AMA House of Delegates

Too soon to predict easy flu season

In response to the flu vaccine shortage, German vaccine is purchased and ethicists are called upon to help decide allocation issues.

By Susan J. Landers — Posted Dec. 27, 2004

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Despite its quiet start, the flu season is not over and physicians should remain vigilant, said Julie Gerberding, MD, MPH, director of the Centers for Disease Control and Prevention.

"Remember that while flu may not be in the news right now, flu is unpredictable; flu is a formidable foe," said Dr. Gerberding, speaking at the AMA's Interim Meeting in Atlanta on Dec. 7. "We can't be confident that we're not going to see more flu before the season has ended. So it's still very important to take this seriously and not give in to the temptation to assume a slow start means it's going to be an easy season."

Last year at this time, the flu was taking a much higher and more visible toll with reports of child deaths prominent in the news. In contrast, the latest CDC flu figures show no pediatric deaths and most states reporting only sporadic flu activity.

Many states also have surplus doses of vaccine and are either allowing people who are not in high-priority groups to receive the shots or are considering doing so.

Meanwhile, Health and Human Services Secretary Tommy Thompson announced on the same day in Washington that 1.2 million doses of flu vaccine, manufactured in Germany by GlaxoSmithKline, were purchased for use in this country. The purchase of another 3 million doses is expected.

The vaccine, Fluarix, which has been approved by the European equivalents of the Food and Drug Administration but not licensed for use in the United States, will be considered an investigational new drug.

Dr. Gerberding cautioned that this step, which requires patients to sign consent forms warning them of possible adverse effects, may make patients reluctant to roll up their sleeves.

However, the National Institute of Allergy and Infectious Diseases has begun a month-long clinical trial to gather the safety and efficacy information necessary to license the vaccine here.

The trial will enroll 1,000 healthy adults who have not had a flu shot this year.

Fluarix will be distributed by the CDC to areas that still need it, said Thompson, who also praised the health community for an "outstanding job" in making sure the 58 million doses of injectable vaccine and 3 million doses of inhaled vaccine that were available went to those most in need.

The nation's physicians had expected about 100 million doses of the vaccine, but the Chiron Corp., one of only two U.S.-licensed manufacturers of injectable vaccine, was unable to deliver its 48 million doses because of a contamination problem at its Liverpool, England, plant.

The problems associated with redistributing the flu vaccine from those who had received all they had ordered from Aventis Pasteur to those who had received none led the CDC to assemble a panel of ethicists to help sort through the allocation issues.

The group debated whether to further prioritize those who should have the shot, since physicians and public health clinics didn't have enough vaccine for patients who were designated by the CDC as being most in need.

Although the CDC decided to continue to leave the matter of subpriorities in the hands of private physicians and state and local health departments, the agency determined that a permanent working group of ethicists should be appointed to advise the agency on any number of similarly thorny issues that are likely to arise suddenly.

While the CDC had assembled such panels in the past to help sort through public health issues, a recent change of directors and a general reorganization resulted in the ethics committee falling through the cracks, said Dixie Snider, MD, the CDC's chief science officer. The agency is now reading resumes of about 50 ethicists to select a group of five to eight who will serve as a working group of the CDC director's advisory committee, said Dr. Snider.

Flu vaccine may continue to be a topic of discussion because, given Chiron's troubles, there may be ongoing shortages, said Dr. Snider.

"Suppose we have a shortage again next year," Dr. Snider said. "What lessons did we learn this year and what does ethics have to inform us about how we might do our allocation? Will we do it the same way or would setting subpriorities be meaningful and useful?"

The AMA also adopted several new policies at its Interim Meeting aimed at mitigating future vaccine shortages. "We can use what we've learned from this year's flu vaccine shortage to help enact overall improvements in the way we deliver all vaccines," said AMA President John C. Nelson, MD, MPH.

New policies call for the AMA to work with its partners to achieve strong adult and adolescent immunization programs, thus supporting ongoing demand for vaccines and stability in the supply. The AMA also called for improvements in the public health infrastructure and greater incentives to encourage manufacturers to produce vaccines. The Association urged that physicians be allowed to form purchasing alliances that would enable them to compete with pharmacies and grocery chain stores for vaccine.

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External links

Highlights of vaccine news from the AMA Interim Meeting (link)

Vaccine-related actions, Reference Committee J, AMA Interim Meeting (link)

The 2004 National Influenza Vaccine Summit, co-sponsored by the American Medical Association and the Centers for Disease Control and Prevention (link)

The Centers for Disease Control and Prevention on the current flu season (link)

U.S. Dept. of Health and Human Services on flu vaccine and flu prevention (link)

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