Published 21 October 2009, doi:10.1136/bmj.b4335 Cite this as: BMJ 2009;339:b4335
News
Only 12% of Germans say they will have H1N1 vaccine after row blows up over safety of adjuvants
Ned Stafford
1 Hamburg
Concerns are growing in Germany about the safety of the swineflu vaccine that will be available to the general populationafter news was leaked last weekend that top politicians andsome government employees will be given an alternative vaccine.
State and federal health officials announced in August the purchaseof 50 million doses of Pandemrix, the H1N1 vaccine producedby GlaxoSmithKline. Pandemrix contains an adjuvant that includessqualene and boosts the effectiveness of the vaccine, meaninga much smaller amount of inactivated virus is needed for aneffective dose. However, some experts say that adjuvants canproduce inoculation reactions, such as headache and fever, orpossibly even longer term side effects.
Michael Kochen, president of the German College of General Practitionersand Family Physicians, told the BMJ that Pandemrix has not beensufficiently tested to be declared safe for millions of people,especially small children and pregnant women. His main concernis the adjuvant.
He will not take the vaccine himself and has advised doctorsin the association not to give it to patients, saying that thepotential risks outweigh the benefits. He described the 50 milliondoses for Germany as "a large scale experiment on the Germanpopulation."
Some doctors have voiced mild concern about Pandemrix in thepast two months, especially about potential side effects inpregnant women and children. But those scattered concerns eruptedinto widespread protest over the weekend, after Der Spiegelnews magazine reported that the federal interior ministry hadbought 200 000 doses of Celvapan, Baxter’s adjuvant-freeH1N1 vaccine, to be used by top government officials (www.spiegel.de,19 Oct, "Germans unhappy with alternative swine flu vaccinefor politicians").
The controversy seemed to be gaining momentum in the days afternews of the interior ministry’s purchase, with Frank UlrichMontgomery, vice president of the German Medical Association,calling for adjuvant-free vaccinations for pregnant women andchildren. In the German press he accused the government of mismanagementand creating an "appalling information chaos" surrounding H1N1vaccination.
Recent polls show that only 12% of Germans definitely plan tobe vaccinated against H1N1, with 19% saying that they will probablyhave the vaccine.
A spokeswoman for the German interior ministry rejected accusationsthat the ministry had ordered a less risky vaccine for top officials,saying that the order was placed "months ago" before the differencebetween the two vaccines was deemed important.
In the same article, Der Spiegel quoted doctors concerned aboutthe safety of adjuvants. In response to the article, GlaxoSmithKlineGermany issued a press release saying that the interior ministry’spurchase of a second vaccine was "legitimate" and does not indicatethat one vaccine is better than the other.
GlaxoSmithKline defended the safety of the vaccine, noting thatthe European Medicines Agency, after reviewing clinical studies,had recommended that both vaccines, as well as Focetria fromNovartis, be authorised by the European Commission. It addedthat so far 22 governments had ordered 440 million doses ofPandemrix, and other governments are considering purchases.
Disclosure of the interior ministry’s purchase of theH1N1 vaccine came a week after the defence ministry confirmednews reports that Bundeswehr soldiers and their families onforeign deployments or preparing for missions abroad would bevaccinated with Celvapan.
After news of the interior ministry purchase, both the chancellor,Angela Merkel, and the federal health minister, Ulla Schmidt,indicated that they would not take Celvapan. Chancellor Merkel’sspokesman told reporters that she planned to discuss the H1N1vaccination with her personal doctor, who is in private practiceand would have access only to Pandemrix. If he advises her totake the vaccine, then she will, the spokesman said.
Ms Schmidt was quoted as saying that she will be vaccinatedwith the same vaccine as "the people," describing Pandemrixas safe and effective.
Wolf-Dieter Ludwig, chairman of the German Medical Association’sdrug commission, has described the whole swine flu vaccinationprogramme as a scandal and was quoted widely in the German press:"The health authorities have succumbed to a campaign by thepharma companies, which simply want to earn money from a supposedthreat."
In an interview with the BMJ, Dr Ludwig confirmed that he hadmade the statement. He said that he thinks the German governmentwas too compliant to the demands of GlaxoSmithKline for buying50 million doses, which cost at least 600m (£550m; $900m),a price that he says was too high. He also said that the governmentshould not have agreed to carry legal risk in the event of lawsuitsby patients experiencing any negative side effects from thevaccine. "I think this is not fair," he said. "The pharma companiesshould be responsible for the risk."
Dr Ludwig still thinks that Pandemrix has not been adequatelytested. However, he also believes that Celvapan has not beensufficiently tested.
Wolfgang Wodarg, a doctor and a member of the Bundestag, isalso concerned about the safety of swine flu vaccines. "Theclinical trials have not been sufficient for us to vaccinatemillions of people," he told the BMJ, adding that governmentshave created a lot of unnecessary panic. He said that he thinksthe World Health Organization "carries a lot of the burden forthis."
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."
