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Fast-tracking new flu vaccine sparks doubts among experts

IN a drive to inoculate people against swine flu before winter, many European governments said they will fast-track the testing of a new flu vaccine, arousing concern among some experts about safety issues and proper vaccine doses.

The European Medicines Agency, the EU's top drug regulatory body, is accelerating the approval process for a swine flu vaccine, and countries such as Britain, Greece, France and Sweden said they'll start using the vaccine after it's been given the green light - possibly within weeks.

Dr Keiji Fukuda, the World Health Organization's flu chief, warned about the potential dangers of untested vaccines, although he stopped short of criticizing Europe's approach outright.

"One of the things which cannot be compromised is the safety of vaccines," he said last Friday. "There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies."

Flu vaccines have been used for 40 years, and many experts say extensive testing is unnecessary, since the swine flu vaccine will simply contain a new ingredient: the swine flu virus.

But European officials won't know if the new vaccine causes any rare side effects until millions of people get the shots. Still, they say the benefit of saving lives is worth the gamble.

"Everybody is doing the best they can in a situation which is far from ideal," said Martin Harvey-Allchurch, a spokesman for the EMA. "With the winter flu season approaching, we need to make sure the vaccine is available."

In Europe, flu vaccines are usually tested on hundreds of people for several weeks or months, to ensure the immune system produces enough antibodies to fight the infection.

But to ensure swine flu vaccine is available as soon as possible, the EMA is allowing companies to skip testing in large numbers of people before the vaccine is approved.

The main issue is probably that without thorough testing it's difficult to gauge the effective dosage - meaning Europeans might get too weak a vaccine. It's unlikely the vaccine would endanger anyone, but until it is used in large numbers of people, no one will know for sure.

Europeans appear ready to use the vaccine widely before conducting any big studies to prove it is safe and effective.

Neither the vaccine makers nor the EMA would specify what basic safety tests are being done.

The United States is taking a more cautious approach: the government called last Wednesday for several thousand volunteers to be injected with the swine flu vaccine in tests beginning in August to assess the vaccine's safety.

American officials said results should be ready by the time the US plans to roll out a vaccination campaign in October.


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