Shingles vaccine revisited
Posted by medconsumers on January 24, 2011
Last year I reported a three-year safety study that showed the shingles vaccine has no serious adverse effects. It was an offshoot of the same large clinical trial that showed the vaccine halves the chance of getting the painful blistering herpes zoster rash called shingles and its severe complication postherpetic neuralgia (PHN). The Shingles Prevention Study was funded by Merck, maker of Zostavax, the first shingles vaccine to received FDA approval (2006). It is approved only for people, age 60 years and older.
A new study has followed up on those given Zostavax in the real-world practice of medicine (as opposed to the idealized circumstances of a clinical trial). It confirmed both the 50% cut in the risk of getting shingles and PHN as well as the absence of serious adverse effects. For an update on side effects, go to this FDA website.
This study, published in the Journal of the American Medical Association, involved vaccinated and unvaccinated members of the Kaiser Permanente Southern California health plan. Here’s how the research team led by Hun Fu Tseng, MD, described the vaccine’s 50% reduction in getting shingles and PHN: In the nearly three-year duration of the study, there were 6.4 shingles cases per 1,000 vaccinated people in a year; while it was twice that — 13 shingles cases per 1,000 — in the unvaccinated. The Kaiser study also found that the vaccinated people were less likely to get a particularly awful version of shingles that afflicts the eye.
This type of retrospective study is a good idea, and we can only hope for more of them for other common treatments. Most clinical trials designed to gain FDA approval are looking at a vaccine or drug in the best of circumstances. For example, the study participants are almost always healthier than the people likely to take the drug or vaccine once approved. Then there’s always the potential for bias, unconscious or not, in assessing the results of a trial funded by the company that stands to make a fortune once the vaccine takes off.
The Kaiser study, however, is not entirely free of bias (hardly any studies are). Three co-authors, for example, have received Merck funding for other vaccine studies. And the Kaiser study participants might not reflect the real-world of Zostavax recipients. Its vaccinated population, for example, had a disproportionate number of healthy white women.
Where things stand now
There is now five to six years of follow-up information on people given Zostavax, and things are looking good so far. It remains to be seen how long the protection holds and whether booster shots will be needed.
Unfortunately, the vaccine is largely inaccessible, especially to elderly people without a primary care physician. And that’s only the start of the problem. Its cost is high ($200 or more); it must remain frozen; and many physicians either do not have freezer storage space or are reluctant to store large quantities of such an expensive vaccine. Consequently, some physicians prefer to write a prescription for the vaccine; the patient must purchase it directly from the pharmacy; and get to the doctor’s office for the injection within a half hour of purchase. According to the CDC website, “All Medicare Part D plans cover the shingles vaccine. The amount of cost-sharing (money you have to pay) for vaccination varies.” This CDC website will also list who should not get the shingles vaccines, e.g., people taking drugs that affect the immune system, such as steroids.
March 15, 2011 update: Attention all Medicare enrollee with Part D drug insurance. After writing this article, I paid $275 to have the Zostavax vaccine administered in a doctor’s office. I received only $81.62 in reimbursement. I am filing a complaint with Prescription Solutions (UnitedHealth Group) and will keep you posted. I chose to go the doctor’s office route after learning at my local pharmacy that the vaccine alone would cost $205, but I’d have to go elsewhere to have it administered. Update added April 13, 2011: I received a letter from UnitedHealth Care stating that the company received by request for appeal on March 16, 2011, but it could not “meet the required decision timeframe of seven calendar days after getting your request to give you an answer.” Therefore my appeal was sent to the Independent Review Organization for review. I took the company up on its offer to send me a copy of my claim file on April 13. On April 16, I received a letter from Maximus Federal Services informing me that my appeal was rejected because Medicare Parat D is not required to provide additional payment for the Zostavax vaccine. So the Medicare Part D information about reiumbursement on the CDC website is incorrect, at least in my case.
February 2, 2011 Update: A new study found that 5% of people with a history of shingles suffered a recurrence.
Maryann Napoli, Center for Medical Consumers©