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 blas bout 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.
http://seattletimes.nwsource.com/cgi-bin/PrintStory.pl?document_id=2009938638&zsection_id=2003960373&slug=vaccine25m&date=20090925
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Comment by KP Stoller, MD:
From: ""
Date: Fri, 25 Sep 2009 21:12:25 GMT
To: William.Harvey@state.nm.us,
Adela.Padilla@state.nm.us
Subject: RE: case number 2009-055
Mr. Harvey:
I would like to herewith petition that you reopen case 2009-055.
The Board of Pharmacy closed it after getting reassurance form the NM DOH that pregnant women and children under 3 would not receive H1N1 vaccine containing Thimerosal (even though the petition was about exceeding FDA recommendations for giving pregnant women flu vaccine regardless of what was in it).
If you will read the post by the DOH (State of Washington):
http://www.doh.wa.gov/cfh/immunize/providers/h1n1-thimerosal.htm
You will see that they have suspended their normal operating procedures and will now give vaccine with Thimerosal to infants and pregnant women because they have already been notified there will be a severe shortage of Thimerosal free H1N1 vaccine.
This is exactly what I anticipated would happen and it was why I filed my complaint with the BoP. You closed the case inappropriately by getting assurance that only Thimerosal free vaccine would be given to pregnant women and children under 3. If the NM DOH follows the lead of the State of Washington, you received false assurance.
So I need to file a new complaint or can you reopen the one you just closed?
KP Stoller, MD, FACHM
President, International Hyperbaric Medical Assoc
www.hyperbaricmedicalassociation.org
Medical Director, Hyperbaric Medical Center of New Mexico (the Authorized hyperbaric facility of the 377th Med Sqdn)
www.hbotnm.com Medical Director, San Francisco Institute of Hyperbaric Medicine www.sfhbo.com Medical Director, Hyperbaric Recovery Center, Larkspur www.hyperbaricrecoverycenter.com Medical Director, Hyperbaric Oxygen Clinic Sacramento www.hbot.info
---------- Original Message ----------
From: "KP Stoller, MD"
To: William.Harvey@state.nm.us
Cc: Adela.Padilla@state.nm.us
Subject: RE: case number 2009-055
Date: Wed, 5 Aug 2009 18:30:38 GMT
Inspector Padilla:
I was just sent an internal draft CDC Media Strategy, made public for the first time (see attached), which concedes that CDC does not have sound science supporting vaccine safety and must therefore resort to a program of misinformation and propaganda, referring to critical parents and safety first advocacy organizations as anti-vaccine.
In addition to conceding that fear-based propaganda will have to substitute for basic science, the memo reveals how completely CDC has descended into a military them-against-us mind set. Critics of vaccine safety are labeled anti-vaccine, as hostile parents, or as adversaries of vaccination, with no acknowledgment that criticism and inquiries can be in good faith, can sincerely be interested in promoting vaccine safety as a sensible, indeed necessary, scheme to protect the benefits to public health of mass immunization.
CDC admits: Risk communication messages regarding vaccine adverse reactions are difficult to develop. Yes, exactly, because they just dont know the risks. How, then, can CDC claim as a strength of their media plan that the [b]enefits of vaccination far outweigh the risks?
This is a hungry lie.
Instead of actually doing the science to accurately ascertain the risks of vaccination, and make appropriate changes to the schedule, screening, etc., CDC proposes an aggressive public/private media
campaign: [C]ommunity acceptance of vaccination demands that we take a stand to not only explain the risks of complication due to natural disease, but also toward unfounded arguments or [sic] adversaries of vaccination.
CDC makes a stunning admissions: Some claims against vaccine cannot be disproved. And: CDC does not have complete adverse event surveillance data on which to base health messages.
As previously explained, the FDA does not recommend flu vaccine for pregnant women - that has not changes and the CDC has gone rogue in this area.
KP Stoller, MD, FACHM
President, International Hyperbaric Medical Assoc
Medical Director, Hyperbaric Medical Center of New Mexico
www.hbotnm.com