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AAP releases first rotavirus vaccine recommendations

The vaccine was also recommended for routine use by the Advisory Committee on Immunization Practices.

[Contraindications]

[Your turn]

December 1998

ELK GROVE VILLAGE, Ill. - The American Academy of Pediatrics (AAP) recently issued guidelines regarding the use of rotavirus vaccine.

The release of the AAP statement is in response to the Food and Drug Administration approval in August of the first vaccine for the prevention of rotavirus gastroenteritis, and the recent vote by the Advisory Committee on Immunization Practices (ACIP) to add the vaccine to the routine childhood immunization schedule.

The oral, tetravalent vaccine (RotaShield, Wyeth-Lederle Vaccines and Pediatrics) is now available and is indicated for infants at 2, 4 and 6 months of age.

The first dose of the three-dose series may be given as early as 6 weeks of age and as late as 6 months of age. However, each subsequent dose should be given at intervals of at least three weeks, according to the package insert.

The AAP recommends special efforts be made to immunize infants prior to the anticipated annual onset of rotavirus infections in their local communities.

Because none of the clinical trial data extend beyond two years, duration of protection beyond this time is uncertain, but protection similar to that after natural infection is expected, according to the AAP statement.

Data are needed to establish the safety, immunogenicity, and, if possible, efficacy of the rotavirus vaccine and of future rotavirus vaccines in several populations, including premature infants and children with acute diarrhea, chronic gastrointestinal tract disease, immunosuppression, children in long-term care facilities, and children ages 1-3 years.

Studies also are needed to determine the efficacy of a two-dose immunization schedule as well as the effect of maternal rotavirus immunization on maternal milk and serum antibody titers and the protection afforded to nursing infants by these maternal antibodies.

Morbidity from rotavirus disease in the United States and cost to the health care system and society associated with rotavirus disease are substantial. These considerations in conjunction with vaccine safety and efficacy justify a nationwide immunization program for prevention or modification of rotavirus disease in infants and young children.

Contraindications

Despite its safety, rotavirus vaccine is contraindicated in the following situations:

• Infants with hypersensitivity to aminoglycoside antibiotics, amphotericin B, or monosodium glutamate that are components of the vaccine, should not receive this vaccine. In addition, rotavirus vaccine should not be administered to people who have experienced an anaphylactic reaction to a previous dose of rotavirus vaccine.
• The rotavirus vaccine, like other vaccines, can be given to infants with a low-grade fever. Infants with moderate or severe febrile illness should not receive the rotavirus vaccine during the illness, but should be immunized as soon as they have recovered from the acute phase of their illness.
• Until further data are available, children who are known or suspected to be immunosuppressed or immunodeficient should not receive this live-attenuated virus vaccine. The vaccine should not be administered to infants born to women known to be HIV-infected until tests for HIV infection in the infant are negative at 2 months or older by polymerase chain reaction or culture. Infants living in households with people known or suspected to be immunocompromised should be immunized.
• Breast-feeding is not a contraindication to administration of rotavirus vaccine.
• This rotavirus vaccine is not recommended for children with acute vomiting or diarrhea because vaccine efficacy in these circumstances has not been established. Consideration should be given to immunizing children with chronic gastrointestinal tract disease until further data are available to make definitive recommendations for this group.
• Although data are limited, premature infants may receive rotavirus vaccine at or after discharge from the hospital nursery if they have achieved a chronological age of at least 6 weeks.
• If a child is hospitalized after administration of rotavirus vaccine, the child can be managed by standard precautions and does not need to be placed in contact precautions unless diarrhea, vomiting, or both occur. Children may attend their child care facilities after administration of rotavirus vaccine.

American Academy of Pediatrics Rotavirus Vaccine Recommendations Specific AAP recommendations for use of rotavirus vaccine are as follows.

Based on safety and efficacy data, rotavirus vaccine is recommended for use in infants at 2, 4 and 6 months of age for prevention of rotavirus disease; routine implementation of this recommendation will require reconciliation of related economic issues. The first dose of rotavirus vaccine may be given to infants as early as 6 weeks of age. For children in whom initiation of vaccine has been delayed, the first dose may be given as late as 6 months of age. Each subsequent dose should be given at an intervals of at least 3 weeks. Special efforts should be made to immunize infants before the anticipated annual onset of rotavirus disease activity in their local communities. Increased rates of fever have been reported in vaccine recipients after the first and second doses, but fevers generally are mild and last less than 24 hours. Initiation of immunization after 6 months of age is not recommended because of the age-related occurrence of fever after receipt of the first dose of vaccine. All three doses of vaccine should be administered during the first 12 months of age because data regarding the safety and efficacy of vaccine administration to older children are not available. The rotavirus vaccine can be administered at the same time as diphtheria-tetanus-acellular pertussis (DTaP) or whole-cell pertussis, Haemophilus influenzae type b (Hib), hepatitis B, or inactivated poliovirus/oral poliovirus (IPV/OPV) vaccines as recommended in the routine immunization schedule. Modification of timing of administration of rotavirus vaccine is not necessary after administration of antibody-containing blood products, including blood, plasma and immune globulin. To ensure maximum immunity, the recommended three-dose rotavirus immunization schedule should be completed even if a child has had a documented episode of wild-type rotavirus gastroenteritis.

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