CLEVELAND, Ohio — When University Hospitals needed volunteers willing to test an experimental vaccine for COVID-19, UH’s Dr. Margaret Larkins-Pettigrew signed up, and brought along her physician husband as well.
The couple learned they will undergo two injections of either the vaccine or a placebo; they won’t be told which they were given.
Over the next two years, they will undergo periodic physicals, keep track of their symptoms and turn over their medical records to trial organizers if they are hospitalized for COVID-19.
Larkins-Pettigrew said she felt an obligation, as a physician, to participate in the vaccine trial.
“This is a safe trial to be involved in,” said Larkins-Pettigrew, who is UH Edgar B. Jackson chair of Clinical Excellence & Diversity. “Science will direct us to make sure all of us are protected.”
All over the world, people like Larkins-Pettigrew are signing up to help pharmaceutical companies test prospective COVID-19 vaccines, as part of an effort to get vaccines to the public and stop the pandemic’s devastating effect.
In Ohio, Pfizer and its partner BioNTechSE, and Moderna — forerunners in the race to develop a vaccine — are conducting trials at research centers across the state to determine their safety and efficacy.
Ohio State University Wexner Medical Center is the site of a two-year, Phase 3 trial of the vaccine developed by AstraZeneca, a British-Swedish company, and the University of Oxford.
University Hospitals and the Louis Stokes Cleveland VA Medical Center are among 120 clinical investigational sites around the world that will collectively enroll up to 44,000 participants in a Phase 3 trial to test the vaccine BNT162b2, developed by Pfizer and the German company BioNTechSE.
Rapid Medical Research Inc., in Beachwood is testing the mRNA-1273 vaccine from Moderna in a two-year trial. Two sites in Cincinnati are also testing this vaccine.
How much protection will these vaccines offer? Will we need to get a coronavirus shot every year?
“These are all open questions,” said Dr. Carlos Malvestutto, assistant professor of infectious disease and co-chair of the COVID-19 Task Force, at Ohio State University Wexner Medical Center.
“The only way to answer them is through clinical trials,” Malvestutto said.
The public has questions as well, such as how these vaccines work inside the body, why some trial participants receive a placebo and how to join a trial.
Let’s get some answers.
How do these vaccines work?
All vaccines trigger the body’s immune system to mount a defense against invading illnesses. The approach taken by AstraZeneca is different from how Pfizer and Moderna are approaching the problem.
AstraZeneca’s vaccine uses a modified chimpanzee adenovirus, altered to make it harmless to humans, Malvestutto said. The adenovirus is used as a viral vector to carry a single coronavirus gene into the body. The coronavirus components of the vaccine spark an immune response against the actual coronavirus.
The vaccine does not include the whole virus and cannot cause COVID-19, Malvestutto said.
The Pfizer vaccine candidate is made up of messenger RNA coupled to a