Only 12% of Germans say they will have H1N1 vaccine after row blows up over safety of adjuvants
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, Baxters 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 ministrys 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 that they will probably have the vaccine.
A spokeswoman for the German interior ministry rejected accusations that the ministry had ordered a less risky vaccine for top officials, saying that the order was placed "months ago" before the difference between the two vaccines was deemed important.
In the same article, Der Spiegel quoted doctors concerned about the safety of adjuvants. In response to the article, GlaxoSmithKline Germany issued a press release saying that the interior ministrys purchase of a second vaccine was "legitimate" and does not indicate that one vaccine is better than the other.
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.
Disclosure of the interior ministrys purchase of the H1N1 vaccine came a week after the defence ministry confirmed news reports that Bundeswehr soldiers and their families on foreign deployments or preparing for missions abroad would be vaccinated 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 Merkels spokesman told reporters that she planned to discuss the H1N1 vaccination with her personal doctor, who is in private practice and would have access only to Pandemrix. If he advises her to take the vaccine, then she will, the spokesman said.
Ms Schmidt was quoted as saying that she will be vaccinated with the same vaccine as "the people," describing Pandemrix as safe and effective.
Wolf-Dieter Ludwig, chairman of the German Medical Associations 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."
Cite this as: BMJ 2009;339:b4335