Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Discuss the new recombinant herpes zoster vaccine (RSV) and clinical recommendations
2. List potential adverse events a patient may expect following administration of RSV

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.

The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from March 4 2018 through 07/15/2022, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.3 contact hours.

Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

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 

Related ObG Topics:

CDC Vaccination Schedule: Birth – 18 years

CDC Adult Vaccination Schedule

CDC Releases Emergency Preparedness and Response Advisory for Flu Season 2017/2018