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I have noticed that a lot of visitors to my blog have come from searches that make it apparent they are looking for information on whether the swine flu vaccines contain thimerosal/mercury, so I thought I would collate the information from the package inserts for each of the available shots here for easy reference.

Novartis, Influenza A (2009) Monovalent Vaccine -Licensed for persons 4 years of age and older

  • 0.5 ml prefilled single dose syringe contains less than or equal to 1 microgram mercury per dose (residual mercury from manufacturing process)
  • 5 ml multidose vial contains 25 micrograms of mercury per 0.5 ml dose (as preservative)

Sanofi Pasteur, Influenza A (2009) Monovalent Vaccine – Licensed for persons 6 months of age and older

  • Prefilled syringe, 0.25 mL, for 6 through 35 months of age – contains no mercury (no mercury used in manufacturing process) – distinguished by a pink syringe plunger rod
  • Prefilled syringe, 0.5 mL,  for 36 months of age and older – contains no mercury (no mercury used in manufacturing process)
  • Single-dose vial, 0.5 mL, for 36 months of age and older – contains no mercury (no mercury used in the manufacturing process)
  • Multi-dose vial, 5 mL, for 6 months of age and older, 25 micrograms of  mercury per 0.5 ml shot (as preservative).

CSL Limited, Influenza A (H1N1) 2009 Monovalent Vaccine – licensed for persons 18 years of age and older

  • 0.5 mL single-dose, pre-filled syringe – no mercury (no mercury used in manufacturing process)
  • 5 mL multi-dose vial  each 0.5 mL dose contains 24.5 micrograms of mercury

MedImmune LLC,  Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
– (Live, Attenuated Intranasal Vaccine – LAIV) Licensed for persons from 2 years to 49 years

  • Prefilled single-dose intranasal sprayer containing 0.2 mL suspension (0.1 ml per nostril) – no mercury
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The CDC advised states to stop confirming cases of H1N1 back in July, presumably because it was a waste of resources when H1N1 had already been declared to be at epidemic levels. The assumption was that everyone who presented with flu-like illness was ill with H1N1.

CBS News asked the CDC to release data on the confirmed cases, and when the CDC did not respond to their request immediately they filed a Freedom of Information Act (FOIA) request for the data, and concurrently undertook a three-month, state-by-state inquiry concerning data of confirmed cases prior to the CDC’s recommendation to stop confirming H1N1 via laboratory test.

CBS found that the states were confirming swine flu in about 1%-17% of cases of persons sick with flu-like illness. The majority of the other flu-like illnesses were caused by non-influenza causes (83%-97%), although there were small amounts of cases confirmed to be seasonal influenza.

And of course during this time the presumption is that all these cases are swine flu, making it seem far more prevalent than it really is.  CBS cites the case of a recent “outbreak” of 250 students at Georgetown University, where the presumption is that there are 250 cases of H1N1, when in reality, those cases have not been confirmed and it is nothing more than a counting of students who went to the unversity’s health service with flu-like symptoms.  It’s very likely that few of those 250 students actually have swine flu.

This has problematic implications for vaccination recommendations as well (setting aside the question of whether the vaccine is safe and effective).  The CDC recommends that unless you have had a laboratory-confirmed H1N1 diagnosis you should get the swine flu vaccine, which means that some people who have actually been ill with swine flu will be getting an unnecessary jab, and people who think they have been ill with H1N1 will mistakenly assume that they are immune.

I was reading a New York Times article this moring about the State of New York’s recent mandate that all healthcare workers receive the swine flu vaccine.

It was shocking to learn that hospitals incent healthcare workers to get vaccines by offering them time off work or the chance to win a vacation or holiday trip. It reminds me of parents offering their children ice cream if only they eat their broccoli.

It’s probably more appropriate in a non-paternalistic state to offer healthcare workers good reasons to have the shots than to offer them bribes.  Good reasons would include: 1)  evidence that the shot is necessary (meaning that we have good reason to believe that this strain of flu is particularly dangerous or virulent),  2) evidence that the shots are effective, and 3) evidence that the shots have been adequately tested and are safe.

The article also says that workers who decline vaccines even when they are “voluntary” are often punished by having notes concerning their noncompliance with the vaccine recommendations put into their personnel file or else they are forced to wear face masks at all times.

The FDA announced today that it approved four Swine Flu (H1N1) vaccines manufactured by Sanofi Pasteur, Novartis, MedImmune and CSL Limited and expects that the vaccines will be  available in approximately four weeks.  Vaccines will be available both with and without thimerosal.

Last week the two of the four companies who manufacture the approved vaccines had findings published in the New England Journal of Medicine:   CSL Limited and Novartis.

The worrying aspect of all of this rush to make H1N1 vaccines available is the seemingly small numbers of people on whom the vaccines are being tested before they are approved.

Details from the website of the National Institute of Allergy and Infectious Disease at the National Institute of Health detail five clinical trials taking place under the support of the NIAID in addition to trials that are being (or have been) undertaken by the manufacturers.

The NIAID-supported trials have tested two strengths of H1N1 vaccines made by CSL Limited and Sanofi Pasteur in 200 people, each receiving two doses of the vaccine given 21 days apart.  Half of the people tested were 65+ years old, the other half were between 18-64.

The other three NIAID trials are testing pediatric doses of the vaccine,  (these trials are expected to be completed in April of 2010), and the H1N1 vaccines given simultaneously and sequentially with the seasonal flu vaccine, both in adults and in children (these trials have the largest enrollment, up to 800 persons).

At the end, this means that 200 people between the ages of 18-64 were trialed with two doses of either the Sanofi Pasteur and CSL H1N1 vaccines, half of which got a larger dose of vaccine, and half of which got a smaller dose.  In CSL’s NEJM article, an additional 240 people were trialed (half less than 50 years old, half equal to or greater than 50 years old).

There was a good deal of the unsurprising injection-site tenderness, and symptoms like headache and pains, but no deaths and no serious adverse events.

But it’s not terribly surprising that there aren’t any serious adverse events showing up in very small group of people receiving a vaccine (100-200). The question is whether we will see any adverse events emerge in four weeks when the vaccines are made available to the public.

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