First and foremost, there is no reason to worry about squalene because it simply is not present in vaccines in the US. According to Patricia El-Hinnawy, a spokesperson for the US Food and Drug Administration: “There is no squalene in any FDA-approved vaccine in the US. There is no squalene in any kind of seasonal flu vaccine or in the H1N1 vaccine.”
So, now that we know that, what exactly is squalene? It’s a naturally occurring organic compound that’s made in the livers of animals (including humans) and in plants. It circulates in our bloodstream. The squalene added to food, cosmetics, and health supplements is generally derived from shark liver oil. What’s more, the American Cancer Society reports that recent studies have found the substance decreased the spread of cancerous lung tumors in laboratory animals.
In Europe squalene is added to flu vaccines in an emulsified form known as an adjuvant, a substance added to vaccines to improve their efficacy and boost immune system response. An adjuvant like squalene can be used to stretch the availability of a vaccine, since adjuvant-supplemented vaccines are more effective and can thus be given in smaller doses. Before developing the H1N1 vaccine, the US government purchased oil-in-water bulk adjuvant from GlaxoSmithKline and Novartis in the event that the H1N1 virus mutates and becomes more dangerous. An adjuvant could, under that circumstance, boost the vaccine’s effectiveness and help stretch its supply.
While the government has an adjuvant on hand, at the moment there are no plans to use it. “Based on the current flu we’re seeing, we have no intention of using it,” says Gretchen Michael, a spokesperson at the U.S. Department of Health and Human Services. “We made our initial vaccine order not knowing what the epidemic was going to look like. If the virus does change and there’s a need, we’re not ruling anything out.”
Even if that happens, there is still no cause for concern about squalene’s safety. Since 1997, tens of millions of doses of Fluad, the European vaccine that contains squalene, have been administered safely to patients in Germany and Italy.
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