According to the Centers for Disease Control and Prevention, more than 237 million doses of the mRNA COVID-19 vaccines manufactured by Pfizer or Moderna have been administered in the United States. Current research suggests that anaphylaxis – or a severe allergic reaction – to these mRNA vaccines occurs in about 2.5 to 5.5 people per 1 million doses.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is leading a multi-center clinical trial to study the incidence of anaphylactic reactions to mRNA vaccines, and whether certain risk factors increase the likelihood of experiencing these potentially life-threatening allergic reactions. The goal of this phase 2, randomized, placebo-controlled study is to provide evidence-based data to help determine if people with severe allergies, or a mast cell disorder, are at a greater risk of severe allergic reactions to the mRNA COVID-19 vaccines.
Cleveland Clinic is the only clinical site in Ohio involved in the study and will recruit up to 113 patient volunteers. Overall, this study will enroll 3,400 adults across 35 academic allergy-research institutions nationwide. About 60% of study participants will have a history of severe allergies or a diagnosis of a mast cell disorder. The remaining 40% will have no history of allergies.
David Lang, M.D., chairman of the Department of Allergy & Immunology in the Cleveland Clinic Respiratory Institute, is a principal investigator of the trial. Co-investigators include Steven Gordon, M.D., chairman of the Department of Infectious Disease, and allergists Mark Aronica, M.D.; James Fernandez, M.D., and Lily Pien, M.D.
Prospective study participants will be between the ages of 18-69 years. People who have already received a COVID-19 vaccine (Pfizer, Moderna or Johnson & Johnson) are not eligible to participate.
Individuals in high-risk populations for illness from COVID-19 or severe allergic reactions to vaccines –such as people of African descent , African Americans, Hispanics and women – are especially encouraged to sign up.
“We recognize that some people may be hesitant about getting vaccinated,” said Dr. Lang. “Participants in this study will receive either the Pfizer or the Moderna vaccine under the watchful eye of an allergist trained to recognize and treat anaphylaxis.” Emergency medications, oxygen and medical equipment will be on hand to treat allergic reactions as needed. Participants will be observed for at least 90 minutes after each injection in case any type of reaction occurs—three times longer than current CDC guidance.
Study participants will be randomly divided into groups, and given either two doses of either Pfizer BioNTech vaccine or two doses of a Moderna vaccine. One out of every three participants will receive a placebo injection (salt water) before they receive the first dose of the vaccine. Initially, neither the participants nor the study team will know who is receiving a vaccine or placebo, or which vaccine is being administered. All participants ultimately will receive a full two-dose course of either the Pfizer-BioNTech vaccine or the Moderna vaccine.
“Severe allergic reactions to the COVID-19 vaccines are very rare,” said Dr. Lang. “ The benefits of vaccination far outweigh the potential risk.”
After each injection, participants will be asked to monitor their symptoms for one week and will be contacted after each injection by the study team. Depending on whether participants receive the placebo, participation in the trial will last four to nine weeks.
For more information about participating in this study, please call 216-444-8758 or email firstname.lastname@example.org.