Systemic allergic reactions to SARS-CoV-2 vaccinations

About this study

This study is a multi-center, randomized clinical trial to assess systemic allergic reactions to SARS-CoV-2 vaccinations in two populations:

  • The first population includes individuals with a history of recent, severe allergic reactions, poorly controlled allergic asthma, or mast cell disorders.
  • The second population is a comparison group that includes individuals without severe allergies or mast cell disorders.

The lead principal investigator of SARS-CoV-2 is Dr. Jane Buckner at the Benaroya Research Institute. CDSI is one of thirty subsites participating in this study, and Dr. Elizabeth Phillips is the site PI. 

Over 3,000 participants were enrolled nationwide to assess the risk of systemic allergic reaction to the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine. Approximately two-thirds of participants were female because most cases of severe allergic reactions or anaphylaxis to the COVID-19 vaccines have occurred in women.

Participants were blinded to whether they received a placebo or vaccine during their first visits, and knew their vaccine status by their second injection visits. Participants randomized to the placebo received a placebo as a first dose and then received two doses of their assigned active vaccine at subsequent visits. Follow-up occurred for up to 64 days to observe patients for reactions and collect study data.  


Follow up

CDSI was also one of a subset of sites invited to participate in a SARS-CoV-2 follow-up study. As part of this study, we are contacting participants to complete an optional follow-up visit approximately 12 to 24 months after their last dose of the study vaccine. The purpose of this supplemental visit is to collect an additional blood sample and updated medical history from each participant. This information is intended to evaluate the persistence and potential clinical significance of any elevation of anti-polyethylene glycol (PEG) antibody levels.   


Questions? 

Please email drugsafetyresearch@vumc.org for more information.