US health workers who give flu jabs to healthy people could face fines or imprisonment
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《英国医生杂志》
London
It looks increasingly certain that the United States will enter the influenza season seriously short of vaccine, after a Food and Drug Administration team visiting Britain declared that 48 million potentially contaminated units of vaccine were 38unsafe for use.
People queue for flu vaccination at a supermarket in Rhode Island
Credit: VICTORIA AROCHO/AP
The vaccines represented half of the United States's planned supply for this year. The manufacturer, the Chiron Corporation of California, had to close its Liverpool factory after its licence to produce Fluvirin vaccine was suspended by the United Kingdom's Medicines and Healthcare Products Regulatory Agency ( BMJ 2004;329: 876, 16 Oct).
The vaccines have already been produced, but regulators fear that they are contaminated by the bacterium Serratia marcescens. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, visited the Liverpool factory last week to discover if any of the vaccine could be salvaged.
But Lester Crawford, the FDA's acting commissioner, said last week, "We believe that all of the lots produced by that plant are suspect at this point. So we cannot allow them to be used in the United States, in the interest of public health." He said that only high risk groups such as infants, elderly people, and health workers will be eligible for vaccination this year.
Several states, including New Mexico, Oregon, Michigan, and Massachusetts, have threatened fines or jail terms for healthcare workers who give flu shots to healthy people.
Six million units of Chiron's Fluvirin vaccine have already been shipped to the United States, but Dr Crawford was "not optimistic" that these would be usable. He said the FDA is looking for replacement supplies: "Every known manufacturer of flu vaccine in the world is being contacted, and some progress is being made."
Chiron, whose director Richard Wills resigned last week, received a grand jury subpoena from the US Attorney's Office for the Southern District of New York, requesting information on its vaccine production and the factory's closure.
The flu vaccine issue has become entangled in the presidential race, as Democrats aired a television advertisement blaming the debacle on President George Bush. Mr Bush suggested that his government was "working with Canada to hopefully... help us realise the vaccine necessary." But the health and human resources secretary, Tommy Thompson, later told reporters that Canadian vaccine was not licensed for use in the United States and was unlikely to be approved in time for this year's flu season. "It doesn't look promising," he said.
Julie Gerberding, director of the Centers for Disease Control and Prevention, said federal health authorities will take over the distribution of 22 million unshipped vaccines from the country's remaining supplier, Aventis Pasteur. The rest of Aventis's 52 million units have already been delivered to customers.
Reports of intermediaries exploiting the shortages to put up the price of the vaccine have been widespread. (See p 936.)(Owen Dyer)
It looks increasingly certain that the United States will enter the influenza season seriously short of vaccine, after a Food and Drug Administration team visiting Britain declared that 48 million potentially contaminated units of vaccine were 38unsafe for use.
People queue for flu vaccination at a supermarket in Rhode Island
Credit: VICTORIA AROCHO/AP
The vaccines represented half of the United States's planned supply for this year. The manufacturer, the Chiron Corporation of California, had to close its Liverpool factory after its licence to produce Fluvirin vaccine was suspended by the United Kingdom's Medicines and Healthcare Products Regulatory Agency ( BMJ 2004;329: 876, 16 Oct).
The vaccines have already been produced, but regulators fear that they are contaminated by the bacterium Serratia marcescens. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, visited the Liverpool factory last week to discover if any of the vaccine could be salvaged.
But Lester Crawford, the FDA's acting commissioner, said last week, "We believe that all of the lots produced by that plant are suspect at this point. So we cannot allow them to be used in the United States, in the interest of public health." He said that only high risk groups such as infants, elderly people, and health workers will be eligible for vaccination this year.
Several states, including New Mexico, Oregon, Michigan, and Massachusetts, have threatened fines or jail terms for healthcare workers who give flu shots to healthy people.
Six million units of Chiron's Fluvirin vaccine have already been shipped to the United States, but Dr Crawford was "not optimistic" that these would be usable. He said the FDA is looking for replacement supplies: "Every known manufacturer of flu vaccine in the world is being contacted, and some progress is being made."
Chiron, whose director Richard Wills resigned last week, received a grand jury subpoena from the US Attorney's Office for the Southern District of New York, requesting information on its vaccine production and the factory's closure.
The flu vaccine issue has become entangled in the presidential race, as Democrats aired a television advertisement blaming the debacle on President George Bush. Mr Bush suggested that his government was "working with Canada to hopefully... help us realise the vaccine necessary." But the health and human resources secretary, Tommy Thompson, later told reporters that Canadian vaccine was not licensed for use in the United States and was unlikely to be approved in time for this year's flu season. "It doesn't look promising," he said.
Julie Gerberding, director of the Centers for Disease Control and Prevention, said federal health authorities will take over the distribution of 22 million unshipped vaccines from the country's remaining supplier, Aventis Pasteur. The rest of Aventis's 52 million units have already been delivered to customers.
Reports of intermediaries exploiting the shortages to put up the price of the vaccine have been widespread. (See p 936.)(Owen Dyer)