Overview

SARS-CoV-2, the causative agent of COVID-19, relies on the interaction between its trimeric spike (S) glycoprotein and angiotensin-converting enzyme 2 (hACE2) expressed on host cells in order to establish a productive infection in humans. Antibodies directed against the S protein are capable of blocking S-hACE2 interactions and neutralizing viral particles and are present in convalescent patients and those who have been inoculated against COVID-19. Nuvaxovid (NVX-CoV2373) contains a recombinant mutant S protein that is codon-optimized for baculovirus-mediated expression in Sf9 cells derived from Spodoptera frugiperda together with a Matrix-M adjuvant (Fractions A and C from Quillaja saponaria extract). The resulting stable perfusion S protein nanoparticles are thermostable and capable of inducing productive cellular and humoral immune responses in humans and across a wide range of animal models. The European Commission granted Novavax conditional marketing authorization for nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 on December 20, 2021 and full marketing authorization on Jul 06, 2023. On February 17, 2022, nuvaxovid was approved by Health Canada. On July 13, 2022, nuvaxovid was granted an emergency use authorization by the FDA for the prevention of COVID-19 in adults, which was expanded to include patients ≥12 years of age in August 2022.

Indication

Nuvaxovid is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in patients 12 years of age and older. Nuvaxovid is also available in the US under an emergency use authorization (EUA) for the prevention of COVID-19 in patients ≥12 years of age.

Associated Conditions

Coronavirus Disease 2019 (COVID‑19)

Research Report

Published: Oct 7, 2025

Nuvaxovid (COVID-19 Vaccine, Adjuvanted): A Comprehensive Monograph on its Biotechnology, Clinical Profile, and Global Regulatory Status

Section 1: Introduction and Manufacturer Profile

1.1. Overview of Nuvaxovid

Nuvaxovid is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19), the illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).[1] As a biotech product, it is classified as a recombinant, adjuvanted, protein subunit vaccine, a technological approach that distinguishes it from the messenger RNA (mRNA) and viral vector platforms that were first to market during the COVID-19 pandemic.[4] The vaccine is identified by the DrugBank ID DB15810.[4]

The proper name for the product is "COVID-19 Vaccine, Adjuvanted".[1] It is marketed under several trade names globally, most notably Nuvaxovid in the United States, Europe, and Australia, and Covovax in other regions, particularly when manufactured by the Serum Institute of India.[4] During its development phase, the vaccine candidate was known by the codename NVX-CoV2373.[4]

The primary indication for Nuvaxovid is the prevention of COVID-19. However, the specific populations for which it is approved vary significantly across different regulatory jurisdictions, a reflection of differing public health strategies and risk-benefit assessments. In the United States, for example, its full approval is restricted to individuals aged 65 and older, and those aged 12 through 64 who have at least one underlying condition that places them at high risk for severe outcomes from COVID-19.[1] In contrast, the European Medicines Agency has authorized its use more broadly for individuals aged 12 years and older.[3]

Table 1: Key Characteristics of Nuvaxovid

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Strain Change Study for SARS-CoV-2 rS Vaccines	2024/05/10	NCT06409663	Phase 3	Completed	Novavax
A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine	2024/03/04	NCT06291857	Phase 3	Active, not recruiting	Novavax
Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations	2023/09/07	NCT06027229	Phase 2	Completed	University of Wisconsin, Madison
Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines	2023/06/29	NCT05925127	Phase 2	Completed	Novavax
Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines	2023/05/25	NCT05875701	Phase 3	Completed	Novavax
Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults	2022/07/18	NCT05463068	Phase 3	Completed	Novavax
Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines	2022/05/12	NCT05372588	Phase 3	Completed	Novavax
A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)	2022/03/29	NCT05299359	Phase 3	Completed	Takeda
Efficacy of Different COVID-19 Vaccine Combinations in Inducing Long-term Humoral Immunity [PRIBIVAC]	2021/12/02	NCT05142319	Phase 4	Completed	Tan Tock Seng Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Activist Investor Shah Capital Calls for Novavax Sale Amid COVID Vaccine Market Share Struggles

24 days ago

Shah Capital, Novavax's second-largest shareholder with a 7.2% stake, has urged the company's board to pursue a sale, citing three consecutive years of poor COVID-19 vaccine performance.

Novavax and Takeda Strengthen Partnership with Improved Terms for COVID-19 Vaccine in Japan

6 months ago

• Novavax has secured significantly improved financial terms in its amended collaboration agreement with Takeda for Nuvaxovid, including upfront payments, seasonal milestones, and ongoing royalties. • The strengthened partnership ensures continued availability of Nuvaxovid, a protein-based non-mRNA COVID-19 vaccine, in Japan's pharmaceutical market, the third largest globally. • This agreement validates Novavax's technology platform featuring protein-based nanoparticles and proprietary Matrix-M adjuvant, supporting the company's strategy to become a preferred partner through strategic collaborations.

FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval

6 months ago

The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.

Novavax Pivots Business Model, Shifts Focus from Vaccine Development to Technology Licensing

8 months ago

• Novavax reported significant revenue decline with Q4 sales dropping to $88 million from $291 million year-over-year, reflecting diminishing COVID-19 vaccine demand and strategic repositioning. • The company is transforming from a vaccine manufacturer to a technology platform company, focusing on partnerships and licensing its Matrix-M adjuvant technology to major pharmaceutical firms. • Strategic cost-cutting measures aim to reduce annual expenses by 80% to $250 million by 2027, while a partnership with Sanofi could yield $175 million upon FDA full authorization of their COVID vaccine.

EU Expands COVID-19 Vaccine Options: New Protein-Based Vaccines Join mRNA Offerings for 2024

9 months ago

• The European Commission and 15 EU countries have initiated a joint procurement for protein-based COVID-19 vaccines, providing alternatives to mRNA vaccines for the 2024 vaccination campaigns. • Four COVID-19 vaccines are currently authorized in the EU: two mRNA-based (Comirnaty and Spikevax) and two protein-based (Nuvaxovid and Bimervax), with adapted versions targeting newer variants. • The European Medicines Agency has approved multiple adapted vaccines for autumn 2024, including Comirnaty JN.1, Spikevax JN.1, and Nuvaxovid JN.1, with Bimervax JN.1 under current assessment.

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