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Shingles Vaccine (Zostavax) Confirmed Safe

Shingles (herpes zoster) is no fun. It usually begins with a couple of days of pain, then a painful rash breaks out and lasts a couple of weeks. The rash consists of blisters that eventually break open, crust over, and consolidate into an ugly plaque. It is localized to one side of the body and to a stripe of skin corresponding to the dermatomal distribution of a sensory nerve. Very rarely a shingles infection can lead to pneumonia, hearing problems, blindness, brain inflammation (encephalitis) or death. More commonly, patients develop postherpetic neuralgia (PHN) in the area where the rash was. The overall incidence of PHN is 20%; after the age of 60 this rises to 40%, and after age 70 it rises to 50%. It can be excruciatingly painful, resistant to treatment, and can last for years or even a lifetime.

Shingles is caused by the varicella zoster virus, the same virus that causes chickenpox. In fact, you can’t get shingles unless you’ve had chickenpox (or, rarely, chickenpox vaccine). Some of the virus hides in a dorsal root ganglion and remains dormant for years, then travels down the nerve to affect the associated area of skin. Shingles itself is not contagious, but it is possible to get chickenpox from contact with a shingles patient.

By various estimates somewhere between one out of five and one out of three Americans will get shingles in their lifetime; it’s more common after age 50 due to an age-related decline in cell-mediated immunity, and it’s more common in patients who are immunosuppressed. If you live to be 85, there is a 50% chance that you will have had shingles by then.

Since 2006, a shingles vaccine (Zostavax) has been available. It contains a live attenuated virus. It is recommended for everyone over the age of 60, even those who have already had shingles. There are a few contraindications like allergy to neomycin, immunosuppression, or contact with a pregnant woman who has not had chickenpox. But how safe is it? A new study is reassuring.

Pre-marketing tests showed that it was safe, but now a post-marketing study has expanded our knowledge. The VA did a randomized double-blind trial of Zostavax with over 38,000 subjects and followed them for 3.4 years. Serious adverse events occurred in 1.4% of patients who got the vaccine, but they also occurred in 1.4% of those who got a placebo! There was no indication that any of these reactions were actually caused by the vaccine. The incidence of minor inoculation-site effects (redness, swelling, pain and tenderness at the injection site) was higher in the vaccine (48%) than in the placebo group (16%), as would be expected.

How effective is it? Zostavax has been demonstrated to prevent 51% of shingles and 67% of postherpetic neuralgia. By one estimate, the number needed to treat (NNT) to prevent one case of shingles over a 3 year period is 58 and the NNT to prevent one case of PHN is 364. It is estimated that this vaccine could prevent 250,000 cases of shingles a year in US plus reduce the severity of the disease in another 250,000.

The public health implications of varicella vaccines are controversial. People living with children are less likely to get shingles — about 25% of cases are prevented. Apparently this is because adults are re-exposed to the virus and this boosts their immunity. As more children are vaccinated against chickenpox, this protective re-exposure effect will disappear; hence, more cases of shingles in the short term. In the long term, vaccinating children could drastically reduce the incidence of shingles in the population.

Only about 7% of eligible patients have received the vaccine. It costs around $200 and must be kept in a freezer. It’s covered under Medicare part D, but not part B.

For more information, see the CDC website.

Conclusion

Zostavax is safe and effective. Although not as effective as we could wish, it can significantly reduce the burden of a serious disease in the elderly population. It is recommended for everyone age 60 and over by the CDC and by many medical organizations like the American Academy of Family Physicians. Admittedly, the arguments for this vaccine are nowhere near as compelling as the arguments for polio, DPT and MMR vaccines for children. After learning the facts, not everyone will choose to take Zostavax. I chose to take it, and so did my husband.

Posted in: Vaccines

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51 thoughts on “Shingles Vaccine (Zostavax) Confirmed Safe

  1. Just to confirm that I’m understanding this correctly. At this point science doesn’t know what percentage of people immunized for chicken pox will go on to get shingles vs the percentage that had chicken pox that will go on to get shingles, although there is some evidence that the immunized will have a lower risk. Right? We still have to wait until the current crop of children who have been immunized grow up and reach “shingles” ages.

  2. Ian says:

    The term “live attenuated virus” kind of annoys me since viruses aren’t living to begin with, so I really don’t know what that is supposed to mean.

  3. WilliamLawrenceUtridge says:

    In contrast to the “killed” virus, though perhaps the term “biologically in/active” might be better.

    They’re on the borderline, depends on your definition.

  4. Watcher says:

    It’s much easier to refer to a virus as live to a layperson. Going into the in’s and outs and variations of technically alive vs. technically dead is a sure bet to getting glossed over eyes in the person you’re trying to explain it to. In the public’s eye, something that’s dead can’t hurt you.

  5. Joe says:

    Is there a simple explanation why they don’t simply give a dose of the chicken pox vaccine? The safety of that must have been established a while ago.

  6. Fredeliot2 says:

    Biggest problem around where I am located is a supply shortage. Hopefully there will be some by the end of the month.

  7. Harriet Hall says:

    Joe asks “Is there a simple explanation why they don’t simply give a dose of the chicken pox vaccine?”

    Don’t know. I had wondered the same thing. Can any of the other commenters explain?

  8. moderation says:

    The difference between Varivax (for children) and Zostavax (for adults) is the concentration of the virus particles. Zostavax has 14x the concentration of Varivax (19,000 v 1400pfu).

  9. LMAO says:

    From the CDC website:

    What is the difference between Zostavax® and Varivax®?
    Zostavax®, the vaccine to prevent shingles, consists of attenuated (Oka-strain) varicella virus at a concentration at least 14 times that found in Varivax®, the vaccine to prevent varicella (chickenpox). Zostavax® cannot be used in children and cannot be used in place of varicella vaccine. Varivax® cannot be used in place of Zostavax®.

    And from the ACIP recommendations:

    If a provider mistakenly administers varicella vaccine to persons indicated for zoster vaccine, no specific safety concerns exists [sic], but the dose should not be considered valid and the patient should be administered a dose of zoster vaccine during that same visit. If the error is not immediately detected, a dose of zoster vaccine should be administered as soon as possible but not within 28 days of the varicella vaccine dose to prevent potential interference of 2 doses of live attenuated virus.</blockquote

  10. moderation says:

    The higher concentration being needed to trigger an immune response in adults.

  11. wales says:

    Regarding Zostavax vs. Varivax, moderation is correct. Varivax, ProQuad and Zostavax contain increasing concentrations of the virus. ProQuad 7x more than Varivax; Zostavax 14x more than Varivax. This is interesting, given the recent publicity that ProQuad exhibits a higher risk of febrile seizures in children versus MMR + Varivax. See question #8 in link below.

    http://www.immunize.org/askexperts/experts_zos.asp

    Regarding whether viruses are “living” vs. “non-living”: either way they are” the “most abundant biological entities on the planet with the total number of virus particles exceeding the number of cells by at least an order of magnitude”.

    http://www.biology-direct.com/content/1/1/29

    “By weight, the unicellular microorganisms comprise more than 95% of the living material in the ocean. If viruses are also included, then nearly all of the biomass in the ocean is microbial. Numerically, the abundance of unicellular microbes ranges from about 500,000 to 5 million microbes per mL, while viruses are typically about 10-fold more abundant.”

    http://www.un.org/Depts/los/consultative_process/documents/8_abstract_suttle.pdf

    Listen to an interesting podcast “It’s a Virus World and We Just Live On It”

    http://www.microbeworld.org/index.php?option=com_content&view=article&id=614:mts46-curtis-suttle-its-a-virus-world-and-we-just-live-on-it&catid=37:meet-the-scientist&Itemid=155

  12. khan says:

    I know of no one in my family that has had shingles, but I’ll get the shot anyway. Will be my 60th birthday present.

  13. Ken Hamer says:

    Wow, suddenly I feel like and old coot.

    I had chickenpox as a child (in the mid-60s).

    In my 30s (I think – mid 80s) I developed a minor case of shingles. I don’t recall if I was given any medication at the time, but it passed after a few weeks and without any complications. In fact other than the novelty and minor itching there did not seem to be any other effects, though I did have the regular symptoms – rash, blisters, etc.

    I had another bout of shingles a few years ago — I think I was 50 years old. In this case I was given a medication (an anti-viral, I think.) Like the previous encounter it passed after a few weeks with no lasting effects.

    But I’m wondering if my recent encounter has re-inoculated me?

  14. Josie says:

    booooo. I am allergic to neomycin so I guess I won’t be going for this shot.

    I assume neomycin a component of the vaccine? Or is there a different reason for the contraindication?

    While I am allergic to neomycin (produces a poison ivy like rash when I use it topically) I did get a small pox vaccination a few years ago due to my work handling Vaccinia virus.

    I remember that the small wound took a lot longer to fully heal than expected –is that the extent of harm the neomycin might cause?

  15. Josie says:

    I should have included a line to say that neomycin allergy is also a contraindication for the small pox vaccine! (hence why I brought it up as a comparison )

  16. KathyO says:

    If the shingles vaccine is safe and effective, why not give it at 50 or 40? Why wait until 60? I realize that the risk increases at that age, but there’s some risk of getting shingles before then. Why take the chance?

    I’m also interested in whether people who have had the chicken pox vaccine can ever get shingles. I guess they can always get the shingles vaccine just to be sure. But again, why wait until age 60? That seems kind of weird to me.

  17. qetzal says:

    Josie,

    Neomycin is not so much a component of the vaccine as a residual contaminant. The live attenuated virus is grown in cultured human cells (MRC-5 cells derived from normal human lung tissue). Neomycin is commonly included as a component of cell growth media, to prevent bacterial contamination. I assume that’s the case here. The Zostavax package insert (pdf) says the final product contains “trace quantities of neomycin” (see Section 11 on page 6 of the link). That’s almost certainly because the process to purify live virus from the cell culture medium doesn’t get rid of all the neomycin.

    However, the contraindications section, (Section 4, pg 2) states:

    Do not administer ZOSTAVAX to individuals with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine.

    So maybe it’s OK for you to take it after all? I am not an MD, so obviously you should discuss with your doc.

  18. Josie says:

    Nice info qetzal, thank you! I will be asking the ol doc specifically about it :)

  19. desta says:

    Sign me up for the vaccine, even though I’m ‘too young’ by the recommendation’s standards.

    My spouse had it a few years ago; pain off and on for months, weird tingling pains long after the lesions went away—no fun at all. Wouldn’t want to consider the even more serious manifestations.

    Anyone know if major insurance carriers are tending to cover it?

    Also, I’m remembering hearing somewhere that once you have the shingles, you are more (not less) likely to get shingles again? Is that true? Anyone have any data on what the chances are of reinfections once you’ve already had shingles once?

  20. Millicent says:

    My grandmother who is in her 90s, has postherpetic neuralgia at the moment and its incredibly painful.

  21. weing says:

    desta,

    I was taught that shingles occurs only once, but that may be changing with less chickenpox around to give your immunity a boost. It used to be that a second occurrence of shingles was associated with weakened immunity due to an occult malignancy and it would necessitate such a search. In practice lately, I haven’t been finding any malignancies in these circumstances.

  22. ccbowers says:

    “I was taught that shingles occurs only once, but that may be changing with less chickenpox around to give your immunity a boost. ”

    Shingles recurrence is most likely when a person initially has shingles at an early age, has a compromised immune system, and/or they live to an old age. I imagine that your comment is part of the reason, in addition to people living longer with conditions that result in (or require pharmacologically) compromised immune systems.

  23. Calli Arcale says:

    I’m way too young for the vaccine, but I plan on getting it. Several relatives have suffered shingles, and one had serious complications — the left half of her face is still mostly paralyzed, years later, and gives her constant pain. I did not get the chickenpox vaccine. I got the real thing instead; I’d had chickenpox as an infant, so was presumed immune and allowed to babysit kids with chickenpox — and guess what! I wasn’t immune after all! I expect to get shingles eventually, and am not looking forward to it.

  24. tmac57 says:

    I will definitely get the vaccine when I am eligible. I had a case of shingles when I was 45 that occurred over my right kidney. It took more than 3 days for the rash to appear from the onset of pain,which I would describe as someone periodically jabbing me in the back with an icepick. My doctor couldn’t figure out what was going on, and twice had me tested for blood in my urine,thinking that I had a kidney stone. After the third day, I saw a small rash over the area of pain, and I diagnosed it myself by reading a family medical care book ( the doctor agreed with me when he saw the rash). For about two weeks, even the lightest contact with anything would trigger off a stabbing pain. I got around that by wrapping the area with an elastic bandage. It turned out that constant contact was less painful than erratic contact such as you would get from your shirt brushing against your skin. That was probably the worst ordeal of pain that I have experienced so far, and absolutely one that I will try to avoid in the future.

  25. Enkidu says:

    I got an incredibly light case of chicken pox as a kid. I think I had 10 lesions total. I basically just got a free week off school! Of course I gave it to my sister and she had 100s of lesions, down her throat, in her hair, in the crease of every joint, it was awful.

    I keep wondering, with the weak case I had, if I am prone to getting chicken pox again (was my lame infection able to set up latency?), or if it has any bearing on my chances of developing shingles.

    Anyways, that said, I am all for the shingles vax when I get older. I want no parts of that disease.

  26. beautyranker says:

    Great post! I am just starting out in community management/marketing media and trying to learn how to do it well – resources like this article are incredibly helpful. As our company is based in the US, it?s all a bit new to us. The example above is something that I worry about as well, how to show your own genuine enthusiasm and share the fact that your product is useful in that case.

    http://www.webhealthfind.com/ScienceMedicine

  27. WilliamLawrenceUtridge says:

    Josie,

    I believe the reason you have to worry is thanks to the autism nutters. Thimerosal used to be used as a very effective preservative and antimicrobial. Vaccine manufacturing is now more difficult because this substance was removed after their fearmongering.

  28. qetzal says:

    WilliamLawrenceUtridge,

    I doubt there’s a connection there. Thimerosal is/was added to final vaccine dosage forms, to be a preservative in the vial. Neomycin is added to prevent bacterial growth during culture of the human (or mammalian) cells that are producing the virus. It’s not meant to carry all the way through to the final vial and take the place of thimerosal. The Zostavax package insert even says that it only contains “trace quantities of neomycin.”

    I think neomycin would still be used to manufacture Zostavax even if they could add thimerosal.

    However, if I’m wrong or if I’ve misunderstood your point, please elaborate. Thanks!

  29. Kyle_Carm says:

    Working with an ophthalmologist and having seen more than one nasty facial case and the risk of developing retinal damage I definitely suggest it as a NON-MD. Not pretty at all.

    Having gotten a case at the tender age of 36 on a tender part of my body, my butt, I will be getting the vaccine later this year. My doc suggested that I was most probably covered from another outbreak for 5-6 years, I’m not waiting to see if I am for 5 or 6….I’m not feeling that lucky.

  30. canuck says:

    Just reading this all and wondering where all the critics have gone. Seems to be a fairly mutual admiration society on this study and it’s conclusions. If this were a study confirming the safety and effectiveness of chiropractic manipulation we would all be over it. What gives?

    Just a couple things that I noted in a cursory glance of the article and study itself is the assertion that when comparing a placebo to the vaccine itself in the first 42 days the results are statistically insignifant. Beyond 42 days however this does not seem to be the case however the authors do not clearly address this finding and in the substudy at least equate this anomoly to chance. I am no statistician and understand enough about research to adequately evaluate most but maybe somebody can really evaluate the strength of what their results. stats and methodology are demonstrating.

    “The public health implications of varicella vaccines are controversial. People living with children are less likely to get shingles — about 25% of cases are prevented. Apparently this is because adults are re-exposed to the virus and this boosts their immunity. As more children are vaccinated against chickenpox, this protective re-exposure effect will disappear; hence, more cases of shingles in the short term. In the long term, vaccinating children could drastically reduce the incidence of shingles in the population.”

    I am curious about this statement as it is my understanding that increasing chickenpox vaccination in children relates to increased incidence of shingles in adults and not the other way around. I believe studies have indicated a 50 year time frame for this, so certainly the short term and long term are impacted if this is argument is valid.

    Another point I would like to add relates to the general statement that Zastovax is safe and effective. Based on what I see from this study, assuming all conclusions are sound, is that the shingles vaccine appears safe for a population of otherwise healthy 60 – 70 year old, ambulatory, white people with no immune compromising conditions, significant illnesses, no other complications etc. The common pre-selection bias for safety reasons or whatever often excludes the precise target group for such a vaccine. Further, the results only can really target the attenuated virus and trace neomycin specifically and all adjuvants, stabilizers etc would similarly affect both groups. This is my lament in general about most vaccine studies and why they don’t inject something inert like sterile water as a control but I digress.

    Anyway, there are a few otherwise minor issues with the study I see and few are created perfect but to re-iterate my point, I was hoping to see more critical analysis. Also, for the record, I am not an anti-vaxer so please leave those charges for those more deserving.

    Last, there was some great discussion on the recent post related to chiropractic manipulation and stroke risk and many posters opined that cost/benefit analysis is prudent especially when a rare event may have significant consequences. Given this argument, what do those same people feel about this vaccine?

  31. Th1Th2 says:

    Enkidu,

    “Anyways, that said, I am all for the shingles vax when I get older. I want no parts of that disease.”

    Regardless how you acquired the VZV (either through natural infection or inoculation), you already became a candidate for shingles. Congratulations!

    So why do you ask for more?

  32. qetzal says:

    “Congratulations” on being at risk for shingles?

    What a nasty little worm!

  33. Frymax says:

    “‘Congratulations’ on being at risk for shingles?”

    Oh, look, it’s Interferon-Eszett.

    http://tinyurl.com/28eh9cu

  34. Shelley says:

    “Anyone know if major insurance carriers are tending to cover it”

    Depends on the type of coverage you have. I mentioned this vaccine to my parents and they both received it under their retiree benefits plans. Of course, no plan is likely to cover it if you are under 60.

    for Canuk, unless I’m missing something, they follow-ed up on deaths and hospitalizations up to 4 years after, stratified by age group and found no significant differences between placebo and treatment groups. (See appendix figures).

  35. wales says:

    Canuck you have made some cogent points. I have yet to see sbm’s vociferous critics of all things “alternative” or “chiropractic” criticize anything about vaccines.

  36. Harriet Hall says:

    canuck said “In the long term, vaccinating children could drastically reduce the incidence of shingles in the population.” I am curious about this statement as it is my understanding that increasing chickenpox vaccination in children relates to increased incidence of shingles in adults.

    If enough children are vaccinated, herd immunity will allow chickenpox to die out and vaccination can be stopped and eventually no one will be susceptible to shingles.

    “there was some great discussion on the recent post related to chiropractic manipulation and stroke risk and many posters opined that cost/benefit analysis is prudent especially when a rare event may have significant consequences. Given this argument, what do those same people feel about this vaccine?”

    False analogy. Neck manipulation: no evidence of benefit; evidence of rare but severe harm. Zostavax: clear evidence of benefit; no evidence of significant harm. And the correct term is risk/benefit or harm/benefit; cost/benefit usually refers to monetary factors which we did not discuss.

  37. canuck says:

    Shelley,

    By looking through both studies (source and the one in the post) and the supplemental appendix you will find the source data and discussions and though the authors seemingly go out of their way to not mention it in the summary, discussion, conclusions and abstract the results are clear and are addressed in the study. In the more rigorous substudy there were a significant greater number of subjects who had any serious adverse event (2.5% vs. 1.7%) as well as those having one or more serious adverse events (1.9% vs. 1.3%). Some of the SAE’s resulted in death and several were described as possibly vaccine related though cause is difficult to determine and not addressed. This disparity between the vaccine and placebo group is demonstrated in both the <42 days and post 42 day analysis in the substudy.

    Of note, the authors performed an elaborate breakdown of these SAE’s by system and diagnostic group with some statistical balancing etc. and determined no statistical significance in any particular SAE by subgroup and opine on this and draw a conclusion of chance occurrence or no clinical significance. This conclusion has numerous flaws and is difficult to understand, especially since they jump back and forth between the total population group and the substudy group in the discussion but I will leave it at that and some statistician to suitably parse.

    Last, I will repeat my objection to the use of the vaccine minus the live, attenuated virus and neomycin traces as the placebo when sterile water would be more appropriate. Further, this study was done on a relatively healthy, non-diverse population and these results cannot be readily extrapolated to the entire population of less than healthy people. There are other issues with the study but you get the point.

  38. canuck says:

    Harriet said, “If enough children are vaccinated, herd immunity will allow chickenpox to die out and vaccination can be stopped and eventually no one will be susceptible to shingles.”

    Though I do not disagree with the general theory behind what you state, the reality as I see it is less hopeful. The boosting affect of active chickenpox on the chickenpox vaccine has been relatively well documented and discussed above in the post. Exposure to varicella-zoster virus (VZV) increases the vaccine efficacy. Similarly when dramatic declines in varicella occur in a population, such as by widespread vaccination efforts, there are dramatic drops in the efficacy of the varicella vaccine. Given this, it is not unreasonable that initial efforts to vaccinate large populations would cause a rebound spike of chickenpox as vaccine efficacy decreased. Further, studies have shown how people with chickenpox vaccine become carriers to the natural VZV when exposed and pass this on to others – both vaccinated and non-vaccinated. They also show an increased incidence of shingles during these vaccination programs. This effect is seen in younger adults as increased incidence is not just in the elderly anymore. Estimates on the duration of this entire effect range from 30 to 50 years.

    Other problems with this relate to the problems in universal vaccination programs particularly in the adult population as historically adult programs rarely prove successful. Other issues include the at best 70-90% effectiveness of the vaccine in any person in any given population and the transient, temporary and unknown duration of the effectiveness of any varicella vaccine. Vaccination in children shifts the burden of disease to the adult population which carries much greater risk of death and serious complications compared to children who would carry suspected lifelong immunity upon naturally acquiring chickenpox. Further, the decrease in chickenpox and subsequent increase in shingles brings more risk as shingles has a 3 times greater risk for death and a 5 times greater risk of hospitalization compared to chickenpox. At least one of these vaccines have temporal associations with serious adverse events and death (the other does not seem to have been adequately evaluated) and the increased risks associated with taking vaccines and supposed boosters for chickenpox plus vaccines and boosters for shingles necessary to provide the type of vaccine coverage needed for proposed eradication also needs to be factored into the equation. Another factor is cost and it is estimated that the costs to carry out this program as necessary likely make it economically infeasible. Last it is important to note that both chickenpox and shingles are relatively mild, self limiting conditions and albeit can be painful in the case of shingles, rarely result in death or serious, long term complications.

    Again, this is my understanding and I still fail to see how vaccination programs will effectively eliminate chickenpox and thus shingles. Perhaps I am missing something and I am sure someone will let me know if I am.

    As for your last comment related to the false analogy, I am sorry I used this example involving neck manipulation and will respectfully disagree with your base assumptions. That said, I believe there is enough evidence to demonstrate that Zostavax has at least some evidence of serious harm so a risk/benefit analysis would be prudent. My apologies for the use of cost/benefit and thanks for pointing out the error (part of part of my day job seeping in). I am well aware of the differences in the terms – thank you.

  39. Harriet Hall says:

    Flaws can be found for any study. We will never have 100% reliable perfect evidence. So far all the studies have indicated that the vaccine is safe. I found no evidence that the vaccine causes increased SAE in any population or age group. If any evidence of harm is found later on, we will need to re-assess the situation. Meanwhile, when the data show clear evidence of benefit and no evidence of harm, it seems prudent to vaccinate.

  40. curt cameron says:

    My dad got shingles about four years ago. He was 81. The pain from the PHN lasted the next 18 months, and was debilitating. His health declined rapidly and I’m convinced that the shingles was responsible for shortening his life by years.

  41. curt cameron says:

    Upon rereading it’s not clear – the PHN lasted 18 months until he died.

  42. wales says:

    Canuck has a point, with regard to an increase in shingles (herpes zoster) due to varicella vaccination programs. The “Vaccines” textbook edited by Plotkin et al states “It is recognized that the risk of acquiring HZ [Herpes Zoster] is related to loss of cell-mediated immunity to VZV [Varicella].” And that mathematical models have been used to “predict the effect that a varicella immunization program may have on HZ incidence. These studies predict that, if exposure to varicella is an important mechanism for preventing reactivation of VZV, [elsewhere it states that several studies lend credence to this hypothesis] a short to medium term (over 10-40 years in one study, up to 70 years in another study) increase in HZ cases may occur after implementation of varicella vaccination program, although, in the long term, a reduction in zoster cases is expected to occur provided that vaccine recipients have a lower risk of developing zoster than persons who acquire natural infection.”

    Note the qualifiers signifying uncertainty. An increase in shingles incidence over 40-70 years affects a large number of individuals. Apparently the potential “positive” loooong term result for the population is seen by vaccination policy makers as a benefit that outweighs any “negative” short to long term effects on individuals.

  43. Chris says:

    Did those studies account for the bump of population in that age group? An age group commonly called “Baby Boomers”?

    Wouldn’t it be better in the long term to prevent chicken pox in children, and deal with older people who have the virus in their system with the shingles vaccines?

  44. Chris says:

    I guess I thought of that because I am a Baby Boomer. Always attending schools that were not prepared for our influx, and listening to how we impacted the system.

    Plus, I remember this paper: Secular Trends in the Epidemiology of Shingles in Alberta, which has this interesting quote:

    The increased rate of shingles in Alberta began before varicella vaccine was licensed or publicly funded in Alberta, and thus cannot be attributed to vaccination.

    It is only one paper, so it has to be taken in with the rest of the research. Which is still being created (my kids all got chicken pox the year before the vaccine!).

  45. Th1Th2 says:

    Harriet Hall,

    “If enough children are vaccinated, herd immunity will allow chickenpox to die out and vaccination can be stopped and eventually no one will be susceptible to shingles.”

    Nonsense. This is what’s going to happen. If the majority group are being inoculated with VZV while some refuse vaccination and rather prefer natural exposure, you just created a bunch of ignorant people who are now qualified to have shingles for the rest of their life.

  46. Th1Th2 says:

    canuck,

    “Again, this is my understanding and I still fail to see how vaccination programs will effectively eliminate chickenpox and thus shingles. Perhaps I am missing something and I am sure someone will let me know if I am. ”

    Oh sure you do. It is akin to saying that you also failed to see how eating a high-fat diet and smoking will cut the risk of ischemic heart disease and CABG. Hello!

    First off, stop the source of varicella and shingles! Break the chain of infection. That means, stop the inoculation and deliberate exposure!

    Don’t make the children diseased!

  47. Th1Th2 says:

    Chris,

    “Wouldn’t it be better in the long term to prevent chicken pox in children, and deal with older people who have the virus in their system with the shingles vaccines?”

    And how do you deal with older people with latent VZV, by inoculating more VZV? Nonsense.

  48. canuck says:

    Harriet,

    I agree, no study is perfect and as you know all studies are not created equally. One error in a study may totally invalidate the entire results whereas other studies may be riddled with errors and still have valid, reproducible results. Personally, my biggest issue with most studies is the post-study analysis, write up and summaries. This is where I see the bias, rationalizations, politicizing and attempts to explain the data when others could just read and draw their own conclusions. But I digress…

    The study cited in the post cherry picks the data and nearly totally omits the findings which suggest safety issues and has virtually no discussion of the vaccine related events that the source article at least offhand mentions. I find these omissions interesting in an article which is supposed to examine the safety of the vaccine and am left wanting. As an example, they state that the cumulative mortality rate in the total study group is insignificant and the cumulative hospital rate in the substudy is also insignificant. Why not mention that these rates are insignificant in both study populations versus separating them out? I am not suggesting that they are otherwise, but this is a curious omission nonetheless. For the record, I believe this has been verified through another source, but it is not totally clear either way. Anyway, going to the source study, I quote:

    “In the substudy, during the 42 days after vaccination, significantly more subjects in the vaccine group had serious adverse events than in the placebo group (1.9 percent vs. 1.3 percent, respectively; P=0.03).”

    The authors then go on to how they looked for links based on an admittedly flawed system by system and body part analysis, and found “no clinically meaningful differences between the groups in the pathophysiology, nature, timing, intensity, or outcome of these events” This is good information but does not explain the statistically significant difference in SAE’s from one group to the next.

    Though not discussed specifically, Table 4 lists some of the study results. It would be nice if there was a detailed breakdown of the total population and subgroup studies, by age, mortality, hospitalization, vaccine related events, serious adverse events etc. but there is only select data presented. That said, they do acknowledge that in the substudy in the first 42 days that there were 6.3% vaccine related systemic adverse events compared to 4.9% in the placebo group. Looking below they list some local differences at the inoculation site but fail to address what these systemic adverse events are, if they were serious or otherwise.

    Another difficult to find piece of information that is dismissed as ‘similar’ in the discussion is the serious vascular events. In the total study population these events were similar in the vaccine group and placebo group, however in the substudy there were nearly twice as many serious adverse events associated with vascular pathology. This category of events includes vascular pathologies which were not apparent at the outset of the study and included death, tissue damage etc. related to heart attacks, congestive heart failure etc. There are similar disparities in the “other” classification which includes gastrointestinal and endocrine disorders, seizures, mental status changes etc.

    All this said, the study does a poor job at presenting the significant safety issues and serious risks with the vaccine. I find it interesting that if you were to look at the prescribing information published by Merck that they clearly detail the risks I am attempting to highlight here. Of note, the patient info sheet does not mention these risks which begs me to recall statements related to consent made by others in another post discussion regarding the absolute need to disclose risks that though rare, may have a serious and long lasting impact, but I digress again.

    Either way, I believe there is enough information provided in this one study to demonstrate increased SAE’s in a population or group associated with this vaccine. VAERS data also demonstrates some possible harm and though we all know this data is underreported and the issues with VAERS data, with 1 serious adverse event reported per approximately 33,000 doses of vaccine given, there again is some plausible harm. I am not saying causation as we all know that this is problematic, but definitely correlation and I know you certainly would not hide behind this argument used so often by defenders of those things less scientific. I would also like to add that Merck states how they have not actually conducted any placebo controlled trials using the current formulation of their vaccine or conducted any similar trials in adults or adolescents in their product literature to evaluate safety. This to me is also telling.

    In closing, given the increased risk in incidence of shingles overall and chickenpox in adults associated with varicella vaccination efforts described in a previous comment combined with the information presented above, I respectfully disagree with the statement that there is “no evidence of harm”. Last, given historical mortality rates and projected risk of naturally occurring VZV disease clearly a more prudent analysis of risk/benefit seems warranted not to mention additional study.

  49. twinzs says:

    Hey All

    Read the recent article in MACLEANS….The authors are now saying that the chicken pox vaccine in kids is now creating more cases of shingles in young adults!…the solution?
    More vaccines!as they think that the chicken pox vaccine isnt working…hmmmmm.

    Quote from the article last line ” maybe a on ounce of prevention isnt worth a pound of cure”.

  50. Chris says:

    What is “MACLEANS”? Can you just give the PubMed number to that article so it can be evaluated on something other than your summary?

    Actually, re-vaccination would not be necessary once kids who have not had chicken pox become older adults. It kind of takes time. Like the time it took to not need OPV, and the IPV was sufficient for polio.

  51. squirrelelite says:

    Chris,

    Evidently Macleans is a weekly news magazine that is Canada specific, sort of their version of Time or Newsweek.

    Here is the link to the on-line article.

    http://www2.macleans.ca/2010/08/16/generation-at-risk/

    Basically, what is happening is an unintended consequence of a successful chickenpox vaccination program which reduces ongoing exposure that would boost immunity.

    Here are a few quotes:

    Here’s why: according to studies conducted in the 1960s by the British GP and epidemiologist Robert Edgar Hope-Simpson, those who are repeatedly exposed to chicken pox—health care workers, say, and families with young children—are less prone to a reactivation of the virus. Greater exposure actually lessens the risk of shingles. It follows, McGeer says, that the immune systems of young adults who didn’t get the varicella vaccine won’t have that extra boosting that would help prevent shingles—the younger, vaccinated generation won’t provide any exposure. So adults in their 20s and 30s have two strikes against them: they’ve had the virus, so it can be reactivated, and they haven’t had the exposure that would heighten their immunity. “They are going to have a problem,” concludes McGeer.

    However, there may be a silver lining to this problem although a few victims like the young lady discussed in the article can have unfortunate longterm effects.

    the disease is typically less severe with fewer complications in younger adults. Plus, a shingles vaccine called Zostavax was authorized in Canada in 2008. But so far it has only been approved (and shown to be effective) for adults over the age of 60, and it protects only half of those vaccinated.

    The Canadians are trying to decide what to do.

    Right now, the National Advisory Committee on Immunization in Canada is reviewing new evidence on the benefits of a two-dose schedule for the vaccine, and the new guidelines will be published in the fall.

    Theoretically, two doses for children rather than the currently recommended single dose would provide even better protection against the virus. However, as Fisman says, “We may have created a different disease epidemiology for which the only fix would be to vaccinate more.” So even seemingly benign medical innovations can have unintended consequences, leading Fisman and others to wonder if, with shingles, an ounce of prevention does not, in fact, equal a pound of cure.

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