ES-Welcome to the COVID Vaccine Allergy Study
The COVID Vaccine Allergy Study's goal is to:
- Assess the number of participants with allergic reactions to either the Pfizer BioNtech or the Moderna COVID-19 Vaccine in the High-Allergy/Mast Cell Disorder (HA/MCD) population.
The study doctors are trained to recognize and treat allergic reactions.
Participating in the Study
We are recruiting volunteers who have not yet been vaccinated to recieve the Pfizer BioNtech COVID-19 Vaccine. Participants will be divided into 2 groups (as show in the accompanied image).
These vaccines are administered in two doses. Participants randomized to the placebo groups will receive placebo (salt water) as a first dose and will receive two doses of their assigned vaccine at their next two visits.
You cannot choose your group. A computer will randomly pick which group you will be in. Three days following your second dose you will receive a follow-up call letting you know whether your first dose contained placebo or vaccine and you will schedule a third visit to recieve your second vaccine dose if you were in the placebo group. Only one in three participants will receive placebo. If you do receive placebo, you will receive your first dose of active vaccine one week later.
At the beginning of each visit, you will recieve a dose. You will stay at the clinic for 90 minutes after each dose to be observed for an allergic reaction. The study doctors are trained to recognize and treat allergic reactions. Even if you do not have allergies, you have to stay the whole 90 minutes.
Depending on which vaccine you receive and whether you get placebo first, your participation will last between 4 and 6 weeks.