"A randomized double-blinded trial to assess recurrence of systemic allergic reactions following COVID-19 mRNA vaccination".

Journal: The Journal of allergy and clinical immunology

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Affiliated Institutions:  Food Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD. Office of the Clinical Director, National Institute of Mental Health, National Institutes of Health, Bethesda, MD. Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD. Investigational Drug Management and Research Section, Clinical Center, National Institutes of Health, Bethesda, MD. KalVista Pharmaceuticals, Cambridge, MA. Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina Chapel Hill, Chapel Hill, NC. Department of Internal Medicine, Division of Rheumatology, Allergy, and Immunology, Virginia Commonwealth University, Richmond, VA. Translational Allergic Immunopathology Unit, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD. Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Food Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Electronic address: pamela.guerrerio@nih.gov.

Abstract summary 

Systemic allergic reactions (sARs) following coronavirus disease-2019 (COVID-19) mRNA vaccines were initially reported at a higher rate than traditional vaccines.We aimed to evaluate the safety of revaccination in these individuals and to interrogate mechanisms underlying these reactions.In this randomized, double-blinded, phase 2 trial, individuals 16-69 years who previously reported a convincing sAR to their first dose of COVID-19 mRNA vaccine were randomly assigned to receive second dose of BNT162b2 (Pfizer-BioNTech; Comirnaty®) vaccine and placebo on consecutive days in a blinded, 1:1 cross-over fashion at the National Institutes of Health (NIH). Five months later, an open-label BNT162b2 booster was offered if the second dose did not result in severe sAR. None of the participants received the mRNA-1273 (Moderna; Spikevax®) vaccine during the study. The primary endpoint was recurrence of sAR following second dose and booster vaccination; exploratory endpoints included biomarker measurements.Of 111 screened individuals, 18 were randomized to receive study interventions. Eight received BNT162b2 second dose followed by placebo; eight received placebo followed by BNT162b2 second dose; two withdrew before receiving any study intervention. All 16 received the booster dose. Following second dose and booster vaccination, sARs recurred in two subjects (12.5%, 95% CI 1.6-38.3). No sAR occurred after placebo. An anaphylaxis mimic, immunization stress-related response (ISRR), occurred more commonly than sARs following both vaccine and placebo and was associated with higher pre-dose anxiety scores, paresthesias, and distinct vital sign and biomarker changes.Our findings support revaccination of individuals who report sARs to COVID-19 mRNA vaccines. Distinct clinical and laboratory features may distinguish sARs from ISRRs.

Authors & Co-authors:  Khalid Zektser Chu Li Utoh Ryan Loving Harb Kattappuram Chatman Hartono Claudio-Etienne Sun Feener Li Lai Le Schwartz Lyons Komarow Zhou Raza Pao Laky Holland Brittain Frischmeyer-Guerrerio

Study Outcome 

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Statistics
Citations : 
Authors :  27
Identifiers
Doi : S0091-6749(24)00236-7
SSN : 1097-6825
Study Population
Male,Female
Mesh Terms
Other Terms
Allergic reaction;Anaphylaxis;COVID-19;ISRR;Immunization Stress-Related Response;PEG;Vaccine;mRNA
Study Design
Study Approach
Country of Study
Publication Country
United States