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Are vaccines safe? Response to a reader comment.

October 8, 2009

On the ‘eve of a pandemic’ everyone is asking me this: Are vaccines safe?
Western medicine generally says “yes” bearing in mind that the small risks are largely outweighed by the benefits of gaining immunity to some pretty nasty infections. I am NOT an expert. I’m just collecting and displaying some facts. For more information, there is a great paper from the Medical Journal of Australia that addresses each of the vaccine components in turn.

A specific comment on my blog reads:

“Why if a patient is already immunocompromised would you recommend the annual seasonal flu vaccination or the H1N1 vaccine that is laden with toxins like mercury, antifreeze, spermicides, adjuvants?  Knowing full well there is no efficacy rate or long term clinical studies on fertility or any thing else WHY DO YOU RECOMMEND THIS for anyone let alone patients with underlying problems? “


For our benefit, I will refer to the monographs for seasonal flu vaccination (at the bottom of this entry). Because the H1N1 vaccine is relatively new, still undergoing testing, and does not yet have any long-term data behind it, I will defer comments on it specifically. However, I will say that we may draw some parallels between the seasonal vaccine and that for H1N1, and it would be logical to deduce that the new vaccine will have a similar benefit and risk profile as the established vaccines.

 

1. Mercury?: Thimerosal from MMR vaccines was reported in the Lancet to be linked with Autism in 12 cases. The late 1990s paper has has since been retracted. The controversy of that article is detailed here; basically, there was an undisclosed conflict of interest, with the prime researcher receiving funding to prove the link. The results did not stand the test of time, as they were never reproduced. A great review of literature, concluding that no link can be drawn between thimerosal-containing vaccines and autism, can be found here.  Evidence does not support a causal association.

The CDC agrees that vaccines containing thimerosal are safe. We know that thimerosal is cleared from the body faster than environmental (methylmercury) and less likely to accumulate in our tissues. The doses in most vaccines are insignificant although in a few types of shots (including flu shots), they can be as high as 50ug/dose. See http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/07vol33/acs-06/index_e.html for the government’s perspective. Their bottom-line recommendation is “There is no legitimate safety reason to avoid the use of thimerosal-containing products for children or older individuals, including pregnant women.” Also, if this doesn’t set your mind at ease, you could simply ask for a single vial dose which does not contain the mercury.

2. Antifreeze? (ethlyne glycol/methanol/propylene glycol): This is not present in vaccinations. Perhaps you are thinking of formaldehyde (the systematic name of which is “methanal”) which is present in trace quantities as it is used to deactivate the virus so that it is not active when the vaccine is injected. Formaldehyde is a suspected carcinogen but in studies of those exposed to large volumes (i.e. formaldehyde industry workers) no link has been established (http://www.ncbi.nlm.nih.gov/pubmed/15191929?dopt=Abstract).

3. Spermicides?: I could identify no components that are known to inactivate or kill sperm. I haven’t heard this concern before except with respect to Africa and the public fear of infertility from vaccination. See this article for a good handle on the subject. Also, there are vaccines under development for gonorrhoea and chlamydia which could increase female fertility by preventing Pelvic Inflammatory Disease (PID). On the other side, consideration has been given to an anti-sperm vaccination as a means of contraception.

4. Adjuvant?: Adjuvant is a word that means “something in addition to.” Yes there are preservatives and a solute into which the active portion of the vaccine must be dissolved in order to facilitate delivery. Almost anything we ingest or imbibe follows this pattern. When we peanut butter and jam on our toast, the condiments could be considered adjuvants. The adjuvants in the seasonal flu vaccine are mostly salts (sodium phosphate, sodium chloride) and sugar (sucrose). EDIT: In the context of vaccinations, an adjuvant is a specific chemical added to a vaccine to improve the immune response so that less vaccine is needed to provide protection. See the comments for a very helpful, indepth explanation,

5. No efficacy of flu vaccines?: A study that compared the effectiveness of the inactivated influenza vaccine during influenza seasons with differing degrees of vaccine match illustrates the importance of the fit between circulating influenza virus strains and the vaccine. During the 2004-2005 influenza season, the antigenic match was only 5 percent compared with 91 percent during the 2006-2007 season, which resulted in a vaccine effectiveness of 10 versus 52 percent, respectively. The Cochrane group – one  of the most recognized collectives in Evidence Based Medicine – did a meta-analysis of studies pertaining to influenza vaccination and efficacy. Conclusion? “Influenza vaccines are effective in reducing cases of influenza.” Simple.

6. No long term studies on fertility?: A search of PubMed for ‘vaccination and fertility’ revealed NO papers supporting a  link between government approved vaccinations designed to prevent infection and a state of infertility in recipients. Usually, phase 4 studies are not undertaken to search for specific consequences, but if they should arise, studies are published. One fallacy of medical literature is that negative results are rarely published. How many papers that say “there is no link between vaccination and infertility over a 20 year study” would be considered glamorous? The lack of negative reporting is something that is changing in medicine, but for now, it is fair to assume that because no links have been drawn, it is unlikely that fertility has been profoundly affected by our policy of universal vaccination.

7. Recommendations to patients with underlying problems: It is specifically because an immunocompromised person has a lessened ability to naturally fight off infection that they would benefit from a preventative measure such as a vaccine. If they were to contract influenza, their risk of morbidity and mortality would be much greater than that of a healthy immunocompetent person. The Lancet put something out in August looking at this very issue.

In my opinion, the regular foods we eat contain often contain more crap than do vaccines, and offer little to nothing in the way of therapeutic benefit. Everything in medicine is about weighing the benefits against the risks. When weighing the options, the potential of a serious illness (or death) compared to the potential of a muscle ache in my arm or an anaphylactic reaction to the components of a vaccine, I’d chose the vaccine. You don’t have to, but you must consider that your choice also affects those around you.


Monographs:

 

Vaxigrip

Drug Substance

VAXIGRIP® [Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)]

For the 2009-2010 season each 0.5 mL dose of VAXIGRIP® contains:

15 μg HA A/Brisbane/59/2007 (H1N1)-like strain [A/Brisbane/59/2007 (IVR-148)]

15 μg HA A/Brisbane/10/2007 (H3N2)-like strain [A/Uruguay/716/2007 (NYMC X-175C)]

15 μg HA B/Brisbane/60/2008-like strain (B/Brisbane/60/2008)

Other Ingredients

≤30 μg formaldehyde, up to 0.5 mL sodium phosphate-buffered, isotonic sodium chloride

solution. 2 μg thimerosal*, Triton® X-100, trace amounts of sucrose and neomycin.

* added as a preservative in multidose presentation only

For the 2009-2010 season each 0.25 mL dose of VAXIGRIP® contains:

7.5 μg HA A/Brisbane/59/2007 (H1N1)-like strain [A/Brisbane/59/2007 (IVR-148)]

7.5 μg HA A/Brisbane/10/2007 (H3N2)-like strain [A/Uruguay/716/2007 (NYMC X-175C)]

7.5 μg HA B/Brisbane/60/2008-like strain (B/Brisbane/60/2008).

Other Ingredients

≤15 μg formaldehyde, up to 0.25 mL sodium phosphate-buffered, isotonic sodium chloride

solution, 1 μg thimerosal*, Triton® X-100, trace amounts of sucrose and neomycin.

* added as a preservative in multidose presentation only

(https://www.vaccineshoppecanada.com/secure/pdfs/ca/vaxigrip_e.pdf.)

Fluviral S/F

Fluviral S/F for i.m. injection is a trivalent, split-virion influenza vaccine prepared from virus grown in the allantoic cavity of embryonated hens’ eggs. The virus is inactivated with formaldehyde purified by centrifugation and disrupted with sodium deoxycholate in Triton X-100. Each dose of 0.5 mL of a whitish, slightly opalescent liquid, contains: hemaglutinin 15 µg of each of the following strains: A/Beijing/262/95 (H1N1), A/Sydney/5/97 H3N2, B/Harbin/7/94. The composition of Fluviral S/F is established in agreement with the recommendations of the Canadian National Advisory Committee on Immunization (N.A.C.I.). Thimerosal 0.01% is present in both whole and split-virion preparations as a preservative. Split-virion vaccine also contains trace residual amounts of egg proteins and deoxycholate.(http://www.rxmed.com/b.main/b2.pharmaceutical/b2.1.monographs/CPS-%20Monographs/CPS-%20(General%20Monographs-%20F)/FLUVIRAL%20S.html)

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10 Comments leave one →
  1. October 8, 2009 11:32 pm

    Thanks for this very thorough debunking.

    • October 9, 2009 1:56 am

      It took a while and it doesn’t cover everything, but I’m glad if it helps clear some things up. Some of the resources I link to are far more useful than my post, but I wanted to frame it as a response to that comment. That’s because one of my goals with this blog is to open up discussion, and I hope it continues.

      Thanks for reading Dave!

  2. October 12, 2009 9:02 am

    Nicely done doc.

  3. Brian permalink
    October 18, 2009 6:03 am

    Excellent summary – thanks for this!

  4. bbobbo permalink
    October 22, 2009 10:05 am

    just to clear up a few of your responses to the commenter:

    2) antifreeze: the commenter wasn’t referring to formaldehyde but rather polyethylene glycol, which in the vaccines you cited is listed as triton x-100. triton x-100 is used in the preparation of the sanofi pasteur swine flu vaccine.

    ethylene glycol is a precursor to polyethylene glycol, but it is not the same thing as polyethylene glycol.

    3) spermicide: the commenter is referring to nonylphenol ethoxylate, which is used in the preparation of the novartis swine flu vaccine.

    nonoxynol-9, which is a spermicide, is one form of nonylphenol ethoxylate. however,

    a) there is no information that this is the form used by novartis

    b) the amount of nonylphenol ethoxylate which may be present is miniscule (not more than 0.015% w/v)

    c) nonoxynol-9 works by direct contact with sperm, not through the bloodstream.

    4) adjuvant: in terms of vaccines, an adjuvant is not just “something in addition to”; rather, it is an ingredient added specifically to enhance the efficacy of the vaccine. adjuvants allow vaccine makers to prepare more doses of the vaccine with the same amount of viral material and may also provide a stronger or longer-lasting effect.

    while other countries (such as canada) have decided to use adjuvants in their swine flu vaccines, there are no adjuvants in the swine flu vaccines available in the united states.

    you can see the package inserts for all the swine flu vaccines here:

    Package Inserts and Manufacturers
    for some US Licensed Vaccines and Immunoglobulins

    • October 22, 2009 6:24 pm

      fantastic! that is extremely helpful.

      Like I said, I’m not an expert. I found it difficult to respond to the original comment with H1N1 specific info as the composition was not yet approved in Canada and because I really am not an authority on the subject.

      We use adjuvant therapy in medicine all the time, for example, today I dosed a patient with oral probenecid before IV cefazolin. I stand corrected in that I took the commenters term “adjuvant” at face value rather than in the context of vaccines. Having read more since then, I learned that one of the main reasons that Canada will be able to provide vaccination for the whole population is because they can ‘stretch’ the viral material in this way.

      Anyhow, thanks for your valuable contribution to this discussion . I feel like I can better inform my patients when the time comes to roll up our sleeves!

  5. bbobbo permalink
    October 22, 2009 10:13 am

    well, i just noticed that you are actually in canada, so here is something additional about the adjuvant being used there:

    What is an adjuvant and why is Canada using one?

    An adjuvant is a chemical additive used in some vaccines to ramp up the response the immune system generates to a vaccine. Adjuvants aren’t new in Canada; they’re already used in pneumococcal and meningococcal vaccines, for example.

    With an adjuvant, less pure vaccine antigens are needed, so one dose of vaccine can be stretched into four doses. An adjuvant boosts immune response so that recipients are more likely to develop antibodies to the swine flu virus. It also makes the immune response more “durable,” so it lasts longer, and it creates a wider response, so that if the swine flu virus “drifts” or changes, this vaccine should still offer some protection.

    While the U.S. is not using an adjuvant in its swine flu vaccines, Canada chose to use an adjuvant after there were initial problems with slow vaccine production and the WHO requested manufacturers use “antigen sparing strategies” to stretch out supplies.

    Because flu vaccines don’t normally use an adjuvant, Canada’s manufacturer, GlaxoSmithKline could not use the” fast-track” vaccine approval system that allows seasonal flu vaccines to be tweaked every year with small adjustments to the strains. Adding the adjuvant made the Canadian version of the pandemic vaccine different enough from seasonal flu vaccine in its design such that a new licence is required and more clinical trials were needed to assess safety.

    GSK, Canada’s pandemic vaccine manufacturer, says its vaccine contains its own proprietary adjuvant system, called AS03. It is a based on a natural organic compound obtained from fish oil and mixed with water and vitamin E.

    The company says it has tested AS03 in H5N1 influenza (bird flu) on more than 43,000 volunteers and says the adjuvant has been shown to be safe.

    taken from ctv news:

    Frequently Asked Questions about the swine flu vaccine

Trackbacks

  1. Are vaccines safe? « Dr. Ottematic | H3N2FLU.US
  2. Are vaccines safe? « Dr. Ottematic | H1N1VACCINATION.US
  3. H1N1 (Swine Flu) Vaccine rolling out in Canada « Dr. Ottematic

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