ATLANTA - Upon approval for licensure by the Food and Drug Administration (FDA), the first rotavirus vaccine (RotaShield, Wyeth-Lederle Vaccines and Pediatrics) will be added to the recommended childhood immunization schedule, based on a recent vote by the Advisory Committee on Immunization Practices (ACIP).
The oral, tetravalent, rhesus rotavirus vaccine will be indicated for administration to infants at 2, 4 and 6 months of age for the prevention of severe rotavirus-induced diarrhea.
An FDA advisory committee in December 1997 reviewed the license application and unanimously agreed that the data indicated the vaccine is safe and efficacious and can be given with routine vaccines. Company officials anticipate FDA approval in April, at which time the ACIP will review the draft and complete the wording of this formal recommendation.
However, the ACIP committee voted against a recommendation for routine administration of the vaccine to premature infants, defined as infants born at less than 37 weeks gestation. The committee will again review this decision upon approval of the vaccine.
ACIP chairman and chairman of the committee's rotavirus working group John F. Modlin, MD, said that the working group struggled with this issue. The draft recommendation for rotavirus immunization states that data are insufficient to determine if premature infants are at increased risk for rotavirus hospitalizations, added Modlin, professor of medicine, and maternal and child health, Dartmouth Medical School, Lebanon, N.H.
Committee member Mary P. Glode, MD, professor of pediatrics, The Children's Hospital, Denver, stated that the recommendation to routinely vaccinate premature infants should be withheld until more data are available.
"I would conclude the data are insufficient at the present time with regard to safety and immunogenicity in premature infants to recommend this vaccine for premature infants. But, I don't think it's necessarily contraindicated," Glode said.
Several members of the committee also voiced concern over the ultimate cost of the vaccine, which members fear if too high could limit the availability to the children who need it most.
"My only concern is that we don't have the cost of the vaccine. We do have a ballpark cost, and I think the ACIP members need to decide what they can say on the basis of the information available," said Neal A. Halsey, MD. "It's really unfortunate that there isn't a systematic way to work closer with the manufacturer because I think cost may also be driven by the strength of the recommendation."
Rumors of a high cost have circulated, but according to Peter R. Paradiso, PhD, Wyeth-Lederle vice president of Scientific Affairs and Research Strategy, the cost of the rotavirus vaccine has yet to be determined, although he said it will be cost-effective and within the price range of other vaccines for routine immunization.
A previous cost-effective analysis study by Roger Glass, MD, PhD, chief of the Centers for Disease Control and Prevention Viral Gastroenteritis Section, estimated the vaccine cost could range from $9 to $56 and still be cost-effective.
However, Walt Orenstein, MD, National Immunization Program, stressed that the vaccine has proven it can prevent diarrhea and hospitalizations, and the cost of the vaccine is not supposed to impact the committee's vote.
"I've never heard that before where we've held the vaccine hostage to a price. I think we've made our decisions on what we feel is in the best interest of children or adults or both. We could have a cost today and make a recommendation and the cost could change tomorrow," said Orenstein. "I think holding it hostage, in my opinion, is a mistake."
As with any recommendation, Orenstein said, this recommendation will be accepted by some groups and rejected among others. However, making a recommendation before the vaccine is approved provides much-needed awareness about the vaccine.
"I don't see this written in stone, nevertheless, I think it would be helpful to have a recommendation so we can alert people that this is coming down the road so they can begin thinking about it and preparing for it, even if new information suggests a change later on," he said.
The American Academy of Pediatrics (AAP) is also reviewing its recommendation on rotavirus vaccine administration, according to Halsey, AAP liaison representative to the ACIP. The Red Book Committee is in the process of drafting a statement and will soon review specific topics related to the vaccine.
The vaccine was developed by Wyeth-Lederle in cooperation with the National Institute for Allergy and Infectious Diseases.
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