NY Times Squalene IN SWINE H1N1 Vaccines?

Benefit and Doubt in Vaccine Additive
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LinkedinDiggFacebookMixxMySpaceYahoo! BuzzPermalinkPublished: September 21, 2009
(Page 2 of 2)



Alum is not used in flu shots because it has little effect. But Novartis and GlaxoSmithKline are selling pandemic flu vaccines containing newer adjuvants they have developed. They are oil-in-water emulsions of squalene, a lipid that is found in the body. Glaxo’s also contains vitamin E.

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A seasonal flu vaccine containing Novartis’s MF59 adjuvant has been used in Europe since 1997. Glaxo’s adjuvant, called AS03, is in a vaccine approved in Europe for use against the H5N1 bird flu, which spurred fears of a pandemic a few years ago.

For the bird flu, an adjuvant was crucial because vaccines without adjuvants did not work well in tests and required huge doses. Glaxo’s vaccine required only one twenty-fourth as much antigen, the viral component of the vaccine, as another company’s vaccine that did not contain an adjuvant.

Thinking the swine flu might pose the same problem, federal officials ordered $700 million worth of adjuvant from Novartis and Glaxo.

If the adjuvants were used, they would have to be combined with the vaccine before the injection was given. And because the adjuvants have not been approved by the F.D.A., they would fall under a so-called emergency use authorization.

But in the last two weeks it has been learned that the vaccines against the H1N1 virus stimulate a strong response on their own. A single shot containing 15 micrograms of antigen — the same amount used for each strain in a seasonal flu vaccine — should confer adequate protection for most people.

Preliminary data from GlaxoSmithKline show that a vaccine with an adjuvant might use only one-fourth as much antigen. But federal officials say the savings are not large enough to offset the possible risks and extra complexity of using the adjuvants.

While adjuvants tend to increase the temporary pain, swelling or fatigue caused by a vaccine, the main concern is whether they might cause an autoimmune disease, like rheumatoid arthritis, in which the immune system attacks the body’s own tissues. Some animal studies have suggested that possibility.

Last year, the F.D.A. halted a clinical trial of a hepatitis B vaccine containing a novel adjuvant after one participant developed a type of blood-vessel inflammation that is considered an autoimmune disease. But the agency lifted its hold this month, apparently satisfied that the vaccine, made by Dynavax Technologies, was not the cause.

Adjuvant makers say there is no cause for concern with the flu vaccines. Dr. Bruce Innis, head of the clinical flu vaccine team at GlaxoSmithKline, said the immune response spurred by his company’s adjuvant was directed only at the antigen in the vaccine. “There is not a general upregulation of immune responses across the body,” which would be needed for an autoimmune disease, Dr. Innis said.

Novartis says more than 40 million doses of vaccine with its adjuvant have been used in Europe, with no signs of problems. But Dr. Fauci, of the National Institute of Allergy and Infectious Diseases, said Novartis’s adjuvant had been used mainly among the elderly, who tended to have weaker immune systems. There is less data, he said, on its use among children, younger adults and pregnant women.