New production logjam for H1N1swine flu vaccine

WASHINGTON - August 18, 2009

"We're trying to bring on more manufacturing" for the packaging step that has emerged as a logjam, said Dr. Robin Robinson, the Department of Health and Human Services official in charge of vaccine procurement. "Hopefully, there are ways to bring that number up."

HHS has long predicted it would have 120 million doses on hand by Oct. 15, but now expects just 45 million by that date. It now appears to be more of a delay than a shortage: More will arrive rapidly, about 20 million more doses shipped every week, by Robinson's new calculations.

If that's the case, there should be 85 million doses on hand by October's end, and the full 195 million the government has ordered by December, the long-set date for final delivery.

The nation hardly ever administers that much regular flu vaccine so early in the season, and the change won't delay plans to go ahead and start swine flu inoculations, Robinson said.

But he acknowledged that if there are early outbreaks in September and October, there could be increased demand for the swine flu vaccine.

"As we've all along said, if things can go wrong they will," Robinson said.

Manufacturers around the world revealed in July that they were having serious problems brewing shots. The chief ingredient is grown in eggs, and companies were getting far fewer doses per egg than they usually do for regular winter flu vaccine.

Health authorities have delivered new "seed strains" of the virus to manufacturers to help with that problem, Robinson said.

But in addition to the packaging logjam, other factors are adding to the delay, including:

-One manufacturer, Sanofi-Pasteur, took longer than expected to finish brewing the regular winter flu vaccine, delaying the swine flu work, Robinson said. "We knew there were problems," but only recently the extent, he said.

-Another supplier, Australia's CSL, recently notified the U.S. that its shipments will arrive later than promised because it first must provide batches to its home country, where the flu season is winding down. Although the U.S. signed a contract with CSL first, "there was always the possibility they could do that," Robinson said. "Our laws can do the same thing. We don't, but we could."

-And it took health authorities longer than anticipated to develop the tests, called reagents, required to ensure doses are at the proper strength before they're cleared for use.


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