From the British Medical Journal, 21 October 2009 (by Ned Stafford in Hamburg)
Concerns are growing in Germany about the safety of the swine flu vaccine that will be available to the general population after news was leaked last weekend that top politicians and some government employees will be given an alternative vaccine.
State and federal health officials announced in August the purchase of 50 million doses of Pandemrix, the H1N1 vaccine produced by GlaxoSmithKline.
Pandemrix contains an adjuvant that includes squalene and boosts the effectiveness of the vaccine, meaning a much smaller amount of inactivated virus is needed for an effective dose. However, some experts say that adjuvants can produce inoculation reactions, such as headache and fever, or possibly even longer term side effects.
Michael Kochen, president of the German College of General Practitioners and Family Physicians, told the BMJ that Pandemrix has not been sufficiently tested to be declared safe for millions of people, especially small children and pregnant women. His main concern is the adjuvant.
He will not take the vaccine himself and has advised doctors in the association not to give it to patients, saying that the potential risks outweigh the benefits. He described the 50 million doses for Germany as "a large scale experiment on the German population."
Some doctors have voiced mild concern about Pandemrix in the past two months, especially about potential side effects in pregnant women and children. But those scattered concerns erupted into widespread protest over the weekend, after Der Spiegel news magazine reported that the federal interior ministry had bought 200 000 doses of Celvapan, Baxter's adjuvant-free H1N1 vaccine, to be used by top government officials (www.spiegel.de, 19 Oct, "Germans unhappy with alternative swine flu vaccine for politicians").
The controversy seemed to be gaining momentum in the days after news of the interior ministry's purchase, with Frank Ulrich Montgomery, vice president of the German Medical Association, calling for adjuvant-free vaccinations for pregnant women and children. In the German press he accused the government of mismanagement and creating an "appalling information chaos" surrounding H1N1 vaccination.
Recent polls show that only 12% of Germans definitely plan to be vaccinated against H1N1, with 19% saying thatthey will probably have the vaccine.
GlaxoSmithKline defended the safety of the vaccine, noting that the European Medicines Agency, after reviewing clinical studies, had recommended that both vaccines, as well as Focetria from Novartis, be authorised by the European Commission. It added that so far 22 governments had ordered 440 million doses of Pandemrix, and other governments are considering purchases.
Wolf-Dieter Ludwig, chairman of the German Medical Association's drug commission, has described the whole swine flu vaccination programme as a scandal and was quoted widely in the German press: "The health authorities have succumbed to a campaign by the pharma companies, which simply want to earn money from a supposed threat."
In an interview with the BMJ, Dr Ludwig confirmed that he had made the statement. He said that he thinks the German government was too compliant to the demands of GlaxoSmithKline for buying 50 million doses, which cost at least ?600m (£550m; $900m), a price that he says was too high.
He also said that the government should not have agreed to carry legal risk in the event of lawsuits by patients experiencing any negative side effects from the vaccine. "I think this is not fair," he said. "The pharma companies should be responsible for the risk."
Dr Ludwig still thinks that Pandemrix has not been adequately tested. However, he also believes that Celvapan has not been sufficiently tested.
Wolfgang Wodarg, a doctor and a member of the Bundestag, is also concerned about the safety of swine flu vaccines. "The clinical trials have not been sufficient for us to vaccinate millions of people," he told the BMJ, adding that governments have created a lot of unnecessary panic. He said that he thinks the World Health
Organization "carries a lot of the burden for this."