News Release 

New research reviews the state of vaccine safety science

Pediatric Academic Societies

BALTIMORE - A new systematic review provides a succinct summary of the scientific evidence for and/or against causal associations for 47 adverse events following immunization (AEFI). Findings from the study will be presented during the Pediatric Academic Societies (PAS) 2019 Meeting, taking place on April 24 - May 1 in Baltimore.

"Health care providers desire objective and clear information on a broad range of vaccine safety issues to assist them in answering patient questions," said Matthew Dudley, PhD, MSPH, one of the authors of the study. "There have been no recent comprehensive reviews on AEFI, and previous reviews were not written for providers or the public. This systematic review provides an update to the scientific evidence assessing possible causal associations of AEFI compiled in the 2012 report from the Institute of Medicine (IOM) and the 2014 report from the Agency for Healthcare Research and Quality (AHRQ), along with clear causality conclusions intended for health care providers."

The review found that for 12 of the 47 AEFI studied, a causal relationship has been established with at least one vaccine currently routinely recommended to the general population in the U.S. These 12 confirmed adverse reactions are: anaphylaxis, arthralgia/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. Most of these adverse reactions are rare.

For the other 35 AEFIs, the evidence does not support a causal relationship with vaccines recommended for routine use in the U.S. In particular, the evidence shows a clear lack of association between certain vaccines and AEFIs: influenza vaccines do not cause asthma, childhood vaccines do not cause autism, vaccines do not cause diabetes, vaccines given to immunocompetent persons do not cause hepatitis, influenza vaccines do not cause MS in adults, and DTP and hepatitis B vaccines do not cause Sudden Infant Death Syndrome (SIDS).

Dr. Dudley added, "Although vaccines currently recommended for the general population in the U.S. do cause some adverse reactions, vaccines have an excellent safety profile overall and provide protection against infectious diseases to individuals and the general population."

Dr. Dudley will present findings from "The State of Vaccine Safety Science: Systematic Reviews of the Evidence" on Monday, April 29 at 10:30 a.m. EDT. Reporters interested in an interview with Dr. Dudley should contact PAS2019@piercom.com. Please note that only the abstracts are being presented at the meeting. In some cases, the researchers may have additional data to share with media.

The PAS 2019 Meeting brings together thousands of pediatricians and other health care providers to improve the health and well-being of children worldwide. For more information about the PAS 2019 Meeting, please visit http://www.pas-meeting.org.

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About the Pediatric Academic Societies Meeting

The Pediatric Academic Societies (PAS) Meeting brings together thousands of pediatricians and other health care providers united by a common mission: to improve the health and well-being of children worldwide. This international gathering includes pediatric researchers, leaders in pediatric academics, clinical care providers and community practitioners. Presentations cover issues of interest to generalists as well as topics critical to a wide array of specialty and sub-specialty areas. The PAS Meeting will be the premier North American scholarly child health meeting. The PAS Meeting is produced through a partnership of four pediatric organizations that are leaders in the advancement of pediatric research and child advocacy: American Pediatric Society, Society for Pediatric Research, Academic Pediatric Association and American Academy of Pediatrics. For more information, please visit http://www.pas-meeting.org. Follow us on Twitter @PASMeeting and #PAS2019, and like us on Facebook.

Abstract: The State of Vaccine Safety Science: Systematic Reviews of the Evidence

Objective: This systematic review provides a succinct summary of the scientific evidence for and/or against causal associations for 47 AEFI.

Design/Methods: We reviewed 44 AEFI studied in the 2012 report from the Institute of Medicine (IOM) and the 2014 report from the Agency for Healthcare Research and Quality (AHRQ). We also reviewed 3 other AEFI and 2 special topics which have been raised as concerns among the media. We updated the evidence base from the IOM and AHRQ reports using systematic English-language PubMed literature reviews. We provide causality conclusions for each of these AEFIs, and the attributable risk (when possible) for AEFIs caused by vaccines.

Results: For 12 of the 47 AEFI studied, a causal relationship has been established with at least one vaccine currently routinely recommended to the general population in the United States. These 12 confirmed adverse reactions are: anaphylaxis, arthralgia/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. Most of these adverse reactions are rare. For the other 35 AEFIs, the evidence does not support a causal relationship with vaccines recommended for routine use in the U.S. In particular, the evidence shows a clear lack of association between certain vaccines and AEFIs: influenza vaccines do not cause asthma, childhood vaccines do not cause autism, vaccines do not cause diabetes, vaccines given to immunocompetent persons do not cause hepatitis, influenza vaccines do not cause MS in adults, and DTP and hepatitis B vaccines do not cause Sudden Infant Death Syndrome (SIDS).

Conclusion(s): Although vaccines currently recommended for the general population in the U.S. do cause some adverse reactions, vaccines have an excellent safety profile overall and provide protection against infectious diseases to individuals and the general population.

Authors (Last Name, First Name): Dudley, Matthew; Halsey, Neal; Omer, Saad; Orenstein, Walter A.; O'Leary, Sean T.; Limaye, Rupali; Salmon, Daniel

Authors/Institutions: M. Dudley, N. Halsey, R. Limaye, D. Salmon, International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, UNITED STATES|S. Omer, W.A. Orenstein, Emory University, Atlanta, Georgia, UNITED STATES|S.T. O'Leary, Pediatrics, University of Colorado Anshutz Medical Campus, Aurora, Colorado, UNITED STATES

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