SUMMARY:  

In October 2017, the FDA approved and ACIP recommended a Shingrix (RZV) vaccine for adults ≥50 years of age. Zostavax (ZVL) is no longer available for use in the United States, as of November 18, 2020.

• Herpes Zoster and Postherpetic Neuralgia
• Zoster Vaccine Recommendations
• Clinical Guidance
• Counseling and Adverse Events
• Special Populations

Herpes Zoster and Postherpetic Neuralgia 

• Herpes zoster is a localized, painful, cutaneous eruption resulting from reactivation of latent varicella zoster virus (VZV) 
• Approximately one million cases occur each year in the United States  
• Incidence increases with age 
  • 50 to 59 years of age: 5 cases per 1,000  
  • ≥80 years: 11 cases per 1,000  
• Postherpetic Neuralgia is the most common complication  
  • Defined as persistent pain for at least 90 days following the resolution of the herpes zoster rash 
  • Occurs in 10 to 13% of herpes zoster cases in persons aged >50 years and risk increases with age 

Herpes Zoster Vaccine Recommendations  

Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults aged ≥50 years 

• Two doses of Shingrix provides strong protection against shingles and postherpetic neuralgia (PHN), the most common complication of shingles
  • Shingles Prevention: In adults 50 to 69 years old who got two doses, Shingrix was 97% effective; among adults 70 years and older, Shingrix was 91% effective
  • Postherpetic Neuralgia: In adults 50 to 69 years old who got two doses, Shingrix was 91% effective; among adults 70 years and older, Shingrix was 89% effective
• Shingrix protection remained high (more than 85%) in people 70 years and older throughout the four years following vaccination
• Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received Zostavax or have already had herpes zoster
• There is no maximum age for Shingrix

Clinical Guidance 

• Administer 2 doses (0.5 mL each) administered intramuscularly 2 to 6 months apart 
• Shingrix may be used in adults aged ≥50 years, irrespective of prior receipt of varicella vaccine or Zostavax 
• If patient previously received Zostavax
  • Consider the patient’s age and when he or she received Zostavax to determine when to vaccinate with Shingrix | Differences in efficacy between Shingrix and Zostavax are most pronounced among older patients
  • Studies examined the safety of Shingrix vaccination five or more years after Zostavax vaccination | Shorter intervals were not studied, but there are no theoretical or data concerns to indicate that Shingrix would be less safe or effective if administered less than five years after a patient received Zostavax
• Screening for a history of chickenpox (varicella) not required  
  • Recombinant and adjuvanted vaccines, such as Shingrix, can be administered concomitantly at the same visit, at different anatomic sites, with other adult vaccines (e.g., influenza and pneumococcal vaccines) 
• Shingrix is not a treatment for herpes zoster or postherpetic neuralgia  
• Pregnancy and breastfeeding 
  • There are no available data to establish whether Shingrix is safe in pregnant or lactating women   
  • Consider delaying vaccination with Shingrix in such circumstance 

KEY POINTS:  

Counseling and Adverse Events  

• Reactions to the first dose of Shingrix did not strongly predict reactions to the second dose 
• Vaccine recipients should be encouraged to complete the series even if they experienced a grade 1 to 3 reaction to the first dose of Shingrix  
  • In studies, Grade 3 solicited symptoms were defined as “preventing normal everyday activity” (pain, headache, fatigue, gastrointestinal symptoms, myalgia, shivering) | surface diameter >100 mm (redness/swelling) | tympanic/oral/axillary temperature >39.0 °C (fever)  
  • Grade 3 unsolicited adverse events were also defined as “preventing normal, everyday activities” 

Adverse Events

• The impact of prophylactic analgesics in conjunction with Shingrix has not been studied 
• Adverse local events are relatively common and include 
  • Pain  
  • Redness  
  • Swelling  
• General adverse reactions include  
  • Myalgia  
  • Fatigue  
  • Headache  
  • Shivering  
  • Fever  
  • Gastrointestinal symptoms
• Severe (rare) events include
  •  Difficulty breathing
  • Wheezing
  • Hives
  • Pale skin
  • Fast heartbeat
  • Dizziness 
• Contraindications 
  • History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine OR after previous dose  
  • Acute episode of herpes zoster | Wait until acute episode has abated 

Special Populations 

• Persons with a history of herpes zoster 
  • Adults with a history of herpes zoster should receive Shingrix as herpes zoster can recur  
• Persons with chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, and chronic pulmonary disease) 
  • Shingrix should be used 
• Immunocompromised persons  
  • Shingrix may be used in persons taking low-dose immunosuppressive therapy (e.g., <20 mg/day of prednisone or equivalent or using inhaled or topical steroids), persons anticipating immunosuppression or who have recovered from an immunocompromising illness
  • Advisory Committee on Immunization Practices recommended 2 RZV doses for prevention of herpes zoster and related complications in immunodeficient or immunosuppressed adults aged ≥19 years
  • Second RZV dose should be given 2 to 6 months after the first | For persons who are or will be immunodeficient or immunosuppressed and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first
• Persons known to be VZV negative 
  • Screening for a history of varicella (either verbally or via laboratory serology) is not recommended 
  • However, in persons known to be VZV negative via serologic testing, ACIP guidelines for varicella vaccination should be followed 
    • All healthy adults should be assessed for varicella immunity, and those who do not have evidence of immunity should receive 2 doses of single-antigen varicella vaccine 4-8 weeks apart 
    • Shingrix has not been evaluated in persons who are VZV seronegative and the vaccine is not indicated for the prevention of chickenpox (varicella) 

Learn More – Primary Sources:

CDC MMWR: Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022 | MMWR (cdc.gov)

CDC: Shingles (Herpes Zoster) Vaccination Information for Healthcare Providers

FDA: SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted)  

CDC Epidemiology and Prevention of Vaccine-Preventable Diseases; The Pink Book: Course Textbook – 13th Edition (2015)

Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study