Switzerland's medical regulator recommended patients with serious autoimmune diseases should not use an H1N1 flu vaccine from Novartis, saying there were no studies assessing the innoculation in that population.
Swissmedic said on Wednesday it could not be ruled out that either or both the adjuvant -- which can enhance the immune response -- and/or the antigen, or less active ingredient, could lead to an intensifying of autoimmune diseases.
Autoimmune diseases, like rheumatoid arthritis, are caused by an overly active immune system attacking its own body, targeting substances which are normally present.
Novartis was not immediately available to comment.
Instead, Novartis was busy flogging its MF59 adjuvant in the US for BIRD FLU. The only problem is that enhanced immune responses are dangerous in people who have autoimmune diseases, or a genetic predisposition to them. And from another of today's Reuters articles:
A vaccine additive made by Novartis (NOVN.VX) and used in its European influenza shots can boost the body's immune response to a wide range of viruses, U.S. researchers reported on Wednesday.
Tests in the laboratory suggested the so-called adjuvant, called MF59, helped the immune system counteract not only the H5N1 virus in the current experimental bird flu vaccine, but mutant viruses as well. The U.S. Food and Drug Administration study, published in the journal Science Translational Medicine, suggests using vaccines with adjuvants may protect patients against even more types of flu viruses than they are being vaccinated against. Adjuvants are widely used in European flu vaccines as well as in Canada. But are not widely used in the United States -- even though the federal government has spent nearly $700 million buying them.
The reason? People might not trust them.
Other studies have shown adjuvants can stretch the supply of flu vaccine, because shots using them require much less of the actual vaccine antigen.
"Adjuvanted vaccines produce higher immune response than unadjuvanted vaccines particularly in the elderly and young children," Dr. Vas Narasimhan, president of Novartis Vaccines USA, told a U.S. Congressional hearing last November.