The Food and Drug Administration approved GlaxoSmithKline's Shingrix vaccine to prevent painful shingles in people 50 and older. (GlaxoSmithKline/AP)
Barbara Campbell has twice had shingles. Each time, one side of her body was covered in “thousands of these horrid blisters.” She could only wear the lightest silk blouse. Anything else touching her skin hurt too much.
“I’m in terror of having it happen again,” said Campbell, 79, of Fort Lauderdale, Fla., describing the painful rash that will affect almost 1 out of 3 people in their lifetime. Because of allergies, she couldn't get the Zostavax vaccine, which is made with live, albeit weakened virus.
But Campbell and millions of other older Americans at risk of shingles — a condition caused by the same virus that causes chickenpox — may soon have another option. A more effective vaccine, Shingrix, was licensed by the Food and Drug Administration on Oct. 20. The federal panel that helps guide U.S. vaccination policy on Wednesday recommended the new vaccine for use in adults 50 and older with normal immune systems.
The panel noted that Shingrix, made by GlaxoSmithKline, provides substantially greater protection than Zostavax, made by Merck. Shingrix's protection is also maintained at a high level for at least four years. The panel recommended that anyone previously vaccinated with the one-dose Zostavax be revaccinated with Shingrix, which is given in two doses.
The recommendations are expected to be approved by the Centers for Disease Control and Prevention next year.
The Washington Post spoke with Edward Belongia, who chaired the shingles vaccine work group of the Advisory Committee on Immunization Practices. The work group spent two years reviewing evidence on the two vaccines. Belongia, 61, is an infectious disease epidemiologist at the Marshfield Clinic Research Institute in Wisconsin.
(The interview has been edited for length and clarity.)
Q: Who’s at risk for getting shingles?
A: Shingles is a serious and very common condition. When people get chickenpox as children, the virus lays dormant in their nerves, held in check by an individual’s immune system. As you get older, your immune system starts to decline. People over 50 have an increased risk of developing shingles, which is a reactivating of the dormant virus.
There are about 1 million cases of shingles in the United States every year. It typically resolves in one to three weeks, and it’s painful while you have it.
Q: What are some of the complications associated with shingles?
A: About 15 percent of people who get shingles develop chronic severe pain, known as post-herpetic neuralgia, or PHN. It’s severe pain that can last for months. Your risk increases as you get older. There are also rare complications, such as increased risk for stroke and vision loss. But PHN is the most common complication. It can be very, very debilitating.
Q: Can people with compromised immune systems get Shingrix?
A: At this point, the license is for prevention in people ages 50 and older, with normal immune systems. But there are studies underway, and over the next year we expect to be looking at results that have the potential to be helpful for this population.
The only absolute reason why you should not get [Shingrix], if you’re 50 and older, is if you have a history of allergic or severe reactions to any component of the vaccine.
Q: Should people like Barbara Campbell, who already had shingles, still get the new vaccine?
A: Yes. She is certainly eligible to get it. There isn’t any reason not to get it.
Q: Why should someone who has already gotten Zostavax get revaccinated with Shingrix?
A: Zostavax provides a moderate level of protection. That protection declines over time, and by five years, that protection is only about 35 percent.
The new vaccine uses an entirely different technology. Shingrix is substantially different in terms of overall efficacy and duration of protection. It was shown to be highly effective even in the oldest age groups, people in their 70s and 80s.
Q: When should someone who has already received Zostavax get the new vaccine?
A: The committee did not want to prescribe a specific interval. The minimum interval should be eight weeks. That’s a decision each individual should make with his or her own health-care provider.
Q: Should people who have received Zostavax and also had shingles get Shingrix?
A: Yes. The clinical trials did not include people who had already had shingles. But there was a small study of 96 people over age 50 who had a previously documented episode of shingles. They got a strong response [with Shingrix]. They did not find any adverse events.
Q: What about side effects or problems with Shingrix?
A: The clinical trials did not find any evidence of increased risk for serious adverse events, such as death, hospitalization or disability. However, about 80 percent of individuals had some type of vaccine reaction, compared to 30 percent of people who got a placebo.
Most symptoms were mild or moderate. Most common was a sore arm and pain after injection. About half the people also developed more general side effects, such as muscle ache, fatigue and headaches that resolved in two to three days. It’s important to understand that these side effects are expected and resolve fairly quickly, and they should not discourage anyone from getting the second dose.
About 15 percent of people who got the vaccine had a reaction that interfered with their normal daily activities. Those resolved within two to three days.
Q: What about ongoing safety monitoring of this vaccine?
A: There’s going to be extensive safety monitoring. This vaccine uses a new adjuvant [an immune-system booster]. We don’t have experience with hundreds of thousands and even millions of people having received it. Even though clinical trials look reassuring, we know from past experience that things pop up and it’s not evident until a much larger number of people have received it.
GlaxoSmithKline is conducting a safety study. The CDC-funded Vaccine Safety Datalink is safety monitoring in near-real-time for this vaccine as it is rolled out. And there’s the Vaccine Adverse Event Reporting System, which reports episodes of vaccine-related adverse events.
Q: What information is there about the effectiveness of just one dose of Shingrix?
A: Almost nothing.
Q: Will it be hard to persuade patients to return for a second dose? What’s the recommended interval between doses?
A: Education is going to be key so we can manage expectations. We don’t want people feeling like they have to go to the emergency room for reactions that are normal and expected.
The recommendation for the second dose is anywhere from two to six months.
Q: Will insurance cover Shingrix if you've already gotten Zostavax?
A: Our expectation is that it will be covered.
Q: You’re in the recommended age range to get a shingles vaccine. Did you get Zostavax?
A: I was eligible to get the vaccine, and I’ve been waiting [for Shingrix]. I knew what was coming.
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