HHS Announces Purchase of Extra Doses of Flu Vaccine From Abroad
HHS Secretary Tommy Thompson announced on Tuesday that FDA has authorized the use of GlaxoSmithKline's flu vaccine Fluarix under an investigational new drug application, and HHS will purchase 1.2 million doses of the vaccine. Beginning this week, those doses will be sent to CDC for distribution to areas in the United States experiencing the most acute shortage. Under the agreement, GSK will make up to four million doses available for U.S. purchase (HHS release, 12/7).
The additional doses will mitigate a U.S. flu vaccine shortage that developed 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 doses 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.
The additional foreign doses the United States was considering purchasing were manufactured by a German GSK plant and a Canadian ID Biomedical plant, both of which FDA officials in late October began inspecting for safety. ID Biomedical officials have said they have 1.2 million doses that were manufactured in the event of an unexpected increased demand in Canada (American Health Line, 12/6).
FDA officials have completed inspections in which they examined the foreign vaccine's effectiveness against the season's current flu virus strain, the method used to store the vaccine and the sterility of the manufacturing plants and processes, according to HHS officials (Sherman, AP/Las Vegas Sun, 12/7). The investigational new drug license eliminates the need for the vaccine to pass a 12-month licensing process but requires patients to "read and sign lengthy consent forms," the Atlanta Journal-Constitution reports (McKenna, Atlanta Journal-Constitution, 12/7).
The provisional license also requires that patients see a doctor to receive the vaccine (Rubin, USA Today, 12/7). Surveys have indicated that the additional requirements could discourage some people from seeking the shot (Atlanta Journal-Constitution, 12/7).
The HHS release did not address the purchase of ID Biomedical's doses of flu vaccine (HHS release, 12/7). In a conference call with investors on Monday, ID Biomedical CEO Anthony Holler said that the company might be obligated to reserve its 1.2 million vaccine doses for the Canadian government (USA Today, 12/7). There has been no official announcement of a Canadian flu vaccine shortage, but demand has increased as U.S. residents have traveled to the country in search of the vaccine (Timmerman, Seattle Times, 12/6). Holler said, "We have recently been approached by the Canadian government to purchase these doses, as they are now short of vaccine and they are concerned there could be a spike in demand later in the season" (USA Today 12/7).
ID Biomedical President Todd Patrick said, "[A]s a Canadian company, our board believes we have an obligation to do what they want and a contractual commitment" (Seattle Times, 12/6). Public Health Agency of Canada spokesperson Aggie Adamczyk acknowledged that increased demand could lead to a Canadian shortage; however, she said that the agency has not requested the ID Biomedical doses and that Canada has "enough supply to meet the demand of the public [health] programs" (USA Today, 12/7).
CDC Director Julie Gerberding, speaking at a meeting of the American Medical Association, noted that the flu season has gotten off to a slow start, with 12 states reporting no flu activity and 35 states reporting "occasional cases" as of Nov. 27, the Journal-Constitution reports. Only New York, Minnesota and Washington state have reported "noticeable" flu activity, according to the Journal-Constitution (Atlanta Journal-Constitution, 12/7).
However, Gerberding said, "A slow start doesn't necessarily reflect a slow season." She added, "The most common month of peak activity is February." Gerberding also praised U.S. residents' "volunteerism" in foregoing the flu vaccine, saying, "The people who should step aside, stepped aside" (Odum, AP/Miami Herald, 12/6).
Officials for ID Biomedical and GSK have said they "plan to seek FDA approval to enter the U.S. [flu vaccine] market on a regular basis," USA Today reports (USA Today, 12/7). ID Biomedical 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 purchase could occur as early as 2005 and 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 (Bloomberg/New York Times, 12/7). 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 (Seattle Times, 12/6).
Robert Baird analyst Aaron Geist said such contracts could indicate that more companies will enter the U.S. flu vaccine market. CDC spokesperson Bonnie Ahebert said that it was premature to assume that the company could mitigate a U.S. flu vaccine shortage next flu season (Bernstein, Long Island Newsday, 12/6).