Factory's loss of licence halves supply of flu vaccine to US
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《英国医生杂志》
US health officials are having to cope with the loss of half of this season抯 expected supply of flu vaccine, after last week抯 decision by the UK Medicines and Healthcare Products Regulatory Agency to temporarily shut down the Liverpool factory of one of the world抯 largest vaccine manufacturers.
The agency revoked the manufacturing licence of Chiron Corporation抯 factory for three months pending further investigation, after an inspection of the plant raised concerns over possible contamination. The agency gave no details, but in August Chiron acknowledged that some four million doses of its Fluvirin flu vaccine were potentially contaminated with Serratia marcescens, a bacterium linked to infections caught through dialysis and pneumonia.
At the time the company warned of possible delays in replacing some faulty batches but said it intended to meet its commitments. Now the company抯 entire supply has been cut off, leaving US federal health agencies 48 million doses short of the 100 million doses they planned to distribute this year.
Chiron was also contracted to provide 2.2 million vaccines to Britain, about 17% of the country抯 needs. But a spokesman for the Department of Health said the UK government has already arranged to buy replacement stocks from the six other companies supplying flu vaccines to Britain.
The US government has no such recourse, as all its injectable flu vaccine comes from just two manufacturers, Chiron and Aventis Pasteur. Aventis Pasteur抯 facilities will not be able to begin extra production until it fills its current orders next month, too late for this flu season.
Federal health agencies are particularly embarrassed, because the news follows a public awareness campaign urging Americans to get vaccinated against influenza. Now the government has reversed that position, asking healthy people to forgo the flu shot and urging clinicians to restrict vaccines to high risk groups.
According to the Centers for Disease Control and Prevention, 94.9 million Americans are in high risk groups, which include children aged 6 to 23 months, people aged 65 years or more, pregnant women, and healthcare workers.
The elimination of Chiron抯 vaccine leaves only 52 million doses of injectable vaccine available for the US market, all of them being made by Aventis Pasteur, compared to the 100m doses originally ordered.
In a typical year more than 50% of high risk US patients fail to get vaccinated, so the remaining stock should be adequate to cover high risk patients seeking vaccination if low risk patients abstain. Last year抯 uptake of flu vaccine, at 80 million, was the highest ever, with high risk patients accounting for half of the number vaccinated. About 36 000 Americans die from flu in a typical year.
Anthony Fauci, head of the US National Institute of Allergy and Infectious Diseases, said previous research indicated that giving half doses might be one way to stretch the supply. "That is something we will at least consider," he said.
The US government has not ruled out the possibility of changing the British regulator抯 decision and getting some of Chiron抯 vaccine released. A team of inspectors from the Food and Drug Administration is visiting Britain this week to review the agency抯 findings.(London Owen Dyer)
The agency revoked the manufacturing licence of Chiron Corporation抯 factory for three months pending further investigation, after an inspection of the plant raised concerns over possible contamination. The agency gave no details, but in August Chiron acknowledged that some four million doses of its Fluvirin flu vaccine were potentially contaminated with Serratia marcescens, a bacterium linked to infections caught through dialysis and pneumonia.
At the time the company warned of possible delays in replacing some faulty batches but said it intended to meet its commitments. Now the company抯 entire supply has been cut off, leaving US federal health agencies 48 million doses short of the 100 million doses they planned to distribute this year.
Chiron was also contracted to provide 2.2 million vaccines to Britain, about 17% of the country抯 needs. But a spokesman for the Department of Health said the UK government has already arranged to buy replacement stocks from the six other companies supplying flu vaccines to Britain.
The US government has no such recourse, as all its injectable flu vaccine comes from just two manufacturers, Chiron and Aventis Pasteur. Aventis Pasteur抯 facilities will not be able to begin extra production until it fills its current orders next month, too late for this flu season.
Federal health agencies are particularly embarrassed, because the news follows a public awareness campaign urging Americans to get vaccinated against influenza. Now the government has reversed that position, asking healthy people to forgo the flu shot and urging clinicians to restrict vaccines to high risk groups.
According to the Centers for Disease Control and Prevention, 94.9 million Americans are in high risk groups, which include children aged 6 to 23 months, people aged 65 years or more, pregnant women, and healthcare workers.
The elimination of Chiron抯 vaccine leaves only 52 million doses of injectable vaccine available for the US market, all of them being made by Aventis Pasteur, compared to the 100m doses originally ordered.
In a typical year more than 50% of high risk US patients fail to get vaccinated, so the remaining stock should be adequate to cover high risk patients seeking vaccination if low risk patients abstain. Last year抯 uptake of flu vaccine, at 80 million, was the highest ever, with high risk patients accounting for half of the number vaccinated. About 36 000 Americans die from flu in a typical year.
Anthony Fauci, head of the US National Institute of Allergy and Infectious Diseases, said previous research indicated that giving half doses might be one way to stretch the supply. "That is something we will at least consider," he said.
The US government has not ruled out the possibility of changing the British regulator抯 decision and getting some of Chiron抯 vaccine released. A team of inspectors from the Food and Drug Administration is visiting Britain this week to review the agency抯 findings.(London Owen Dyer)