The FDA blocked shingles vaccine safety studies: Here’s how to counsel your patients
Industry Buzz
There’s been a whole host of studies that have come out recently that show some really nonspecific benefits of [the] shingles vaccine. The one that’s been most exciting is the decreased risk of dementia following [the] shingles vaccine. And who wouldn’t want a decreased risk of dementia?
—Dean Blumberg, MD
Although there’s virtually no mortality—there are no deaths associated with this infectious event—it can be very, very debilitating.
—William Schaffner, MD
The FDA recently blocked the publication of several studies demonstrating the safety of the shingles vaccine.[]
Here’s the advice experts say physicians should give their patients about the shingles vaccine.
“The shingles vaccine is safe. It’s effective, and there’s some really exciting news with the shingles vaccine. There’s been a whole host of studies that have come out recently that show some really nonspecific benefits of [the] shingles vaccine. The one that’s been most exciting is the decreased risk of dementia following [the] shingles vaccine. And who wouldn’t want a decreased risk of dementia?” Dean Blumberg, MD, an infectious disease expert at the University of California, Davis, tells MDLinx.
“There’s other benefits of the vaccine. It does seem to have an association [with] reduced risk of vasculopathies, so decreased risk of cardiovascular disease, ophthalmic disease, and specifically with stroke. So there’s all these side benefits to [the] shingles vaccine,” Dr. Blumberg adds.
About the vaccine
In the United States, the recombinant zoster (shingles) vaccine is known as Shingrix.[]
It is recommended for those aged 50 years and older, as well as adults 19 years and older who have a weakened immune systems.[]
About 1 in 3 people in the US will experience shingles in their lifetime, and this risk increases with age.[]
“If you reach 80 years of age, you have between a 30% and 50% chance of experiencing shingles. Shingles initially can be painful and discomforting and disfiguring, but what we’re really concerned about is post-shingles pain, namely, postherpetic neuralgia, [which] is the fancy name for it,” William Schaffner, MD, an infectious disease physician at Vanderbilt University, tells MDLinx.
“The virus travels along pain fibers and actually destroys part of the pain fibers, and so the pain fibers keep firing, which give[s] us the sensation of pain,” Dr. Schaffner says. “That can be stimulated by really minor events, such as a shirt touching the affected area, or wind suddenly being on the area, [which] can evoke pain. And that pain can be severe [and] repeated. It can awaken you at night [and] interfere with eating and your general life. And so it can be very, very debilitating.”
Related: Research points to a possible link between shingles and cognitive decline. Here's what to know.The shingles vaccine is highly effective
The vaccine is given as a two-dose series, spaced 2 to 6 months apart for those aged 50 and over and 1 to 2 months apart following the initial dose for those 19 and older with a weakened immune system.[]
In adults 50 to 69 years old with healthy immune systems, studies show that the vaccine is 97% effective in preventing shingles. In those 70 years and older, it is 91% effective.[]
It is also 91% effective at preventing postherpetic neuralgia in those aged 50 and older.[]
Along with counseling patients about the risks of shingles and the benefits of the vaccine, Dr. Schaffner says it’s important to inform them that they may experience some pain with the vaccination.
“The vaccine is a bit painful when you get it, so you have to alert the individual that there will be some pain going in—and [the pain] varies. My wife got it, and she didn’t bat an eye. … I had a sore arm for about 3, 3.5 days,” he says.
But Dr. Schaffner says patients should be made aware that the benefits of the shingles vaccine far outweigh the risks.
“Although there’s virtually no mortality—there are no deaths associated with this infectious event—it can be very, very debilitating. And … it’s frequent, somewhere between a third and a half of the population will be affected by this illness. So it’s very worth preventing,” Dr. Schaffner says.