Last reviewed 2026-06-02 · How we verify

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]

Janssen Vaccines & Prevention B.V. · Phase 3 active Biologic

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] is a Recombinant viral vector vaccine Biologic drug developed by Janssen Vaccines & Prevention B.V.. It is currently in Phase 3 development for Prevention of Ebola virus disease, Prevention of Marburg virus disease.

MVA-BN-Filo is a recombinant modified vaccinia Ankara (MVA) vaccine expressing Filovirus glycoproteins that primes the immune system to recognize and respond to Ebola and Marburg viruses.

MVA-BN-Filo is a recombinant modified vaccinia Ankara (MVA) vaccine expressing Filovirus glycoproteins that primes the immune system to recognize and respond to Ebola and Marburg viruses. Used for Prevention of Ebola virus disease, Prevention of Marburg virus disease.

Likelihood of approval

62.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
Big-pharma sponsor +3.0pp
Janssen Vaccines & Prevention B.V. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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 name	MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]
Sponsor	Janssen Vaccines & Prevention B.V.
Drug class	Recombinant viral vector vaccine
Target	Filovirus glycoproteins (Ebola virus GP, Marburg virus GP)
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

This vaccine uses a non-replicating viral vector (MVA) engineered to express surface glycoproteins from Ebola and Marburg viruses. It stimulates both cellular and humoral immune responses, training T cells and B cells to recognize filoviral antigens before natural infection occurs. MVA-BN-Filo is typically used as a prime in heterologous prime-boost vaccination regimens to establish broad immunity against filovirus infection.

Approved indications

Prevention of Ebola virus disease
Prevention of Marburg virus disease

Common side effects

Injection site pain or erythema
Myalgia
Fatigue
Headache
Fever

Competitive intelligence

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

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] CI brief — competitive landscape report
MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] updates RSS · CI watch RSS
Janssen Vaccines & Prevention B.V. portfolio CI

Frequently asked questions about MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]

What is MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]?

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] is a Recombinant viral vector vaccine drug developed by Janssen Vaccines & Prevention B.V., indicated for Prevention of Ebola virus disease, Prevention of Marburg virus disease.

How does MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] work?

MVA-BN-Filo is a recombinant modified vaccinia Ankara (MVA) vaccine expressing Filovirus glycoproteins that primes the immune system to recognize and respond to Ebola and Marburg viruses.

What is MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] used for?

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] is indicated for Prevention of Ebola virus disease, Prevention of Marburg virus disease.

Who makes MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]?

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] is developed by Janssen Vaccines & Prevention B.V. (see full Janssen Vaccines & Prevention B.V. pipeline at /company/janssen-vaccines-prevention-b-v).

What drug class is MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] in?

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] belongs to the Recombinant viral vector vaccine class. See all Recombinant viral vector vaccine drugs at /class/recombinant-viral-vector-vaccine.

What development phase is MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] in?

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] is in Phase 3.

What are the side effects of MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]?

Common side effects of MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] include Injection site pain or erythema, Myalgia, Fatigue, Headache, Fever.

What does MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] target?

MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] targets Filovirus glycoproteins (Ebola virus GP, Marburg virus GP) and is a Recombinant viral vector vaccine.

Drug class: All Recombinant viral vector vaccine drugs
Target: All drugs targeting Filovirus glycoproteins (Ebola virus GP, Marburg virus GP)
Manufacturer: Janssen Vaccines & Prevention B.V. — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Prevention of Ebola virus disease
Indication: Drugs for Prevention of Marburg virus disease

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