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    Wednesday, February 01, 2006

    Flu Blues II: Sanofi-Pasteur has sold out of next year's flu vaccine already. From their vaccine ordering website:

    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 except its no preservative Fluzone vaccine in pediatric doses. Sanofi pasteur anticipated a surge in demand for its influenza vaccine and doubled the capacity of its phone lines and on-line ordering systems. Under normal conditions, the company receives an average of 1,500 customer calls per day. During the eight-hour period from noon to 8 PM yesterday, the company received as many calls as it normally receives in a six-month period.

    The company plans to produce approximately 50 million doses of all Fluzone vaccine formulations for U.S. distribution by the end of October. Additional doses could be produced for delivery in November or December based on customer needs and production yields. To determine customer need, sanofi pasteur established a waiting list of customers who were unable to prebook and will contact those providers to offer the alternative of accepting later delivery. Customers willing to accept later delivery will have the option to cancel their request later in the year if they are able to obtain earlier delivery from another supplier. At this time, the company is no longer accepting additional customers on the waiting list.

    The company is currently unable to supply the entire U.S. influenza vaccine market. However, based on public statements made by other influenza vaccine manufacturers, the company anticipates that there will be an adequate supply of vaccine to meet the nation’s needs for the 2006-2007 season. Sanofi pasteur is sending apologies to its customers for the frustration they experienced in attempting to place their requests. Immunization providers who were unable to prebook their vaccine with sanofi pasteur will likely be able to look to other manufacturers to meet their vaccine needs.

    One of those other manufacturers would be Chiron, which had production problems for the past two years, and which this year, shipped their product to their big customers (chain stores, etc.) before they shipped it to their physician customers. (But whose distributors are still taking orders for next year's vaccine.) I know doctors who didn't recieve their order until the end of December. By that time, most of their patients had gotten the vaccine elsewhere. That left one group practice with a $20,000 loss. Would you want to order from that company again? Or even take a chance on purchasing the flu vaccine at all?

    One reason that Sanof-Pasteur had such a quick run is that they have been reliable about delivering the vaccine to all its customers regardless of size, and because they haven't had the history of production problems that Chiron has had.

    GlaxoSmithKline also has a flu vaccine, although it was approved under an accelerated FDA program, which leaves some physicians a little leary of it (including this one). Just how "accelerated" was the approval process and what steps got skipped?

    Accelerated approval allows products that treat serious or life-threatening illnesses to be approved based on successfully achieving an endpoint that is reasonably likely to predict ultimate clinical benefit, usually one that can be studied more rapidly than showing protection against disease. In this case, the manufacturer demonstrated that after vaccination with Fluarix adults made levels of protective antibodies in the blood that FDA believes are likely to be effective in preventing flu. GlaxoSmithKline, the manufacturer of Fluarix, will do further clinical studies as part of the accelerated approval process to verify the clinical benefit of the vaccine.

    A few too many "believe's" and "likely's" in their for my comfort.

    UPDATE: Here's more on the surge:

    A flurry of physicians attempting to order influenza vaccine for the 2006-07 flu season directly from manufacturer sanofi pasteur temporarily "maxed out" the Web servers supporting the company's VaccineShoppe.com site Jan. 31, according to John Zahradnik, M.D., sanofi pasteur's director of immunization policy.

    The ordering frenzy that followed sanofi pasteur's previously announced noon EST opening of physician prebooking for next season's flu vaccine also overloaded the company's toll-free ordering phone lines, despite the addition of extra staff to handle the anticipated greater volume.

    The result: Many would-be visitors to the Web site couldn't get through, especially early in the afternoon. Some switched to the phone lines and succeeded in their efforts to prebook vaccine; others still could not make those connections. Members of the Academy's Influenza Vaccine Task Force reported mixed results when they tried to order vaccine from sanofi pasteur that day. Those who eventually succeeded in prebooking vaccine using one or the other method typically did so only later that evening.

    The distribution system, obviously, continues to be imperfect:

    "It's an indication that this whole system of flu vaccine production, purchasing and distribution -- from egg to arm -- doesn't work. The entire ordering process needs to be examined, with preference given to those who serve high-risk patients -- physicians, hospitals and long-term care facilities.

    "This is just another example of the larger fact that this system isn't working. The manufacturers, distributors, CDC and organized medicine are going to have to work out a better system for getting influenza vaccine into the hands of physicians."

    I think we have to face it. We simply don't have the ability to make enough flu vaccine for everyone. Maybe we need to go back to just recommending it for those who are at true risk from influenza. And just missing a few days from work doesn't count as risk.

    posted by Sydney on 2/01/2006 10:14:00 PM 0 comments


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