What information is included in the package insert for the Shingrix (zoster vaccine) vaccine?

SHINGRIX Package Insert Information

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is supplied as a two-component system requiring reconstitution: a lyophilized antigen powder and an adjuvant suspension liquid, administered as a 0.5 mL intramuscular injection containing 50 mcg recombinant varicella zoster virus glycoprotein E (gE), combined with AS01B adjuvant system. 1

Vaccine Composition and Description

Active Components:

• 50 mcg of recombinant gE antigen - produced in genetically engineered Chinese Hamster Ovary cells, purified through multiple chromatographic steps 1
• AS01B adjuvant system containing:
  • 50 mcg of MPL (3-O-desacyl-4'-monophosphoryl lipid A from Salmonella minnesota) 1
  • 50 mcg of QS-21 (saponin purified from Quillaja saponaria Molina) 1
  • Liposomal formulation with DOPC (dioleoyl phosphatidylcholine) and cholesterol 1

Inactive Ingredients per 0.5 mL dose:

• 20 mg sucrose (stabilizer) 1
• 4.385 mg sodium chloride 1
• 1 mg DOPC 1
• 0.54 mg potassium dihydrogen phosphate 1
• 0.25 mg cholesterol 1
• Various phosphate buffers and 0.08 mg polysorbate 80 1

Manufacturing residuals:

• Residual host cell proteins (≤3.0%) 1
• Residual DNA (≤2.1 picograms) 1
• No preservatives, no natural rubber latex in vial stoppers 1

Dosing Schedule and Administration

Standard Regimen:

• Two-dose series with second dose administered 2-6 months after the first dose for adults aged ≥50 years 2
• Minimum interval of 4 weeks between doses - if administered earlier, the dose must be repeated 2
• Intramuscular injection route 2

Special Populations:

• Immunocompromised adults aged ≥18 years: shortened schedule with second dose at 1-2 months after first dose 2
• After previous Zostavax vaccination: administer SHINGRIX at least 2 months after ZVL 2
• After shingles episode: wait at least 2 months before vaccination 2

Storage and Handling Requirements

Before Reconstitution:

• Store both components refrigerated at 2-8°C (36-46°F) 1
• Protect vials from light 1
• Do not freeze - discard if either component has been frozen 1

After Reconstitution:

• Administer immediately or store refrigerated at 2-8°C for up to 6 hours maximum 1
• Discard if not used within 6 hours 1
• Do not freeze reconstituted vaccine 1

Product Presentations and NDC Numbers

Available configurations:

• Single-dose carton (NDC 58160-819-12): Contains one vial of adjuvant suspension (NDC 58160-829-01) and one vial of lyophilized antigen (NDC 58160-828-01) 1
• 10-dose carton (NDC 58160-823-11): Contains 10 vials of each component 1
• Packaged without syringes or needles 1

Vaccine Efficacy and Clinical Performance

Proven Effectiveness:

• 97.2% efficacy in preventing herpes zoster in adults aged ≥50 years in pivotal trials 2
• Protection maintained above 83.3% for at least 8 years with minimal waning 2
• Real-world effectiveness: 70.1% for two doses and 56.9% for one dose in Medicare beneficiaries 3
• 76.0% effectiveness against postherpetic neuralgia 3

Completion Rates:

• 70% complete the two-dose series within 6 months, 80% within 12 months in real-world use 4

Concomitant Vaccine Administration

SHINGRIX can be administered simultaneously with:

• PNEUMOVAX 23 (pneumococcal polysaccharide vaccine) - no interference demonstrated 1
• PREVNAR 13 (pneumococcal conjugate vaccine) - no interference demonstrated 1
• BOOSTRIX (Tdap vaccine) - no interference with SHINGRIX response, though reduced anti-pertactin response noted (clinical significance unknown) 1

Safety Profile

Common Adverse Reactions:

• 9.5% experience grade 3 injection-site reactions (pain, redness, swelling) versus 0.4% with placebo 2
• 11.4% report systemic symptoms versus 2.4% with placebo 2
• No serious safety concerns identified in large clinical trials 2

Important Tolerability Consideration:

• Concerns about side effects are the leading barrier to both initiation and completion of the vaccine series 5
• Individuals concerned about tolerability are 1.22 times more likely to receive no doses and 1.83 times more likely to receive only one dose 5

Special Population Considerations

Immunocompromised Patients:

• SHINGRIX is preferred over live-attenuated Zostavax due to its non-live, recombinant nature 2
• Safe for use in patients on immunosuppressive therapy, including those with autoimmune conditions, cancer, or receiving chemotherapy 2
• Effectiveness maintained even in immunocompromised populations, though immune response may be somewhat reduced 2

Patients on Disease-Modifying Drugs:

• Consider holding methotrexate for 2 weeks after vaccination 6
• For rituximab: vaccinate ≥6 months after last dose and 4 weeks before next dose when possible 6
• Concomitant low-dose glucocorticoids (<10 mg/day prednisone equivalent) do not adversely impact vaccine response 2