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 instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

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 March 3 2021, 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 new ‘recombinant herpes zoster’ (RZV) vaccine for adults ≥50 years of age. According to the CDC, this is the “preferred vaccine” to protect against shingles and postherpetic neuralgia when compared to the previously available ‘zoster vaccine live’ (ZVL).  ACIP has released a report that outlines recent recommendations as well as guidance for use of RZV and ZVL in adults.

Note: ZVL will no longer be sold in the United States starting July 1, 2020 | Some pharmacies and clinics may still have ZVL in stock after this date | The CDC states that “This vaccine is safe and may be used until the supply expires (before or by 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 
  • 50–59 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 10-13% of herpes zoster cases in persons aged >50 years and risk increases with age 

Herpes Zoster Vaccine Recommendations  

RZV 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, RZV was 97% effective; among adults 70 years and older, RZV was 91% effective
  • Postherpetic Neuralgia: In adults 50 to 69 years old who got two doses, RZV was 91% effective; among adults 70 years and older, RZV was 89% effective
• RZV protection remained high (more than 85%) in people 70 years and older throughout the four years following vaccination

RZV is recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received ZVL 

• ZVL effectiveness wanes substantially over time, leaving recipients with reduced protection against herpes zoster 
• RZV elicited similar safety, reactogenicity, and immunogenicity profiles regardless of prior ZVL receipt 
• RZV is preferred over ZVL for the prevention of herpes zoster and related complications  
  • In clinical trials, for all age categories, RZV estimates of efficacy were higher than those for ZVL 
  • ZVL efficacy wanes substantially during the 4 years following vaccination

Note: There is no maximum age for RZV 

Clinical Guidance 

• Administer 2 doses (0.5 mL each) administered intramuscularly 2–6 months apart 
• RZV may be used in adults aged ≥50 years, irrespective of prior receipt of varicella vaccine or ZVL  
• Screening for a history of chickenpox (varicella) not required 
• While RZV is now the preferred vaccine over ZVL, however, ZVL may still be used  in healthy adults ≥60 years in some situations such as an individual who
  • Is allergic to RZV
  • Prefers ZVL
  • Requests immediate vaccination and RZV is unavailable
• Care should be taken not to confuse ZVL with RZV 
  • ZVL is stored in the freezer and administered subcutaneously 
  • RZV is stored in the refrigerator and administered intramuscularly 
• Based on expert opinion, RZV should not be given <8 weeks after receipt of ZVL 
• Coadministration with other vaccines 
  • Recombinant and adjuvanted vaccines, such as RZV, can be administered concomitantly, at different anatomic sites, with other adult vaccines 
  • Concomitant administration of RZV with quadrivalent influenza vaccine (QIV)  
    • No evidence for interference in the immune response to either vaccine or safety concerns  
  • Coadministration of RZV with 23-valent pneumococcal polysaccharide vaccine (PPSV23) and Tdap 
    • Studies are ongoing 
  • The safety and efficacy of administration of two adjuvanted vaccines (e.g., RZV and adjuvanted influenza, either concomitantly or at other intervals 
    • Not yet evaluated 
• RZV is not a treatment for herpes zoster or postherpetic neuralgia  
• Pregnancy and breastfeeding 
  • There are no available data to establish whether RZV is safe in pregnant or lactating women  
  • Currently, there is no ACIP recommendation in this population  
  • Consider delaying vaccination with RZV in such circumstance 

KEY POINTS:  

Counseling and Adverse Events  

• Reactions to the first dose of RZV did not strongly predict reactions to the second dose 
• Vaccine recipients should be encouraged to complete the series even if they experienced a grade 1–3 reaction to the first dose of RZV  
  • 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 RZV 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  

Special Populations 

• Persons with a history of herpes zoster 
  • Adults with a history of herpes zoster should receive RZV as herpes zoster can recur 
• Persons experiencing an episode of herpes zoster 
  • Delay vaccination until the acute stage is over and symptoms abate 
    • Studies are ongoing 
• Persons with chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, and chronic pulmonary disease) 
  • Should receive RZV 
• Immunocompromised persons 
  • As with ZVL, RZV can be used in persons taking low-dose immunosuppressive therapy (e.g., <20 mg/day of prednisone or equivalent or using inhaled or topical steroids) and persons anticipating immunosuppression or who have recovered from an immunocompromising illness  
  • RZV is licensed for all persons aged ≥50 years however, immunocompromised persons and those on moderate to high doses of immunosuppressive therapy were excluded from the efficacy studies and therefore ACIP has not made recommendations regarding the use of RZV in these patients while awaiting further data 
• 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 
    • RZV 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

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