Swine Flu Vax Reference Guide: Thimerosal (Mercury) Amounts in Approved H1N1 Vaccines

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
  

CBS Says Swine Flu Cases Are Being Grossly Overestimated by the CDC

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.

HPV Vaccine for Boys Is Not Cost Effective

A new report in the British Medical Journal is bound to ruin the day of company officials (and shareholders) of the current human papilloma virus (HPV) vaccine manufacturer, Merck, who were undoubtedly pleased that an FDA committee recently recommended that the government agency okay the use of Gardasil in males against genital warts.

An economic analysis of the cost effectiveness of vaccinating boys for HPV in order to prevent cervical cancer caused by certain HPV variants in girls was done at the Harvard School of Public Health.  The researchers concluded that vaccinating girls resulted in a cost of $50,000 per quality adjusted life year (QALY), which means that for every additional year of perfectly healthy life that is gained via the vaccine, the cost is $50,000.00.  The cost for including boys in the HPV vaccination efforts raised the cost of one QALY to over $100,000, which “…exceeds conventional thresholds of good value for money,” the researchers said.

The researchers made the calculations assuming 75% vaccination coverage rate, and also assumed that the immunity to the cancer-causing variants of HPV that the vaccine is supposed to confer lasts a lifetime, which is of course unknown at this stage, since the vaccines in question have only been in use for a few years.

The immunity conferred by every other vaccine appears to wane over time, so until we have evidence to the contrary, it is rational to assume that any immunity conferred by Gardasil and Cervarix will wane as well.  If repeated vaccination is necessary, this will raise the cost of each QALY even further.

Nonetheless, it seems likely that the current push to recommend the use of HPV vaccines in males will continue with a simple shift in focus on genital warts instead of cervical cancer.

The two currently FDA approved vaccines for human papilloma virus are manufactured by Merck & Co.  (Gardasil, ) and GSK, GlaxoSmithKlein (Cervarix).

Hospitals Offer Raffle Tickets in Exchange for Workers’ Vaccinations

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.

H1N1 Looking Largely Like Seasonal Flu

The CDC just recently released an update on the  H1N1 Swine Flu situation on their website, and it’s quite clear that as of now, the dire straits over Swine Flu are not materialising as expected.

For example, it turns out that visits to physicians for influenza-like illness are massively up.  That’s not surprising to me, and can probably be explained by all the panic in the press over this new killer influenza.  Lots of people who would have probably stayed home and toughed it out with chicken soup are now probably racing to the doctor just to make sure death isn’t imminent.

Hospitalisations for influenza are “similar to or lower than”  expected rates for regular, seasonal flu.  But they are higher for this time of year.  We’ll have to wait to see if this just a flu bug that is hitting earlier than usual, or whether this is going to develop into more cases of flu than usual. It’s too soon to know for sure.

Deaths attributed to influenza and pneumonia are “low and within the bounds of what is expected at this time of year.”   That’s even better news.

I’m not sure that the continued tremendous fear of this influenza strain is warranted.  However, it’s always good to make sure you have enough Vitamin D.

FDA Approves Swine Flu H1NI Vaccines After Small Trials

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.

Generics Drug Manufacturer Alleges FDA Director has Conflict of Interest and Ties to Pharmaceutical Company

Janet Woodcock, head of the FDA Center for Drug Evaluation and Research is under investigation for ethics violations on the basis of a complaint filed by a drug generics manufacturer Amphastar that she had inappropriate ties to rival manufacturer Momenta Pharmaceuticals for a generic version of the blood-thinner Levenox for which they both sought FDA approval.

It’s interesting to think that a possible remedy to the FDA’s close ties with pharmaceutical companies and device manufacturers might come from some of the companies themselves, complaining about the unfair advantage that other companies enjoy due to their professional relationships with individuals at the FDA.

UK Goverment Planning Media Campaign to Convince Parents to Give MMR

The UK Department of Health is gearing up to spend £400,000 to fund a media campaign to convince parents of young children to give their children the MMR, according to a story in PR Week.

I can’t help but wonder why they don’t take the money, and hold a large televised debate on the merits, completely open to the public.  Since the claim is that the MMR is emphatically not associated with autism, backed up by solid scientific study, why not publicly address parents’ concerns instead of trying to sell them with an advertising campaign?

Aren’t adverts for trying to convince someone to want something that they don’t really want?  Give the parents the discussion and an open forum where difficult questions are addressed with truthful and robust answers.  I suspect that people would really like to really assess the government claim that the risks of side effects of the vaccine-preventable diseases are much higher than the risks of side effects of the vaccines – instead of being “sold” on it by some PR experts.

Paul Offit Expresses Concern About Conflict-of-Interest

I saw an interesting medical news story this morning that said a small study was done that seemed to show that autistic children benefited from hyperbaric oxygen therapy (HBOT) compared to children who were exposed to slightly pressurised room air (hyperbaric oxygen chambers have higher levels of oxygen and are more pressurised).

I haven’t yet had a chance to read the study, so I am not sure how well done it is, but go and have a look to see for yourself.  The study is being published in the peer reviewed journal BMC Pediatrics, here is a link to the abstract and preliminary article.

The thing I found interesting about the particular report of this study in Medpage Today, is that there is some commentary by Paul Offit expressing scepticism about this study because the parties who conducted the studies (Daniel Rossignol, Lanier Rossignol, Scott Smith, Cindy Schneider, Sally Logerquist, Anju Usman, Jim Neubrander, Eric Madren, Gregg Hintz, Barry Grushkin and Elizabeth Mumper) are in some cases DAN! doctors who make their living treating autistic children, and who use HBOT to treat them, at least in some instances.

“I’d like to see [the study] reproduced in an academic medical center that doesn’t have the financial incentives,” said Dr. Offit.

That sounds a bit funny coming from Paul Offit, who spends his time studying, developing, handsomely profiting from and publicly promoting vaccines.  If the physicians in question have prima facie questionable intention and/or honesty because of their capacity to profit from their work, then one can’t help but wonder how Offit can avoid the very same criticism that he levies at them.

I happen to think it’s impossible to be utterly unbiased; every researcher comes to a study with an idea or a viewpoint that they expect to validate.  The methodologies of science aim to minimise these various biases, and of course where conflicts of interests exist, they should be completely disclosed.  But I think it’s quite something to disapprove of a study because the physicians profit from procedures they study and recommend, when one has profited from the development of a vaccine one has studied and recommends.  Offit routinely rebuffs criticism that he has a conflict of interest.  I wonder how he thinks these physicians who studied HBOT are differently situated.

In fact, in 2000 the Committee on Government Reform in the U.S. House of Representatives criticised practices of the Advisory Committee on Immunization Practices (which makes recommendations on childhood vaccines) with regards to their poor management of conflicts of interest, specifically citing Paul Offit (as well as others) who voted for the recommendation of the Wyeth RotaShield (rotavirus) vaccine on three occasions, when he was also developing a rotavirus (RotaTeq) vaccine with Merck, because of their worry about this as a conflict of interest.  They said “A recommendation for Wyeth-Lederle’s vaccine would help pave the way for future recommendations for the products of Merck and SmithKline-Beecham.”

That sounds like at least as worrisome a conflict as he is now concerned about with these DAN! doctors.

Pertussis Outbreak in New Jersey – Vaccinated Are Apparently Not Protected

There’s been a recent outbreak of whooping cough (pertussis) in Hunterdon County, NJ, and the last report I’ve seen puts the number of ill children at 32.  A separate news report stated that the ill children had been vaccinated,  and then another report confirmed that all the infected children had all of their recommended vaccines.

Most of the infected children were (29/32) between the ages of 7-12.  These children, if vaccinated according the CDC recommendations, had DTaP shots at ages 2 months, 4 months, 6 months, 15-18 months and 4-6 years.  That’s FIVE doses.  Five doses of the vaccine, and still this many children are not immune?

There’s been a recent addition of a SIXTH dose of pertussis in New Jersey near age 10, as there is concern that the temporary immunity to pertussis from the previous five doses wanes as quickly as ages 7-9.

Apparently when five doses of a vaccine aren’t sufficient to induce immunity the answer is to just keep giving more doses, as perhaps after the 10th, 25th or 33rd dose they will hit the jackpot.  If we’re lucky.