University of Oklahoma Health Sciences Center

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Author/s:

Castells, Mariana C., Phillips, Elizabeth J.

Date Added:

January 14, 2021

Journal/Publication:

The New England Journal of Medicine

Publication Date:

December 30, 2020

URL:

Maintaining Safety with SARS-CoV-2 Vaccines

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1056/NEJMra2035343

PMID (1):

33378605

Keywords

SARS-CoV-2

SARS coronavirus

COVID-19

COVID-19 vaccine

vaccines

mRNA vaccines

Pfizer–BioNTech mRNA vaccine

MeSH

Adverse Drug Reaction Reporting Systems

COVID-19

RPR Commentary

Experience with and recommendations for management of adverse reactions to the SARS-2 (COVID-19) mRNA vaccines. James W. Mold, MD, MPH

Abstract

To date, the development of mRNA vaccines for the prevention of infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a success story, with no serious concerns identified in the ongoing phase 3 clinical trials.1 Minor local side effects such as pain, redness, and swelling have been observed more frequently with the vaccines than with placebo. Systemic symptoms such as fever, fatigue, headache, and muscle and joint pain have also been somewhat more common with the vaccines than with placebo, and most have occurred during the first 24 to 48 hours after vaccination.1 In the phase 1–3 clinical trials of the Pfizer–BioNTech and Moderna mRNA vaccines, potential participants with a history of an allergic reaction to any component of the vaccine were excluded. The Pfizer–BioNTech studies also excluded participants with a history of severe allergy associated with any vaccine (see the protocols of the two trials, available with the full text of the articles at NEJM.org, for full exclusion criteria).1,2 Hypersensitivity adverse events were equally represented in the placebo (normal saline) and vaccine groups in both trials.1

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