Last reviewed 2026-04-23 · How we verify

NVX-CoV2515

Novavax · Phase 3 active Small molecule

NVX-CoV2515 is a Recombinant protein subunit vaccine Small molecule drug developed by Novavax. It is currently in Phase 3 development for COVID-19 prevention in adults (variant-specific booster formulation). Also known as: Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant.

NVX-CoV2515 is a recombinant protein subunit vaccine that presents the SARS-CoV-2 spike protein to stimulate immune responses against COVID-19 variants.

NVX-CoV2515 is a recombinant protein subunit vaccine that presents the SARS-CoV-2 spike protein to stimulate immune responses against COVID-19 variants. Used for COVID-19 prevention in adults (variant-specific booster formulation).

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-CoV2515
Also known as	Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant
Sponsor	Novavax
Drug class	Recombinant protein subunit vaccine
Target	SARS-CoV-2 spike protein
Modality	Small molecule
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

The vaccine uses recombinant nanoparticle technology to display the spike protein of SARS-CoV-2, combined with an adjuvant (Matrix-M) to enhance immunogenicity. This approach triggers both humoral and cellular immune responses, with the formulation designed to provide protection against emerging variants of concern including Omicron lineages.

Approved indications

COVID-19 prevention in adults (variant-specific booster 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-CoV2515 CI brief — competitive landscape report
NVX-CoV2515 updates RSS · CI watch RSS
Novavax portfolio CI

Frequently asked questions about NVX-CoV2515

What is NVX-CoV2515?

NVX-CoV2515 is a Recombinant protein subunit vaccine drug developed by Novavax, indicated for COVID-19 prevention in adults (variant-specific booster formulation).

How does NVX-CoV2515 work?

NVX-CoV2515 is a recombinant protein subunit vaccine that presents the SARS-CoV-2 spike protein to stimulate immune responses against COVID-19 variants.

What is NVX-CoV2515 used for?

NVX-CoV2515 is indicated for COVID-19 prevention in adults (variant-specific booster formulation).

Who makes NVX-CoV2515?

NVX-CoV2515 is developed by Novavax (see full Novavax pipeline at /company/novavax).

Is NVX-CoV2515 also known as anything else?

NVX-CoV2515 is also known as Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant.

What drug class is NVX-CoV2515 in?

NVX-CoV2515 belongs to the Recombinant protein subunit vaccine class. See all Recombinant protein subunit vaccine drugs at /class/recombinant-protein-subunit-vaccine.

What development phase is NVX-CoV2515 in?

NVX-CoV2515 is in Phase 3.

What are the side effects of NVX-CoV2515?

Common side effects of NVX-CoV2515 include Injection site pain, Fatigue, Myalgia, Headache, Fever.

What does NVX-CoV2515 target?

NVX-CoV2515 targets SARS-CoV-2 spike protein and is a Recombinant protein subunit vaccine.

Drug class: All Recombinant protein subunit vaccine drugs
Target: All drugs targeting SARS-CoV-2 spike protein
Manufacturer: Novavax — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for COVID-19 prevention in adults (variant-specific booster formulation)
Also known as: Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant

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