Concerns about the safety of H1N1 vaccine in Germany has snowballed and appears to derail the vaccination programme.

Only about 12 per cent of people have expressed their willingness to be vaccinated and another 19 per cent have indicated that they would probably have the vaccine.

The controversy is about the use of adjuvant in H1N1 vaccine. Adjuvant is a substance that is added to the vaccine to improve body’s response, and its use will reduce the amount of inactivated virus needed for an effective dose.

What started as concerns expressed by a few physicians about the safety of vaccine containing an adjuvant has now become a major issue.

Michael Kochen, President of the German College of General Practitioners and Family Physicians was quoted as saying in the British Medical Journal (BMJ) that “Pandemrix [H1N1 vaccine containing an adjuvant] has not been sufficiently tested to be declared safe for millions of people, especially small children and pregnant women.”

He has apparently told BMJ that he will not take the vaccine and has also advised other doctors not to take it. Pandemrix is manufactured by GlaxoSmithKline.

But what made things worse was a report by Der Spiegel magazine that the Federal Interior Ministry had bought 2,00,000 doses of Celvapan, an adjuvant-free vaccine to be used by top government officials. Celvapen is manufactured by Baxter.

The Defence Ministry had later confirmed the procurement of Celvapen, and according to BMJ, it was intended for use by Bundeswehr soldiers and their families on foreign deployments or preparing for missions abroad.

The German Medical Association has now advised against giving the adjuvant vaccine to children and pregnant women.

However, the World Health Organisation recommends the use of an adjuvant as it would increase the number of people who can be vaccinated. The European Medicines Agency had cleared Pandemrix and Celvapen for H1N1 vaccination.

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

Wolf-Dieter Ludwig, Chairman of the German Medical Association’s Drug Commission had described the swine flu vaccination programme as a “scandal.” According to BMJ, Dr. Ludwig thinks that Pandemrix has not been adequately tested. However, he thinks the same about Baxter’s adjuvant-free H1N1 vaccine Celvapan, too.

GlaxoSmithKline in a press release dated October 23 announced that more than 150,000 people had received Pandemrix, as part of government initiated vaccination programmes across Europe. Additionally, over 2,000 people have received Pandemrix in clinical trials which are ongoing. The company has not raised any safety concerns about its product.

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