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| ISV Paper of the Month |
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July 2011 |
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Intussusception risk and health benefits of rotavirus
vaccination in Mexico and Brazil |
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Patel MM, López-Collada VR, Bulhões MM, De Oliveira LH,
Bautista Márquez A, Flannery B, Esparza-Aguilar M, Montenegro Renoiner EI, Luna-Cruz
ME, Sato HK, Hernández-Hernández Ldel C, Toledo-Cortina G, Cerón-Rodríguez M, Osnaya-Romero
N, Martínez-Alcazar M, Aguinaga-Villasenor RG, Plascencia-Hernández A, Fojaco-González
F, Hernández-Peredo Rezk G, Gutierrez-Ramírez SF, Dorame-Castillo R, Tinajero-Pizano
R, Mercado-Villegas B, Barbosa MR, Maluf EM, Ferreira LB, de Carvalho FM, dos Santos
AR, Cesar ED, de Oliveira ME, Silva CL, de Los Angeles Cortes M, Ruiz Matus C, Tate
J, Gargiullo P, Parashar UD |
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N Engl J Med. 2011 Jun 16;364(24):2283-92 |
BACKGROUND:
Because postlicensure surveillance determined that a previous rotavirus vaccine,
RotaShield, caused intussusception in 1 of every 10,000 recipients, we assessed
the association of the new monovalent rotavirus vaccine (RV1) with intussusception
after routine immunization of infants in Mexico and Brazil.
METHODS:
We used case-series and case-control methods to assess the association between RV1
and intussusception. Infants with intussusception were identified through active
surveillance at 69 hospitals (16 in Mexico and 53 in Brazil), and age-matched infants
from the same neighborhood were enrolled as controls. Vaccination dates were verified
by a review of vaccination cards or clinic records.
RESULTS:
We enrolled 615 case patients (285 in Mexico and 330 in Brazil) and 2050 controls.
An increased risk of intussusception 1 to 7 days after the first dose of RV1 was
identified among infants in Mexico with the use of both the case-series method (incidence
ratio, 5.3; 95% confidence interval [CI], 3.0 to 9.3) and the case-control method
(odds ratio, 5.8; 95% CI, 2.6 to 13.0). No significant risk was found after the
first dose among infants in Brazil, but an increased risk, albeit smaller than that
seen after the first dose in Mexico--an increase by a factor of 1.9 to 2.6 - was
seen 1 to 7 days after the second dose. A combined annual excess of 96 cases of
intussusception in Mexico (approximately 1 per 51,000 infants) and in Brazil (approximately
1 per 68,000 infants) and of 5 deaths due to intussusception was attributable to
RV1. However, RV1 prevented approximately 80,000 hospitalizations and 1300 deaths
from diarrhea each year in these two countries.
CONCLUSIONS:
RV1 was associated with a short-term risk of intussusception in approximately 1
of every 51,000 to 68,000 vaccinated infants. The absolute number of deaths and
hospitalizations averted because of vaccination far exceeded the number of intussusception
cases that may have been associated with vaccination. |
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