State lifts limit on mercury preservative in swine-flu shots
By Sandi Doughton
Seattle Times science reporter

In preparation for swine-flu vaccinations next month, Washington's Health Department on Thursday temporarily suspended a rule that limits the amount of a mercury preservative in vaccines given to pregnant women and children under the age of 3.

The preservative, thimerosal, has never been linked to any health problems, said Secretary of Health Mary Selecky. But a vocal minority believes the compound could be linked to autism. The state Legislature adopted the limit in 2006.

Thimerosal has been eliminated from most vaccines in the United States, but it will be added to the bulk of the swine-flu vaccine being produced to stem a pandemic that health officials estimate could sicken more than a third of the state's residents.

Pregnant women and young children are considered at high risk for swine flu, and lifting the mercury limits will give them quicker access to the vaccine, Selecky said.

"It's vital that everyone in a high-risk group has the choice to be vaccinated when swine-flu vaccine becomes available," she said.

About 15 percent of the vaccine supply will be mercury-free, but people may have to wait longer for it to become available.

U.S. Health and Human Services Secretary Kathleen Sebelius said Thursday that 6 million to 7 million doses of the vaccine will be available the first week in October, mainly in the form of a nasal spray called FluMist.

About 40 million flu shots should be ready by the middle of October, with an additional 10 million to 20 million doses rolling off the assembly lines every week after that for a total of 250 million doses.

"We will have enough vaccine to immunize every American who wants to be immunized," Sebelius said in a briefing. "But it won't all be available at the same time."

The vaccine itself will be free, Sebelius said, but health-care providers can charge to administer it.

Thimerosal will be added to the vaccine because it is being produced in vials that contain enough medication for 10 shots. The mercury compound kills bacteria, lowering the risk that the drug will be contaminated by needles used to withdraw separate doses.

"Every time you introduce a needle, you run a risk of introducing a potential contaminant," said Dr. Tony Marfin, state epidemiologist for infectious disease.

Mercury-free vaccine will be produced in single-dose vials. Nasal sprays do not contain mercury but are not recommended for children under the age of 2 and pregnant women, because they contain live, weakened virus.

An analysis published Thursday also found that the nasal spray is less effective than shots in adults under 50.

Selecky said the law limiting the mercury preservative will be suspended for six months and applies only to the swine-flu vaccines.

Once common in vaccines, thimerosal has been largely phased out in most wealthy nations. Children's vaccines in the United States are almost exclusively mercury-free, single-dose injections.

However, numerous studies have found no link between thimerosal and disorders in children.

Early results with the new vaccine against swine flu, technically known as H1N1, show it quickly induces a strong immune response, and most people over the age of 10 will require only a single dose.

The rate of side effects also appears to be low. Out of nearly 44,000 people inoculated in China, 14 "adverse events" have been reported, all very mild, said Dr. Marie-Paule Kieny, director of the World Health Organization's (WHO) Initiative for Vaccine Research.

WHO and the Centers for Disease Control and Prevention (CDC) will carefully monitor side effects, she said.

After 1976's mass vaccination against a different swine-flu strain, about 500 people developed a neurological disorder called Guillain-Barre Syndrome (GBS), and some died.

Scientists still haven't figured out why, but there has never again been a connection between flu vaccine and GBS, Marfin said.

Americans are often blasé about flu, with less than half of people — including health-care workers — bothering to get annual shots.

One reason may be that flu shots are not as effective as many other vaccines, offering about 60 to 70 percent protection against the seasonal virus. That's largely because scientists have to guess which strains will be circulating each year.

With swine flu, they know exactly which strain is involved, said Dr. Anne Schuchat, chief health officer for the CDC's H1N1 response. "We would expect the vaccine to be very effective against the disease we are seeing."

But will it be ready in time?

"Right now we're in a race with the virus and the vaccine," she said.

Flu usually peaks in Washington in February and March, but the new swine-flu strain is already hitting the region. Both Washington State University and the University of Washington have reported outbreaks, and absenteeism exceeds 10 percent at some local schools.

The state is working with clinics, doctors, hospitals and others to set up inoculation programs — and bracing for crowds.

"We are expecting high interest," Selecky said.

[While the sample size was small and any conclusions need to be tempered with caution...

The NHS Information Centre found one in every hundred adults living in England has autism, which is identical to the rate in children.

Thiomersal is very toxic by inhalation, ingestion, and in contact with skin (EC hazard symbol T+), with a danger of cumulative effects. It is also very toxic to aquatic organisms and may cause long-term adverse effects in aquatic environments (EC hazard symbol N).[8] In the body, it is metabolized or degraded to ethylmercury (C2H5Hg+) and thiosalicylate.[2]

The U.S. Environmental Protection Agency (EPA) Safety of Exposure Standard is 0.1 g/kg body weight/day, equating to 7 g for a 70-kg adult. Fully vaccinated children receive as much as 237.5 g mercury from vaccines in doses of up to 25 g each, which far exceeds the EPA safety standard. Administration of the three thimerosal-containing influenza vaccines could raise this exposure to as high as 275 g mercury

The effect of mercury on the immune system has been studied mostly in rodents. These studies have revealed that subtoxic doses of mercury exposure in genetically susceptible H-2 mice strains result in the development of systemic autoimmunity

Too dangerous for human use, Squalene is not licensed for use in the United States. Oil adjuvants like squalene have been ordinarily used to inflict diseases in animals – for experimentation and study. According to anthrax vaccine expert Gary Matsumoto and other reliable sources, the US military used an unlicensed, experimental anthrax vaccination laced with squalene, with disastrous consequences, including Gulf War Sydrome.

There is, therefore, an uncertainty that arises in applying the methylmercury-based guidelines to thimerosal. Lacking definitive data on the comparative toxicities of ethyl- versus methylmercury, FDA considered ethyl- and methyl-mercury as equivalent in its risk evaluation.

Several cases of acute mercury poisoning from thimerosal-containing products were found in the medical literature with total doses of thimerosal ranging from approximately 3 mg/kg to several hundred mg/kg. These reports included the administration of immune globulin (gamma globulin) (Matheson et al. 1980) and hepatitis B immune globulin (Lowell et al. 1996), choramphenicol formulated with 1000 times the proper dose of thimerosal as a preservative (Axton 1972), thimerosal ear irrigation in a child with tympanostomy tubes (Rohyans et al. 1994), thimerosal treatment of omphaloceles in infants (Fagan et al. 1977), and a suicide attempt with thimerosal (Pfab et al. 1996). These studies reported local necrosis, acute hemolysis, disseminated intravascular coagulation, acute renal tubular necrosis, and central nervous system injury including obtundation, coma, and death. (IOM)