Photograph by Joe Raedle/Getty Images
As confirmed Covid-19 cases surged toward the half-million mark in Georgia, the first 5,850 doses of the Pfizer vaccine arrived in Savannah on December 14 like a beachhead in the battle against disease. Within days, more healthcare workers and long-term care residents in Atlanta will roll up their sleeves and get some protection. It’s the beginning of the end of the pandemic.
While that’s great news, the rest of us are in for a wait. Even with the emergency authorization of a second vaccine from the pharmaceutical company Moderna, it will take months before the average Atlantan has easy access to a Covid-19 vaccine. But there is a way to get a shot at a new vaccine before almost anyone else—all in the name of science.
Next week, Emory University and Morehouse School of Medicine are expected to begin enrolling participants in a Phase 3 trial of a vaccine produced by Maryland-based Novavax. Since it’s a study, there’s a caveat: Not everyone will get the actual vaccine. But the odds are pretty good. Instead of a one-to-one match between people who got vaccine and those who got a placebo, or saline shot, in previous vaccine trials, the Novavax ratio will be two-to-one. Participants have a 67% chance of getting the vaccine.
“Being in the vaccine trial might be a faster way to actually get a real vaccine,” says Lilly Immergluck, a pediatrician and infectious disease expert who is principal investigator for the trial site at Morehouse School of Medicine, where she is also a professor.
Having different versions of a vaccine has been the plan all along. Even with their ambitious efforts, Pfizer and Moderna likely won’t produce enough to vaccinate the entire country in the next six months or so. Under Operation Warp Speed, the US government funded 200 million doses of the Moderna vaccine, or enough for 100 million people to receive the two-dose regimen. The program purchased 100 million doses of the Pfizer vaccine, which also requires two-doses, so that covers another 50 million people. There are about 330 million people in the US.
“We need these other products to ensure we have an adequate supply for whoever wants them over the long-term,” as well as for global supply, says Colleen Kelley, an infectious disease physician and principal investigator at Emory’s Ponce De Leon Center/Grady Clinic study site.
Here is some information to help you decide if joining the vaccine trial is right for you:
Who is eligible to sign up? The Novavax trial is open to adults 18 and older who are “at substantial risk of exposure and infection with SARS-CoV-2,” the virus that causes Covid-19. That includes people who are unable to work from home. Novavax also seeks to include people of color, older adults, and people with stable chronic medical conditions—populations that have had higher rates of Covid-19 infection or more severe disease and are most likely to benefit from the vaccine. People who are not eligible include those who are immunosuppressed or take medicines that lower their immune function; women who are pregnant (or may become pregnant) or breastfeeding; and people who have medical conditions that aren’t well-controlled. Nationwide, 30,000 people will enroll at 115 sites.
What’s in the vaccine? Novavax uses advanced technology to produce nanoparticles of the protein found in the outer spike of the coronavirus, turning moth cells into a manufacturing site for the very tiny particles. Still, this vaccine is similar to other products on the market (such as the hepatitis B vaccine) that use virus proteins to stimulate the body’s immune defenses. (Pfizer and Moderna use a synthetic messenger RNA that causes the body’s own cells to create the protein.) Novavax adds an adjuvant, or a chemical that enhances the immune effects.
Is it safe? Early tests showed that the vaccine produced a strong immune response without causing serious side effects. People who have allergies to any of the vaccine components or who have a history of severe allergic reactions after vaccination should not take the vaccine.
What are the requirements? The study lasts two years, and Novavax expects participants to return at intervals to get the second dose and to have blood drawn to test for immune response. Participants receive a kit to take saliva samples for testing if they develop symptoms of Covid. The investigators realize that it’s a bit complicated to run a clinical trial while an authorized vaccine is publicly available. “There’s a provision in the Novavax protocol that says any participant can leave the trial if they choose, if an effective, [authorized] vaccine becomes available to them,” says Kelley, who is an associate professor of medicine at Emory. Participants will not know if they got the placebo or vaccine, unless the trial ends early because of clear evidence of effectiveness. Those who got the placebo might then be offered the vaccine, although all of the participants will still be asked to continue returning for the two-year period of study assessments.
How do I sign up? The main portal for registering is through the Covid-19 Prevention Network. Morehouse also has a toll-free number (888-788-0644) to provide information about clinical trials or other Covid concerns. “We want to be a trusted source of information if people have questions about Covid,” says Immergluck. Morehouse also has a mobile research unit that will make enrollment and participation easier in rural areas or communities in which people are less likely to access clinical trials, she says.
