are interested in how well the vaccine protects people who are vulnerable to COVID-19, so you can enroll if you have a medical condition (such as diabetes or hypertension) as long as it has been stable for at least three months.
Those interested can complete a registration form with the COVID-19 Prevention Network or you can contact one of the three Emory-related sites: Emory Children’s Center at Emory University; Hope Clinic in Decatur; or the Infectious Disease Program at the Ponce de Leon Center.
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