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Swine Flu Vaccinations To Be Expedited In Europe

July 26, 2009

Many European governments say that they will fast-track the testing of a new swine flu vaccine in an attempt to vaccinate people before winter, although some experts say they are concerned about risking safety and giving proper vaccine doses.

The European Medicines Agency is accelerating the approval process for the swine flu vaccine. Countries like Britain, Greece, France and Sweden all say that they will start using the vaccine once it is given approval, which could happen within weeks.

“One of the things which cannot be compromised is the safety of vaccines,” Dr. Keiji Fukuda of the World Health Organization said in an interview Friday. “There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies.”

Many experts say extensive testing is unnecessary because flu vaccines have been used for 40 years and the swine flu vaccine simply contains a new ingredient.

However, European officials will not know if the new vaccine causes any side effects until millions of people get the shots.  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.”

Flu vaccines are tested on hundreds of people for several weeks or months in Europe, which helps to see if the immune system produces enough antibodies to fight the infection.

But to speed the process up, the European Medicines Agency is letting companies skip testing large groups of people before the vaccine is approved.

Although it is unlikely that the vaccine will endanger anyone, experts say that cannot be determined until it is used in large numbers of people.

The U.S. is taking a more cautious approach.

On Wednesday the U.S. government called 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 the results would be ready in October, which is when the U.S. plans to roll out a vaccination campaign.

Since countries like Britain plan to start vaccinating before any American trial data is available, they will be limited in knowing what the results could be from any US tests.  Also, the vaccines used in the U.S. will be different from those in Europe.

Some experts encourage urgent action.

“The consequences of not having a vaccine if this virus gets worse are very high,” said Leonard Marcus, a public health expert at Harvard University. “If (regulatory authorities) took all the time that was necessary to make sure there are no side effects, ironically, in the effort to save a few lives, many lives could be lost.”

However, critics say that dangers lurk in rushing to vaccinate without thorough testing.

“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.

Many people remain skeptical of vaccinations in Britain because of unsubstantiated allegations linking the measles, mumps and rubella vaccine to autism.  That might lead millions of people refusing to take the vaccination.

The European Medicines Agency designed a special protocol to approve a vaccine when the bird flu crisis hit several years ago.

The agency allowed companies to submit a “mock-up” vaccine using H5N1 bird flu.  The idea was for most of the testing to be complete before the epidemic hit. That way drug makers could insert the pandemic virus into the vaccine at the last minute.

When the swine flu vaccine doses are ready, the European Medicines Agency will approve them largely based on data from the bird flu vaccine, which both have the same basic ingredients.

Spokesman Harvey-Allchurch said that if the agency thinks the bird flu data predicts how the swine flu virus will work, they will approve it.

The agency will then require regular reports of the vaccine’s effects as it is being administered.

Fukuda, Assistant Director-General for Health Security and Environment at the World Health Organization (WHO), said everyone involved in making the vaccine is looking at steps to be taken to expedite the process.

“But there is no one who disagrees that one of the absolutes is that there can’t be any question whether the vaccine is safe or not,” he said.

The WHO said that the swine flu viruses are not producing enough key vaccine ingredients, which might limit how much vaccine is available.  Its laboratory network is now working to produce a new set of viruses that it hopes will work better.

However, drug makers such as Baxter International, GlaxoSmithKline PLC, Novartis, and Sanofi-Pasteur all insist they will be able to start shipping the first batches of vaccine soon.

In Britain, health officials have repeatedly said that they will start vaccinating people in August, which is when they expect it will receive approval from the European agency.

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