Flu Vaccine Fiasco

The 2005-06 flu season has barely begun in the Eastern U.S., yet NEXT year’s vaccine supply is already “sold out,” according to its manufacturer. How did this happen (again)?

I’m going to try very hard to stick to the facts here. Doing my own investigative journalism is not what I intended in starting this blog, but I’m so outraged by the flu vaccine fiasco, that I’m left with no choice. So, here’s the story. I apologize for being long-winded, but stay with me, it’s important:

1. The CDC and AAP recommend that all children between 6-24 months receive a flu vaccine. We can certainly debate this for a while, but it’s a fact.

2. Sanofi Pasteur (formerly Aventis Pasteur) makes the only commercially available flu vaccine for children in the US. According their own web site (highlights are mine):

Our Vision is of a world in which no one suffers or dies from a vaccine-preventable disease.

Our Mission is to protect and improve human health worldwide by providing superior, innovative vaccines for the prevention and treatment of disease and by playing an active role in the Immunization Community to
maximize vaccination.

3. In a press release dated March, 2005, Sanofi announces that their “new formulation (trade name: Fluzone®, Influenza Virus Vaccine, No Preservative) will be the only injectable influenza vaccine approved by the FDA that does not introduce a preservative at any stage in the manufacturing process.” Great news for anti-thimerosal advocates. In fact, several states have already enacted legislation to ban the use of thimerosal-containing vaccines, and others are in the process of doing so; Congress may also act to ban thimerosal vaccine nationally.

4. Over the past few years, we’ve all heard the promises from Sanofi and from our government that we won’t have to deal with flu vaccine shortages again – yet each year, we do. So, Sanofi announces that this year, they’ll “pre-book” vaccine orders beginning on January 31 (last Tuesday) for the 2006-07 flu season (nearly a year ahead of time) in order to produce enough vaccine (at least that’s what we all thought). After all, more vaccines=more dollars, no? In fact, the preservative-free versions cost more per dose than the thimerosal versions.

5. My office calls (like many others) on January 31 to prebook. Busy signal all day. All day – like a Stones concert. Tried the web (www.vaccineshoppe.com) – can’t get through. Apparently we’re not alone. Call our local Sanofi office rep on Wednesday AM – she says she’ll take our order – but not sure what’ll happen to it. No one calls us back. By Friday, we’ve established that the entire allotment of flu vaccine wass “sold out” – booked – on the 31st – the very first day we were allowed to prebook.

6. Sanofi Press Release, dated 2/1/06:

Swiftwater, PA – February 1, 2006 – Recognizing Sanofi Pasteur Inc. as a reliable supplier of influenza vaccine, immunization providers contacted the company in record numbers yesterday requesting Fluzone®, Influenza Virus Vaccine for the 2006-2007 season. During the first 30 minutes of accepting

prebooking requests, the company received over 40,000 phone calls and more than 200,000 calls came in during the first eight hours.
As a result of the unprecedented demand, the company has committed all influenza vaccine doses planned for production for the next season.

There’s a note in the press release that’s misworded – leads you to believe they actually have more PRESERVATIVE-FREE vaccine to book, when in reality, those small supplies were reserved well before the multi-dose regular vaccine. At least according to my sources at Sanofi. One can only hope one hand doesn’t know what the other is doing and that there will indeed be more supply.

How does Sanofi reconcile this fiasco with their vision and mission statements, to “maximize vaccination” in “a world in which no one suffers or dies from a vaccine-preventable disease”? Millions of children (and adults at risk) will be left unprotected against flu this coming winter. Even worse, countless others will receive thimerosal-containing vaccine simply because the company will not make enough preservative-free vaccine to meet demand. Whether or not you believe it is necessary to avoid injecting thimerosal into babies, this “here-we-go-again” feeling has to disturb you. Make your voice heard, and spread the word – to patients, media, Congress, and of course, Sanofi.


  1. From “The Bergen Record” (NJ):
    Flu shots already short for next season
    Wednesday, February 8, 2006
    Dr. Lawrence Rosen didn’t receive enough vaccine for this year’s flu season — and now the Old Tappan pediatrician is unlikely to get enough for next season.
    Pennsylvania-based drug manufacturer Sanofi Pasteur Inc. has notified Rosen, the four other pediatricians and three internists in his practice that, because of a record surge in orders, it has already sold all of the flu vaccine it expects to make for the 2006-07 season.
    “I’ve been unable to reach anyone at Sanofi’s home office,” said Rosen, who also is director of pediatrics at Pascack Valley Hospital in Westwood. “There’s no response. It’s frustrating.”
    Rosen last talked to the company Friday, placing an order for only a third of the vaccine he estimates his practice will need next season.
    “They’re obviously overwhelmed, and they haven’t even started production,” Rosen said of Sanofi and its 2006-07 flu vaccine.
    Only one of 20 practices in the country on Rosen’s computer list was able to reserve its full order from Sanofi, he said.
    Thousands of calls
    The manufacturer received 400,000 calls last week from health care providers attempting to reserve vaccine — more than it normally receives in a year, spokesman Len Lavenda said.
    “By the end of the first day, we actually spoke to over 20,000 customers,” Lavenda said in a phone interview Tuesday. “We pre-booked all the vaccine we had available,” except for some remaining pediatric vaccine, he said. The company will produce 50 million doses for next season.
    Americans should not worry, however, because other drug manufacturers and distributors will take up the slack, federal vaccine officials said Tuesday.
    “We recognize that not all providers were able to pre-book with Sanofi,” said Mitchel C. Rothholz of the National Influenza Vaccine Summit in Atlanta. The Summit is an initiative co-sponsored by the federal Centers for Disease Control and Prevention and the American Medical Association.
    “But we are encouraged that an estimated 120 million doses of influenza vaccine — the greatest number of doses in our country’s history — are expected to be available for the 2006-2007 season,” Rothholz, a pharmacist, said in a statement.
    “We see this unprecedented early demand as proof of the public’s growing awareness of the importance of obtaining vaccination for influenza,” he said.
    Injectable flu vaccine will also be produced by Chiron Corp. and GlaxoSmithKline, and MedImmune will supply a nasal vaccine, Rothholz said.
    Production in spring
    Because flu viruses change each year, manufacturers usually begin producing vaccine in the spring after federal health officials determine which three viral strains — one new and two from the previous season — are most likely to appear next season.
    Health care providers may want to split their vaccine orders among distributors to ensure they get what they need, especially for people considered to be at high risk, including the elderly, Rothholz said.
    Rosen, the Old Tappan pediatrician, said this is the fourth year he has had difficulty getting flu vaccine.
    “We gave 600 doses to children, but we were short about 200 doses,” he said.
    This season isn’t over, and next season is already a problem, he said.
    600 doses short
    Physicians and other health care providers traditionally order vaccine in January for the following fall.
    “We were told Jan. 31 was the first day you could place requests,” Rosen said. “But nobody could get through.
    “My understanding [was] demand was up, so they wanted to do a pre-booking to gauge demand and supply. Apparently there is a capacity of what they can make. They do not have the ability to supply the entire country with flu vaccine.”
    Rosen, who uses only vaccine without the mercury preservative thimerosal, said he was able to order 300 doses from Sanofi on Friday, 600 doses short of what he needs.
    “I’m going to keep reaching out to Sanofi,” he said. “But I’m doubtful they’ll come through.”
    E-mail: groves@northjersey.com

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