Doctors hit with flu vaccine delays, distribution hiccups

Large numbers of doses might be delivered before the season's end, but physicians say they'll believe it when they see it.

By Victoria Stagg Elliott — Posted Nov. 7, 2005

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After last season's flu vaccine debacle, internist Yuan-Po Tu, MD, hedged his bets.

Last time, nearly all of the more than 20,000 doses of vaccine he ordered for Washington state's Everett Clinic, where he is a staff physician, were supposed to come from Chiron Corp. Ultimately, though, his multispecialty clinic received only about 1,000 shots as part of a reallocation of available supplies in December 2004.

This year he ordered from wherever he could. As of mid-October, he had gotten nearly 8,000 doses from Sanofi Pasteur and GlaxoSmithKline. The thousands of doses he ordered from Chiron have been promised, although it is unclear when they will arrive.

"We're sitting on pins and needles waiting for Chiron to release," Dr. Tu said. "And I won't believe they're providing flu vaccine until I see the whites of the vials in my office."

Despite predictions that this year's flu vaccine supplies would be plentiful, physicians and public health officials are realizing that such forecasts are not so straightforward. Eventually the supply might be ample, but it hasn't been yet.

"It seems we have another year where influenza vaccine is a challenge," said Raymond Strikas, MD, associate director for adult immunization at the Centers for Disease Control and Prevention, during an October conference call to update physicians.

Few physicians have all they ordered. Many have some. Others have none at all.

"People need to remember who they ordered vaccine from," Dr. Strikas said. "If you ordered from Chiron or a company that uses Chiron vaccine, you won't have received vaccine yet, unfortunately."

Last year, nearly half the expected supply was lost mid-season when Chiron was forced to scrap its lots because of contamination problems. This year, Chiron is back in the market, albeit late because of the efforts required to change the production process to get official approval. The Food and Drug Administration gave the go-ahead to distribute the company's first 1.5 million doses last month. More doses are expected.

At press time, however, it was still unclear how many this company will provide. CEO Howard Pien said during an investor conference call that it would be fewer than the 18 million doses previously announced.

Meanwhile, physicians have expressed significant frustration over the lack of information about when Chiron's doses will arrive in their offices and how much there will be. Many were hesitant to order from the company because of last season's problems.

But they felt they had little choice because Sanofi, the biggest player in the flu vaccine market with the longest record of reliability, capped orders based on amounts purchased in previous years and other factors. Their total expected supply also was fully booked within days of beginning to take orders earlier this year.

"[Sanofi] would not take the order," said Mark Krotowski, MD, a family physician in Brooklyn, New York, who ordered 200 doses for his practice from a distributor working with Chiron, and is also on Sanofi's waiting list. He has yet to receive any.

By far the biggest frustration is less about the actual number of doses than about timing. Public health officials long have sung the merits of administering late-season vaccine, and physicians agree that, healthwise, it makes sense. But they add that it's a hard sell.

"The vaccine is nonreturnable, and there's no guaranteed delivery date," Dr. Tu said. "We usually move vaccine in October. It's impossible after Thanksgiving, and you can't give it away after Christmas."

Physician frustration

But while vaccine from Chiron remains a wild card, the other companies appear to be doing better.

GSK has manufactured 8 million doses for the U.S. market -- all of which is on the way to physicians or already has arrived.

Medimmune also is providing slightly more than 3 million doses of the nasal version.

Sanofi has been shipping since early August and will have shipped 45 million doses before the end of October, with 95% of customers receiving at least part of their order, according to company spokesman Len Lavenda. Another 15 million doses are expected to go out in November.

But while physicians are frustrated with the fact that they might or might not have influenza vaccine supplies when they need it, their angst is amplified by the perception that those who provide vaccine in community settings such as grocery stores and pharmacies have plenty.

"[The distributor] keeps saying 'next week.' It's driving me bonkers," said Ruben Caride, MD, an internist in Miami who ordered 100 shots for his practice. "My patients are calling me, and I feel like a jerk telling them they're going to have to get it from the drug store."

Those who provide flu shots in such settings countered that the fact that these clinics are in a public space creates a perception of bountiful supplies of vaccine. But this impression is not necessarily accurate.

"We all wish there was more vaccine earlier in the season. We are all very frustrated with the lack of information coming from Chiron at this point," said Steve Wright, national director of wellness services at Maxim Health Systems.

"And there are not unlimited supplies on this side of the fence either," he added. Maxim has received less than 50% of the 2 million to 3 million doses ordered and provides shots in retail settings as well as assisted-living and senior centers.

Equitable distribution has long been a concern of those working on supply issues, such as members of the National Influenza Vaccine Summit, which is organized annually by the American Medical Association and the Centers for Disease Control and Prevention.

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Patient demand for antivirals increases

The patient was in tears when she called Frank Landry, MD, MPH, her longtime internist in Burlington, Vt., from Hong Kong. She traveled to Asia frequently and, with the media filled with reports of avian influenza, she was terrified. So, he wrote her a prescription for oseltamivir (Tamiflu) just in case. A couple of other patients who rarely left the state also requested the same. To them, he said no.

"She was scared to death, and it seemed appropriate. She does have potential exposure," he said. "If you're sitting at home, it doesn't make a lot of sense. It may expire before you can use it."

Dr. Landry is one of many physicians having to deal with increasing requests for antivirals as some patients decide to stock up in case avian influenza strikes. According to IMS Health, a pharmaceutical market research and consulting firm, the number of prescriptions written for oseltamivir from January to August 2005 increased 544% over the same period in 2004.

This phenomenon, however, is causing public health officials a great deal of concern, particularly because avian influenza may be developing resistance. According to a brief report in the October issue of the journal Nature, a resistant strain of this virus was isolated from a Vietnamese girl who was given prophylactic doses and then went onto develop a full-blown case of avian flu.

Public health officials are asking that physicians be prudent about writing these prescriptions and be sure that no patients receive the drugs without being instructed about how and when to take them.

"We have not recommended that any antiviral drug be purchased and held by the public," said Raymond Strikas, MD, associate director for adult immunization at the Centers for Disease Control and Prevention. "Right now this is better done in consultation with a physician."

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External links

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

A range of influenza resources from the CDC (link)

Influenza Vaccine Lot Release Status, Food and Drug Administration (link)

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