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RegulatorsEuropean Medicines Agency (EMA)European Union

EMA ETF recommends updating COVID-19 vaccines to target XFG variant for 2026/2027 campaign

The Emergency Task Force of the EMA has recommended that marketing authorisation holders update their COVID-19 vaccines to target the XFG variant for the 2026/2027 vaccination campaign due to decreased efficacy of existing vaccines.

PV Impact Brief

Urgency: MonitorConfidence: high
Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Action needed

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

Owner

Regulatory Intelligence Lead

Review cadence

quarterly

Regulatory action details

Action type
Regulatory Recommendation / Public Health Communication
Publication date
2026-05-29
Last updated
2026-05-29
Safety issue
Decreased efficacy of existing vaccines against the evolving XFG variant of COVID-19.

Affected products

  • COVID-19 vaccines
    Marketing authorisation holders (various)

PV internal implications

Requires monitoring of vaccine efficacy signals and potential preparation for strain change variations.

View regulator source

Evidence and confidence

Confidence: highSource updated: May 29, 2026

Full briefing

What changed

ETF recommended that marketing authorisation holders update their COVID-19 vaccines to target the XFG variant for the 2026/2027 vaccination campaign.

Why it matters

Decreased efficacy of existing vaccines against the XFG variant could reduce protection against COVID-19, necessitating vaccine strain updates.

Practical implication

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

#Safety Signals#Vaccine Updates#Regulatory Recommendation / Public Health Communication#European Medicines Agency (EMA)#other#firecrawl-agent#regulatory-extraction

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