SARS-CoV-2 rS/Matrix M1-Adjuvant

Novavax · Phase 3 active Biologic

SARS-CoV-2 rS/Matrix M1-Adjuvant is a vaccine Biologic drug developed by Novavax. It is currently in Phase 3 development for Prevention of COVID-19. Also known as: NVX-CoV2373.

SARS-CoV-2 rS/Matrix M1-Adjuvant is a vaccine that uses the SARS-CoV-2 spike protein and Matrix M1 adjuvant to stimulate an immune response against SARS-CoV-2.

SARS-CoV-2 rS/Matrix M1-Adjuvant is a vaccine that uses the SARS-CoV-2 spike protein and Matrix M1 adjuvant to stimulate an immune response against SARS-CoV-2. Used for Prevention of COVID-19.

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 name	SARS-CoV-2 rS/Matrix M1-Adjuvant
Also known as	NVX-CoV2373
Sponsor	Novavax
Drug class	vaccine
Target	SARS-CoV-2 spike protein
Modality	Biologic
Therapeutic area	Infectious Disease
Phase	Phase 3

Mechanism of action

The vaccine works by introducing the SARS-CoV-2 spike protein and Matrix M1 adjuvant to the body, which triggers an immune response and helps the body recognize and fight the virus. The Matrix M1 adjuvant enhances the immune response by activating immune cells and increasing the production of antibodies.

Approved indications

• Prevention of COVID-19

Common side effects

• Pain, redness, or swelling at the injection site
• Fatigue
• Headache

Key clinical trials

• Safety and Immunogenicity of NVX-CoV2705 (PHASE3)
• Efficacy and Safety of NVX-CoV2705 (PHASE4)
• A Strain Change Study for SARS-CoV-2 rS Vaccines (PHASE3)
• A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine (PHASE3)
• Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines (PHASE3)
• Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines (PHASE3)
• A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom (PHASE3)
• Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (PHASE1, PHASE2)

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:

• SARS-CoV-2 rS/Matrix M1-Adjuvant CI brief — competitive landscape report
• SARS-CoV-2 rS/Matrix M1-Adjuvant updates RSS · CI watch RSS
• Novavax portfolio CI

Frequently asked questions about SARS-CoV-2 rS/Matrix M1-Adjuvant

What is SARS-CoV-2 rS/Matrix M1-Adjuvant?

SARS-CoV-2 rS/Matrix M1-Adjuvant is a vaccine drug developed by Novavax, indicated for Prevention of COVID-19.

How does SARS-CoV-2 rS/Matrix M1-Adjuvant work?

SARS-CoV-2 rS/Matrix M1-Adjuvant is a vaccine that uses the SARS-CoV-2 spike protein and Matrix M1 adjuvant to stimulate an immune response against SARS-CoV-2.

What is SARS-CoV-2 rS/Matrix M1-Adjuvant used for?

SARS-CoV-2 rS/Matrix M1-Adjuvant is indicated for Prevention of COVID-19.

Who makes SARS-CoV-2 rS/Matrix M1-Adjuvant?

SARS-CoV-2 rS/Matrix M1-Adjuvant is developed by Novavax (see full Novavax pipeline at /company/novavax).

Is SARS-CoV-2 rS/Matrix M1-Adjuvant also known as anything else?

SARS-CoV-2 rS/Matrix M1-Adjuvant is also known as NVX-CoV2373.

What drug class is SARS-CoV-2 rS/Matrix M1-Adjuvant in?

SARS-CoV-2 rS/Matrix M1-Adjuvant belongs to the vaccine class. See all vaccine drugs at /class/vaccine.

What development phase is SARS-CoV-2 rS/Matrix M1-Adjuvant in?

SARS-CoV-2 rS/Matrix M1-Adjuvant is in Phase 3.

What are the side effects of SARS-CoV-2 rS/Matrix M1-Adjuvant?

Common side effects of SARS-CoV-2 rS/Matrix M1-Adjuvant include Pain, redness, or swelling at the injection site, Fatigue, Headache.

What does SARS-CoV-2 rS/Matrix M1-Adjuvant target?

SARS-CoV-2 rS/Matrix M1-Adjuvant targets SARS-CoV-2 spike protein and is a vaccine.

Related

• Drug class: All vaccine drugs
• Target: All drugs targeting SARS-CoV-2 spike protein
• Manufacturer: Novavax — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for Prevention of COVID-19
• Also known as: NVX-CoV2373