ATLANTA - The Advisory Committee on Immunization Practices (ACIP) recently revised the recommendation statement on rotavirus immunization to encourage providers to vaccinate premature infants.
At the time the original statement was approved by the committee, sufficient data regarding immunization with rhesus rotavirus vaccine (RotaShield, Wyeth-Lederle Vaccines) were not available to allow for the recommendation of this population. However, while only limited data remain available, the CDC advisory committee opted to move forward with the broadened recommendation.
In contrast with the original statement that recommended immunization for all full-term infants (>37 weeks gestation), the updated statement calls for immunization of all infants, with an expanded section on special circumstances.
"These changes were made to ensure that the greatest number of vulnerable children benefit from the rotavirus vaccine," said Red Book Editor, Larry K. Pickering, MD. "The ACIP and the American Academy of Pediatrics statements are now in harmony and offer similar recommendations regarding the use of this vaccine."
The original draft approved during the October 1998 meeting stated that data were insufficient to fully establish the safety and efficacy of rotavirus vaccine in premature infants, but some experts believe that the benefits outweigh the theoretical risks. Until needed data are available, practitioners should consider the potential risks and benefits of vaccination of premature infants against rotavirus, according to the original statement.
The revised recommendation now states that the ACIP supports immunization of prematurely born infants if they meet three criteria: at least 6 weeks of age; are leaving the nursery or are no longer hospitalized; and, are clinically stable.
However, the number of premature infants studied in clinical trials is insufficient to confidently establish the safety and efficacy of the vaccine for all premature infants. The lower level of maternal antibody to rotaviruses present in very low birth weight premature infants could theoretically increase the risk of fever following rotavirus vaccination. Until further data are available, the ACIP believes that the benefits of rotavirus immunization of premature infants outweigh the theoretical risks.
While the committee expanded the vaccine's use in premature infants, it revised the contraindications section to recommend against vaccinating children with diarrhea.
The recommendation now states that while the vaccine is likely to be safe for infants with gastrointestinal disease, it is theoretically possible that immunogenicity and efficacy may be compromised.
Citing the diminished antibody response seen in infants given oral poliovirus vaccine, the committee recommended rotavirus vaccine be withheld from infants with acute, moderate-to-severe vomiting or diarrhea.
Vaccination of infants with mild, self-limited gastrointestinal illness may be warranted if deferral of vaccination is likely to result in a significant delay in vaccination of the infant against rotavirus.
The recommendation also states that infants with pre-existing chronic gastrointestinal disease, including congenital malabsorption syndromes, Hirschsprung's disease, short gut syndrome or persistent vomiting of unknown cause may potentially benefit from immunization, although the safety and efficacy of rotavirus vaccine for these infants is unknown.
The remainder of the statement is unchanged.
In August 1998, the Food and Drug Administration approved rotavirus vaccine for the prevention of rotavirus gastroenteritis. The oral, tetravalent vaccine was available in September 1998.
Rotavirus is the most common cause of epidemic severe acute gastroenteritis in infants and young children in industrialized and developing countries.
"There's no child anywhere who is going to escape rotavirus infection. It is a very egalitarian virus, infecting nearly every child in industrialized and developing countries, and sanitary conditions do not seem to matter. However, it's the consequences of these infections that do matter," said Albert Z. Kapikian, MD, head of the epidemiology section of the Laboratory of Infectious Diseases at the National Institute for Allergy and Infectious Diseases. Kapikian and his colleagues were the first team to identify rotavirus in the United States - a virus that was discovered in Australia. Kapikian and colleagues also developed the first licensed rotavirus vaccine.
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