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ACIP Issues Guidelines for Prevention of Rotavirus Gastroenteritis

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Laurie Barclay, MD

February 6, 2009 — The Advisory Committee on Immunization Practices (ACIP) has issued guidelines for the prevention of rotavirus gastroenteritis among infants and children, as well as maximum ages for doses, contraindications, precautions, and special situations regarding the administration of rotavirus vaccine. The new recommendations, which update and replace the 2006 ACIP statement for prevention of rotavirus gastroenteritis, are published in the February 6 issue of Morbidity and Mortality Weekly Report.

“Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide,” write Margaret M. Cortese, MD, and Umesh D. Parashar, MBBS, MPH, from the Division of Viral Diseases, National Center for Immunization and Respiratory Diseases. “Rotavirus causes approximately half a million deaths each year among children aged <5 years, with >80% of deaths occurring in developing countries…. Before initiation of the rotavirus vaccination program in 2006, nearly every child in the United States was infected with rotavirus by age 5 years; the majority had gastroenteritis, resulting annually during the 1990s and early 2000s in approximately 410,000 physician visits, 205,000–272,000 emergency department…visits, 55,000–70,000 hospitalizations, and total annual direct and indirect costs of approximately $1 billion.”

In their statement, the ACIP describes recommendations for use of 2 rotavirus vaccines in US infants, RV5 and RV1. In February 2006, the US Food and Drug Administration (FDA) licensed RotaTeq (RV5; Merck and Company), a live, oral, human-bovine reassortant rotavirus vaccine. For prevention of rotavirus gastroenteritis, ACIP recommends routine use among US infants of a 3-dose series of RV5.

In April 2008, the FDA licensed Rotarix (RV1; GlaxoSmithKline Biologicals), a live, oral, human attenuated rotavirus vaccine. After RV1 was licensed as a 2-dose series for use among US infants in April 2008, ACIP updated its rotavirus vaccine recommendations in June 2008 to include use of RV1.

The revised ACIP recommendations are for routine vaccination of US infants with rotavirus vaccine, noting that the composition and administration schedule are different for RV5 and RV1. However, ACIP does not express a preference for either RV5 or RV1.

Both RV5 and RV1 are administered orally. The administration schedule for RV5 is a 3-dose series, with doses given at ages 2, 4, and 6 months. The 2-dose series for RV1 calls for doses to be administered at ages 2 and 4 months.

Specific changes to recommendations from the 2006 ACIP statement are as follows:

  • Use of a second rotavirus vaccine, RV1, is acceptable. This is administered in a 2-dose series at ages 2 and 4 months.
  • The maximum age for dose 1 of rotavirus vaccine is now 14 weeks and 6 days, increased from the previous recommendation of 12 weeks.
  • The maximum age for the last dose of rotavirus vaccine is now to 8 months and 0 days, whereas the previous recommendation was 32 weeks.
  • Between doses of rotavirus vaccine, the minimum interval is now 4 weeks, and no maximum interval is set, whereas the previous recommendation was for a maximum interval of 410 weeks between doses.
  • The updated guidelines describe considerations that support rotavirus vaccination of HIV-exposed or HIV-infected infants.
  • Although the 2006 statement recommended deferring vaccination, if possible, for 42 days after receiving an antibody-containing product, the current statement allows for the administration of rotavirus vaccine at any time before, concurrent with, or after administration of any blood product, including antibody-containing products, following the routinely recommended schedule for rotavirus vaccine.

Specific recommendations for the routine use of rotavirus vaccine for US infants, and their accompanying level and strength-of-evidence rating, are as follows:

  • Routinely vaccinate with RV5 at ages 2, 4, and 6 months or with RV1 at ages 2 and 4 months (level of evidence, 1A).
  • Vaccine can be administered to breast-fed infants (level of evidence, 1A).
  • Vaccine can be coadministered with DTap, Hib vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, and pneumococcal conjugate vaccine (level of evidence, 1A).
  • Vaccine can be administered to infants with mild gastroenteritis or other mild illness (level of evidence, 1B).
  • Either vaccine is contraindicated for infants who have had a severe allergic reaction to a vaccine component or previous vaccine dose (level of evidence, 3B).
  • Precautions for use of the vaccine include altered immunocompetence; moderate to severe illness, including gastroenteritis; chronic gastrointestinal disease; history of intussusceptions; and infants with spina bifida or bladder extrophy (all level of evidence, 3C).
  • Special situations discussed in the report include preterm infants (younger than 37 weeks; level of evidence, 1B), infants living in households with immunocompromised persons or with pregnant women, regurgitation of vaccine, infants hospitalized after vaccination, and infants who have received antibody-containing blood products (all level of evidence, 3C).

“Additional studies would be valuable to evaluate the safety and efficacy of rotavirus vaccine administered to infants who are born preterm, have immune deficiencies, live in households with immunocompromised persons, have chronic gastrointestinal disease, or start the series late,” the statement authors conclude. “Postlicensure studies also could determine the relative effectiveness of rotavirus vaccine when less than the full series is administered and evaluate possible secondary transmission of vaccine virus.”

Morb Mortal Wkly Rep. 2009;58(RR02):1–25.

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Written by pkids

March 10, 2009 at 6:55 pm

Posted in Immunizations

Tagged with ,

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