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Physicians prepare for a busy flu season

Officials say last year's vaccine shortages could boost this season's demand

From the July-August ACP Observer, copyright © 2004 by the American College of Physicians.

By Gina Rollins

For New West Physicians, in Golden, Colo., the run on flu vaccine last year began when newspapers reported the deaths of two children from influenza in the state in late November.

"That generated a tremendous amount of fear and concern, and brought people in by the droves," said New West's medical director Kenneth R. Cohen, FACP. The practice—which has more than 40 internists and family physicians—quickly exhausted its original shipment of 8,000 vaccine doses. Even after the group scrambled to secure an additional 1,600 doses, Dr. Cohen said, "We turned a lot of people away."

Patients across the country last year made panicked runs on flu shots, and not just in states like Colorado, Texas and Nevada that experienced early outbreaks. The mismatch between the vaccine and one of the influenza A strains in circulation contributed to public concern. At the same time, what the media billed as unusually high numbers of pediatric deaths from flu created intense demand among parents and children.

The result? For the first time in years, the country's entire supply of injectable vaccine was depleted.

"Many people couldn't get a shot before the flu peaked in their communities," said Kathleen Neuzil, FACP, MPH, a member of the College's Adult Immunization Initiative Physician Advisory Board and ACP's representative to the immunization advisory board for the Centers for Disease Control and Prevention (CDC). "By the time some high-risk patients came in, the vaccine was already out."

As health officials look ahead to the coming flu season, they say that last year's experience may color the attitudes of patients this year. Patients with vivid memories of last year's shortages, for example, may show up early and in larger numbers to be vaccinated. Public health officials also say that new recommendations and clarifications about exactly who should get immunized may also boost demand.

Last season's post-mortem

The outbreaks reported last November had health officials predicting an unusually severe flu season. A big concern was the fact that 87% of virus samples being submitted to the CDC were similar to the H3N2 "Fujian" influenza A strain, which wasn't one of the three strains included in both the injectable and newly-launched intranasal trivalent vaccine.

Also troubling were headlines announcing the season's unusually high toll of flu fatalities among children. At press time, 152 deaths due to laboratory-proven influenza in children under age 18 during the 2003-04 flu season had been reported to the CDC.

But was the season's pediatric death toll particularly high? According to CDC officials, they don't really know.

"We don't have any similar surveillance data from before now to compare that to," said Raymond A. Strikas, FACP, associate director for adult immunization in the CDC's national immunization program. Instead, he explained, the public health agency has mathematical models that say that as many as 92 children under five years of age will die of the flu in any given year, over a 10-year period.

"That number," Dr. Strikas added, "is roughly in line with what we saw this past year." While CDC officials intend to begin compiling actual data on pediatric mortalities for the first time during the coming season, Dr. Strikas classified 2003-04 as "moderately severe."

While the data are not entirely clear, last year's flu season did have some unique characteristics. For one, the disease struck "unusually early," Dr. Strikas said, beginning in November and peaking in December, not in January or February. In addition, he noted, "We ran out of injectable vaccine, and that hasn't happened in anyone's memory."

A total of 83 million injectable doses produced last season were used, about the same number used to immunize patients the previous year. In 2002-03, however, 12 million of the 95 million doses produced had to be destroyed, leading vaccine manufacturers to cut back on production.

This fall, vaccine companies expect to produce between 90 million and 100 million doses. At press time, production was on schedule and no shipment delays were expected.

In addition to the H3N2-like "Fujian" strain, this year's vaccine will contain the H1N1-like "New Caledonia" influenza A strain and the influenza B "Shanghai" strain.

System 'fragility'

Even with increased production, officials say last year's shortage—as well as production delays in previous years—have served as a wake-up call, highlighting what Scott A. Harper, ACP Member, medical officer in CDC's National Center for Infectious Diseases, called the "fragility of the system."

"If [distribution] takes a hit or there's a sudden unexpected demand for vaccine," Dr. Harper said, "there's not necessarily a good solution in the short term."

One short-term solution the CDC will implement for the first time this year is to stockpile vaccine for children. According to Dr. Strikas, the CDC this year and next will use $40 million from the agency's Vaccines for Children Program to buy up to 4 million doses of vaccine to keep in reserve. Those additional doses will be on top of the 90 million to 100 million doses available for distribution.

"It would nominally be a stockpile to give to children," Dr. Strikas said. "We're asking companies to make some vaccine late, to be available in December if necessary."

And if the upcoming season proves to be mild? That vaccine "may not get used," he conceded. "We're paying for that insurance policy to have some extra around."

Another short-term solution—one that proved to be a tough sell in its first season last year—would be wider use of FluMist, the live intranasal vaccine marketed for healthy patients between the ages of 5 and 50. A clarification issued in April 2004 by the CDC's Advisory Committee on Immunization Practices (ACIP) spells out who should receive and administer the live attenuated vaccine.

According to the ACIP, the traditional injectable vaccine is recommended over live intranasal vaccine only for health care workers, household members and others in close contact with patients so severely immunocompromised that they require a protected environment, such as those receiving hematopoietic stem cell transplants. If they choose to be immunized with live vaccine, the ACIP said, health care workers should refrain from contact with severely immunocompromised patients for seven days.

Otherwise, health care professionals or family members of patients with lesser degrees of immunosuppression, such as asthma or HIV, can receive intranasal vaccine. At the same time, professionals at high risk for flu complications—including pregnant women, asthmatics and people over age 50—can administer FluMist to others.

Those recommendations should allay fears that probably hindered use of FluMist last season, pointed out Gregory A. Poland, FACP, Chair of ACP's Adult Immunization Initiative Physician Advisory Board and professor of medicine and director of the Mayo Vaccine Research Group at Rochester's Mayo Clinic.

"There was a gross misconception [about the vaccine] by health care workers and the public," Dr. Poland said. "They falsely assumed that shedding of the live attenuated virus would lead to transmission."

In fact, he said, transmission from live vaccine is exceedingly rare, and resulting disease has never been documented. (see "After disappointing season, FluMist manufacturer looks to future".)

As far as long-term solutions to shortages and delays, Dr. Strikas pointed out that HHS has invested $50 million in exploring ways to produce vaccine through cell culture, rather than the current—and much more time-consuming—process of using embryonated eggs.

"Can we build a better vaccine, one that can be made more quickly with a different technology?" he said. Among alternative vaccine technologies, cell culture is the closest to market, but it is still, he said, several years away from being available.

Higher demand?

The ACIP issued another recommendation that may affect vaccine demand. It advised that children between the ages of six months and 23 months, as well as their close contacts, be immunized. While that recommendation was issued last October, the upcoming flu season will be the first that the recommendation is in effect for the entire season.

That recommendation may bring even more healthy patients in for vaccination-and lead to more widespread immunization among health care workers, another group now being targeted by the College and others for much broader vaccination. (See "Should vaccinations be required for health care workers?") At Colorado's New West Physicians, for instance, Dr. Cohen expects the new recommendation on immunizing younger children to "definitely" lead to higher demand.

To make sure it doesn't run out of vaccine, the practice has boosted its initial order of vaccine by 20%. And in response to the supply problems it encountered last year, the group has established an e-mail notification system specifically for high-risk patients. The goal is to make sure those patients come in for an immunization when vaccine becomes available.

With the vaccination of high-risk patients scheduled to begin the first week of October, said Dr. Cohen, "We'll start sending out e-mail notifications at the beginning of September."

Gina Rollins is a freelance writer in Silver Spring, Md.

The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP.

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After disappointing season, FluMist manufacturer looks to future

Experts hailed last year's arrival of live-attenuated, intranasally administered influenza vaccine FluMist as the first major innovation in flu vaccine in 50 years. An alternative to a shot in the arm for healthy people ages 5 to 50, FluMist was seen as a highly-marketable alternative to injectable vaccine.

But the breakthrough technology fell far short of expectations—despite a moderately severe season in which the country's entire supply of injectable vaccine was exhausted.

MedImmune Inc., which manufactures the intranasal vaccine, projected that it would sell 4 million doses. However, the company reportedly sold less than one-fourth of that figure. Lackluster sales led MedImmune in April 2004 to sever marketing ties with pharmaceutical giant Wyeth.

What went wrong? Cost was undoubtedly a factor. The wholesale price of FluMist at the beginning of last season was $46 per dose, more than three times the price of injectable vaccine.

Faced with sluggish sales, MedImmune began offering a $25 rebate in November, effectively cutting the price to $21 per dose. The following month, the company struck a deal with the CDC to sell as many as 3 million doses to public health agencies for $20 each. In January 2004, the company offered 250,000 doses free-of-charge to public health officials. Even then, it couldn't find many takers.

Physicians found "a number of patients who said they didn't like having a shot, but when they found out the cost of FluMist, they said 'Oh, I think I'll have the shot,' " reported Neal L. Sklaver, FACP, an internist with Medical Specialists Associates in Dallas.

Does the group intend to offer it again this year? "We're not going to carry it," he said, "unless the price comes down." At press time, a MedImmune spokesperson announced that the price for FluMist in the 2004-05 season would be $23.50 per dose and that the company expects to produce between 1 million and 2 million doses.

Other factors in FluMist's disappointing debut included the vaccine's limited availability, storage requirements (which include a special freezer) and the fact that it's approved for only healthy people between the ages of 5 and 50.

The company plans to seek expanded approvals after it has more data, and it is now conducting phase 3 trials on a second-generation vaccine that does not need to be kept frozen.

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New pilot program can help boost adult immunizations

ACP recently launched a three-year pilot program to help practices increase their number of adult influenza and pneumococcal immunizations.

The pilot study is testing a new software tool called the Adult Clinic Assessment Software Application (ACASA). Developed by the CDC and customized by ACP, the program allows physicians to log patients' immunization data. Those data can then be used to produce an electronic snapshot of their immunization rates and identify ways to broaden immunization patterns.

"We expect practices using the tool to see an increase of 25% in their immunization rates as a result of the study," said Matt Smith, College Coordinator of the pilot program. "We hope the program will help push adult immunization to become the standard of care."

Doron Schneider, ACP Member, is one of 17 general internists from three states—Pennsylvania, New Jersey and Delaware—who are participating in the pilot for the next flu season. The program calls for groups to manually enter immunization data for 100 of their patients into the software. ACP staff will then analyze the data and help participants develop customized quality improvement plans for their practices.

Dr. Schneider, medical director of the ambulatory service unit and anticoagulation clinic at Abington Memorial Hospital in Abington, Pa., said he considers the ACASA program a springboard to the rapidly approaching era of pay-for-performance. Physicians will soon be required to measure quality of care in many areas, he said, and that includes immunizations.

"There has been a realization in my hospital community that quality is where the future lies," said Dr. Schneider. "We can use the methodology learned from ACASA—from how to pull sample charts to how to design practice improvement models—to improve our performance in other domains, such as diabetes and various screening procedures."

Expanding nationwide next year, ACP's ACASA pilot program is looking for more enrollees from around the country. For more information or to participate, contact Matt Smith at 800-523-1546, ext. 2602, or online.

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