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Clinicians Echoed 2006 FDA Approval of RotaTeq


 

More than 80% of pediatricians surveyed in January and February 2006 said they would recommend the rotavirus vaccine, reported Dr. Allison Kempe from the University of Colorado, Denver, and colleagues in the January 2007 issue of Pediatrics.

The vaccine in question is RotaTeq (Merck & Co.) and was approved by the Food and Drug Administration on Feb. 3, 2006—in the middle of the survey period. It is not clear what percentage of the survey's 305 mail and Internet respondents answered before or after the approval (Pediatrics 2007;119;1–10).

The FDA approval subsequently was followed by a recommendation from the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP) for routine use of the vaccine in infants in August 2006 (dose one at 12 weeks of age and all three vaccinations by 32 weeks of age, with at least a 4- to 10-week interval between doses), and a similar recommendation from the American Academy of Pediatrics shortly afterward, in November.

“The findings of this nationally representative survey demonstrate that pediatricians recognize the burden of rotavirus disease and the value of a rotavirus vaccine for children in this country,” wrote the authors. Of the respondents, 51% strongly agreed that the burden of rotavirus disease was sufficient in the United States to justify the need for a vaccine, while 83% agreed the burden in developing countries was sufficient to justify a global need.

When asked what they would recommend in the event that ACIP recommended routine use of the vaccine, 50% of the respondents said they would strongly recommend the vaccine and 34% said they would recommend it but not strongly.

Additionally, 52% said they would begin using the vaccine within 6 months of the recommendation, 27% from 6 months to 1 year, 7% from 1 to 2 years, and 1% more than 2 years after the recommendation. A total of 0.3% said they would never use the vaccine, and 13% were unsure. The most common reasons given for delaying for more than 6 months from the recommendation were as follows: determining that insurers would cover the vaccine; waiting to see if there were adverse effects reported; and ensuring that vaccine supplies were adequate.

Respondents indicated that the three most commonly perceived barriers to implementing rotavirus vaccine recommendations were their concerns about uneven coverage by insurers, concerns about lack of adequate reimbursement, and parents' safety concerns in light of the withdrawal of the previous RotaShield (Wyeth Laboratories) vaccine from the market in 1999 because of its association with intussusception, wrote the authors.

“Implementation in this country will be greatly facilitated if lessons learned from the implementation of other recent new vaccines such as PCV7 [the heptavalent pneumococcal conjugate] vaccine are heeded,” Dr. Kempe and her associates suggested.

“Some of the problems faced by pediatricians in the initial stages of implementation, including substantial delays in being able to bill for vaccines to insurers who have not yet changed their billing procedures to accommodate a new vaccine and unsynchronized timing of coverage between the public and private sectors, might well be ameliorated by an increased coordination between ACIP, vaccine manufacturers, and health plans before recommendation of a new vaccine,” they concluded.

The surveyed physicians are representative of pediatricians in the AAP nationally in regards to practice characteristics, demographics, and location throughout the United States, they said. The response rate to the survey was high.

Dr. Kempe and associates indicated they have no conflicts of interest to disclose. The study was funded by a CDC grant.

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