Last reviewed 2026-06-02 · How we verify

NVX-CoV2540

Novavax · Phase 3 active Small molecule ✓ Verified Jun 2026

NVX-CoV2540 is a Recombinant protein vaccine Small molecule drug developed by Novavax. It is currently in Phase 3 development for COVID-19 prevention in adults (variant-updated formulation). Also known as: Omicron BA.5 SARS-CoV-2 rS /Matrix-M Adjuvant.

NVX-CoV2540 is a recombinant protein vaccine that presents the SARS-CoV-2 spike protein to stimulate immune responses against multiple variants of concern.

NVX-CoV2540 is a vaccine being studied for its safety and immunogenicity in treating COVID-19 and SARS CoV 2 Infection. It is part of a bivalent vaccine combination, specifically NVX-CoV2373 + NVX-CoV2515, in a Phase 3 boosting study for the SARS-CoV-2 rS variant vaccines.

Likelihood of approval

59.3% 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.

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	NVX-CoV2540
Also known as	Omicron BA.5 SARS-CoV-2 rS /Matrix-M Adjuvant
Sponsor	Novavax
Drug class	Recombinant protein vaccine
Target	SARS-CoV-2 spike protein (multiple variant epitopes)
Modality	Small molecule
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

The vaccine uses Novavax's recombinant nanoparticle technology to display stabilized spike proteins from multiple SARS-CoV-2 variants, combined with Matrix-M adjuvant to enhance immune activation. This approach aims to broaden protection against circulating and emerging variants by eliciting both antibody and T-cell responses.

Approved indications

COVID-19 prevention in adults (variant-updated formulation)

Common side effects

Injection site pain
Fatigue
Myalgia
Headache
Fever

Key clinical trials

Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines (PHASE3)

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:

NVX-CoV2540 CI brief — competitive landscape report
NVX-CoV2540 updates RSS · CI watch RSS
Novavax portfolio CI

Frequently asked questions about NVX-CoV2540

What is NVX-CoV2540?

NVX-CoV2540 is a Recombinant protein vaccine drug developed by Novavax, indicated for COVID-19 prevention in adults (variant-updated formulation).

How does NVX-CoV2540 work?

NVX-CoV2540 is a recombinant protein vaccine that presents the SARS-CoV-2 spike protein to stimulate immune responses against multiple variants of concern.

What is NVX-CoV2540 used for?

NVX-CoV2540 is indicated for COVID-19 prevention in adults (variant-updated formulation).

Who makes NVX-CoV2540?

NVX-CoV2540 is developed by Novavax (see full Novavax pipeline at /company/novavax).

Is NVX-CoV2540 also known as anything else?

NVX-CoV2540 is also known as Omicron BA.5 SARS-CoV-2 rS /Matrix-M Adjuvant.

What drug class is NVX-CoV2540 in?

NVX-CoV2540 belongs to the Recombinant protein vaccine class. See all Recombinant protein vaccine drugs at /class/recombinant-protein-vaccine.

What development phase is NVX-CoV2540 in?

NVX-CoV2540 is in Phase 3.

What are the side effects of NVX-CoV2540?

Common side effects of NVX-CoV2540 include Injection site pain, Fatigue, Myalgia, Headache, Fever.

What does NVX-CoV2540 target?

NVX-CoV2540 targets SARS-CoV-2 spike protein (multiple variant epitopes) and is a Recombinant protein vaccine.

Drug class: All Recombinant protein vaccine drugs
Target: All drugs targeting SARS-CoV-2 spike protein (multiple variant epitopes)
Manufacturer: Novavax — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for COVID-19 prevention in adults (variant-updated formulation)
Also known as: Omicron BA.5 SARS-CoV-2 rS /Matrix-M Adjuvant

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