Mar 5, 2008 (CIDRAP News) – Starting next fall, how will the healthcare system get influenza vaccine into the arms (or noses) of tens of millions of additional children each year, given that the vaccination season is limited and many children don't have regular medical checkups?
That's probably the central—though not the only—question raised by last week's recommendation by the federal Advisory Committee on Immunization Practices (ACIP) to vaccinate all school-aged children against influenza.
"I think it will be difficult," said Deborah Wexler, MD, executive director of the Immunization Action Coalition, a St. Paul–based nonprofit group that campaigned for the ACIP recommendation.
Until now, the Centers for Disease Control and Prevention (CDC), which is advised by the ACIP, recommended flu vaccination for children from 6 through 59 months old. The new ACIP recommendation expands the target groups to include children from ages 5 through 18 years. That adds about 30 million children to the groups targeted for flu shots, the CDC estimates.
The advisory group endorsed the change on the grounds that it will reduce flu and related medical needs in children and may limit spread of the disease in the community. In a nod to uncertainties about the adequacy of the vaccine supply next fall and winter, the CDC said the recommendation "is to take effect as soon as feasible, but no later than the 2009-2010 influenza season."
Immunization advocates and primary care physician groups say it will be a challenge to immunize millions more children, because many of them rarely visit a doctor and because the timing of flu vaccination season doesn't mesh well with the timing of routine checkups for the children that do have them. Some experts say vaccines will have to be offered in settings other than physicians' offices.
In addition, one primary care group, the American Academy of Family Physicians, worries that providers may not have enough vaccine next season and has questions about the cost-effectiveness of the new policy.
How much of a demand surge?
Although an additional 30 million children are now advised to get flu shuts, the CDC expects only a fraction of that number will seek vaccination next season. "It takes a while for uptake to reach levels we'd like, but based on experience with childhood vaccines, we estimate about 7 million [more] doses will be used next year," said Curtis Allen, a spokesman for the CDC's National Center for Immunization and Respiratory Diseases (NCIRD).
Allen said vaccine company representatives who were at the ACIP meeting all promised to do "everything possible" to produce adequate supplies for next season. He said their major concern was their ability to change all three flu strains in the vaccine, as recommended recently by the World Health Organization in light of suboptimal matches between this year's vaccine and the viral strains in circulation.
Even assuming the doses are available, Allen acknowledged that immunizing 7 million additional children will be a challenge. "One reason is that vaccine typically reaches the market in late September or early October. Most children start school earlier, and many will have visited their pediatrician or family physician in August," he said.
Allen added that children and adolescents are "notoriously difficult to reach in that, once a child reaches a certain age, they rarely see a physician unless they're sick. So this is a whole new cohort we'll have to reach with information about the importance of flu vaccination."
Lance Rodewald, MD, head of the immunization services division in the NCIRD, said the need for flu immunization might be seen as a tool to push for annual medical exams for children. But that may not be practical, because the flu immunization season runs only about 3 to 4 months. "For pediatricians to see all their patients once a year, they are going to have to be scheduled throughout the year," he said.
Alternative vaccination venues
"Pediatricians and family physicians are probably going to do a fair amount of vaccination, but this would really stress the office capacity to vaccinate everyone in this narrow time frame," Rodewald said. "Probably a lot of the adolescents and school children will have to get their vaccines at places other than a provider office."
One way pediatricians might meet an increased demand for flu shots would be to offer special Saturday or evening clinics where children would be immunized without undergoing a full medical checkup, Rodewald suggested.
Another possible option is school-based immunization, a topic that was discussed at the ACIP meeting, he said. Schools, like medical clinics, face limitations because many of them no longer have a staff nurse, but they could work with public health agencies or other partners to vaccinate students, he said.
"We're looking for sustainable methods to use schools and community vaccinators to partner together to reach schoolchildren, because it's a promising working venue," Rodewald commented.
The American Academy of Pediatrics (AAP), which supported the ACIP recommendation, is open to the idea of children receiving flu shots elsewhere than their regular clinic if need be, said Henry Bernstein, DO, a member of the AAP's Committee on Infectious Diseases and chief of general academic pediatrics at the Children's Hospital at Dartmouth in Lebanon, N.H.
"Certainly the AAP supports the concept of a medical home, so we'd like children to be immunized in their medical home," he said. "But if there are other opportunities or places for people to get flu vaccine in a given season, that's good. What's critically important is that if they get it outside their medical home, it gets into their medical record with their primary care provider."
Bernstein said pediatricians feel there is "huge value" in expanding the flu immunization to all children. "But everyone is certainly aware of the fact that implementation and logistics need to be closely examined to really make this happen," he added.
AAFP leader concerned
Jim King, MD, president of the American Academy of Family Physicians (AAFP), voiced concern about the cost-effectiveness of the ACIP recommendation and its possible impact on family physicians next season.
King, who practices in Selmer, Tenn., said the AAFP has long recommended voluntary flu shots for children older than 6 months. However, he said, "It's already past the point for physicians to order flu vaccine [for next fall], so getting the amount of vaccine is going to be difficult for most family physician offices."
Commenting that about 76 million children nationwide will now be covered by flu vaccination recommendations, King said manufacturers may not be able to make enough vaccine to meet the increased demand.
"Are we going to do this on an annual basis, and how much money is this going to cost the healthcare system?" he said. "We haven't seen the outcome data to show that it's cost-effective for us to do this." He added that he has seen many patients this year who contracted flu even though they had been vaccinated.
King said he also expects some parental concerns about the cost of immunization and whether insurance will cover it, though he doesn't expect a big backlash so long as the vaccination is not required.
He said the AAFP would reexamine its policy on flu immunizations for children in light of the ACIP recommendation.
Wexler, of the Immunization Action Coalition, counseled modest expectations about the early impact of the ACIP recommendation.
"I don't think we should expect that we're going to be reaching the kinds of rates we achieve with other vaccines, because there's no catch-up period—this is a year-after-year thing. It's going to be different," she said. "I think the goal is to do the best you can and every year you do a little better."
"We're never going to achieve 90% [coverage], and I don't think we should expect to," she said, adding, "We have to think about alternate venues, not just the practitioner's office."
Wexler said anti-vaccine groups have already begun expressing opposition to the new recommendation. "I think because flu vaccine is the only one other than Japanese encephalitis that has some thimerosal [a mercury compound] in it, that's a big issue for anti-vacciners. This has been going on for many years now, and I don’t' know that it's going to be any more difficult than it's already been."
She said she doesn't expect much opposition from parents—"not with children dying of influenza. Parents want to protect their children, and they hear the stories, and they mostly trust their physicians."
Wexler also said the effort to immunize more children offers a good opportunity to prepare for a flu pandemic—a view also voiced by Bernstein. "How do we mobilize, how do we reach the most people in the least time?" she said. "It's going to be a learning curve, but it's not too soon to start."
Bernstein said that, while the move to immunize school children is a major step, it doesn't add as many children to the target groups as may appear at first glance.
"Medically I think this is an important step to take; it really adds a number of children to the ranks," he said. "But to be perfectly honest, essentially half of them should already be getting the flu vaccine every year, because 10% of them have conditions that warrant it, and another 40% of them are household contacts of someone who would not do well if flu was brought into the home." The CDC currently recommends flu immunization for close contacts of people at risk for serious complications of flu.
Wexler observed that the ACIP recommendation pushes the country closer to embracing universal flu vaccination. Previously, flu immunization recommendations covered groups constituting about 74% of the US population, she said. Now, "it's probably up to 90%, or at least up to 85%."
In light of those numbers, she said, "I think it would be better to recommend vaccination for everyone. It's much simpler. . . . It's going to save clinicians a lot of time, instead of having to wade through and figure out who's supposed to be vaccinated. It'll be much easier for [insurance] coverage to be ascertained. . . . And I think it'll reduce influenza in circulation."
Feb 27 CIDRAP News story "ACIP recommends flu shots for all school children"