Quality & complianceOfficial

Denmark reports Bexsero pre-filled syringe supply problems linked to higher demand

🇩🇰 DKMA · Wed 04 Nov 2026

The Danish Medicines Agency says GlaxoSmithKline's meningococcal B vaccine faced shortages from April to mid-June 2026, with increased sales and demand cited as the cause.

The Danish Medicines Agency (DKMA) has published a supply notice for Bexsero, the multicomponent meningococcal group B vaccine, in the form of suspension for injection in pre-filled syringes. The marketing company named is GlaxoSmithKline Pharma A/S.

According to the notice, first posted on 20 April 2026 and last updated on 10 July 2026, the expected period of supply difficulty ran from the start of April to mid-June 2026. DKMA gives the reason as increased sales and demand.

The notice lists the active substance as meningococcal protein B (Meningococcus B, multicomponent vaccine) and the ATC code as J07AH09. It does not name alternative products, describe any substitution arrangements or say how many patients or vaccination programmes were affected.

DKMA says questions about the current status should go to the company. The notice sits in the agency's register of supply announcements for human medicines. It does not say whether supply has returned to normal after the stated period.

What it means for your team

  • Supply and market-access teams in Denmark should check the notice's expected period (April to mid-June 2026) against current Bexsero availability and contact GSK for the latest status.
  • DKMA names increased demand, not a quality or safety problem, as the cause, so this notice does not signal a quality defect or recall.
  • The notice gives no alternatives or substitution guidance, so any contingency planning for vaccination schedules will need other sources.

Official source: DKMA ↗

Article written by VigiEye from the official source (DKMA). AI-assisted; check the source before acting.

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