Vaccine reallocation leaves doctors with tough choices

Physicians are having to prioritize their high-risk patients for flu shots, and some are using novel methods to stretch supplies.

By Victoria Stagg Elliott — Posted Nov. 22, 2004

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David L. Bramm, MD, a family physician in Huntsville, Ala., hasn't given his wife a flu shot, although he received one himself. His nurses all got the vaccine, but their healthy children didn't, in accordance with recommendations issued by the Centers for Disease Control and Prevention after one manufacturer experienced contamination problems affecting 46 million to 48 million doses.

These were the easier decisions to make when it came to doling out the 50 shots he shared with the three other physicians in his group practice. This flu shot tally is far short of the several hundred expected -- leaving the group with more high-risk patients than vaccine. The hard part has been to decide who among these patients should be at the front of the line.

"We targeted our supplies to employees and our sickest patients, and we don't have any left," he said.

Dr. Bramm is one of the many physicians across the country struggling with this year's unusual situation. After Chiron Corp.'s Oct. 5 announcement that it would not be shipping any vaccine for the 2004-05 flu season, the other two manufacturers ramped up their production. Still, the new total will be far below the nearly 100 million doses initially predicted.

Now, more than 58 million doses of injectable and 3 million nasal vaccines will be available this flu season. Aventis Pasteur has been shipping doses of the injectable vaccine to those identified as serving high-risk populations, in accordance with a reallocation plan worked out by the CDC, manufacturers and others. All of the first million doses of the nasal vaccine have been distributed, but another 2 million are expected in mid-November.

"We are and will continue to take all the steps possible to get vaccine out in an equitable way to those who need it most," said CDC director Julie Gerberding, MD, MPH.

Many physicians praised the reallocation plan, but were frustrated by this year's challenge.

"My compliment is to the concept. It's a great idea, but logistically it's been very difficult," said Mitchell B. Miller, MD, a family physician from Virginia Beach, Va., and immediate past president of the Medical Society of Virginia, who has yet to receive any vaccine.

Public health officials advised physicians not to give up as they try to identify coverage gaps and fill them.

"We understand their frustration, and we hope they have made sure that the entity they ordered it from carries the message that they need x number of vaccines for their high-risk patients," said Raymond Strikas, MD, associate director for adult immunization at the CDC's National Immunization Program. "Also, you can let public health officials know that you're waiting for vaccine. They may not have any to share now, but they may later."

Following the guidelines

Physicians are also struggling with unprecedented demand for a product that in some years is hard to give away. Several municipalities have even made giving the flu shot to someone who is not at high risk a misdemeanor. Such rules will give physicians more power to say no.

"The CDC guidelines and the flu vaccine shortage put physicians and other providers in a difficult situation," said AMA Trustee Ronald M. Davis, MD. "It's difficult to say no, but they can say that they have to comply with this state public health order or be thrown in jail."

The AMA has long been a leader regarding issues related to flu vaccine supply and demand by hosting, in conjunction with the CDC, an annual Flu Vaccine Summit.

Meanwhile, some physicians are using unusual means to stretch what they have. Mary Morris, MD, an internist and allergist in La Crosse, Wis., received about 200 doses but ordered about 900. She has been injecting her patients with a one-fifth dose into the skin rather than the recommended full dose into the muscle. She learned this method from her physician father, who used the technique during the 1957 influenza epidemic.

"When we're so short on vaccine, it's either not have enough to do most of the people or do it this way and cover a lot larger group of people," she said.

The approach does have some scientific backing from several studies over the past 30 years. Most recently, two reports published in November in the New England Journal of Medicine found that it could elicit an antibody response equivalent to the traditional method in those ages 18 to 60, although it was less successful in older patients.

But public health officials acknowledge that the data are intriguing although not strong enough to make a recommendation.

"It's too premature, and these are small studies looking at healthy people," said Dr. Strikas. "There's more work to be done."

For this year, however, most flu watchers are praying for an easy season. At press time, sporadic activity had been reported in 17 states.

But there also may be a silver lining. After years of flu-shot difficulties, this situation may finally trigger decisive action to restructure the distribution system as well as shortfalls in the supplies of many other vaccines and medications.

"The magnitude of the issue this year is going to force the kind of policy decisions that have been needed to be addressed for some time, said Pat Libbey, executive director of the National Assn. of County and City Health Officials.

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Dispelling Internet flu myths

Myth: All of the flu vaccine is tainted, so nobody should get the shot.
Truth: The Food and Drug Administration has not found any problems with the injectable version produced by Aventis Pasteur or the nasal one produced by MedImmune Inc.

Myth: The shortage itself is a hoax. There is plenty of vaccine.
Truth: 58 million doses of the injectable and 3 million of the nasal vaccine are expected to be produced before the end of January. The United States used just over 86 million doses last year and was expecting nearly 100 million for this year.

Myth: The shortage is the fault of former vice presidential hopeful Sen. John Edwards, who filed a lawsuit in the late 1980s on behalf of a North Carolina man who caught the flu despite having received the shot. The man was awarded $5 million. After that case, most U.S. companies left the market.
Truth: According to Edwards' office, he never filed such a lawsuit. Independent investigations have been unable to find any official record of said case.

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External links

Influenza vaccine supply update from the AMA (link)

Centers for Disease Control and Prevention on the 2004-05 flu vaccine shortage (link)

"Serum Antibody Responses after Intradermal Vaccination against Influenza," abstract, New England Journal of Medicine, Nov. 25, published online Nov. 3 (link)

"Dose Sparing with Intradermal Injection of Influenza Vaccine," abstract, New England Journal of Medicine, Nov. 25, published online Nov. 3 (link)

"Intradermal Influenza Vaccination -- Can Less Be More?," abstract, New England Journal of Medicine, Nov. 25, published online Nov. 3 (link)

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