Untested swine flu vaccine could put British public at risk, warn experts

Published on Sunday 26 July 2009 22:15

EXPERTS have warned about the potential dangers of using untested vaccines as the British government prepares to fast-track inoculations against swine flu.

The European Medicines Agency, the EU's top drug regulatory body, is accelerating the approval process for swine flu vaccine in order to have it ready before winter.

Many European countries – including Britain – plan to start using it as soon as it has been approval, possibly within weeks.

Martin Harvey-Allchurch, a spokesman for the European Medicines Agency, said: "Everybody is doing the best they can in a situation which is far from ideal.

"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, a process which is being skipped in this case.

Some experts say extensive testing is unnecessary since flu vaccines have been used for 40 years, and this version will simply contain a new ingredient – the swine flu virus.

However, the US is taking a more cautious approach, carrying out tests on several thousand volunteers from next month to assess the vaccine's safety.

"I can't see any possible excuse to not test it for safety before it's given to anyone," said George Annas, a bioethics expert at Boston University. The warnings came as it was revealed the UK government had been forced to accept legal liability for the swine flu vaccine in case it triggered side effects.

Ministers have taken on all the risk for the 60 million doses they have ordered from GlaxoSmithKline and the Baxter group, after both firms said they would refuse to produce it unless legally protected, The Scotsman's sister paper Scotland on Sunday revealed.

In 1976, hundreds of people in the US developed Guillain-Barre syndrome, a paralysing disorder, after being vaccinated against flu. The reasons for the disorder remain unknown.

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

"One of the things which cannot be compromised is the safety of vaccines," he said.

"There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies."

Experts have agreed there are unlikely to be any side effects from a swine flu vaccine, but warn that it cannot be known for sure.

One issue could be that without thorough testing the effective dosage would not be used, meaning Europeans may get too weak a vaccine.

Meanwhile, pregnant Scot Sharon Pentleton remained in a "critical but stable" condition in a Swedish hospital yesterday.

The 26-year-old mother of one from Ayrshire suffered a rare reaction after contracting the H1N1 virus and is undergoing a procedure where her blood is circulated outside her body.