ATLANTA - Recommendations for the use of rotavirus vaccine for the prevention of rotavirus gastroenteritis were recently published by the Centers for Disease Control and Prevention (CDC).
Rotavirus vaccine (RotaShield, Wyeth-Lederle Vaccines) was approved by the Food and Drug Administration in August 1998, and was recommended for inclusion into the harmonized childhood immunization schedule in February 1998 by the Advisory Committee on Immunization Practices. The complete recommendations are published in the March 19 issue of Morbidity and Mortality Weekly Report.
Rotavirus is indicated for routine administration with three oral doses to be administered at 2, 4 and 6 months of age. However, rotavirus immunization can be initiated any time between the ages of 6 weeks and 6 months, with the second and third doses following the preceding dose by at least three weeks.
All doses of vaccine should be administered before the child's first birthday because safety and efficacy data among children age 1 year and older are insufficient.
Infants with documented rotavirus gastroenteritis before receipt of the full course of rotavirus vaccinations should still complete the three-dose schedule because the initial infection frequently provides only partial immunity. In addition, special efforts should be made to vaccinate children before onset of winter rotavirus season.
Although breastfeeding can decrease the child's humoral immune response to the vaccine after a first dose, rotavirus vaccine is recommended for children who are breastfed because no significant decrease in immune response or in overall efficacy has been observed.
Like other childhood vaccines, rotavirus vaccine can be administered simultaneously with vaccines in the routine childhood schedule, including diphtheria-tetanus-pertussis (and acellular pertussis), Haemophilus influenzaetype b, oral polio virus, inactivated polio virus, and hepatitis B.
Rotavirus vaccine can also be administered to infants with transient, mild illnesses, with or without low-grade fever, according to the recommendations.
Contraindications for administration of rotavirus vaccine include altered immunity, allergy to vaccine components, acute gastroenteritis and moderate to severe febrile illness.
Children with primary immunodeficiency disorders and both children and adults who have received hematopoetic, hepatic or renal transplants are at risk for severe or prolonged rotavirus gastroenteritis and can shed virus for prolonged periods. In addition, rotavirus vaccine should not be given to children of mothers with HIV infection unless the child is confirmed as HIV negative by a clinician.
Children with hypersensitivity to any component of the vaccine or who have experienced an anaphylactic reaction to a previous dose of rotavirus vaccine should not complete the series.
The vaccine may be indicated for infants with mild gastrointestinal illness, but is not indicated for infants with acute, moderate to severe vomiting or diarrhea until the condition resolves. However, infants with moderate to severe febrile illness should be vaccinated as soon as possible after recovery from the acute phase of the illness. This precaution avoids superimposing adverse effects of the vaccine on the underlying illness or mistakenly attributing a manifestation of the illness to the vaccine, the recommendations state.
No evidence of seroconversion to, or shedding of, vaccine strains has been observed among unvaccinated children, according to studies conducted in U.S. day care centers. However, a large vaccine trial in Venezuela revealed that high concentrations of wild-type rotavirus was found in stool samples from study children with rotavirus diarrhea. Rotavirus vaccine strains were detected by polymerase chain reaction in stool samples from 15% of vaccinated and 13% of nonvaccinated children in concentrations too low to be detected by enzyme immunoassay or polyacrylamide gel electrophoresis.
These data support the possibility that vaccine strains spread to some unvaccinated children, but indicate that the vaccine strains alone were not the cause of diarrhea, according to the CDC report.
The vaccine has been administered to nearly 7,000 infants between the ages of 6 and 28 weeks, including 2,208 infants in placebo-controlled studies and 4,740 infants in three studies that were not placebo controlled.
The vaccine has been associated with a statistically significant excess of fever (>38° C) following the first dose compared with placebo (21% vs. 6%), with fever occurring three to five days after administration. Decreased appetite, irritability, and decreased activity were reported following the first dose in some trials. However, these symptoms were associated with fever in both vaccine and placebo recipients.
Following the second dose, a significant excess of fever of higher than 38° C was again noted, but no increase in any symptoms was noted following the third dose of rotavirus vaccine.
No overall difference in the rate of diarrhea was observed in the placebo-controlled trials, but in the efficacy study in Finland, vaccinated children had a significantly increased rate of diarrhea after the first dose of vaccine compared with placebo recipients (2.8% vs. 1.4% [P0.05]).
For more information:
- CDC. Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children. MMWR 1999;48(RR-2):1-22.
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