Published online December 31, 2007
PEDIATRICS Vol. 121 No. 1 January 2008, pp. 223 (doi:10.1542/peds.2007-1896)

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LETTER TO THE EDITOR

Efficacy of the Pentavalent Rotavirus Vaccine in Subjects After 1 or 2 Doses in the Rotavirus Efficacy and Safety Trial

David Bernstein, MD
Division of Infectious Diseases
Cincinnati Children's Hospital Medical Center
University of Cincinnati
Cincinnati, OH 45229

To the Editor.—

The purpose of this letter is to point out data discrepancies between an American Academy of Pediatrics (AAP) guideline and an Infectious Diseases Society of America (IDSA) abstract and to request clarification/explanation.

In the January 2007 issue of Pediatrics, the policy statement "Prevention of Rotavirus Disease: Guidelines for Use of Rotavirus Vaccine"¹ was published by the AAP Committee on Infectious Diseases. The committee reported the efficacy of the licensed pentavalent rotavirus vaccine at reducing the number of emergency department visits and hospitalizations for rotavirus gastroenteritis in children receiving fewer than 3 doses of vaccine. The AAP referenced an abstract that was published by the IDSA at its 2006 meeting.² The post–dose-1 efficacy estimates in the abstract are quite different from those quoted in the AAP guideline. The 29% efficacy shown in the IDSA abstract was also stated in a review article that was recently submitted by one of the authors of the IDSA abstract. The 2 data sets are summarized in Table 1.

View this table: [in this window] [in a new window]   TABLE 1 Efficacy Against Hospitalizations and Emergency Department Visit After 1, 2, and 3 Doses of RotaTeq

 
Data from Merck & Co's Rotavirus Efficacy and Safety Trial (REST) were used for both of these posthoc analyses, although the RotaTeq prescribing information states: "The clinical studies were not designed to assess the level of protection provided by only one or two doses of RotaTeq."³

Because the efficacy reported in the policy statement may lead physicians to believe that only 1 dose of the pentavalent vaccine is necessary to provide significant protection against severe rotavirus disease, we request that the data and methodology used to generate the data in the AAP policy statement be made available for peer review.

REFERENCES

1. American Academy of Pediatrics, Committee on Infectious Diseases. Prevention of rotavirus disease: guidelines for use of rotavirus vaccine. Pediatrics. 2007;119 :171 –182[Abstract/Free Full Text]
2. Vesikari T, Matson D, Dennehy P, et al. Efficacy of the pentavalent rotavirus vaccine in subjects after 1 or 2 doses in the Rotavirus Efficacy & Safety Trial (REST) [abstract]. Presented at: the 44th annual meeting of the Infectious Disease Society of America; October 12–15, 2006; Toronto, Ontario, Canada
3. Merck & Co. RotaTeq prescribing information. Available at: www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf. Accessed November 7, 2007

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PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics

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This Article Extract Full Text (PDF) Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Request Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Web of Science (2) Citing Articles via Google Scholar Google Scholar Articles by Bernstein, D. Search for Related Content PubMed PubMed Citation Articles by Bernstein, D. Related Collections Infectious Disease & Immunity Social Bookmarking                         What's this?