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NVX-CoV2705

Phase 3

COVID-19 | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment676
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07079670Safety and Immunogenicity of NVX-CoV2705PHASE3 COMPLETED 676 — — Oct 9, 2025May 11, 2026Jun 5, 202610 United States
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Study Endpoints
Primary Endpoints
Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as GMFR
Day 28

Pseudovirus neutralization (ID50) GMFR for the Omicron JN.1 subvariant at Day 28 following study vaccination.

Secondary Endpoints
Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as GMT
Day 28
Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as SRR
Day 28
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Day 28
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
NVX-CoV2705EXPERIMENTALNVX-CoV2705 vaccine in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant.
Interventions
NameTypeDescription
NVX-CoV2705BIOLOGICALIntramuscular (deltoid) injection at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant.
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Eligibility Criteria
Age Range12 Years — 90 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * To be included in this study, each individual must satisfy all the following criteria: 1. Participants ≥ 65 years of age and participants 12 through 64 years who have at least one underlying condition that puts them at high risk of severe outcomes from COVID-19 at time of s...

Countries:United States
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Competitive Landscape -COVID-19 39 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE10PHASE3ibuzatrelvir, remdesivir, nirmatrelvir, ritonavir, COVID-19 Vaccine
BioNTech SE Sponsored ADRBNTX3PHASE3BNT162b2, BNT162b2 Vaccine, Bivalent BNT162b2 3 microgram dose, Bivalent BNT162b2 6 microgram dose, Bivalent BNT162b2 10 microgram dose
Merck & Co., Inc.MRK1PHASE3Molnupiravir
Invivyd, Inc.IVVD2PHASE3VYD2311-SD, VYD2311-MD, VYD2311
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
BioVie Inc. Class ABIVI1PHASE2NE3107
ImmunityBio IncIBRX2PHASE2Anktiva, N-803
Traws Pharma, Inc.TRAW1PHASE2Ratutrelvir non-randomised, Paxlovid, Ratutrelvir
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Unity Health TorontoUBX1PHASE3Paxlovid, Antioxidant
Moderna, Inc.MRNA1 — SPIKEVAX Bivalent BA.1, SPIKEVAX XBB.1.5, SPIKEVAX JN.1
Abbott LaboratoriesABT1NAUndisclosed
Design Therapeutics, Inc.DSGN1EARLY_PHASE1COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
Jade Biosciences, Inc.JBIO1NAUndisclosed
Structure Therapeutics, Inc. Sponsored ADRGPCR1NAUndisclosed
Co-Diagnostics, Inc.CODX1 — Undisclosed
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Recent Changes (Last 90 Days)
HIGHJun 5, 2026NCT07079670Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 5, 2026NCT07079670Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 5, 2026NCT07079670Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 5, 2026NCT07079670Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 26, 2026NCT07079670primaryCompletionDate: changed
LOWMay 24, 2026NCT07079670studyFirstPostDate: changed