Europe will fast-track swine flu vaccine

Published 27 July 2009

Worried about the eruption of swine flu infection during the coming winter, the European drug agency is accelerating the approval process for swine flu vaccine; critics, and even WHO, worry about the potential dangers of the accelerated approval process

In a drive to inoculate people against swine flu before winter, many European governments say 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 swine flu vaccine, and countries such as Britain, Greece, France, and Sweden say they’ll start using the vaccine after it’s greenlighted — possibly within weeks.

In an interview with AP, Dr. Keiji Fukuda, the World Health Organization’s (WHO) 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 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 forty years, and many experts say extensive testing is unnecessary, since the swine flu vaccine will simply contain a new ingredient: the swine flu virus.

European officials will not 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 European Medicines Agency. “With the winter flu season approaching, we need to make sure the vaccine is available.”

AP reports that 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. To ensure swine flu vaccine is available as soon as possible, the European Medicines Agency 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 European Medicines Agency would specify what basic safety tests are being done.

The United States is taking a more