THE GERMAN Medical Association (BAK) has advised against giving young children and pregnant women the new swine flu vaccine Pandemrix, containing an immune system-stimulating compound.
Instead the BAK, the equivalent of the Irish Medical Organisation, has called for the federal government to hand over to high-risk groups another, standard vaccine – Celvapan – which was ordered for use on armed forces and state employees.
“It would be wise to swap – the federal government should use the normal vaccine and make its own doses available to those who should be using the better-tested vaccine,” said Dr Frank Ulrich Montgomery, vice-president of the German Medical Association.
“We know the effects of the various ingredients in adjuvant vaccines but not the combined effect. It’s understandable that people are wary of getting jabs of drug cocktails.”
Health authorities in Ireland and Germany have recommended swine flu vaccination and have ordered the same two vaccines – Celvapan by Baxter and Pandemrix by GlaxoSmithKline (GSK).
The latter was licensed last month by the European Medicines Agency (EMA) for use on all people except children under six months.
But Pandemrix has divided health professionals in Germany.
Many leading paediatricians, virus experts and medical organisations are concerned about the “adjuvant” booster compound it contains and oppose its use in high-risk groups until more long-term data are collected.
“While Pandemrix contains no components that are completely unknown to us, the more components a vaccine has, the greater the chance of side effects,” said Prof Lothar Wieler of the Institute for Microbiology and Animal (Epizootic) Diseases at Berlin’s Free University.
“Thus I think young children would be better off with non-adjuvant vaccines.”
The EMA licensed Pandemrix in September in an expedited process of “rolling review”.
A GSK spokesperson confirmed yesterday that the company would monitor the effects of the vaccine in an ongoing clinical trial.
The company says it hasn’t had the opportunity to collect a significant amount of data on the use of Pandemrix, but that it has experience with similar vaccines for seasonal flu, bird flu, as well as data on the use of adjuvants.
But Germany’s DAK opposes the vaccine’s use in risk-groups saying that, since the risks of swine flu are lower than initially feared, it would be unwise to rely exclusively on new vaccines containing adjuvants if alternatives are available.
“If there was only a risk of mild side effects, one could ignore them in the face of the danger of a pandemic,” said Dr Montgomery, DAK vice- president.
“But what we don’t know from less-researched vaccines is the long-term damage that might only occur in one case in a million.
“That only becomes a matter of consequence in a mass vaccination programme.”
As in Germany, the HSE in Ireland has ordered Pandemrix and Celvapan, although the latter has yet to arrive.
“Currently what’s being distributed is Pandemrix,” said a HSE spokesperson, “but we’re satisfied that both have good safety profiles.
“Both are licensed for use both by the European Medical Agency and the Irish Medicines Board,” the HSE said.