The state of vaccine safety science: systematic reviews of the evidence

Matthew Z Dudley; Neal A Halsey; Saad B Omer; Walter A Orenstein; Sean T O'Leary; Rupali J Limaye; Daniel A Salmon

doi:10.1016/S1473-3099(20)30130-4

The state of vaccine safety science: systematic reviews of the evidence

Lancet Infect Dis. 2020 May;20(5):e80-e89. doi: 10.1016/S1473-3099(20)30130-4. Epub 2020 Apr 9.

Authors

Matthew Z Dudley¹, Neal A Halsey², Saad B Omer³, Walter A Orenstein⁴, Sean T O'Leary⁵, Rupali J Limaye⁶, Daniel A Salmon⁷

Affiliations

¹ Department of International Health, Johns Hopkins University, Baltimore, MD, USA; Institute of Vaccine Safety, Johns Hopkins University, Baltimore, MD, USA.
² Department of International Health, Johns Hopkins University, Baltimore, MD, USA; Institute of Vaccine Safety, Johns Hopkins University, Baltimore, MD, USA; Department of Pediatrics, Johns Hopkins University School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
³ Epidemiology of Microbial Diseases, Yale School of Public Health, Yale School for Global Health, and Yale School of Medicine, New Haven, CT, USA.
⁴ Department of Pediatrics and Emory Vaccine Center, School of Medicine, Emory University, Atlanta, GA, USA.
⁵ Adult and Child Consortium for Health Outcomes Research and Delivery Science and Department of Pediatrics, Anschutz Medical Campus and Children's Hospital, University of Colorado, Aurora, CO, USA.
⁶ Department of International Health, Johns Hopkins University, Baltimore, MD, USA; Institute of Vaccine Safety, Johns Hopkins University, Baltimore, MD, USA; Department of Health, Behavior & Society, Johns Hopkins University, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA; International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
⁷ Department of International Health, Johns Hopkins University, Baltimore, MD, USA; Institute of Vaccine Safety, Johns Hopkins University, Baltimore, MD, USA; Department of Health, Behavior & Society, Johns Hopkins University, Baltimore, MD, USA. Electronic address: dsalmon1@jhu.edu.

PMID: 32278359
DOI: 10.1016/S1473-3099(20)30130-4

Abstract

This Review updates the scientific evidence assessing possible causal associations of adverse events following immunisation (AEFI) compiled in the 2012 report from the Institute of Medicine and the 2014 report from the Agency for Healthcare Research and Quality. For 12 of 46 AEFI examined, a causal relationship has been established with at least one vaccine currently routinely recommended to the general USA population: anaphylaxis, arthralgia or arthritis (mild, acute, and transient, not chronic), deltoid bursitis (when vaccine is administered improperly), disseminated varicella infection (in immune deficient individuals for whom the varicella vaccine is contraindicated), encephalitis, febrile seizures, Guillain-Barré syndrome, hepatitis (in immune deficient individuals for whom the varicella vaccine is contraindicated), herpes zoster, immune thrombocytopenic purpura, meningitis, and syncope. Other than mild acute and transient arthralgia or arthritis, which is very common in adult women after rubella vaccine, these adverse reactions are rare or very rare. Vaccines have an excellent safety profile overall and provide protection against infectious diseases to individuals and the general population.

Publication types

Research Support, N.I.H., Extramural
Systematic Review

MeSH terms

Communicable Diseases / immunology
Humans
Safety
Vaccination / adverse effects*
Vaccines / adverse effects*
Vaccines / immunology

Substances

Vaccines

Grants and funding

R01 AI110482/AI/NIAID NIH HHS/United States