By Marie Rosenthal, MS
The CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the recombinant zoster vaccine (RZV, Shingrix, GlaxoSmithKline) to prevent herpes zoster and its related complications, most notably postherpetic neuralgia (PHN), in immunocompetent adults 50 years and older. (MMWR Morbid Mortal Wkly Rep 2018;67[3]:103-108).
The ACIP said that RZV was preferred over the live-attenuated zoster vaccine (ZVL; Zostavax, Merck) and that RZV can be given to adults who previously received ZVL.
The FDA approved the new shingles vaccine last October based on data pooled from two pivotal phase 3 clinical trials in more than 37,000 people, which demonstrated an efficacy rate against shingles greater than 90% independent of age, as well as a sustained efficacy over the four-year follow-up period (N Engl J Med 2015;372[22]:2087-2096).
RZV also reduced the overall incidence of PHN, the most common and oftentimes debilitating chronic nerve pain associated with shingles. The benefit of RZV in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of shingles.
In addition, the immune response is expected to be longer with RZV—around 19 years—than ZVL, which wanes at around 10 years, according to Lisa A. Prosser, PhD, from the University of Michigan, in Ann Arbor, who was among the ACIP Herpes Zoster Work Group that reviewed the data during the committee meeting last year to decide whether to include the new vaccine in the adult vaccination schedule.
The RZV vaccine requires two doses, and the ACIP recommended that the second dose be given two to six months after the first. The series does not need to be restarted, however, if the second dose is given later than six months. The vaccine can be administered concomitantly, at different anatomic sites, with other adult vaccinations.
For the full prescribing information, click here.
Shingles is caused by reactivation of the varicella zoster virus (VZV), which causes chickenpox. As people age, cells in the immune system lose the ability to maintain a strong and effective response to VZV reactivation. Shingles typically presents as a painful, itchy rash that develops on one side of the body, and can last for two to four weeks. The pain associated with shingles is often described as burning, shooting or stabbing. Even once the rash is gone, a person can experience PHN lasting from at least three months up to several years. PHN is the most common complication of shingles, occurring in 10% to 18% of all shingles cases.
There are an estimated 1 million cases of shingles in the United States each year. More than 99% of those older than 50 are infected with VZV, and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults aged 85 years and older.
RZV combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age.
Both vaccines are being studied in immunocompromised patients, according to Edward Belongia, MD, the director of the Center for Clinical Epidemiology & Population Health at the Marshfield Clinic Research Foundation, in Wisconsin, and the ACIP Herpes Zoster Work Group chair.