MARYLAND, USA — The University of Maryland and National Institutes of Health are recruiting thousands of volunteers to test a Covid-19 vaccine.
The NIH announced last week that after eliciting an immune response in patients in preliminary trials, the Moderna vaccine was ready to move into a phase 3 clinical trial that would involve 30,000 participants.
Lead investigator at UMD Dr. Matt Laurens said they'll be working with 500 people. You can sign up for their trial here.
“The important component that this phase 3 study brings in is efficacy," Dr. Laurens said. "In other words, how well does this vaccine work to protect people who are vaccinated against Covid-19 in the community.”
He spoke with WUSA 9's Jess Arnold to answer some of the most asked questions about the vaccine and clinical trial process.
Q: How will the study work for participants?
A: Dr. Laurens said everyone will receive two injections about four weeks apart, with half the group getting the vaccine, and the other half, a placebo. He said they will ask volunteers to record their symptoms for a week following each injection and report to investigators.
Then, he said they'll monitor them for efficacy and side effects for two years, by checking in weekly.
Dr. Laurens said researchers are also prepared to compensate participants for their travel and time with up to $1,375.
Q: Does that timeline mean that it would be at least two years until any vaccine would be released to the public?
A: “Not necessarily. I want to emphasize that while we’ll be following them for two years, that’s the initial plan, so things could change with the trial such that if we get a readout on efficacy sooner, then, that might change the endpoints for the trial," Dr. Laurens said. "We're hoping to have an answer much much sooner than that, but that will depend on how many individuals get Covid-19 who were in the study, and that will allow us to do the calculation for efficacy."
Q: How is the team selecting participants for the trial?
“What we want is a vaccine that works for everyone," Dr. Laurens said. "So this study will plan to recruit from individuals who are at higher risk for Covid-19 illness, in other words, those who are in the community and exposed...We also plan to recruit those with chronic medical conditions…We will also recruit individuals over the age of 65, because again we want the vaccine to work for everyone."
Q: How will researchers make sure the studies are equitable and represent communities that are disproportionately affected by the virus, like Black and LatinX communities?
“That’s something that we’re definitely aware of, especially since Covid-19 is disproportionately affecting those communities as you said, and we want the vaccine to work for all," he said. "So, we’re making special outreach efforts, and those are still in the works, and we’re working with community groups that already have links to those populations, and other non-government organizations that have those strong community ties."
Q: Some people are worried that these clinical trials are being rushed. How does the speed of these studies compare to a typical one?
A: “You’re right, this trial has advanced much faster than previous trials," Dr. Laurens said. "What we’re seeing here is a timeline that normally takes six years compressed into six months…but that doesn’t mean that the safety has been compromised, because safety is being carefully followed…It’s the investment that has helped this to progress so rapidly and the risk that companies are willing to take that’s being buffered by private organizations and government organizations to ensure that we advance this as fast as possible."
Q: How many people would need to get the vaccine for it to be effective in slowing rates?
A: “When we think of a vaccine for Covid-19, it would actually prevent transmission in the community, that’s when we can think about herd immunity and what effect this vaccine might have on transmission locally," Dr. Laurens said. "So the vaccine would have to be very effective not in just preventing severe illness, but it also would prevent anyone from turning positive and therefore shedding virus and that would be transmitted to other individuals in the community.”
Q: What efficacy are researchers aiming to achieve?
A: “The influenza vaccine is about 50% efficacious, so we’re thinking we want something at least as efficacious as the influenza vaccine, hopefully better," Dr. Laurens said.
Q: What side effects have participants in preliminary trials shown?
A: He said participants exhibited fevers, chills, muscle aches, fatigue, or soreness at the injection site—all of which dissipated relatively quickly and are typical side effects of vaccinations.
The goal is to uncover any other rarer side effects in the phase three clinical trial, he said.
Nicole Brady said she does not plan to volunteer for the clinical trial.
“I think just given some previous drugs that have been on the market and then have come back later, you know with side effects, with different categories of people who shouldn’t have taken them," Brady said. "So, I get really nervous and anxious about the fact that we really don’t know how it affects people in certain risk factors and underlying conditions.”
To that point, Dr. Laurens said, “We definitely would encourage you to discuss the safety concerns with the investigation team and your family and doctor…At the same time, we know that it’s imperative for our society to develop a vaccine, and in order to do that, we have to have individuals that are willing to take on that risk and help us to test this vaccine in order to save more lives as we discussed.”
Others like Tommy Luginbill, however, are ready to take on that risk. He said he signed up as soon as he found the link.
“I got heavily involved in the outbreak, and I’ve seen what’s going on from a first hand perspective, and I know how bad it is," he said. "I see what the nurses and doctors are going through, so this was a no brainer for me, and when I heard about it, I said I have to sign up.”
Researchers are actively recruiting volunteers, so if you feel compelled, they ask that you sign up.
The University of Maryland School of Medicine provided the footage and pictures included in the above video report.