AUS DEM SPIEGEL
Ausgabe 32/2009

The Injection Business How Safe Is the Swine Flu Vaccine?

By SPIEGEL Staff

Part 2: Americans More Cautious than Europeans


Frank Ulrich Montgomery, the deputy head of the German Medical Association, finds the German approach surprising. "In a mass vaccination program like this, it is preferable to resort to proven methods and substances."

In fact, it would have been safer to use the conventional influenza vaccine, which has been used and proven safe millions of times, as the basis for the new swine flu vaccine. Instead, new production methods are also being tested. For the first time, flu vaccines that are not cultivated in chicken eggs but on cell cultures will be used on a large scale.

Holidaymakers in Mallorca. The German tabloid press have daily updates on swine flu on the holdiay island.
DPA

Holidaymakers in Mallorca. The German tabloid press have daily updates on swine flu on the holdiay island.

Novartis has already applied for approval in Europe of its pandemic vaccine based on cell cultures. "Approval is expected to be issued in mid-October," reports Johannes Löwer, president of the Paul Ehrlich Institute (PEI), the national control authority charged with approving vaccines.

Germans could also receive this cell-culture-based vaccine, if the German states decide to order a second batch of vaccine from Novartis instead of GlaxoSmithKline. However, the rapid market introduction has sparked concerns, because the viruses used to make the Novartis vaccine grow on dog cells, which can cause tumors in animal experiments. Consequently, it is critical that these cells not enter the eventual vaccine.

Other concerns have been raised about GlaxoSmithKline's new pandemic vaccine, which is expected to be available first. The vaccine contains an adjuvant known as AS03, which is added to amplify the immune response so that fewer killed swine flu virus cells are needed.

"This means that more doses of vaccine can be produced with less material. In addition, the vaccine is designed to protect against other mutated H1N1 viruses," says PEI President Löwer, who is quick to add: "The safety data look good." However, the data are not as comprehensive is Löwer implies. Besides, adjuvants are by no means as harmless as the name would suggest. A 57-member World Health Organization (WHO) panel concluded in early June that the effects on young children and women in the early stages of pregnancy required further study. The panel also noted that there were no clinical experiences that made it possible to assess the risks and benefits of adjuvanted and non-adjuvanted H1N1 vaccines.

The US agency charged with regulating drugs, the Food and Drug Administration (FDA), has thus far refused to approve flu vaccines containing adjuvants. Besides, Americans generally tend to be more cautious than Europeans. Although the Centers for Disease Control and Prevention (CDC) have recommended vaccinating 160 million US citizens, the US swine flu vaccine is based on a seasonal flu vaccine.

'There Are Still Some Unkowns'

To be on the safe side, US authorities are also stockpiling adjuvants. "If it turns out, in September or October, that the virus has become more dangerous, we will still be able to approve the adjuvants in an expedited process and then add them to the vaccine," explains Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which manages vaccine trials. Fauci also points out that his agency is "not as confident in adjuvants, because there are still some unknowns."

The Americans have good reason to be cautious. Their health officials still have uneasy memories of what the New York Times called the "swine flu fiasco" of 1976, when 13 soldiers at a military base contracted a new H1N1 virus and one of them died. Because of fears that the world could face a new flu pandemic almost as deadly as the 1918-1919 "Spanish flu," more than 40 million people were immunized with a hurriedly produced vaccine.

The pandemic never materialized, but instead there were many reports of presumed vaccine complications. One that was particularly insidious was Guillain-Barré syndrome, a neurological disorder that causes paralysis in the legs and can lead to severe pulmonary complications.

That experience prompted the FDA to establish stricter standards for the approval of new vaccines, requiring manufacturers to conduct costly studies with thousands of volunteers. Given these regulations, it is only too convenient for drug companies when new vaccines and production processes to combat swine flu are tested on millions of Europeans. Indeed, instead of having to pay for testing, the drug companies stand to profit handsomely from this approach.

It is already clear that GlaxoSmithKline will be the greatest beneficiary of the swine flu. According to information obtained by SPIEGEL, one dose of vaccine will cost €8.33 ($11.9), and GSK stands to earn revenues upwards of €410 million ($588 million) in Germany alone.

Costs Could Reach €1 Billion

And then there is the cost of administering the vaccine on such a large scale, which will not be borne by the health ministers who have ordered the vaccine from the pharmaceutical companies, but by Germany's health insurance agencies. This, at any rate, is the way German Minister of Health Ulla Schmidt, a Social Democrat, wants the cost issue to be handled. The "summary minutes" of a teleconference of state health ministers also call for the insurance companies to carry the full cost of vaccine administration.

The least expensive option, at least in cities, would be for public health agencies to implement the vaccination program. In that case, the authorities anticipate a markup of approximately €10 per person. It would cost an estimated two or three times as much if doctors in private practice administered the vaccinations and purchased the vaccine from pharmacies.

In the end, each of the German states will define its own procedure. Depending on how the vaccine is administered to the population, the program will cost the health insurance agencies between €650 million and upwards of a €1 billion for the amount of vaccine currently on order.

But things could actually turn out somewhat differently. Health insurance agencies will only pay for vaccines that are in fact administered, while the states will end up paying for unused doses. And perhaps the anticipated surge in demand for vaccinations will never materialize. "Imagine if we have a pandemic, and no one gets vaccinated," says a ministry official from one of the eastern German states.

MICHAEL FRÖHLINGSDORF, MARKUS GRILL, VERONIKA HACKENBROCH, GERALD TRAUFETTER

Translated from the German by Christopher Sultan

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