Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013

Autor: Paige Lewis, Elaine R. Miller, Tom T. Shimabukuro, Pedro L. Moro, Maria Cano, Marthe Bryant-Genevier
Rok vydání: 2015
Předmět:
Post licensure
Adult
Male
Pediatrics
medicine.medical_specialty
Adolescent
MEDLINE
Article
Pneumococcal Vaccines
03 medical and health sciences
Adverse Event Reporting System
Young Adult
0302 clinical medicine
Pregnancy
030225 pediatrics
medicine
Product Surveillance
Postmarketing
Adverse Drug Reaction Reporting Systems
Data Mining
Humans
030212 general & internal medicine
Young adult
Adverse effect
Child
Aged
Safety surveillance
General Veterinary
General Immunology and Microbiology
business.industry
United States Food and Drug Administration
Public Health
Environmental and Occupational Health
Infant
Newborn
Infant
Bayes Theorem
Middle Aged
Pneumococcal polysaccharide vaccine
United States
Clinical trial
Infectious Diseases
Child
Preschool
Immunology
Molecular Medicine
Female
Centers for Disease Control and Prevention
U.S
business
Licensure
Zdroj: Vaccine. 34(25)
ISSN: 1873-2518
Popis: Background 23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax ® 23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. Objective To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. Methods We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. Results During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. Conclusions We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies.
Databáze: OpenAIRE
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