THE NEW swine flu vaccine, when it becomes available here in coming weeks, will only be available with a mercury-based preservative included.
The same vaccine will be available in the US both with and without the substance – the mercury-free form for pregnant women and young children.
The HSE has confirmed it plans only to acquire the vaccine in doses containing the mercury-based preservative Thimerosal.
“The vaccine will be administered to everybody including pregnant women on the basis of informed consent,” a HSE spokesman said.
The vaccine is being formulated both with and without Thimerosal in the US. The preservative-free doses will be directed at children under six and pregnant women.
Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases (NIAID), which is overseeing the development of a H1N1 vaccine, said there would be three forms of the vaccine available. “There are 10-dose vials which have Thimerosal. The other is single-dose vials that don’t need Thimerosal, and the other is pre-loaded syringes which don’t have Thimerosal.”
Speaking on a webcast on pregnancy and swine flu, hosted last month by the US department of health and human sciences, he said: “There are doses that will have Thimerosal and there are doses that don’t have Thimerosal. We are preferentially directing the non-Thimerosal doses to children and to pregnant women.”
People “are concerned” about Thimerosal, he said. While not dismissing this, he said scientific data suggested there was no safety issue. “But people do still feel concerned. We want to alleviate that concern. We try to make the vaccines Thimerosal-free for the children and for pregnant women.”
The mercury-based compound has been used as a preservative in vaccines since the 1930s. Some have attempted to link the substance with an increased risk of autism and other brain development disorders.
These concerns were brought to the fore in 2001 by Cure Autism Now, the world’s largest private funder of biomedical research into autism. That year, it called on the immunisation safety review committee of the National Academy of Sciences to recommend the removal of Thimerosal from vaccines for pregnant women and children. As set out in a briefing document on Thimerosal from the US Food and Drug Administration (FDA), the review committee could neither accept nor reject a causal relationship between Thimerosal and neurodevelopmental disorders.
It did, said the FDA, conclude that a link between Thimerosal and neurodevelopmental disorders “was biologically plausible”.
The document continues: “As a precautionary measure, the public health service, the Center for Disease Control and the American Academy of Paediatrics issued two joint statements urging vaccine manufacturers to reduce or eliminate Thimerosal in vaccines as soon as possible. The US public health service agencies have collaborated with various investigators to initiate further studies to better understand any possible health effects from exposure to thimerosal in vaccines.”
A spokesman for the HSE, when asked whether consideration was being given to provision of a Thimerosal-free formulation of the vaccine, said: “Nothing like that is being mooted.”
Separately, a pilot study in England on the vaccine suggests just one dose may be needed to get a “strong immune response”.
