HHS Will Import Up To 4M German-Made Doses of the Flu Vaccine

After receiving FDA approval, HHS officials have agreed to purchase 1.2 million doses of GlaxoSmithKline's flu vaccine Fluarix -- manufactured at a plant in Germany -- to compensate for an unexpected national flu vaccine shortage, and the department could purchase an additional 2.8 million doses "if demand for flu shots remains high," the Atlanta Journal-Constitution reports. However, Canada-based ID Biomedical, which has been negotiating with U.S. public health officials since October over the purchase of an additional 1.2 million doses, on Tuesday announced that the company will not provide any doses to the United States this season, reserving them instead for Canadian residents in case of an unexpected increase in demand (McKenna, Atlanta Journal-Constitution, 12/8). The U.S. flu vaccine shortage emerged in October when California-based Chiron announced that the British Medicines and Healthcare Products Regulatory Agency suspended the company's manufacturing license at a Liverpool, England, plant that produces about half of the United States' flu vaccine supply. As a result, Chiron will not ship any flu vaccine to the United States this season. U.S. officials expected to have about 100 million flu vaccine doses this year. France-based Aventis Pasteur has provided the United States with 58 million flu vaccine doses, and Maryland-based MedImmune provided about three million doses of the nasal-spray flu vaccine FluMist (Kaiser Daily Health Policy Report, 12/7).

CDC Distribution
The GSK vaccine, which is not licensed in the United States but was approved by FDA under an investigational new drug application, will be sent to CDC for distribution to areas in the United States experiencing the most acute shortage, HHS Secretary Tommy Thompson said in a news conference Tuesday. CDC is weighing whether to ship the vaccine to state health departments -- as it has done with other additional doses acquired throughout the shortage -- and will announce a distribution plan in the next few days, according to Ray Strikas of CDC's National Immunization Program. Thompson also said that HHS officials are negotiating with two other firms in Canada and Switzerland to purchase additional doses of flu vaccine in time for the current season (Atlanta Journal-Constitution, 12/8).

Unconventional Approval
FDA approved the German-made vaccine after completing inspections of the sterility of the manufacturing plants and processes, the method used to store the vaccine and the vaccine's effectiveness against the season's current flu virus strain. The investigational new drug license eliminates the need for the vaccine to pass a 12-month licensing process but requires patients to see a doctor and sign a consent form to receive the vaccine (Kaiser Daily Health Policy Report, 12/7). GSK also will be required to monitor the use of the vaccine and report any adverse reactions to FDA officials. CDC officials will assist the company in the process, according to Thompson (Rubin, USA Today, 12/8).

Cost
The 1.2 million Fluarix doses will cost $8.4 million, and patients likely will pay $15 to $20 "in administrative costs" for the shots, according to the Washington Post. CDC flu expert Mitch Cohen said, "We still have licensed vaccine available, and it is certainly simpler to use the licensed vaccine first" (Connolly, Washington Post, 12/8).

Reaction
In the news conference, Thompson said, "This vaccine is being used in 30 other countries around the world. The expectation of increased risk from this vaccine is very low indeed" (Atlanta Journal-Constitution, 12/8). He added, "The bottom line is that this is more good news on the flu front" (Fagan, Washington Times, 12/8). New Mexico Gov. Bill Richardson (D) said the HHS purchase, "while welcome, is late and costly." He said New Mexico would "keep its options open" by continuing efforts to acquire vaccine from abroad through a partnership with Illinois and New York City (Washington Post, 12/8). Rep. Gil Gutknecht (R-Minn.) said that the announcement on Tuesday "underscores the inconsistencies of the FDA. The agency has told American consumers time and again that it is unsafe to import prescription drugs from other industrialized countries, yet they are simultaneously importing four million flu vaccinations" (Washington Times, 12/8). Rep. Rahm Emanuel (D-Ill.) said, "It's ironic the U.S. government wants to deny consumers the right to access international markets when in fact that's exactly what the federal government does when it needs Cipro or flu vaccine" (Washington Post, 12/8). Thompson said that drug reimportation -- sought by some members of Congress -- is "completely a different subject" than the HHS vaccine purchase because prescription drugs imported by U.S. residents or pharmacists would not be inspected by FDA (Washington Times, 12/8). Vanderbilt University Medical Center Chair of Infectious Diseases William Schaffner predicted that most of the imported vaccine will not be used. He said, "We'll need it if -- big if -- flu takes off this year. Absent that, I think that most of this vaccine will remain on the shelf" (USA Today, 12/8).

ID Biomedical Response
ID Biomedical officials indicated that the company originally hoped that an agreement to provide the United States with vaccine during the shortage "would help speed safety testing to enter the U.S. [flu vaccine] market on a more widespread basis next year," the AP/Las Vegas Sun reports. However, company officials recently became aware that FDA requirements would not allow for a truncated process, "so they saw no advantage in selling vaccine now," according to the AP/Sun (Meckler, AP/Las Vegas Sun, 12/7). ID Biomedical Chief Operating Officer Staph Bakali said that the company's primary obligation is to supply the Canadian government with vaccine in the event that media attention on the U.S. shortage spurs a higher-than-expected number of Canadian residents seeking vaccine. Bakali said, "ID Biomedical is a Canadian-based company and although our longer-term strategy includes a significant presence in the U.S. market, we are pleased to supply these additional doses to Canada this year. The Canadian government is our most important client and has been a long-term partner of the company" (AP/Las Vegas Sun, 12/7).

Still Looking?
According to USA Today, FDA Acting Commissioner Lester Crawford said that FDA is still in negotiations with ID Biomedical (USA Today, 12/8). The Wall Street Journal reports that Crawford said the agency had inspected ID Biomedical's Canadian manufacturing plant but required additional information from the company before it could approve the doses (Corbett Dooren, Wall Street Journal, 12/7). ID Biomedical on Monday said they expect to have a license to sell vaccine in the United States by 2007; however, according to the AP/Sun, "they hope an accelerated approval process might allow it in time for the 2005-06 flu season" (AP/Las Vegas Sun, 12/7). ID Biomedical officials on Monday announced that the company has an agreement with wholesalers Henry Schien, AmerisourceBergen and McKesson to sell vaccine once it receives full FDA approval. The deal could be contracted through 2015. If the vaccine is available by the 2007-2008 flu season, company officials have said the agreement could reach $2.3 billion. If the FDA grants the vaccine accelerated approval, the company plans to supply 10 million to 15 million doses of flu vaccine to the United States next year, 20 million to 25 million doses the next season and at least 38 million doses in subsequent years (Kaiser Daily Health Policy Report, 12/7).

Illinois' Request Under Consideration
Thompson on Tuesday said that no decision has been made on Illinois Gov. Rod Blagojevich's (D) proposal -- announced in late October -- to purchase 650,000 doses of flu vaccine from European wholesalers (Bush/Chase, Chicago Tribune, 12/8). New York City and New Mexico officials have partnered with Illinois in the request. Blagojevich said he has negotiated with wholesalers to pay $7 per dose (Kaiser Daily Health Policy Report, 12/6). Blagojevich "remained optimistic" that officials would approve about 200,000 of the doses he has negotiated for because they are coming from the same German plant as the vaccine HHS purchased, according to the Tribune. Health officials have said the state currently has enough vaccine to inoculate high-risk state residents, though some doctors "still face a shortage," the Tribune reports. Blagojevich said, "We just need to put more pressure on Aventis" -- the other manufacturer involved in the Illinois request -- "and they need to give the FDA what they're asking for. I hope this is not being used as some sort of political statement" (Chicago Tribune, 12/8).

Congressional Memo
In a House Government Reform Committee memo released Tuesday, Democratic legislators accused Crawford of distorting facts to minimize FDA's apparent responsibility for the vaccine shortage. According to USA Today, the memo cites Crawford's testimony before the committee on Nov. 17 and 18 as evasive and contradictory to FDA documents and statements. Drew Crockett, a spokesperson for Republicans on the committee, called the memo "a regurgitation of the accusations made at the last flu hearing" (USA Today, 12/8).

Chiron Suspension Extended
British regulators extended for three additional months the suspension of the Chiron Liverpool plant's manufacturing license, "heightening concern about another vaccine shortage next year," the Los Angeles Times reports. A spokesperson for FDA said that the extension was planned and that the work necessary to reopen the plant is "not insignificant" (Gellene/Peterson, Los Angeles Times, 12/8). An HHS spokesperson said the extension was not the result of new findings and added that FDA and MHRA officials would visit the factory soon to verify the progress. The spokesperson said, "The suspension can be lifted at any time if Chiron is able to satisfy (authorities) that it has rectified the site's problems" (Wall Street Journal, 12/8). Chiron has four weeks to contest the extension, but company officials said they do not plan to do so. It is unclear whether the company will be able to supply vaccine for the 2005-06 flu season. Sanford Bernstein analyst Geoffrey Porges said that he doubted that Chiron could find a buyer for its vaccine if it is not available until November 2005. Porges said, "The company should clear the air on this and say they'll be out of the business for the next eight or nine months" (Los Angeles Times, 12/8).

Broadcast Coverage
CNN's "Wolf Blitzer Reports" on Tuesday reported on the U.S. purchase of German-made flu vaccine. The segment includes comments from Crawford; Thompson; and Dr. Mark Siegel, a physician who has rationed the flu vaccine (Snow, "Wolf Blitzer Reports," CNN, 12/7). The complete transcript is available online.