This study will evaluate the safety of administering an additional dose of an mRNACOVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have hadadverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19vaccine to individuals with a personal history of allergic reaction. In addition, thisstudy will evaluate the safety of administering an initial or additional dose or bivalentbooster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to anatural COVID-19 infection ("long COVID").Eligible participants enrolled in this trial will receive an initial or additional doseof either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalentvaccine. Participants will also be required to have 1-2 in person visits along with phonecall follow up visits.We hypothesize that individuals who have had adverse reactions to a previous dose of anmRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine orbivalent booster, as indicated, and those with a personal history of allergic reactionwill tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that thoseindividuals experiencing an adverse reaction will tolerate an initial or additional doseof a primary mRNA COVID-19 bivalent vaccine, as indicated.The study hypothesizes that individuals that have had adverse reactions to a dose of anmRNA COVID-19 vaccine will tolerate an additional dose and those with a personal historyof allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
Not Provided
Biological: Pfizer-BioNTech mRNA COVID-19 vaccine
Participants will receive an initial or additional dose of a highly protective COVID-19
mRNA vaccine for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus
in an environment where the investigators and staff are experienced in the care of
patients with allergic reactions.
Other Name: Comirnaty
Inclusion Criteria
1. Age over 18.
2. Participant must be able to understand and provide informed consent
3. No evidence of infectious illness (defined as fever >38⁰C, vomiting, diarrhea, new
cough, new shortness of breath, new congestion, new runny nose, new headache or sore
throat) within 14 days of vaccine administration.
4. Subjects must have a history of adverse reaction to either the Pfizer-BioNTech mRNA
COVID vaccination or the Moderna mRNA COVID vaccination, a personal history of
allergic reaction without prior mRNA COVID vaccination, or a history of adverse
reaction to natural COVID infection.
5. Females of childbearing potential must have a negative pregnancy test prior to
vaccination.
Exclusion Criteria
1. Under age 18
2. Inability or unwillingness of a participant to give written informed consent
3. Evidence of COVID-19 infection within 21 days of vaccination visit
4. History of antibody agent or convalescent plasma for treatment or prevention of
COVID-19 within 90 days
5. Individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to
any component of the Pfizer-BioNTech mRNA COVID-19 vaccination or the Moderna mRNA
COVID-19 vaccination.
6. History of underlying immune disorder.
- Pregnancy
- Immunocompromised
- Persons with primary or acquired immunodeficiency
- Persons on anti-rejection therapy following solid organ transplant or bone
marrow transplant
- Persons on biologic therapeutic agents
- Persons with malignancy and ongoing or recent chemotherapy
- Persons receiving systemic immunosuppressive therapy, including
corticosteroids equivalent to 20 mg/day of prednisone for 2 weeks
- Persons with chronic kidney disease stage 3 or higher
- Persons with history of significant pulmonary compromise
University of Michigan
Ann Arbor, Michigan, United States
Investigator: Sara Jaafar
Contact: 734-998-6270
jaafarsa@med.umich.edu
Investigator: James Baker, MD
Sara Jaafar
734-998-6270
allergycovidstudy@med.umich.edu
James Baker, MD
734-647-2777
jbakerjr@med.umich.edu
James Baker, MD, Principal Investigator
University of Michigan