Concern in Germany as safety of swine flu vaccines questioned

GERMANY’S SWINE flu vaccination programme has been hit by public health concerns over the vaccines being used – one of which …

GERMANY’S SWINE flu vaccination programme has been hit by public health concerns over the vaccines being used – one of which has been ordered by the Irish Government.

Germany’s 16 federal states have spent a reported €600 million buying 50 million doses of the Pandemrix vaccine, produced by GlaxoSmithKline (GSK).

This new vaccine, one of two to be offered by Irish doctors, is the subject of controversy in Germany because it contains a “booster” substance known as an “adjuvant”. This allows less virus material to be used per dose and, according to GSK, boosts the immune system’s response to the jab.

Pandemrix was approved for use by the European Medicines Agency last month and has the approval of Germany’s Paul Ehrlich Institute, which advises the government on vaccination matters. However, another government body, the Federal Vaccination Agency, has contradicted the institute and has advised against the use of vaccines containing adjuvants.

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Concerns about Pandemrix’s safety and efficacy have been raised by several German medical organisations, with warnings against using it to vaccinate high-risk groups such as pregnant women and children.

Dr Wolfram Hartmann, president of the German association of paediatricians, accused the federal government of “false testimony” for recommending Pandemrix for use on young children – six weeks after it issued advice to the contrary.

“The vaccine has not yet been tested on children under three, so the risk is simply too big to use on them without misgivings,” he said.

The vaccine confusion grew over the weekend when it emerged that the German government and armed forces are to receive a different jab to the public. Celvapan, produced by drug company Baxter, is a traditional vaccine containing no booster substances.

The interior ministry in Berlin denied yesterday it was a case of two-tier medical care. A spokesperson said the federal government had a contract to buy Baxter flu vaccination products for state employees.

The Health Service Executive (HSE), now delivering the GSK vaccine to GPs and awaiting supplies of the Baxter one, said the safety data base for the GSK adjuvant includes more than 10,000 individuals.

“As with any vaccines, risks have to be balanced with the benefits and the authorities in Ireland are satisfied that the benefits from both vaccines outweigh any possible risks of side effects.” The HSE said Ireland continues to see an increase in swine flu cases every week as well as fatalities associated with this virus. The fifth fatality was confirmed last night. The deceased, an adult male in the east, had an underlying medical condition.

“Vaccination is the most important tool we have to protect the Irish population,” the HSE said.

Stirring things up even further in Germany yesterday, outgoing interior minister Wolfgang Schäuble said: “I’m not even sure if I will be getting vaccinated at all.”

In an attempt to calm the situation, Chancellor Angela Merkel’s spokesman said the German leader, if so advised by her doctor, would be vaccinated with Pandemrix.