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Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022

Author/s: 
Anderson, T. C., Masters, N. B., Guo, A., Shepersky, L., Leidner, A. J., Lee, G. M., Kotton, C. N., Dooling, K. L.

Zoster Vaccine Recombinant, Adjuvanted (Shingrix, GlaxoSmithKline [GSK]) is a 2-dose (0.5 mL each) subunit vaccine containing recombinant glycoprotein E in combination with adjuvant (AS01B) that was licensed in the United States for prevention of herpes zoster for adults aged ≥50 years by the Food and Drug Administration (FDA) and recommended for immunocompetent adults aged ≥50 years by the Advisory Committee on Immunization Practices (ACIP) in 2017* (1). On July 23, 2021, the FDA expanded the indication for recombinant zoster vaccine (RZV) to include adults aged ≥18 years who are or will be at increased risk for herpes zoster because of immunodeficiency or immunosuppression caused by known disease or therapy (2). On October 20, 2021, ACIP recommended 2 doses of RZV for the prevention of herpes zoster and related complications in adults aged ≥19 years† who are or will be immunodeficient or immunosuppressed because of disease or therapy. RZV is the first herpes zoster vaccine approved for use in immunocompromised persons. With moderate to high vaccine efficacy and an acceptable safety profile, RZV has the potential to prevent considerable herpes zoster incidence and related complications. This report updates previous ACIP recommendations for the prevention of herpes zoster (1,3).

Keywords 
Zoster Vaccine Immunocompromised Adults recommendations Advisory Committee

Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure

Author/s: 
Izurieta, H. S., Wu, X., Forshee, R., Lu, Y., Sung, H. M., Agger, P. E., Chillarige, Y., Link-Gelles, R., Lufkin, B., Wernecke, M., MaCurdy, T. E., Kelman, J., Dooling, K.

Background
Shingrix (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as 2 doses given 2–6 months apart among adults aged ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster, but post-market performance has not been evaluated. Efficacy of a single dose and a delayed second dose and efficacy among persons with autoimmune or immunosuppressive conditions have not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix.

Methods
We conducted a cohort study among Medicare Part D community-dwelling beneficiaries aged >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia was identified using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance and marginal structural models to estimate hazard ratios.

Results
We found a vaccine effectiveness of 70.1% (95% confidence interval [CI], 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for 2 and 1 doses, respectively. The 2-dose vaccine effectiveness was not significantly lower for beneficiaries aged >80 years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4–81.8).

Conclusions
This large real-world observational study of the effectiveness of Shingrix demonstrates the benefit of completing the 2-dose regimen. Second doses administered beyond the recommended 6 months did not impair effectiveness. Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.

Vaccination of Adults in General Medical Practice

Author/s: 
Hunter, P., Fryhofer, S.A., Szilagyi, P.

In vaccinating adults, clinicians face 2 types of challenges: (1) staying current on recommendations for influenza, pneumococcal, hepatitis A and B, zoster, and other vaccines and (2) addressing systemic barriers to implementing practices that increase vaccination rates. Although adult immunization rates remain suboptimal, there has been much good news in adult vaccination recently. New high-dose and adjuvanted influenza vaccines help improve immune response and may reduce influenza complications in older adults. The new recombinant zoster vaccine offers significantly more efficacy against zoster outbreaks and postherpetic neuralgia than zoster vaccine live. Pertussis vaccine given during the third trimester of pregnancy may prevent between 50% and 90% of pertussis infections in infants. Shorter time for completion (1 vs 6 months) of new, adjuvanted hepatitis B vaccine may increase adherence. Clinicians can address systemic barriers to increasing vaccination rates in their clinics and health care systems by following the Centers for Disease Control and Prevention's Standards for Adult Immunization Practice. Clinicians can help increase vaccination rates by writing standing orders and by advocating for nurses or medical assistants to receive training and protected time for assessing and documenting vaccination histories and administration. Strong recommendations that presume acceptance of vaccination are effective with most patients. Communication techniques similar to motivational interviewing can help with vaccine-hesitant patients. Clinicians, as experts on providing preventive services, can educate community leaders about the benefits of immunization and can inform vaccine experts about challenges of implementing vaccination recommendations in clinical practice and strategies that can work to raise vaccination rates. 

Keywords 
adult immunization

Efficacy, Effectiveness, and Safety of Herpes Zoster Vaccines in Adults Aged 50 and Older: Systematic Review and Network Meta-Analysis

Author/s: 
Tricco, Andrea C., Zarin, Wasifa, Cardoso, Roberta, Veroniki, Areti-Angeliki, Khan, Paul A., Nincic, Vera, Ghassemi, Marco, Warren, Rachel, Sharpe, Jane P., Page, Andrea V., Straus, Sharon E.

OBJECTIVE:

To compare the efficacy, effectiveness, and safety of the herpes zoster live attenuated vaccine with the herpes zoster adjuvant recombinant subunit vaccine or placebo for adults aged 50 and older.

DESIGN:

Systematic review with bayesian meta-analysis and network meta-analysis.

DATA SOURCES:

Medline, Embase, and Cochrane Library (inception to January 2017), grey literature, and reference lists of included studies.

ELIGIBILITY CRITERIA FOR STUDY SELECTION:

Experimental, quasi-experimental, and observational studies that compared the live attenuated vaccine with the adjuvant recombinant subunit vaccine, placebo, or no vaccine in adults aged 50 and older. Relevant outcomes were incidence of herpes zoster (primary outcome), herpes zoster ophthalmicus, post-herpetic neuralgia, quality of life, adverse events, and death.

RESULTS:

27 studies (22 randomised controlled trials) including 2 044 504 patients, along with 18 companion reports, were included after screening 2037 titles and abstracts, followed by 175 full text articles. Network meta-analysis of five randomised controlled trials found no statistically significant differences between the live attenuated vaccine and placebo for incidence of laboratory confirmed herpes zoster. The adjuvant recombinant subunit vaccine, however, was statistically superior to both the live attenuated vaccine (vaccine efficacy 85%, 95% credible interval 31% to 98%) and placebo (94%, 79% to 98%). Network meta-analysis of 11 randomised controlled trials showed the adjuvant recombinant subunit vaccine to be associated with statistically more adverse events at injection sites than the live attenuated vaccine (relative risk 1.79, 95% credible interval 1.05 to 2.34; risk difference 30%, 95% credible interval 2% to 51%) and placebo (5.63, 3.57 to 7.29 and 53%, 30% to 73%, respectively). Network meta-analysis of nine randomised controlled trials showed the adjuvant recombinant subunit vaccine to be associated with statistically more systemic adverse events than placebo (2.28, 1.45 to 3.65 and 20%, 6% to 40%, respectively).

CONCLUSIONS:

Using the adjuvant recombinant subunit vaccine might prevent more cases of herpes zoster than using the live attenuated vaccine, but the adjuvant recombinant subunit vaccine also carries a greater risk of adverse events at injection sites.

Keywords 
herpes herpes zoster vaccine herpes vaccine
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