New Guidelines for Pediatric Use of Rotavirus Vaccine
CME/CE
News Author: Laurie Barclay, MD
CME Author: Penny Murata, MD September 5, 2006 — The Advisory Committee on Immunization Practices (ACIP) has issued recommendations for treating and preventing rotavirus gastroenteritis in children and infants using rotavirus vaccine. The new guidelines are published in the August 11 issue of the Morbidity and Mortality Weekly Report.
"Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide," write Umesh D. Parashar, MBBS, and colleagues from the National Center for Immunization and Respiratory Diseases. "Rotavirus gastroenteritis results in relatively few childhood deaths in the United States (approximately 20 - 60 deaths per year among children aged < 5 years). However, nearly every child in the United States is infected with rotavirus by age 5 years, and the majority will have gastroenteritis, resulting in approximately 410,000 physician visits, 205,000 - 272,000 emergency department (ED) visits, and 55,000 - 70,000 hospitalizations each year and direct and indirect costs of approximately $1 billion."
In February 2006, a live, oral, human-bovine reassortant rotavirus vaccine (RotaTeq, Merck & Co) was licensed by the US Food and Drug Administration (FDA) for use among US infants. The ACIP recommends routine vaccination of US infants with 3 doses of this rotavirus vaccine given by mouth at ages 2, 4, and 6 months. The first dose should be administered between ages 6 to 12 weeks; the following 2 doses should be administered at 4- to 10-week intervals; and all 3 doses should be given by age 32 weeks.
Rotavirus vaccine can be given together with other childhood vaccines. The rotavirus vaccine is contraindicated for infants with a serious allergic reaction to any vaccine component or to a previous vaccination.
Although rotavirus infects nearly all children by age 5 years, severe, dehydrating gastroenteritis affects primarily children aged 3 to 35 months. Rotavirus gastroenteritis may range from mild, watery diarrhea of short duration to severe diarrhea with vomiting and fever, resulting in dehydration with shock, electrolyte imbalance, and even death. Up to one third of patients have a fever with a temperature higher than 102°F (> 39°C).
Rotaviruses are transmitted primarily by the fecal-oral route, both through close person-to-person contact and through fomites, as well as by fecally contaminated food and water and respiratory droplets.
Confirmation of rotavirus infection by laboratory testing of stool specimens is necessary for reliable rotavirus surveillance and can facilitate clinical decisions about the use of antimicrobial agents. The most widely available testing method is antigen detection in the feces by enzyme immunoassay. Serologic methods detecting a rise in serum antibodies have also been used to confirm recent infections.
The guidelines note several reasons to adopt vaccination of infants as the primary public health measure for prevention of severe rotavirus disease in the United States.
"First, rates of rotavirus illness among children in industrialized and less-developed countries are similar, indicating that clean water supplies and good hygiene have little effect on virus transmission; therefore, further improvements in water or hygiene are unlikely to have a substantial impact on disease prevention," the authors write. "Second, in the United States, a high level of rotavirus morbidity continues to occur despite available therapies... Third, studies of natural rotavirus infection indicate that initial infection protects against subsequent severe gastroenteritis, although subsequent asymptomatic infections and mild disease might still occur."
Breast-fed infants and infants with transient, mild illnesses with or without low-grade fever can receive rotavirus vaccine. Rotavirus vaccine can be administered together with diphtheria and tetanus antigens in the diphtheria, tetanus, and pertussis (DTaP) vaccine, Haemophilus influenzae type b conjugate vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, and pneumococcal conjugate vaccine without interfering with the immune response.
Precautions involving rotavirus vaccination include considering the specific benefits and risks in the following situations: altered immunocompetence; moderate-to-severe illness, including acute gastroenteritis; chronic gastrointestinal disease; and history of intussusception.
Other special patient groups mandating clinical judgment as to whether rotavirus vaccine should be administered include premature infants (aged < 37 weeks), infants living in households with immunocompromised persons, infants living in households with pregnant women, regurgitation of vaccine, and children hospitalized after vaccination. However, infants living in households with pregnant women and immunocompromised persons and clinically stable preterm infants being discharged from hospital can receive the vaccine. Future research should address these issues.
"The success of a rotavirus vaccination program depends on the acceptance and enthusiasm of physicians and other healthcare providers who care for children and caretakers of infants," the authors note. "In light of the experience with the withdrawal of RRV-TV [rhesus-based tetravalent rotavirus] vaccine because of its association with intussusception, some health-care providers and parents might have concerns about vaccination with current rotavirus vaccine."
"Vaccination program personnel will benefit from education about rotavirus disease and rotavirus vaccine," the authors conclude. "Parental education on rotavirus gastroenteritis and on the vaccine will be essential to establish and maintain public confidence in this vaccine and to avoid confusion caused by cases of gastroenteritis in early childhood resulting from nonrotaviral etiologies and not preventable by rotavirus vaccine."
Individuals from the FDA and Merck & Co, the maker of the rotavirus vaccine, reviewed and contributed to sections of this report.
Morb Mortal Wkly Rep. 2006;55(RR-12):1-11.
