Who makes FSME-IMMUN 0.5ml?

FSME-IMMUN 0.5ml is developed by Pfizer.

What development phase is FSME-IMMUN 0.5ml in?

FSME-IMMUN 0.5ml is FDA-approved (marketed).

Last reviewed 2026-04-20 · How we verify

FSME-IMMUN 0.5ml

Pfizer · FDA-approved active Biologic Quality 1/100

At a glance

Generic name	FSME-IMMUN 0.5ml
Sponsor	Pfizer
Modality	Biologic
Phase	FDA-approved

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

TBE Seropersistence up to 10 Years After First Booster in Adults (PHASE4)
Vaccine Study for Tick-Borne Encephalitis Virus (TBEV) (PHASE2)
Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years (PHASE4)
TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223) (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

FSME-IMMUN 0.5ml CI brief — competitive landscape report
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Pfizer portfolio CI