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

ABSTRACT:

Background

Systemic allergic reactions (sARs) following coronavirus disease 2019 (COVID-19) mRNA vaccines were initially reported at a higher rate than after 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, participants aged 16 to 69 years who previously reported a convincing sAR to their first dose of COVID-19 mRNA vaccine were randomly assigned to receive a second dose of BNT162b2 (Comirnaty) vaccine and placebo on consecutive days in a blinded, 1:1 crossover fashion at the National Institutes of Health. An open-label BNT162b2 booster was offered 5 months later if the second dose did not result in s

SUBMITTER: Khalid MB 

PROVIDER: S-EPMC11162316 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature