Muhammad B Khalid, Ellen Zektser, Eric Chu, Min Li, Joanna Utoh, Patrick Ryan, Hanna S Loving, Roa Harb, Robbie Kattappuram, Lindsay Chatman, Stella Hartono, Estefania Claudio-Etienne, Guangping Sun, Edward P Feener, Zhongbo Li, Samuel K Lai, Quang Le, Lawrence B Schwartz, Jonathan J Lyons, Hirsh Komarow, Zhao-Hua Zhou, Haniya Raza, Maryland Pao, Karen Laky, Steven M Holland, Erica Brittain, Pamela A Frischmeyer-Guerrerio
BACKGROUND: Systemic allergic reactions (sARs) following coronavirus disease-2019 (COVID-19) mRNA vaccines were initially reported at a higher rate than traditional vaccines. OBJECTIVE: We aimed to evaluate the safety of revaccination in these individuals and to interrogate mechanisms underlying these reactions. METHODS: 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)...
March 7, 2024: Journal of Allergy and Clinical Immunology