Novavax

Novavax, Inc.

Company type	Public
Industry	Biotechnology, Pharmaceuticals
Headquarters	Gaithersburg, Maryland , United States
Key people	John Jacobs (CEO), Ruxandra Draghia-Akli (R&D director)
Products	Vaccines (including NVX-CoV2373 COVID-19 vaccine)

Novavax, Inc. is a biotechnology firm based in Gaithersburg, Maryland, United States, dedicated to creating vaccines aimed at combating severe infectious diseases. Prior to 2020, Novavax concentrated on developing experimental vaccines for illnesses such as influenza, respiratory syncytial virus (RSV), Ebola, and various other emerging pathogens. However, in 2020, the company reoriented its business approach to emphasize the development and regulatory approval of its NVX-CoV2373 vaccine targeting COVID-19.

The COVID-19 vaccine developed by Novavax, known commercially as Nuvaxovid, secured approval from European Union regulators by late 2021 and subsequently gained authorization in Canada by February 2022. This vaccine became the fifth COVID-19 immunization to receive official approval following those produced by Pfizer/BioNTech, Moderna, Janssen, and AstraZeneca.

By 2023, Novavax reported revenues nearing US$983.7 million, highlighting its growing footprint and influence within the global vaccine market. The company’s leadership team includes CEO John Jacobs and R&D director Ruxandra Draghia-Akli, whose strategic guidance has been pivotal in advancing Novavax’s development pipeline and strengthening its market position.

History

In June 2013, Novavax expanded its technological capabilities by acquiring the Matrix-M adjuvant platform through the purchase of Swedish firm Isconova AB, which was subsequently renamed Novavax AB.

ResVax

By March 2015, Novavax had finalized a Phase I trial for its candidate Ebola vaccine and completed a phase II study for its RSV vaccine candidate later branded ResVax. The clinical trial for ResVax demonstrated notable effectiveness against respiratory syncytial virus (RSV) using a nanoparticle-based formulation that combined recombinant F lipoprotein with saponin derived from Quillaja saponaria bark, along with cholesterol and phospholipids. This vaccine was developed to protect both infants and adults.

In September 2016, the company’s initial phase III trial, known as the Resolve trial involving 12,000 participants for ResVax, did not meet its endpoints, resulting in an 85% decline in stock value. While Phase II adult trials indicated immune response activation, they failed to demonstrate sufficient efficacy. This setback prompted plans for additional phase II studies utilizing alternative dosing regimens. To tackle these issues, Novavax launched a three-pronged strategy in 2017: reducing expenses through restructuring and a workforce reduction of approximately 30%; intensifying efforts to bring ResVax to market; and commencing clinical trials for a vaccine against the Zika virus.

Alongside adult trials, ResVax was also evaluated in 2016 for prevention of RSV in infants via maternal immunization.

In 2019, further late-stage clinical testing of ResVax again failed to achieve desired results, causing investor confidence to plunge and leading to a 70% drop in market capitalization. As a result, Novavax executed a reverse stock split to comply with Nasdaq listing standards and prevent delisting.

NanoFlu

NanoFlu is a quadrivalent influenza vaccine that successfully completed Phase II clinical trials in 2019. It was granted fast track designation by the U.S. Food and Drug Administration (FDA) in January 2020 and concluded Phase III trials by March of the same year.

Finance and external sponsorships

Novavax's capital is sourced from both public and private investors, with roughly half of its freely traded shares owned by institutional investors. The company has obtained substantial financial support, including an $89 million research grant awarded by the Bill and Melinda Gates Foundation in 2015 to advance an RSV vaccine aimed at protecting infants through maternal immunization.

In May 2020, Novavax secured $384 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to aid the initial development of its COVID-19 vaccine candidate, NVX-CoV2373, and to facilitate preparations for mass production. Prior to this, CEPI had invested $4 million in March 2020.

On 7 July 2020, Novavax was granted a $1.6 billion loan as part of the U.S. government's Operation Warp Speed initiative to finance clinical trials, commercialization efforts, and manufacturing of its COVID-19 vaccine, with a goal of delivering 100 million doses by January 2021.

In October 2024, Novavax formed a $1.2 billion alliance with Sanofi, allowing Sanofi to utilize Novavax’s Matrix-M adjuvant technology across other product lines. Simultaneously, the company reduced its operational scale by approximately $1 billion between 2022 and 2024, cutting back on research and development activities.

By December 2024, Novavax divested its manufacturing plant in the Czech Republic to Novo Nordisk for $200 million.

Vaccine research and development

In January 2020, Novavax unveiled its vaccine candidate, NVX-CoV2373, a protein subunit vaccine designed to target the spike protein of SARS-CoV-2. This candidate competes within the global market alongside numerous other COVID-19 vaccines.

By January 2021, phase III trial data revealed an efficacy rate of 89% against COVID-19 along with robust protection against emerging variants. The company submitted applications for emergency use authorization in both the US and UK, initially planning distribution in the UK. By June 2021, phase III trials conducted in the US and Mexico showed an overall efficacy of 90.4%.

Novavax broadened its international presence through partnerships such as a May 2021 agreement with Moderna and the South Korean government to produce vaccines. Additionally, it collaborates with the Coalition for Epidemic Preparedness Innovations (CEPI) on co-developing the vaccine in India under the Covovax brand, supported by funding up to $399 million.

In September 2021, Novavax together with Takeda Pharmaceutical secured a contract with Japan's Ministry of Health to supply 150 million doses of TAK-019 pending regulatory clearance. Takeda is responsible for manufacturing and distribution within Japan.

By December 2021, findings confirmed that two doses of Novavax’s vaccine elicited an immune response against the Omicron variant. Administration of a third booster dose amplified neutralizing antibody levels by 73.5 times—surpassing Pfizer’s and Moderna’s boosters which raised antibody counts by factors of 25 and 37 respectively—demonstrating Novavax’s competitive edge in booster efficacy amid ongoing pandemic challenges.

Authorization and application

On 1 November 2021, Novavax and the Serum Institute of India (SII) revealed that Indonesia's National Agency of Drug and Food Control (Badan POM) had granted emergency use authorization (EUA) for Novavax's recombinant nanoparticle protein-based COVID-19 vaccine combined with the Matrix-M adjuvant. Produced by SII in India, this vaccine is distributed in Indonesia under the name Covovax.

Subsequently, on 17 December 2021, the World Health Organization (WHO) included Covovax on its emergency use list for coronavirus vaccines, facilitating distribution via the COVAX initiative aimed at low- and middle-income nations. Novavax and SII pledged to supply a total of 1.1 billion doses for this program.

On 20 December 2021, the European Medicines Agency issued a recommendation for conditional marketing authorization of Novavax's Nuvaxovid vaccine. The European Commission then officially approved it, marking Nuvaxovid as the fifth COVID-19 vaccine authorized within the European Union following Pfizer/BioNTech, Moderna, Janssen, and AstraZeneca.

Australia's Therapeutic Goods Administration granted provisional approval for Nuvaxovid on 20 January 2022, making it the first protein-based COVID-19 vaccine authorized in that country.

Novavax filed an EUA application with the U.S. Food and Drug Administration on 31 January 2022; after advisory committee reviews, the FDA panels recommended approval on 7 June. In February 2022, Health Canada authorized Nuvaxovid for adult use (18 years and older).

The FDA issued an EUA for Novavax’s COVID-19 vaccine on 13 July 2022 for adults aged 18 and above. By July 2023, Novavax obtained full marketing authorization from the European Commission for Nuvaxovid, allowing its use as a primary vaccination series for individuals aged 12 and older as well as booster doses in adults. The company intends to pursue complete approvals in the United States and other regions to broaden vaccine options within public health frameworks.

In October 2023, the FDA updated the EUA to include a reformulated version of Novavax’s vaccine incorporating spike protein from the SARS-CoV-2 Omicron variant XBB.1.5 lineage, authorized for people aged 12 and up.

Furthermore, in December 2023, the WHO granted prequalification status to the R21/Matrix-M malaria vaccine developed jointly by Oxford University and Serum Institute of India.

In October 2024, Novavax secured European Union authorization for a COVID-19 vaccine targeting the JN.1 variant.

As of April 2025, Novavax was finalizing additional clinical trials requested by the FDA following submission of a Biologics License Application to achieve full licensure. In May 2025, the FDA approved Nuvaxovid for adults aged 65 years and older, with expanded indications covering individuals aged 12–64 who are at elevated risk due to underlying health conditions.

Vaccine adjuvants

Novavax produces proprietary saponin-based immunologic adjuvants designed to enhance immune responses through its wholly owned Swedish subsidiary, Novavax AB. Its principal adjuvant, Matrix-M, significantly boosts vaccine immunogenicity and is incorporated into Novavax’s authorized COVID-19 vaccine NVX-CoV2373. This adjuvant represents a vital element of Novavax’s product lineup and serves as a key differentiator within the competitive vaccine industry.