The United States attorney’s office has opened an investigation into last week’s closure of a Liverpool factory that led to a drastic shortage in flu vaccines in the US and Britain.
British authorities suspended the plant’s licence for three months following the announcement in August that a batch of flu vaccines had been contaminated.
Chiron, the American owner of the factory, said it had received a subpoena from the US attorney’s office in New York requesting documents related to its flu vaccine, Fluvirin. The subpoena also seeks information on the suspension of the licence by Britain’s Medicines and Healthcare Products Regulatory Agency. The company would give no further details.
The suspension led to the loss of 46-million to 48-million doses of flu vaccine — almost half the US supply — creating a potential crisis as winter approaches. The other supplier is the French group Sanofi-Aventis.
The US has asked people at lower risk to leave supplies for the more vulnerable, including the elderly. GlaxoSmithKline said this week it was in talks with regulators to sell its flu vaccine in the US.
Analysts said the inquiry could focus on how promptly the firm disclosed the problems or on quality control at its plants. California-based Chiron acquired the plant as part of its takeover of PowderJect Pharmaceuticals in June 2003.
The suspension of the British licence has led to hand-wringing in the US over why the food and drug administration did not act earlier. The FDA has rejected reports that it knew, or should have known, about the plant’s problems. – Guardian Unlimited Â