HEALTH & SCIENCE

Flu vaccine system better, still not perfect.

With delays and shortages less an issue, public health workers and physicians are looking for ways to expand demand and meet Healthy People 2010 objectives.

By Victoria Stagg Elliott, AMNews staff. June 10, 2002. Additional information

Atlanta -- Walter A. Orenstein, MD, director of the Centers for Disease Control and Prevention's National Immunization Program, is smiling. Problems with the influenza vaccine appear to be fading. At this year's National Influenza Vaccine Summit in Atlanta, he was able to talk optimistically about the possibility of meeting Healthy People 2010 goals, rather than just looking for ways to address the most immediate supply problems.

"We've had major improvements in vaccine production, and now we can talk about our goal of 152 million doses for 2010," he said to the more than 50 physicians, public health officials, vaccine manufacturers and distributors, and immunization advocates gathered late last month for the meeting.

It's a far different atmosphere than that of last year's summit. Many of those gathered then were still suffering the burns caused by the disastrous 2000-01 season -- characterized by delays and shortages -- and desperately trying to prevent those scenarios from ever playing out again. Now that the fires are out, these stakeholders are starting to look for ways to reach loftier goals.

Could flu vaccine delivery be one of the first health initiatives to eliminate ethnic and racial disparities? Could mass immunizations against the flu act as practice runs for the kinds of mass immunizations that would be necessary in the case of a bioterrorist attack?

The challenges related to any one of these concepts, though, are significant. Just meeting the Healthy People 2010 goals would require 90% of all people older than 65 and 60% of those 18 to 64 at high risk of complications to be vaccinated.

It also would require manufacturing capacity to nearly double to 152 million doses or more. Last year, 87 million doses were produced, while this year, between 90 million and 95 million are expected. More accurate estimates will be available at the end of June.

There are also still problems left over from the past two years. Although the 2001-02 season was easier, it was far from the halcyon days of the 1990s, when vaccination rates climbed significantly and the vaccine arrived when and where it should.

The distribution system is still uneven and leaves some with plenty of vaccine and others with none. Prices have increased significantly, but Medicare reimbursement hasn't kept up.

"We've got a long way to go with a lot of things," said Ronald Bangasser, MD, medical director of Beaver Medical Group in Redlands, Calif.

The time of year the vaccine should be given also has changed, but consumers have not bought into this expanded season. "We struggled to get that message out," Dr. Orenstein said. "And we were not successful."

Vaccine has traditionally been given in October and November. But public health officials have been encouraging administration of vaccine through December and beyond, primarily because that's when some of the supply has become available. Many at the meeting, however, said they tried to hold flu clinics in December and January, but they were often an exercise in futility with few takers.

Still, all are talking about campaigns to push late vaccinations. And, with eyes now focused on the Healthy People 2010 goals, most admit that the longer time window also will be needed to reach this number of people.

Vaccine leftovers

But more immediately, the lack of demand left many physicians and other providers of vaccine with vaccine supplies long after the prevention window had closed. No one has taken a national inventory, but anecdotal evidence indicates that last season millions of doses may have gone unused -- a situation that may jeopardize the whole system.

Some physicians already have ceased providing flu vaccine because the excess inventory combined with the hassles of ordering it and the low reimbursement rates make them question whether it is worthwhile. Those who run large-scale clinics say the leftover supply could put them out of business. Manufacturers say if they can't sell it, they won't make it.

"If you create the demand, we'll create the vaccine," said Uli Bartke, PhD, vice president of sales for PowderJect Pharmaceuticals, one of the three manufacturers. "But if there are leftovers, we won't want to."

There is also concern that the phased-in system may not be the best way to go. The CDC's Advisory Committee on Immunization Practices recommends targeting high-risk individuals in September and October and offering shots to all after Nov. 1.

Initially designed to address distribution during years with shortages or delays, it is now considered the way to go by public health officials and many doctors even during times of plenty.

But those who deliver vaccine, particularly in the workplace or community settings, say that it doesn't make sense to hold back vaccine if they have it. They are in favor of redistributing it as necessary. But if an ample supply is available, why shouldn't they vaccinate the low-risk? And although flu outbreaks usually peak between January and March, the flu can strike earlier. If an epidemic hits early in the season, will physicians be blamed for holding back vaccine? Public health officials admit that it is better for a patient to receive the vaccine in October or November.

"It's not as good to vaccinate in January as in November, but it's better than not at all," said Keiji Fukuda, MD, MPH, chief of the epidemiology section in the CDC's influenza branch.

"We're going to have to figure out how to balance long-term goals with the short-term situation."

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• Uneven distribution
• Higher prices
• Low Medicare reimbursement
• Late-season decline in demand
• Excess inventory

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Healthy People 2010 immunization and infectious diseases page (http://www.health.gov/healthypeople/document/html/volume1/14immunization.htm)

CDC National Immunization Flu Season 2002-03 program (http://www.cdc.gov/nip/flu/)

National Influenza Summit 2002 (http://www.ama-assn.org/ama/pub/article/1826-6268.html)

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Copyright 2002 American Medical Association. All rights reserved.