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The shingles vaccine

Posted by medconsumers on May 17, 2010

By the time age 60 rolls around, everyone knows at least several people who’ve suffered a painful attack of shingles, aka herpes zoster, and its severe complication called postherpetic neuralgia. Consequently, there’s a growing interest in the relatively new shingles vaccine, especially now that this expensive shot is covered by all Medicare part D health plans. The vaccine has been available for several years because it has been proven effective. Its long-term safety, however, has been in question—that is, until now. A newly published safety study that followed vaccinated people more than three years indicates that the vaccine does not cause severe adverse reactions.

First, a retrospective look at what has already been proven in terms of effectiveness. Contrary to what people might expect from this vaccine, it reduces—but does not eliminate—the chance of getting herpes zoster. A large 2005 trial, called The Shingles Prevention Study, randomly assigned about 18,000 people to receive the shingles vaccine and another 18,000 received a placebo vaccine. All participants were over the age of 60.

After three years of follow-up, there were 315 cases of herpes zoster among vaccine recipients and 642 among placebo recipients. As for postherpetic neuralgia, the much-dreaded complication, there were 27 cases among vaccine recipients and 80 among placebo recipients. Of the vaccinated people who developed postherpetic neuralgia, their pain was greatly reduced (by 61%) in comparison to the placebo-vaccinated people who developed this complication.

Now for the recently published safety study. It’s an offshoot of The Shingles Prevention Study, which had singled out the study participants who suffered a serious adverse reaction. After three years of follow-up, this turned out to be exactly the same percentage (1.4%) of the vaccinated and of the placebo groups. The researchers also looked at deaths and hospitalizations and found no difference between the two groups. The less serious side effect of pain and swelling around the injection site was more common in the people who received the shingles vaccine. These results were published in the current issue of Annals of Internal Medicine. The authors identified this limitation of their study, “Confirmation of reported serious adverse events with medical record data was not always obtained.”

Should you get the vaccine?
Shingles can be an extremely painful and debilitating blistering rash that increases in severity with increasing age. The frequency and severity of postherpetic neuralgia also increases with age. The pain and discomfort of postherpetic neuralgia can be prolonged (months, even years) and disabling. We all have a lifetime risk of 20-30% of getting herpes Zoster. That’s if we live to be 80. After that, the risk rises to 50%.

Because the vaccine is expensive (more than $200) and requires refrigeration, many doctors do not want to invest in a supply. Most prefer to write prescription for their patients who must purchase the vaccine at the local pharmacy. The vaccine must be administered within a half hour of purchase. Pretty inconvenient all around.

One additional note of caution regarding FDA and CDC safety requirements, which leave much to be desired:
The Shingles Vaccine Study initially followed its participants for only 42 days. This is all that was required by the Food & Drug Administration to be declared safe. (Zostavax, Merck’s vaccine was the first shingles vaccine to be approved.) The Centers for Disease Control and Prevention has recommended the shingles vaccine for all people over the age of 60 ever since 2008 (when it replaced a CDC provisional 2006 recommendation), though the three-year data on safety only became available this month. Whether this provides sufficient long-term safety information is unknown.

People who should not get this vaccine include those whose immune systems are not working properly, for example, people with AIDS. For more about contraindications, click here

Maryann Napoli, Center for Medical Consumers©

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5 Responses to “The shingles vaccine”

  1. Carol Schaefer said

    My shingles started with a severe pain in my shoulder blade, and flu aches, no energy for two nites until the rash started.. 5 pimple like dots. I got the anti viral med within hours of the breakout, and only had a minimal area like an inch by an inche. The muscle in my shoulder blade was painful but that subsided within the week. Now I Also want to know if I should get the vacine or whether I would have an immunity to it. Or how can I support my immune system?

    • medconsumers said

      You should have immunity after a bout of shingles, but the CDC doesn’t seem to think so. See my response below to Diana Laskin Siegal’s comment. Sorry can’t help you with the immune system support question.

  2. Thank you Diana for your question as my friend is just recovering from shingles and wants the vaccine to avoid a repeat so the answer from Medconsumers was very helpful. I’ve been wondering if I should get this vaccination. I believe in light of the discussion I will ask my doctor for a prescription for the vaccine.

  3. Diana Laskin Siegal said

    I’ve had shingles. Fortunately I was able to start an anti-viral immediately so I had some days of itching and severe pain but no aftereffects. I have asked physicians and pharmacists whether or not I should get the vaccine. Can’t get an answer. Evidently no research has been done about the effectiveness of the vaccine for people who have had shingles. What do you think?

    • medconsumers said

      This CDC Web site states that people who’ve had shingles can be given the shingles vaccine. You ask what I think. I don’t see how the CDC can come to that conclusion given the fact that people who have had shingles are not represented in this new (and only) long-term safety study. Here’s how The Shingles Study authors describe the participants: “We enrolled immunocompetent adults 60 years or older with a history of chickenpox or more than 30 years of residence in the continental U.S. and no history of herpes zoster [i.e., shingles].”

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