Over 500,000 Americans get the painful illness shinglesshingles every year. But that could be changing. In May 2006, the FDA approved the first shingles vaccine -- called Zostavax -- for people 60 and older.
"It's a very important vaccine," says Robert H. Dworkin, PhD, a professor in the department of anesthesiology at the University of Rochester Medical Center in Rochester, N.Y. "It cuts the risk of developing shingles in half."
While shingles could be treated with antiviral drugs to lessen its impact, up until now, doctors had no way to prevent it.
Shingles can be painful in itself, but some of its complications are worse. About 20% to 30% of people who get it go on to develop severe neurological pain called postherpetic neuralgia, or PHN. It can last for months, years, or the rest of a person's life.
Shingles is a disease that primarily affects older people. So a shingles vaccine could make a huge difference as baby boomers reach their sixties.
However, because the vaccine has only just been approved, there are still many unknowns. Researchers don't know whether the vaccine is safe for people under sixty. And it's unclear how much coverage insurance companies -- and MedicareMedicare -- will provide for it.
What Is Shingles?
Shingles is caused by the varicella-zoster virus, the same virus that causes chickenpoxchickenpox. The problem is that once you get the virus, it may not go away. It just lies dormant. Then, if your immune system weakens -- because of illness, medication, or age -- the virus can become active again. The very same infection that gave you chickenpox as a toddler can give you shingles seventy years later.
The illness causes a painful rash that usually appears in a band or belt on the body. (The word has nothing to do with what's on your roof: it comes from the Latin word for "belt.") If the pain lasts for at least four months after the shingles rash appeared, a person is diagnosed with PHN.
The Zostavax vaccine contains a live but weakened version of the virus. This allows your immune system the chance to "learn" to fight the virus with no risk of infection.
"The vaccine is really just a triple dose of the chickenpox vaccine," says Donald H. Gilden, MD, chair of the department of neurology at the University of Colorado School of Medicine in Denver. He says that it doesn't seem to have any significant risks. "The minor side effects included things like itching and redness," he says, "and they were more than outweighed by the benefits."
It's unclear how long the vaccine's effects will last. Gilden believes that its immunity may last decades. Dworkin is less sure.
"All we know is that it protects people for four to five years," he tells WebMD. "In the long run, people might need booster shots. We don't know yet."
Who Needs the Vaccine?
While anyone can get shinglesshingles, it's most common in older people. Over half of all cases are in people who are over 60. The older a person is, the higher the risk of problems.
"About 40% of people 60 and older who get shingles go on to have lasting nerve pain caused by PHN," says Gilden. "And that rises to almost 50% in people 70 or older."
The FDA approved the Zostavax vaccine for people who are 60 or older. Its decision was based largely on the vaccine's impressive results in a study published in the New England Journal of Medicine in June 2005. This study tracked a group of 38,000 people over 60, with a median age of 69. Researchers found that the vaccine cut the odds of getting shingles by 50%.
However, despite the FDA's decision, the vaccine still might be used by some doctors in people under 60. This would be called an "off-label" use. Merck, the vaccine's manufacturer, had hoped to get it approved for people 50 or older. And Gilden says that people from age 50-59 are indeed at increased risk.
"People who are 50-59 account for one out of seven cases of shingles," he tells WebMD. "That's a lot." But since the vaccine hasn't been studied in the 50-59 age group, FDA approval is unlikely any time soon, says Dworkin.
Another unanswered question is whether the vaccine is safe for younger people at risk for shingles because of a weakened immune system. This would include people who have had transplants, cancercancer treatments, or are living with HIV or other illnesses.
"There are a lot of people looking at this question," says Dworkin. "I think we'll start getting answers in the next three to five years."
Doubts About Widespread Use
As promising as the vaccine is, Dworkin points out that we don't really know how many people will wind up getting it. Many things could get in the way.
First of all, a lot of people don't know much about shingles. It doesn't have the fearful reputation of other illnesses. So it's unlikely that the average person will be clamoring for the vaccine as soon as he or she hits 60, says Dworkin.
"A lot of people have heard of shingles," says Gilden, "but they have no idea how devastating an illness it can be."
Adults can also be tough to vaccinate, says Dworkin. While shots in childhood are routine, adult vaccinations are harder to implement. Adults may not see their doctor regularly. They may put off getting a shot. And while the shingles vaccine could prevent hundreds of thousands of cases each year, an average person might be unimpressed that Zostavax only prevents the disease 50% of the time. People might expect a vaccine to protect them from a disease more or less completely, not just reduce the odds to 50/50.
A great deal is resting on doctors and nurses to explain the benefits of the vaccine and the risks of shingles. "But we all know the enormous time pressures that are put on health care providers these days," says Dworkin. "Will they be able to spare the 20 minutes to explain everything? We don't know."
Who Will Pay?
Another unresolved issue is the vaccine's price. Experts believe that the vaccine will cost about $100 to $150. While it's plausible that private insurance companies will cover it, no one knows for sure.
"I know several groups are running cost-benefit analyses on the vaccine now," says Dworkin. "The insurance companies will look carefully at those numbers."
Most people over 65 will probably get some coverage from MedicareMedicare for the vaccine. Right now, Zostavax is expected to be covered by Medicare's prescription drug plan, called Medicare Part D. But as millions of Americans have recently discovered, understanding the details of their Medicare drug coverage can be complicated, to say the least.
One problem is that there are hundreds of Part D plans to choose from. Coverage for the vaccine could vary between them.
"Personally, I think that covering the vaccine is a great investment for Medicare or any insurance company," says Gilden. He says that paying for the vaccine will save insurers the cost of treating people who would otherwise get shinglesshingles. "But right now, we don't know what Medicare or any of the insurance companies will do," he says.
Seeing Your Doctor
Experts agree that there's no question that people over 60 should get the vaccine, provided they can afford it.
"If you were to get shingles, you'd suffer a great deal of pain, a high risk of complications, and lots of medical bills," says Gilden. "Getting the vaccine is very good insurance."
If you're under 60, but worried about shingles -- or feel you are at high risk -- talk to your doctor.
"For now, deciding whether the vaccine should be given to people under 60 is something that a person has to work out with his or her health care provider," says Dworkin.