As a part of the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) is working with Cleveland Clinic to study the incidence of anaphylactic reaction to mRNA vaccines.
According to the Centers for Disease Control and Prevention (CDCP), 237 million doses of the mRNA Covid-19 vaccines have been administered in the United States since December 14, 2020.
However, following the distribution, research published at Science Direct suggests that severe allergic reactions to the mRNA vaccines are found in about 2.5 to 5.5 people per 1 million doses.
This severe allergic reaction is also known as anaphylaxis, which occurs more often in patients with previous systemic allergic reactions to drugs. These reactions are varied from dropped blood pressure, difficulty in breathing, nausea, and vomiting. In worst cases, anaphylactic shock can be life-threatening.
The study will enroll 3,400 adult participants, of whom Cleveland Clinic will recruit 113. These participants will be between the ages of 18 – 69 years who have not received any dose of Pfizer, Moderna, or Johnson & Johnson COVID-19 vaccine before. About 60 percent of the total participant will have a history of severe allergy, while 40 percent will have no drug-related allergy record.
The Department of Allergy & Immunology Chairman of the Cleveland Clinic Respiratory Institute, David Lang, M.D., is the trial's principal investigator. He will work with Mark Aronica, M.D., Steven Gordon, M.D., Lily Pien, M.D., and James Fernandez, M.D. as co-investigators. Overall, the study involves 35 academic research institutions across the nation.