Confirming their worst fears, public health officials said Friday that none of the flu vaccines made at a plant in England were safe to use, which means that the US has to cope this year with half the supply initially expected.
Dr. Lester M. Crawford, acting commissioner of the Food and Drug Administration, said his agency was contacting every maker of influenza vaccines in the world to try to make up for the shortfall because of the closing of the plant, in Liverpool, of Chiron, the biotechnology company in Emeryville, Calif.
It is a humbling search. Crawford is one of several agency officials who have in recent years insisted that imported drugs are unsafe.
Until Oct. 5, Chiron executives told agency officials that they believed that they had found the source of the contamination and had isolated the infected lots, said Dr. Jesse Goodman, director of the Center for Biologics Evaluation and Research.
A 100-page company report that detailed Chiron's investigation into the contamination, a report the company said proved that it had the problem under control, actually suggested to agency inspectors just the opposite, Goodman said.
Quality-control executives at Chiron considered just the obvious sources of contamination, Goodman said. Far from reassuring the agency, the Chiron report suggested that it could not be trusted to ensure vaccine quality, Goodman said.
In a news conference, Crawford said he was optimistic that with the help of British and American regulators Chiron would be able to produce vaccines safely in time for next year.
Public health officials across the country are limiting who is vaccinated. Officials in Massachusetts, Michigan and Washington are threatening doctors and nurses with fines and even jail if they give shots to healthy low-risk people.
In the San Francisco Bay Area, a 79-year-old woman who had been in line at a supermarket waiting for her shot died on Thursday after she fainted or lost her balance and fell, hitting her head on a metal object, The Associated Press reported. Witnesses told the police that the woman and her husband had been in line for about four hours.
Dr. Anthony S. Fauci, director of the Institute of Allergy and Infectious Disease, said 90 million Americans were at the highest risk. Because half of those are vaccinated every year, the country has just enough vaccines from another maker, Aventis Pasteur, to vaccinate the 45 million who are said to be more in need and make the effort to get it.
"Every time a clinic freely gives out vaccine to people who really don't need it that means an equal number of people in a risk category are not getting the vaccine," Fauci said.
Reports of high charges for vaccines have led to accusations of profiteering and investigations.
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