The Swine Flu Business Should Germany Gamble Millions on More Vaccine?

By SPIEGEL Staff

Part 2: Who Should Be Vaccinated? And for How Much?


In this game, the winner is always the pharmaceuticals industry. Indeed, drug companies are very adept at pushing policy -- and no company has been more brazen than Switzerland-based Novartis. Already on May 12, the group sent Germany's Health Ministry contracts that included a side-agreement that had not been previously agreed upon. According to the side agreement, the main contract would become void if vaccines were not ordered within 14 days.

The federal states have still only signed the main contract and, therefore, agreed to prices that are up to 40 percent higher than those offered by the competition, GlaxoSmithKline (GSK). While GSK charges €8.33 per dose of vaccine, Novartis wants up to €11.90, depending on the order volume. Still, Novartis will only enter the picture with the second consignment of doses, as GSK will provide Germany's initial set of vaccines. In late July, the federal states ordered vaccine doses from GSK for 30 percent of the population for a net cost of €410 million. At that time, since nobody knew how the epidemic would progress, the order was only meant to be a security measure.

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But now, instead of just the chronically ill and members of at-risk groups and hospital staffs, PEI President Johannes Löwer wants to vaccinate the entire population. He's hoping to get some backing from the RKI's Permanent Vaccination Commission (STIKO), which met in Frankfurt for a special session on swine flu earlier this week and will issue a statement in favor of or opposed to mass vaccination. The commission seems very inclined to substantially expand the vaccination program. Its deputy chief, Ulrich Heininger, has said that the vaccine should be "offered to every person who wants to reduce his or her personal risk of infection."

Still, questions have been raised about how unbiased and independent the commission is in making its recommendation. Critics note that Heininger -- and the majority of individual's on the STIKO panel -- get their information from reports, studies and presentations that are financed by vaccine manufacturers. And, in fact, some of the most generous sponsors of such information are GSK and Novartis -- precisely the two companies that will be providing the swine flu vaccine. And there are other ties as well, such as the fact that the commission's former head, Heinz-Josef Schmitt, went straight from working with STIKO to being part of Novartis' vaccine division.

Panic and Profits

Corporate lobbying activities are also having an effect. For example, last Friday, there was a great hubbub at the Federal Health Ministry, when rumors surfaced that Uzbekistan was planning to buy up the vaccine consignment intended for Germany. The rumor led ministry officials to call for a prompt decision to be made on whether to purchase more of the vaccine.

For the pharmaceutical giants, the epidemic is developing into a business worth billions. Swiss banking giant UBS estimates that the sale of an extra set of vaccines will bump Novartis' revenues by €1.1 billion and GSK's by €1.5 billion -- and medical insurance will foot the bill. And whereas the cost of the vaccine in Switzerland will be €16, in Germany, it'll be a much steeper €28.

Preliminary studies with the Novartis vaccine show that a single injection might provide adequate protection. But, for the moment, health officials are assuming that each individual needs to be vaccinated twice. So, with the 50 million vaccine shots of the existing order, 25 million people can be immunized.

Even so, the fact still remains that no vaccine has been given final approval. "We sent blood samples to Novartis for analysis just a few days ago," says James Cramer, director of testing at the University Medical Center Hamburg-Eppendorf.

In addition, vaccine production is extremely difficult. For example, manufacturers have been apprehensive about resorting to a new seed virus -- that is, the virus culture used to inoculate a new stock culture for vaccine development -- to boost production. "The amount of time needed for the vaccine to become widely available has been grossly underestimated," says Frank von Sonnenburg, the head vaccine researcher at the University of Munich.

Will Things Get Worse?

Meanwhile, officials in charge of dealing with epidemics are issuing repeated warnings about the possible emergence of a second -- and more intense -- wave of swine flu in the winter.

But if you take a look at how the disease has affected Germany so far, there seems to be much less cause for alarm. According to a recent RKI publication, a review of the first 10,000 swine flu cases in Germany has revealed that, of those who have been infected (mostly 15- to 25-year-olds), not even one in 200 ultimately has come down with pneumonia, and some infections have run their course with few or even no symptoms.

WHO experts, on the other hand, have issued more reassuring findings. According to their reports, most swine-flu-related fatalities have occurred with individuals with pre-existing conditions and weakened immune systems. Likewise, they also report that, to date, there is no evidence that the pathogen will become more aggressive through mutation.

These findings seem to be backed by people working in German health-care facilities. Susan Huggett, for example, who is responsible for examining flu patients at Hamburg's Asklepios Clinic, says that all patients who have been diagnosed with swine flu have been immediately discharged. "Not even five patients were diagnosed with normal type B influenza," Huggett says, referring to patients who would need to remain in hospital for treatment.

"We have to be careful not to forget about the simple seasonal flu," she adds.

MARKUS GRILL, VERONIKA HACKENBROCH, ALEXANDER NEUBACHER, GERALD TRAUFETTER

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