Evaluation of the safety profile of rotavirus vaccines: a pharmacovigilance analysis on American and European data.
Administration, Oral
Adolescent
Adverse Drug Reaction Reporting Systems
Child
Child, Preschool
Databases, Factual
Diarrhea
/ chemically induced
Europe
/ epidemiology
Humans
Infant
Pharmacovigilance
Product Surveillance, Postmarketing
Rotavirus Vaccines
/ administration & dosage
United States
/ epidemiology
Vaccines, Attenuated
/ administration & dosage
Vomiting
/ chemically induced
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
12 08 2020
12 08 2020
Historique:
received:
14
01
2020
accepted:
08
06
2020
entrez:
14
8
2020
pubmed:
14
8
2020
medline:
12
1
2021
Statut:
epublish
Résumé
Rotaviruses (RVs) are the most common cause of severe diarrheal disease. To date two rotavirus oral vaccines are licensed: Rotarix and Rotateq. Our aim was to contribute to the post-marketing evaluation of these vaccines safety profile. We collected all RV vaccines-related reports of Adverse Events Following Immunization (AEFI) in US Vaccine Adverse Events Reporting System (VAERS) and VigiBase between January 2007 and December 2017. A disproportionality analysis using Reporting Odds Ratio (ROR) was performed. A total of 17,750 reports in VAERS and 6,358 in VigiBase were retrieved. In VAERS, 86.2% of the reports concerned RotaTeq, whereas in VigiBase 67.7% of them involved Rotarix. Across the databases, diarrhea (1,672 events in VAERS, 1,961 in VigiBase) and vomiting (1,746 in VAERS, 1,508 in VigiBase) were the most reported AEFIs. Noteworthy, the RV vaccines-intussusception pair showed a ROR greater than 20 in both databases. Some new potential safety signals emerged such as fontanelle bulging, hypotonic-hyporesponsive episode, livedo reticularis, and opisthotonus. Overall, our data show that most of the reported AEFIs are listed in the Summary of Product Characteristics (SPCs). However, there remains the need to investigate the potential safety signals arose from this analysis, in order to complete the description of the AEFIs.
Identifiants
pubmed: 32788620
doi: 10.1038/s41598-020-70653-3
pii: 10.1038/s41598-020-70653-3
pmc: PMC7423960
doi:
Substances chimiques
RIX4414 vaccine
0
RotaTeq
0
Rotavirus Vaccines
0
Vaccines, Attenuated
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
13601Références
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