What is Shingrix (recombinant herpes zoster vaccine)?

What is Shingrix?

Shingrix is a recombinant, adjuvanted, non-live subunit vaccine that prevents herpes zoster (shingles) and its complications in adults aged 50 years and older, as well as immunocompromised adults aged 18 years and older. 1

Vaccine Composition and Mechanism

• Shingrix contains 50 mcg of recombinant varicella zoster virus glycoprotein E (gE) antigen combined with the AS01B adjuvant system in each 0.5 mL dose 1

• The AS01B adjuvant contains 50 mcg of MPL (3-O-desacyl-4'-monophosphoryl lipid A) and 50 mcg of QS-21 (a saponin) in a liposomal formulation, designed to enhance both cellular and humoral immune responses 1, 2

• The gE antigen is produced using genetically engineered Chinese Hamster Ovary cells and purified through multiple chromatographic steps, with no albumin, antibiotics, or animal-derived proteins 1

• The vaccine is supplied as a lyophilized white powder (antigen component) that must be reconstituted with an opalescent adjuvant suspension immediately before intramuscular administration 1

Approved Indications

• Prevention of herpes zoster in adults aged ≥50 years 1

• Prevention of herpes zoster in adults aged ≥18 years who are or will be immunodeficient or immunosuppressed due to known disease or therapy 1

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

Dosing Schedule and Administration

• The standard regimen is a two-dose series with the second dose administered 2-6 months after the first dose for adults aged ≥50 years 3, 4

• The minimum interval between doses is 4 weeks; if administered earlier than this minimum, the dose should be repeated 3

• For immunocompromised adults aged ≥18 years, a shortened schedule with the second dose at 1-2 months after the first dose is recommended 3, 4

• The vaccine is administered via intramuscular injection 3

Clinical Efficacy

• Shingrix demonstrates 97.2% efficacy against herpes zoster in adults aged ≥50 years in the pivotal ZOE-50 trial 3, 5

• Efficacy against postherpetic neuralgia (PHN) is approximately 89% 2

• Protection is maintained above 83.3% for at least 8 years with minimal waning 3

• Real-world effectiveness studies show 70.1% effectiveness for the two-dose series and 56.9% for a single dose 6

• Efficacy is well preserved across all age groups, including adults aged ≥70 years and those ≥80 years 3, 5

Advantages Over Live-Attenuated Vaccine (Zostavax)

• Shingrix offers dramatically superior efficacy compared to Zostavax, which shows only 46-70% initial efficacy that declines to 14.1% by year 10 3, 7

• Unlike Zostavax, Shingrix is non-live and therefore safe for immunocompromised patients, whereas Zostavax is contraindicated in this population 8, 5

• Shingrix maintains high efficacy across all age groups, while Zostavax efficacy decreased significantly with age (70% in ages 50-59 vs. 18% in those ≥80 years) 3

Safety Profile

• Common adverse reactions include injection-site reactions (pain, redness, swelling), with 9.5% experiencing grade 3 injection-site reactions compared to 0.4% with placebo 3, 4

• Systemic symptoms (myalgia, fatigue, headache) occur in 11.4% of vaccine recipients versus 2.4% in placebo recipients 3

• Most solicited adverse reactions are transient and mild to moderate in severity, typically resolving within 4 days 3, 5

• No serious safety concerns have been identified in large clinical trials, with similar rates of serious adverse events between vaccine and placebo groups 3

Special Population Considerations

• Shingrix is the preferred vaccine for immunocompromised patients including those with autoimmune diseases, cancer, HIV, transplant recipients, and those on immunosuppressive therapy 8, 4, 5

• The vaccine can be safely administered to patients on low-dose glucocorticoids (<10 mg/day prednisone equivalent) without adversely impacting vaccine response 3, 4

• For patients with autoimmune inflammatory rheumatic diseases, Shingrix is preferred over live-attenuated vaccine due to safety considerations 3

• Vaccination is recommended regardless of prior herpes zoster history, as natural immunity from a previous episode is insufficient to prevent recurrence 8, 3

Important Clinical Caveats

• Adults who previously received Zostavax should still receive the full 2-dose Shingrix series, with a minimum interval of 2 months after the last Zostavax dose 3, 4

• After an acute shingles episode, vaccination should be delayed at least 2 months until symptoms have resolved 3, 4

• Shingrix can be administered simultaneously with other inactivated vaccines (such as influenza vaccine) without decreased immunogenicity or safety concerns 3

• The vaccine does not contain preservatives or natural rubber latex in the vial stoppers 1

• Real-world data shows that 70% of patients complete the two-dose series within 6 months, and 80% within 12 months 9