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Rotavirus Update: RotaTeq Is Effective, and a Second Vaccine Has Been Approved

The 2007–2008 rotavirus activity was delayed in onset and diminished in magnitude, compared with previous seasons.

RotaTeq, the first licensed rotavirus vaccine, was recommended by the CDC for routine use in infants in February 2006. To examine the incidence of rotavirus during the subsequent winter and spring, the CDC used data from the National Respiratory and Enteric Virus Surveillance System (NREVSS) and the New Vaccine Surveillance Network (NVSN).

Based on NREVSS weekly reports of rotavirus tests (enzyme immunoassays), onset of rotavirus activity was 2 to 4 months earlier during prevaccine seasons (July 1991 through June 2006) than during the 2008 season (mid-November to late February). The percentage of positive rotavirus tests during prevaccine periods peaked by March (range, 30.6% to 45.5%). In 2008, the percentage of positive tests peaked in April at only 17.8%.

Based on prospective NVSN data for rotavirus gastroenteritis in children younger than 3 years from three U.S. counties, the percentage of submitted stools that tested positive for rotavirus from January 1 to April 30 declined from 51% in 2006 and 54% in 2007 to 6% in 2008.

A second rotavirus vaccine, Rotarix, was approved in early 2008 and should be available later this year. Practitioners might want to know the differences between the two vaccines: RotaTeq is a bovine recombinant vaccine that is licensed as a three-dose oral regimen; Rotarix contains an attenuated human strain and is licensed as a two-dose oral regimen. Both vaccines have been shown to be safe and efficacious in large clinical trials — RotaTeq against rotavirus gastroenteritis serotypes G1–4 and Rotarix against rotavirus gastroenteritis G1. New provisional recommendations from the Advisory Committee on Immunization Practices (ACIP) advise use of either vaccine for routine vaccination and do not state a preference. However, the ACIP recommends using the same product for the complete vaccine series, when possible. If both products must be used, three doses of rotavirus vaccine are required.

Comment: Kudos to the pediatric community for having a major effect on this vaccine-preventable disease. The Vaccine Adverse Event Reporting System has not found any increase in intussusception with RotaTeq, as some had feared. The combined safety and efficacy data should be reassuring to families concerned about the risk-benefit ratio. Let’s keep up the good work.

— Peggy Sue Weintrub, MD

Published in Journal Watch Pediatrics and Adolescent Medicine July 30, 2008

Citation(s):

Centers for Disease Control and Prevention (CDC). Delayed onset and diminished magnitude of rotavirus activity — United States, November 2007–May 2008. MMWR Morb Mortal Wkly Rep 2008 Jun 27; 57:697.

• Medline abstract (Free)

FDA approves new vaccine to prevent gastroenteritis caused by rotavirus [press release]. Rockville, MD : Food and Drug Administration; Apr 3 , 2008. (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01814.html)