Physicians watchful after announced flu vaccine delay

One large manufacturer has announced sterility problems that will delay their supplies until early October. Doctors hope that will be just in time.

By Victoria Stagg Elliott — Posted Sept. 20, 2004

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When family physician James Martin, MD, heard the news that one of the two manufacturers of injectable influenza vaccine was experiencing difficulties and would delay until early October delivery of a significant portion of the 97 million expected doses, he panicked. Supply lines for recent seasons have not always been reliable, and his San Antonio medical practice hasn't always had what it needed.

"We were affected last year, pretty substantially, and when I heard, I thought, 'Oh no, we don't need that again,' " he said. "But we're in good shape."

He's one of the lucky ones. As of the end of August, his office already had received half the ordered flu vaccine, and his staff doesn't expect any delays.

Others aren't quite so fortunate.

George Voigtlander, MD, a family physician with Pawnee County Rural Health in Pawnee City, Neb., already has been told he will receive only about three-quarters of his order. When delivery will occur is also an open question.

"I'll have to wait and see what they actually do," he said. "Every year seems to be a little bit worse."

These two physicians are facing examples of the feast and famine that has come to characterize flu vaccine distribution. Some physicians have plenty, while others have none.

For this fall, millions of doses already have been delivered. Many more are on the way, but those who ordered from Chiron, the manufacturer that made news late last month with its announcement that some vaccine lots did not meet sterility specifications, probably will have to wait until the company is back on track.

With 97 million doses expected in the next months, most experts predict the situation to even out by early October when Chiron resumes deliveries, and many physicians doubt that the delay will have much impact on the season as a whole. The majority of flu vaccinations are given in October and November, so if Chiron fulfills its promise, physicians say the delay will barely be noticed.

"If that's the case, then it's probably not going to be a big problem for us," said John Voss, MD, associate professor of internal medicine at the University of Virginia Health System in Charlottesville.

But after several bumpy flu vaccine seasons characterized by shortages and delays, Chiron's self-imposed October deadline is viewed by most with hopeful optimism as well as trepidation.

"Once you have a contamination problem, sometimes it isn't as easy to fix as you think," said Donna E. Sweet, MD, professor of internal medicine at the University of Kansas.

Still, unlike delays in previous seasons, physicians say this one is being handled better, making it easier for planned vaccination clinics or campaigns to be altered as needed. Communications have improved significantly, and physicians report that, rather being told constantly that the vaccine will come "soon," they are now getting more precise information. Improved links between physicians and other vaccine providers also have created an environment in which those who have some are more likely to share with those who have none.

"The system has improved," Dr. Sweet said. "They're manufacturing more, and they're almost anticipating problems."

The situation is being monitored closely by the National Influenza Vaccine Summit organized by the American Medical Association and the Centers for Disease Control and Prevention. The summit issued a statement to members saying it was unlikely that Chiron's announced delay would create problems for the upcoming vaccination season, although some plans might have to be adjusted.

The CDC also decided against implementing the tiered vaccination recommendations used in previous years.

"This is clearly not a crisis," said AMA Trustee Ronald Davis, MD. "We have more doses being manufactured than ever before, and we should still be in good shape."

Chiron expects to manufacture between 46 and 48 million doses of vaccine, and the pediatric version of the vaccine is not affected by the delay. More than 52 million doses are expected from Aventis Pasteur. The company also announced that it is investigating the possibility of making more. Between 1 million to 2 million doses of the live, intranasal vaccine will be available during the season.

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How much vaccine and when

The trouble with the vaccine supply is not so much the amount delivered but when it arrives. Late delivery can throw vaccination efforts into chaos. Here is a breakdown of the vaccine deliveries over the past few years. All numbers are cumulative. Those for 2004-05 are projections.

Millions of doses
July Aug. Sept. Oct. Nov. Dec. Jan.
1999-2000 9.5 29.1 44.3 75.8 76.8 76.8 76.8
2000-01 2.0 7.4 16.6 26.6 48.2 70.4 70.4
2001-02 0.0 2.7 23.9 43.0 76.2 77.7 77.7
2002-03 0.0 14.5 50.7 82.7 83.0 83.0 83.0
2003-04 0.2 18.5 48.1 76.4 80.6 82.6 83.1
2004-05 0.0 5.0 23.0 88.0 97.0 97.0 97.0

Source: Information supplied to the Centers for Disease Control and Prevention by the influenza vaccine manufacturers, updated Aug. 27

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External links

Centers for Disease Control and Prevention's flu information (link)

The CDC and AMA's National Influenza Vaccine Summit (link)

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