As Demand Wanes For Swine Flu Vaccine, Questions Rise On Unfilled Orders

A syringe and vials of swine flu vaccine at a hospital in Essen, Germany, last year. i

A syringe and vials of swine flu vaccine at a hospital in Essen, Germany, last year. Martin Meissner/AP hide caption

itoggle caption Martin Meissner/AP
A syringe and vials of swine flu vaccine at a hospital in Essen, Germany, last year.

A syringe and vials of swine flu vaccine at a hospital in Essen, Germany, last year.

Martin Meissner/AP

In Europe the backlash against what critics call "the false pandemic" is in full cry. The World Health Organization is under fire for hyping the danger to enrich makers of pandemic flu vaccine.

Governments all across Europe are canceling orders of swine flu vaccine as frantically as they were clamoring for it a few month ago. In America, not so much. Or at least not yet.

The U.S. is calmly proceeding with National Influenza Vaccination Week, an annual event. The government is thinking about how much more swine flu vaccine to order up and pay for. But Health and Human Services spokesman Bill Hall says any decision to scale back vaccine orders is "weeks away."

Let's take stock. Last spring the US government signed contracts for $1.5 billion worth of vaccine against the novel H1N1 virus—251 million doses. So far, 55 percent of that amount has been shipped, and something like 60 million Americans have been vaccinated. That leaves 45 percent of the contracted-for vaccine yet to be delivered. That's 115 doses, worth about $675 million.

Who's on the hook for that? Is it the U.S. government, which pushed vaccine makers to stretch their capacity to the limit last summer? Or will it be the companies who willingly took the gamble that somehow they'd be compensated for all that vaccine?

It all depends on when the US government tells vaccine makers to stop producing "bulk antigen," the raw material of vaccines, and when to stop "filling and finishing," that is, putting the finished vaccine into vials for shipment.

Federal officials say the contracts they signed last summer give them the right to tell a company to halt either of those orders at any time. Once the "stop" button is pushed, the government doesn't have to pay any more, they say.

Dr. Bruce Gellin, director of the National Vaccine Program Office, says there's still time to make that decision, based on how many more Americans seek vaccination and whether there's a third wave of swine flu this winter and early spring. "We still have vaccine coming in, they're still making vaccine, and we still have demand out there," Gellin says. "So we need to be further along before we know what the final picture may be."

But some vaccine makers say it's too late for the government to stop payment. "We are nearing the completion of orders for the U.S. government," says Donna Cary, a spokeswoman for Sanofi Pasteur, one of the five pandemic flu vaccine makers that signed contracts to supply the US market. "The bulk of it has been shipped."

Similarly, MedImmune, maker of FluMist, the nasal spray vaccine, says it's already completed manufacture of the 42 million doses worth of bulk vaccine the US government has contracted for.

Will any vaccine makers be stuck with vaccine they can't sell — and that the government won't pay for? "I can't say," Gellin says. "It may vary company by company. That's a trickier question to answer, and particularly to say it about all companies."

But there are two places companies might unload unused vaccine.The U.S. government is prepared to buy 25 million doses for developing countries where pandemic flu is still spreading fast.

And the bulk vaccine that hasn't been put into vials might be saved for next fall's seasonal flu vaccine—as long as the virus doesn't change too much. If it does, all that excess vaccine would be worthless.



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