Shingrix Pre-Filled Syringe (PFS) Formulation
Key Difference: Single-Component Design
The new Shingrix pre-filled syringe eliminates reconstitution because it contains the vaccine as a ready-to-use suspension in a single vial, rather than requiring mixing of the lyophilized antigen powder with the AS01B adjuvant suspension that was necessary in the original two-vial presentation. 1, 2
Original Shingrix Formulation
The original Shingrix vaccine required reconstitution because it was supplied as:
- A lyophilized powder containing the recombinant glycoprotein E antigen in one vial 1, 2
- A separate vial containing the AS01B adjuvant system as a suspension 1, 2
- Healthcare providers had to reconstitute by mixing these two components immediately before administration 1, 2
This two-component system was necessary to maintain the stability of both the recombinant protein antigen and the adjuvant system during storage.
Pre-Filled Syringe Advantages
The PFS formulation offers several practical benefits:
- Eliminates preparation time and potential reconstitution errors 1
- Reduces vaccine wastage from improper mixing 1
- Simplifies administration workflow in busy clinical settings 1
- Maintains the same 0.5 mL intramuscular dose with identical antigen and adjuvant content 1, 2
Important Clinical Considerations
The vaccine composition, dosing schedule, efficacy, and safety profile remain identical between the reconstituted and PFS formulations:
- Both contain recombinant glycoprotein E antigen combined with AS01B adjuvant 1, 2, 3
- Both require the same 2-dose series administered 2-6 months apart 1, 4
- Both demonstrate >90% efficacy against herpes zoster in adults aged ≥50 years 2, 3, 5
- Both are approved for immunocompromised adults aged ≥18 years 4
The PFS formulation represents a pharmaceutical advancement in vaccine delivery without altering the immunological properties or clinical recommendations for Shingrix use.