PEDIATRICS Vol. 122 No. 5 November 2008, pp. 1154 (doi:10.1542/peds.2008-2516)
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LETTER TO THE EDITOR |
Importance of On-time RotaTeq Vaccination and Long-term Active Surveillance: In Reply
Penina Haber, MPHImmunization Safety Office
Office of the Chief Science Officer
Manish Patel, MD
National Center for Immunizations and Respiratory Diseases
John Iskander, MD, MPH
Immunization Safety Office
Office of the Chief Science Officer
Paul Gargiullo, PhD
James Baggs, PhD
Immunization Safety Office
Office of the Chief Science Officer
Umesh Parashar, MBBS, MPH
National Center for Immunizations and Respiratory Diseases,
Centers for Disease Control and Prevention,
Atlanta, GA 30333
We agree in principle with both the points made by Dr Anderson. However, the comment that "much of the risk of intussusception occurred in patients receiving RotaShield late (eg, first dose at 4 or 6 months)" warrants further clarification. The absolute number of intussusception events after RotaShield was greater among older infants, primarily because of an increase in the background rate of intussusception in older infants compared with those <12 weeks of age.1–3 However, the relative risk of intussusception within 3 to 7 days of receiving the first dose of RotaShield was significantly elevated for all age groups for whom sufficient data were available,1 with odds ratios of 30.0 (95% confidence interval [CI]: 3.2–283), 30.7 (95% CI: 6.7–140), and 55.2 (95% CI: 6.5–466) for children vaccinated with the first dose at 49 to 89, 90 to 149, and 150 to 364 days of age, respectively.4 Indeed, the World Health Organization Global Advisory Committee on Vaccine Safety (GACVS) concluded that risk for RotaShield-associated intussusception was high in infants vaccinated after age 60 days and that insufficient evidence was available to conclude that the use of RotaShield at age <60 days was associated with a lower risk.5 The GACVS noted, however, that the possibility of an age-dependent risk for intussusception should be taken into account in assessing future rotavirus vaccines.
As noted by Dr Anderson, data from the United States demonstrate a high compliance with recommendations to administer the first dose of RotaTeq between 6 and 12 weeks of age. In the Vaccine Adverse Event Reporting System, the 3 reported infants with intussusception who received their first dose of RotaTeq beyond 90 days of age were also vaccinated within 2 to 6 weeks (97, 103, and 129 days) of the upper limit of the recommended age window for vaccination. Thus, although information on the safety of administering the first dose of RotaTeq beyond 12 weeks age is of interest, it would potentially take several years to gather robust evidence. Policy decisions in the near future may well have to rely largely on safety data from the recommended age group for vaccination.
For the reasons outlined by Dr Anderson, it is important to monitor the long-term effects of rotavirus vaccination on the incidence of intussusception. With RotaShield vaccine, after the initial increase in the risk of intussusception in the first 3 weeks after receiving the first dose of vaccine, a significant decrease in the relative odds of intussusception was noted in the more distant weeks after vaccine administration.6 In addition, ecologic studies did not find an increase in the overall incidence of intussusception among infants <1 year of age during the period of RotaShield use.3,7 Furthermore, natural rotavirus infection has also been inconsistently linked with other conditions (eg, seizures, Kawasaki disease), and long-term monitoring for these conditions after vaccination may also shed light on these potential etiologic associations.8
REFERENCES
1. Rothman KJ, Young-Xu Y, Arellano F. Age dependence of the relation between reassortant rotavirus vaccine (RotaShield) and intussusception. J Infect Dis. 2006;193 (6):898; author reply 898–899[Web of Science][Medline]
2. Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine.
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3. Simonsen L, Viboud C, Elixhauser A, Taylor RJ, Kapikian AZ. More on RotaShield and intussusception: the role of age at the time of vaccination. J Infect Dis. 2005;192 (suppl 1):S36 –S43[CrossRef][Web of Science][Medline]
4. Gargiullo PM, Murphy TV, Davis RL. Is there a safe age for vaccinating infants with tetravalent rhesus-human reassortant rotavirus vaccine? J Infect Dis. 2006;194 (12):1793 –1794; author reply 1794–1795[CrossRef][Web of Science][Medline]
5. Global Advisory Committee on Vaccine Safety. 1–2 December 2005. Wkly Epidemiol Rec. 2006;81 (2):15 –19[Medline]
6. Murphy TV, Gargiullo PM, Wharton M. More on rotavirus vaccination and intussusception.
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7. Chang HG, Smith PF, Ackelsberg J, Morse DL, Glass RI. Intussusception, rotavirus diarrhea, and rotavirus vaccine use among children in New York state.
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8. Lynch M, Lee B, Azimi P, et al. Rotavirus and central nervous system symptoms: cause or contaminant? Case reports and review. Clin Infect Dis. 2001;33 (7):932 –938[CrossRef][Web of Science][Medline]
PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics
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