ACIP Ponders Changing Its Recommendation Process

AAFP Voices Support for Evidence-based, Graded System

June 30, 2010 04:45 pm David Mitchell

The CDC's Advisory Committee on Immunization Practices, or ACIP, is considering adopting an evidence-based recommendation process similar to that used by the U.S. Preventive Services Task Force, or USPSTF(

The AAFP, the American Academy of Pediatrics and the American College of Physicians voiced support for such a change June 23 during an ACIP meeting in Atlanta.

Doug Campos-Outcalt, M.D., M.P.A., the AAFP's liaison to the ACIP, spoke on behalf of the Academy at the meeting. Campos-Outcalt, who also serves as the AAFP staff liaison to the USPSTF, said in an interview with AAFP News Now that the ACIP lacks a step-by-step process for evaluating and grading evidence, making recommendations, and stating the level of evidence on which recommendations are based.

"It's hard for us to endorse recommendations that don't come from an evidence-based process," Campos-Outcalt said. "It's not that ACIP doesn't use an evidence-based process, it's just that it's not formalized and transparent.

"When we make our own (AAFP) recommendations or endorse the recommendations of others, we look at three things: the completeness of the evidence review, the quality of the evidence and the strength of the recommendation based on the level of evidence."

According to Campos-Outcalt, who is associate head of the department of family and community medicine at the University of Arizona College of Medicine, Phoenix, participants at the ACIP meeting discussed how graded recommendations might affect parental acceptance of vaccines. The ACIP will vote during its October meeting on whether to move forward with a process that would result in graded recommendations and stated grades for the levels of evidence supporting those recommendations.

"It's going to be an interesting meeting," said Campos-Outcalt.

He said the ACIP would not immediately apply the process to vaccines already on the market with established recommendations. Instead it would be applied to new recommendations and revised recommendations.

The advisory committee periodically revises its recommendations, so all vaccines evaluated by the ACIP eventually would be subjected to the new process, if it is adopted.

In other news, the ACIP voted June 24 in favor of new influenza vaccination recommendations for children ages 6 months through 8 years during the 2010-11 flu season. The recommendations will remain provisional until they have been officially approved by HHS and the CDC and published in Morbidity and Mortality Weekly Report.

The provisional recommendations say children in the above age group should receive two doses of seasonal flu vaccine if they meet any of the following conditions:

  • they have never received seasonal flu vaccine;
  • they have received only one dose of seasonal vaccine previously; or
  • they did not receive novel influenza A (H1N1) vaccine last season.

"You have to ask three separate questions," Campos-Outcalt said.

He added that if records are unavailable or it is unclear whether a child has been vaccinated previously, he or she should receive two doses of flu vaccine separated by at least four weeks.

The 2010-11 trivalent flu vaccine will include the 2009 influenza A (H1N1) virus as one of its three strains. During the 2009-2010 flu season, separate vaccinations were required for seasonal and H1N1 flu.

Finally, the ACIP also made a recommendation based on a review of safety data to remove precautionary labeling regarding the risk for Guillain-Barré syndrome, or GBS, after meningococcal vaccination.

Campos-Outcalt said the review indicated there is a small risk of GBS after vaccinations, but that risk is not specific to meningococcal vaccine.

"It's very rare," he said. "It's probably related to genetic predisposition, and there's nothing about meningococcal that stands out more than others."