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Pharmaceutical industry

FDA Approves Third Flu Vaccine, Boosting Country's Stockpile

Strategic Insights

— 2 min read

Federal regulators have approved a third flu vaccine for distribution to Americans, in a bid to avoid a repeat of last year's shortage. The Food and Drug Administration (FDA) has given the green light to Fluarix, made by GlaxoSmithKline in Germany, which will add at least 8 million doses to the country's stockpile. The approval brings the total doses to 61-71 million, with the Centers for Disease Control and Prevention hoping to stockpile up to 98 million doses.

Key Takeaways:

  • The FDA has approved Fluarix, a flu vaccine made by GlaxoSmithKline in Germany, which will add at least 8 million doses to the country's stockpile.
  • The approval brings the total doses to 61-71 million, with the Centers for Disease Control and Prevention hoping to stockpile up to 98 million doses.
  • Sanofi-Aventis has committed to making 50-60 million doses of its vaccine, Fluzone, while MedImmune has promised to produce 3 million doses of its vaccine, FluMist.
  • The FDA is still working with Chiron to remedy the problems at its British plant, potentially allowing it to supply its vaccine, Fluvirin.
  • Pharmaceutical companies typically avoid flu vaccine manufacturing due to low margins and high risks in testing and production, but the US government has pumped funds into research assistance to encourage manufacturing.
  • Sanofi-Aventis reported global sales of human flu vaccines at 518 million euros last year, with a market price of between $9.95 and $13.25 per shot.
  • GlaxoSmithKline has reported global sales of its Fluarix vaccine rose 38 percent last year, to 79 million euros, with a market price of between $9 and $14 per shot for the US.

Statistics:

  • 61-71 million: total doses in the country's stockpile, including the new approval of Fluarix
  • 98 million: target stockpile of doses, as reported by the Centers for Disease Control and Prevention
  • 57 million: total doses obtained by the government last year, after regulators shut down a British plant run by Chiron Corp.
  • 25-30 million: estimated doses that Chiron might supply if it remedies all its problems
  • 518 million euros: global sales of human flu vaccines made by Sanofi-Aventis last year
  • $706.6 million: global sales of human flu vaccines made by Sanofi-Aventis in year-end exchange rates last year
  • 79 million euros: global sales of Fluarix vaccine made by GlaxoSmithKline last year
  • $107.8 million: global sales of Fluarix vaccine made by GlaxoSmithKline in year-end exchange rates last year
  • 1,000: number of patients tested by GlaxoSmithKline to meet FDA safety requirements
  • 50 million-60 million: doses of Fluzone vaccine committed to be made by Sanofi-Aventis
  • 3 million: doses of FluMist vaccine promised to be produced by MedImmune

Sources:

  • The Philadelphia Inquirer, Sept. 1
  • Food and Drug Administration (FDA)
  • Centers for Disease Control and Prevention
  • GlaxoSmithKline
  • Sanofi-Aventis
  • MedImmune Vaccines Inc.
  • Chiron Corp.

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