Chiron Flu Vaccine Manufacturing Plant Suspension Extended, Other Companies Weigh Market Entry
British Medicines and Healthcare Products Regulatory Agency officials late Tuesday extended from January to April the suspension of the manufacturing license for Chiron's plant in Liverpool, England, possibly "jeopardizing" Chiron's ability to contribute to the U.S. flu vaccine supply next season and prompting other manufacturers to consider entering the U.S. market, the Washington Post reports (Rosenwald, Washington Post, 12/9). A U.S. flu vaccine shortage emerged in October when Chiron announced that MHRA suspended the company's Liverpool plant license over contamination issues. Chiron was expected to produce about half of the United States' flu vaccine supply for this season, but because of the suspension it will not ship any doses. U.S. officials initially anticipated having 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. HHS officials on Tuesday also agreed to import 1.2 million doses of GlaxoSmithKline's flu vaccine Fluarix, manufactured in Germany, after the vaccine received provisional FDA approval. U.S. officials could purchase an additional 2.8 million doses from GSK if demand for flu shots continues.
Regulatory officials have said that the extension of Chiron's license suspension was anticipated and was not the result of new findings. FDA and MHRA officials will visit the factory to verify its progress. The suspension could be lifted immediately if Chiron is able to show it has remedied the site's problems. Chiron has four weeks to contest the extension; however, company officials have said they do not plan to do so (California Healthline, 12/8).
An unsuccessful appeal by Chiron would extend the suspension period beyond the April date. FDA Acting Commissioner Lester Crawford next week is expected to meet with British regulators to discuss the situation. Crawford in November told a House Committee on Government Reform that FDA will inspect the plant in February or March (McKenna/Mollison, Atlanta Journal-Constitution, 12/9).
Chiron officials have said that the company must begin vaccine production in March to deliver vaccine by October and November 2005 -- the "peak vaccination months," USA Today reports. However, even if Chiron is able to resume production before April, the company's U.S. business would likely "suffer" because it has lost credibility in the U.S. market, according to USA Today (Schmit, USA Today, 12/9).
According to the Post, Chiron's future in the U.S. flu vaccine market also could be influenced by "the prospect that other companies will seek -- and win -- U.S. approval to sell their vaccines in the future" (Washington Post, 12/9).
Canada-based ID Biomedical on Monday announced that it expects to be licensed to sell vaccine in the United States by 2007. The company has an agreement with wholesalers Henry Schien, AmerisourceBergen and McKesson to sell vaccine once it receives FDA approval. The deal could be contracted through 2015 and could reach as much as $2.3 billion. If FDA grants the vaccine accelerated approval, the company next year plans to supply 10 million to 15 million doses of flu vaccine to the United States, 20 million to 25 million doses the next season and at least 38 million doses in subsequent years (California Healthline, 12/8).
Aventis officials on Wednesday said the company could increase its U.S. market production next year to 60 million doses. Analysts and health officials also on Wednesday said that the FDA's limited approval this year of GSK's Fluarix may have "cleared [a] hurdle" for the company to win a permanent U.S. license. If approved, GSK plans to sell 10 million to 20 million doses next year and has the capacity to produce additional doses. A MedImmune spokesperson on Wednesday said the company could provide as many as 10 million doses of FluMist for next season; however, the production increase is dependent on "several unresolved issues" with FDA, such as expanding regulatory approval to people ages 50 to 64, according to the Post. FluMist currently is approved for use in healthy people ages five to 49.
Chiron executives on Wednesday "said they remain optimistic" that production will begin in time for next season, the Post reports (Washington Post, 12/9). Chiron spokesperson Alison Marquiss said, "It is our aim to achieve full remediation in time for the 2005-06 flu season. We are committing sufficient resources to this matter" (Atlanta Journal-Constitution, 12/9). She added that even if the suspension continues until April, the company is only "looking at a difference of days" from its March production goal (USA Today, 12/9).
CDC spokesperson Glen Nowak said, "We would like and are hopeful that Chiron will do what it needs to do to provide flu vaccine to the United States next year" (Atlanta Journal-Constitution, 12/9). Walter Orenstein, former director of the CDC's National Immunization Program, called the suspension extension a "clearly worrisome development." However, he added, "It seems to me that the FDA is making extraordinary steps to go all out and try to get more vaccine into the U.S. system" (Washington Post, 12/9).
Analysts have "wildly different views" on the impact Chiron's suspension will have on the flu vaccine market, USA Today reports (USA Today, 12/9). Robert W Baird analyst Aaron Geist said, "Even if Chiron is able to come back on the market, we anticipate that Chiron's market share in the U.S. flu market will be lower in future years" (Bloomberg/Washington Times, 12/9).
USA Today reports that Baird sees the extension as a "formality" and believes that the company has ordered supplies to manufacture vaccine for next season. Credit Suisse First Boston said that the suspension extension "reduces the likelihood" of Chiron's participation in the market next year. Merrill Lynch last week downgraded Chiron shares to a "sell" rating and said that the company "may become the vaccine supplier of last resort" (USA Today, 12/9).