What are the indications for Shingrix (zoster vaccine recombinant)?

Shingrix Indications

Shingrix is indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older, and in adults aged 18 years and older who are or will be at increased risk due to immunodeficiency or immunosuppression caused by known disease or therapy. 1

FDA-Approved Indications

The recombinant zoster vaccine (Shingrix) has two primary approved indications: 1

• Adults ≥50 years of age - For prevention of herpes zoster regardless of immune status 1
• Adults ≥18 years of age - Specifically for those who are or will be immunodeficient or immunosuppressed due to known disease or therapy 1

Important Limitation

• Shingrix is not indicated for prevention of primary varicella infection (chickenpox) 1

Clinical Context and Rationale

Immunocompetent Adults ≥50 Years

Shingrix is the strongly preferred vaccine over the older live-attenuated Zostavax in this population. 2

The preference is based on superior efficacy data: 2

• 97.2% vaccine efficacy in adults aged 50+ years (ZOE-50 trial) 2
• 89.8% efficacy in adults aged 70+ years (ZOE-70 trial) 2
• 91.3% efficacy against herpes zoster and 88.8% against postherpetic neuralgia in adults ≥70 years 2
• Protection maintained above 83.3% for up to 8 years, decreasing to 73% at 10 years 2

This contrasts sharply with Zostavax, which showed dramatically declining efficacy with age (70% in ages 50-59 versus only 18% in those ≥80 years) and waning protection (51.3% to 21.2% from years 7-11 post-vaccination). 2

Immunocompromised Adults ≥18 Years

Shingrix is the only appropriate zoster vaccine for immunocompromised individuals, as the live-attenuated Zostavax is absolutely contraindicated in this population. 2, 1

Specific immunocompromised populations with indication include: 2

• Solid organ malignancies - Shingrix is suggested as the preferred vaccine 2
• Hematologic malignancies - Including multiple myeloma, with demonstrated safety and efficacy 2
• Hematopoietic stem cell transplant recipients - Both autologous and allogeneic 2
• Patients on immunosuppressive therapy - Including those with autoimmune conditions on chronic glucocorticoids or other immunosuppressants 2
• HIV/AIDS patients - Given their elevated risk of herpes zoster 2

Prior Herpes Zoster History

Prior herpes zoster infection is NOT a contraindication to vaccination - Shingrix is indicated regardless of previous shingles history. 2

The rationale is the significant recurrence risk (10.3% cumulative recurrence at 10 years), and vaccination should occur at least 2 months after acute symptoms resolve. 3

Prior Zostavax Recipients

Adults who previously received Zostavax should receive Shingrix, given Zostavax's poor long-term protection (efficacy drops to only 14.1% by year 10). 3 The minimum interval between Zostavax and Shingrix is 2 months. 3

Contraindications

The only contraindication is: 1

• History of severe allergic reaction (e.g., anaphylaxis) to any vaccine component or after a previous dose of Shingrix 1

Key Clinical Advantages Supporting Broad Indication

• Non-live vaccine - Safe for immunocompromised patients, unlike Zostavax 2, 4
• Consistent efficacy across age groups - No significant decline in older adults 2
• Durable protection - Minimal waning over 8+ years 2
• Effective against postherpetic neuralgia - The most debilitating complication of herpes zoster 2