US Imports Flu Vaccine From Germany

Faced with an acute shortage of the flu vaccine, US health officials approved the importation of up to four million shot doses from Europe on Tuesday. The decision came after the Food and Drug Administration ruled on the vaccine Fluarix produced in Dresden, Germany by Britain’s GlaxoSmithKline PLC. Since no application had been made for Fluarix to be marketed in the United States – a process that takes at least a year before being cleared for widespread use – it will only be offered as an experimental medicine. People who receive the shot will have to sign a waiver stating that they are aware that the vaccine – which has not gone through the FDA’s rigorous drug-testing process – could entail risks. However, FDA officials have inspected the German plant and are confident the shots, which are approved in 30 countries, are safe and effective. Health and Human Services Secretary Tommy Thompson told a news conference the US government would immediately buy 1.2 million doses and distribute them to needy areas while the British pharmaceutical company agreed to produce three million more in its German factory for availability at a later date.