Evidence map›Paper›PMID 33388478›Full record

ReviewThe journal of allergy and clinical immunology. In practice2021

mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach.

Aleena Banerji, Paige G Wickner, Rebecca Saff, Cosby A Stone, Lacey B Robinson, Aidan A Long, Anna R Wolfson, Paul Williams, David A Khan, Elizabeth Phillips and 1 more

RetractedOpen access · bronzeAbstract readReview
In one paragraph

Review in The journal of allergy and clinical immunology. In practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. Cited by 258 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
258citing papers in PubMed, 5 pooled it
10.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

258 citing papers in PubMed, 5 syntheses or guidelines pooled it, 459 citations in OpenAlex.

  1. Pooled it
  2. Acute disseminated encephalomyelitis (ADEM) following COVID-19 vaccination: A systematic review.Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia · 2023
    Pooled it
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  13. Emerging dendrimer-based RNA delivery strategies.Nanomedicine (London, England) · 2025
    Review
  14. Article
  15. Reshaping the Treatment Landscape of a Galactose Metabolism Disorder.Journal of inherited metabolic disease · 2025
    Review
  16. Article
  17. Article
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  20. Article

198 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Aleena BanerjiDivision of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass. Electronic address: abanerji@mgh.harvard.edu.
Paige G WicknerHarvard Medical School, Boston, Mass; Division of Allergy and Immunology, Department of Medicine, Brigham and Women's Hospital, Boston, Mass.
Rebecca SaffDivision of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.
Cosby A StoneDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.
Lacey B RobinsonDivision of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.
Aidan A LongDivision of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.
Anna R WolfsonDivision of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.
Paul WilliamsAllergy Division, University of Washington School of Medicine, Seattle, Wash.
David A KhanDivision of Allergy & Immunology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.
Elizabeth PhillipsDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.
Kimberly G BlumenthalDivision of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass; Edward P. Lawrence Center for Quality and Safety, Massachusetts General Hospital, Boston, Mass.
Massachusetts General Hospital · USHarvard University · USVanderbilt University Medical Center · USThe University of Texas Southwestern Medical Center · USUniversity of Washington · US

Funding

NATIENS: A Phase III Randomized Double Blinded Study to Determine the Mechanisms and Optimal Management of Stevens-Johnson Syndrome and Toxic Epidermal NecrolysisU01AI154659 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2020 to 2025
$15.5M
Understanding and preventing HLA-associated drug reactionsP50GM115305 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DENNY, JOSHUA C. · 2015 to 2019
$13.0M
Genetic risk and long-term outcomes associated with Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in survivorsR01HG010863 · NHGRI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2019 to 2022
$3.1M
Immune-mediated adverse drug reactions to HIV and TB treatments in South Africa: predict, prevent and improve long-term outcomes (IMARI SA study)R01AI152183 · NIAID · UNIVERSITY OF CAPE TOWN · PI MEINTJES, GRAEME AYTON, PHILLIPS, ELIZABETH · 2020 to 2025
$1.6M
Single Cell definition of pathogenic T cells in Drug-induced Stevens-Johnson-Syndrome/Toxic epidermal necrolysisR21AI139021 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2018 to 2019
$435k
NHGRI NIH HHS R01 HG010863NIAID NIH HHS R01 AI152183NIAID NIH HHS R21 AI139021NIAID NIH HHS U01 AI154659NIGMS NIH HHS P50 GM115305
6 · The paper itself

Abstract

The U.S. Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for 2 highly effective coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech and Moderna. This has brought hope to millions of Americans in the midst of an ongoing global pandemic. The FDA EUA guidance for both vaccines is to not administer the vaccine to individuals with a known history of a severe allergic reaction (eg, anaphylaxis) to any component of the COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) additionally advises individuals with a history of an immediate allergic reaction to a vaccine or injectable or any history of anaphylaxis be observed for 30 minutes after COVID-19 vaccination. All other individuals should be observed for 15 minutes after COVID-19 vaccination. Staff at vaccine clinics must be able to identify and manage anaphylaxis. Post-FDA EUA, despite very strong safety signals in both phase 3 trials, reports of possible allergic reactions have raised public concern. To provide reassurance and support during widespread global vaccination, allergists must offer clear guidance to individuals based on the best information available, but also in accordance with the broader recommendations of regulatory agencies. This review summarizes vaccine allergy epidemiology and proposes drug and vaccine allergy expert opinion informed risk stratification for Allergy specialist use in conjunction with guidance of public health and regulatory authorities. The risk stratification schema guide care for (1) individuals with different allergy histories to safely receive their first mRNA COVID-19 vaccine and (2) individuals who develop a reaction to their first dose of mRNA COVID-19 vaccine.

Indexed as

AnaphylaxisClinical Trials, Phase III as TopicCOVID-19COVID-19 VaccinesHumansmRNA VaccinesUnited StatesUnited States Food and Drug AdministrationVaccines, SyntheticCOVID-19 VaccinesmRNA VaccinesVaccines, SyntheticAllergic reactionsAllergyAnaphylaxisCOVID-19GuidelinesmRNAPolyethylene glycolPolysorbateRisk stratificationVaccine

Identifiers

PMID33388478
PMCPMC7948517
OpenAlexW3114586947

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.