Michigan Medicine Prof. of Biologic Nanotechnology investigates Adverse Reactions Associated with COVID-19 mRNA Vaccines

The founding Director of the Mary H. Weiser Food Allergy Center, and Ruth Dow Doan Professor at Michigan Medicine not to mention an exceptional allergy and clinical immunology specialist, Dr. James Baker Jr., spearheads a 200-patient interventional study titled &ldquo;Assessing Safety of COVID-19 mRNA Vaccine Administration in the Setting of a Previous Adverse Reaction.&rdquo; Launched in the spring, this single-group assignment open-label study runs till December 2024. In the study, the participant receives a dose of Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax), both mRNA COVID-19 vaccines. The goal? Determine primary and secondary endpoints associated with safety of the mRNA-based vaccines. Specifically, the study team hypothesizes that the individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
While the U.S. Food and Drug Administration (FDA) has deemed the mRNA COVID-19 vaccines safe and effective, various side effects and adverse events have been identified, including in the regulatory package insert. For example, a cardiovascular signal has been identified in the form of myocarditis and pericarditis in young persons.