Safety profile of rotavirus vaccines among individuals agedâ¯≥8â¯months of age, United States, vaccine adverse event reporting system (VAERS), 2006-2019.
Vaccine
; 39(4): 746-750, 2021 01 22.
Article
em En
| MEDLINE
| ID: mdl-33267969
ABSTRACT
INTRODUCTION:
In 2006 and 2008, two live, oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), were introduced into the routine immunization program in the United States. A previous rotavirus vaccine, RotaShield, was associated with an increased risk of intussusception, with data suggesting an age-dependent variation in risk. Advisory Committee on Immunization Practices (ACIP) currently recommends that RV5 or RV1 immunization be initiated by age 14â¯weeks and 6â¯days and completed by 8â¯months 0â¯days.METHODS:
We searched for U.S. VAERS reports of RV5, RV1, or unknown rotavirus vaccine brand among individuals agedâ¯≥8â¯months. We analyzed reports by 2 age groups (individuals agedâ¯≥8â¯months-≤5 years andâ¯≥6â¯years), vaccine brand name, adverse event (AE) reported, classification of seriousness (death, non-death serious, and non-serious) and mode of exposure (direct vs. indirect exposure). For serious reports we reviewed available medical records and assigned a primary diagnosis.RESULTS:
VAERS received a total of 344 U.S. reports following rotavirus vaccination among individualsâ¯≥8â¯months of age, 32 (9.3%) were serious. In the younger age-group, 307 (99%) of 309 reports followed direct vaccination of the child. In contrast, in individuals agedâ¯≥6â¯years, 21 (60%) of 35 reports were via potential indirect exposure to a vaccinated child. The frequently reported AEs in the younger age-group were inappropriate schedule of drug administration 104 (34%) and drug administered to patient of inappropriate age 45 (15%); in the older group these were accidental exposure 9 (26%) and eye irritation 7 (20%). No difference in the safety profile was observed between RV1 and RV5.CONCLUSIONS:
We did not identify any unexpected AEs for RV vaccines among individuals agedâ¯≥8â¯months. Health care providers should adhere to the ACIP recommended schedule and older individuals should apply necessary precautions to prevent potential secondary exposure from vaccinated children.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Infecções por Rotavirus
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Vacinas contra Rotavirus
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Intussuscepção
Limite:
Adolescent
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Adult
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Aged
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Child
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Humans
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Infant
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Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article