Last reviewed · How we verify

Investigational Influenza Vaccine

BioNTech SE · Phase 3 active Biologic Quality 18/100

Investigational Influenza Vaccine is a Biologic drug developed by BioNTech SE. It is currently in Phase 3 development.

BioNTech SE's investigational influenza vaccine is in Phase 3 development, positioning it as a potential next-generation flu vaccine in a highly competitive market. A key strength is the company's expertise in mRNA technology, which could offer superior efficacy and rapid adaptability to new strains. The primary risk is the strong competition from established players, and the key composition patent is set to expire in 2028, potentially impacting long-term market exclusivity.

Likelihood of approval
60.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Anti-infectives pathway favourability +2.0pp
    Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameInvestigational Influenza Vaccine
SponsorBioNTech SE
ModalityBiologic
Therapeutic areaInfectious Disease
PhasePhase 3

Approved indications

No approved indications tracked.

Common side effects

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Investigational Influenza Vaccine

What is Investigational Influenza Vaccine?

Investigational Influenza Vaccine is a Biologic drug developed by BioNTech SE.

Who makes Investigational Influenza Vaccine?

Investigational Influenza Vaccine is developed by BioNTech SE (see full BioNTech SE pipeline at /company/biontech-se).

What development phase is Investigational Influenza Vaccine in?

Investigational Influenza Vaccine is in Phase 3.

What are the side effects of Investigational Influenza Vaccine?

Common side effects of Investigational Influenza Vaccine include Injection site pain (PAIN), Fatigue (FATIGUE), Headache (HEADACHE), Chills (CHILLS), Myalgia (MUSCLE PAIN), Arthralgia (JOINT PAIN).

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing