University of Michigan set to study allergic reactions to COVID-19 vaccines
Michigan Medicine, the University of Michigan's health system, will lead the first national study on allergic reactions to the Pfizer and Moderna COVID-19 vaccines, the health system announced Wednesday.
The clinical trials will be the first to examine whether people who are highly allergic or have a mast cell disorder are at greater risk of having a reaction to an mRNA-based vaccine. The two-dose vaccines developed by Pfizer and Moderna are the first to be based on mRNA technology.
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“We’re learning about these reactions to help battle COVID, but this technology will be used to develop new flu vaccines and, likely, vaccines for most respiratory diseases,” Dr. James Baker Jr., director of the Mary H. Weiser Food Allergy Center and national co-chair of the vaccination trial, said in a Wednesday statement.
“These formulations are truly going to transform the vaccine industry.”
Baker noted reports of a small number of people having allergic reactions to the mRNA-based vaccines. But he said it is not yet clear whether those were truly allergic reactions.
Funded by the National Institute of Allergy and Infectious Diseases, the study will enroll 3,400 patients who will receive either the Pfizer or Moderna vaccine. A substantial number will have previously experienced anaphylaxis, a sometimes-fatal allergic reaction.
The shots will be administered by allergists who are trained to recognize and respond to severe allergic reactions within seconds. The allergists will observe all of the participants for at least 90 minutes after they get the shot.
Researchers will study the people who have severe, systemic reactions to determine if they have molecular markers to explain their body's reaction.
“If we find those markers, that tells us it’s an allergic reaction and sends us in one direction,” Baker said. “If we don’t, if we find markers of nonspecific inflammation, it may suggest this is simply a reaction people are having to activation of their immune system. That has different implications from an allergy."
Millions of Americans are already immunized with Pfizer and Moderna vaccines, and the federal government purchased an additional 100 million doses from the two companies in February to meet rising demand, the press release noted. About 23% of Michiganians 16 and older had been fully vaccinated through Monday. But many people are hesitant to get the vaccine or fear a bad reaction.
“It’s important to study people who have many severe allergies and may have even been told because they have allergies they shouldn’t get vaccines,” Baker said. “In the study, we can give them the vaccine safely in a controlled environment.”
“The safety of these vaccines is otherwise remarkably good. So, if we can figure this out, it really facilitates the use of these technologies for vaccines going forward.”
Adults interested in participating in the trial at Michigan Medicine should visit https://michmed.org/lAxgj for information on how to enroll.