A newly approved vaccine appears to bring significantly more protection against shingles, a blistering skin eruption that typically affects people over age 50.

The Food and Drug Administration’s recent approval of Shingrix makes it the first new shingles vaccine in more than a decade and only the second to ever be approved (Zostavax was the first). Last  week the Advisory Committee on Immunization Practices, or ACIP, came out with three major recommendations for Shingrix, and they’ll likely be formalized by the end of this year or early in 2018.

ACIP advised that Shingrix—a two-dose vaccine—be recommended for people starting at age 50, a full 10 years earlier than the Centers for Disease Control and Prevention’s advice for Zostavax. The committee also said that Shingrix should get preference over Zostavax, a one-shot vaccine, and that people who have already gotten Zostavax get Shingrix as well.

“This looks to be a vaccine that will provide substantially long, persistent protection,” says William Schaffner, M.D., a consultant to the ACIP and a professor of medicine in the division of infectious diseases at Vanderbilt University School of Medicine in Nashville, Tenn. “The body responds to Shingrix much more strongly, compared to Zostavax.”

Marvin M. Lipman, M.D., Consumer Reports’ chief medical adviser, notes, “I think that Shingrix will eventually replace Zostavax because the benefit/risk ratio, at the present time, strongly favors Shingrix.”

Zostavax maker Merck, meanwhile, says in a statement that “we believe that a single shot of Zostavax will continue to play an important role in vaccination to help prevent shingles. . . . Consumers should talk with their healthcare providers or pharmacists about each vaccine’s profile (i.e., single dose versus two doses) and make the decision on which vaccine may be best for them.”

Here’s what you need to know about the new vaccine and the new recommendations.

Why a New Shingles Vaccine?

Did we need a new shingles vaccine? To answer that question, it helps to have a bit of background on this infection.

Shingles, which is also called herpes zoster, occurs when the chickenpox virus (varicella zoster), which is dormant in those who’ve had the illness, reawakens later in life. Almost all adults over age 40 carry the chickenpox virus—and the older we get, the more the risk of getting shingles climbs. According to the CDC, the infection strikes about 1 million people in the U.S. each year and nearly one in three adults will experience a bout of shingles in their lifetime.

The two to four weeks of shingles, marked by a blistery and painful rash on one side of the body, can be difficult enough. But about one in five people with shingles go on to develop postherpetic neuralgia, or PHN, which is nerve pain that can linger for months or even years.

Since 2006, we’ve had Zostavax—approved for those between 50 and 59 but recommended by the CDC for adults age 60 and older—as the sole bulwark against shingles. Zostavax offers 70 percent protection against shingles for people between 50 and 59, but only 18 percent in people age 80 and older, according to the “Pink Sheet,” which reports on the pharmaceutical industry. When all ages are taken into consideration, Zostavax cuts the chance of shingles by only 51 percent and the risk of PHN by 67 percent.

In addition, Zostavax’s effectiveness appears to last just five years, according to the CDC. And research presented this month at IDWeek, an annual meeting for infectious disease professionals, suggests that Zostavax may actually wane after only three years.

The Shingrix vaccine (whose two doses will likely be given at least eight weeks apart), according to clinical trials, offers 97 percent protection in people in their 50s and 60s and roughly 91 percent protection in those in their 70s and 80s. And it appeared to retain similarly high effectiveness throughout a four-year study period.

There are key differences between the way Shingrix and Zostavax are designed. The new shingles vaccine contains an adjuvant, a substance that boosts the immune system’s response. This may be what makes Shingrix both more effective and longer-lasting, says Schaffner at Vanderbilt.

Unlike Shingrix, Zostavax contains live—although weakened—herpes zoster virus, so those with significantly weakened immune systems should not receive it. But because the new shingles vaccine contains a nonliving viral particle, it may ultimately be deemed appropriate for those with compromised immunity.

ACIP will issue recommendations on this in February, Schaffner says, adding, “Shingles is a big problem with immunocompromised people.”

 

Can It Cause Side Effects?

Like every vaccine, Shingrix has the potential for side effects, although so far, none seem particularly worrying. The new shingles vaccine does appear more likely to cause pain during injection and at the site of injection for up to three days afterward than Zostavax does.

In clinical trials, the side effects also included injection site redness and swelling, muscle pain, and immune system responses such as headache, shivering, fever, and upset stomach. Most, according to GlaxoSmithKline, its manufacturer, lasted less than three days.

Though Shingrix was tested on some 16,600 adults in clinical trials, it hasn’t been out in real-world situations yet. The company will be conducting additional safety and efficacy studies over the next few years.

“As with any drug that’s approved on the basis of studies in only thousands, strict post-marketing surveillance studies have to be agreed upon, with severe penalties for irregularities,” says CR’s Lipman.

Availability and Cost

Shingrix, according to a representative from its manufacturer, could be available by the end of November. But the $280 cost for the two shots is not likely to be covered by insurance right away.

Schaffner says that ACIP anticipates that deductibles and co-pays aside, private insurers are likely to cover the cost, as they generally do with Zostavax (which costs $213 for those who have to pay full price, according to the CDC).

This should occur by early next year, but Medicare, he notes, may take a little longer. What’s probable is that like Zostavax, Shingrix will be covered under Medicare Part D. That has posed coverage challenges for some consumers.

Read more of CR’s reporting on shingles vaccine coverage issues.