GSK Secures EC Approval for Shingrix in a Prefilled Syringe

GSK Secures EC Approval for Shingrix in a Prefilled Syringe

By, Admin 8 January 2026

GSK has received European Commission (EC) approval for a new prefilled syringe presentation of Shingrix, its recombinant zoster vaccine (RZV).

The approval simplifies how the shingles vaccine is administered across Europe

What Has Changed?

Until now, Shingrix was supplied in two separate vials:

  • One vial with a lyophilised antigen
  • One vial with a liquid adjuvant

Healthcare professionals had to manually reconstitute the vaccine before injection. The new prefilled syringe removes this step.

  • No mixing.
  • No vial-to-vial transfer.
  • Less room for error.

Why This Matters for Healthcare Professionals

The updated presentation:

  • Reduces preparation time
  • Simplifies administration
  • Supports more efficient vaccination workflows

Importantly, there is no change to:

  • Indication
  • Dose
  • Clinical profile

Approval was based on data confirming technical comparability with the existing presentation.

GSK’s Perspective

“This new presentation of Shingrix has been designed to improve ease of administration,” said Tony Wood, Chief Scientific Officer at GSK.

Shingles often affects people with chronic diseases like:

  • Cardiovascular disease
  • Diabetes
  • COPD
  • Asthma

Simpler administration helps expand protection in these vulnerable populations.

The Burden of Shingles

Shingles is caused by reactivation of the varicella-zoster virus (VZV).

Key facts:

  • Up to 1 in 3 adults will develop shingles in their lifetime
  • Over 90% of adults carry dormant VZV
  • Risk increases with age and chronic illness

Symptoms often include a painful rash and blistering. Up to 30% of patients develop post-herpetic neuralgia (PHN), a nerve pain that can persist for months or years.

How Shingrix Works

Shingrix combines:

  • Glycoprotein E antigen
  • AS01B adjuvant system

This formulation helps overcome age-related immune decline, which reduces vaccine effectiveness in older adults.

Shingrix is:

  • Approved in the EU since 2018 for adults aged 50+
  • Approved since 2020 for adults 18+ at increased risk

It is not indicated for preventing chickenpox.

Bottom Line

The EC approval of Shingrix in a prefilled syringe is a practical upgrade, not a clinical one. It removes complexity at the point of care—helping healthcare professionals protect more adults against shingles, faster and more reliably.

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