What is Novavax, Inc. and what is its primary focus?

Novavax, Inc. is an American biotechnology company headquartered in Gaithersburg, Maryland. Its primary focus is on the development of vaccines designed to combat serious infectious diseases.

In which industry does Novavax operate?

Novavax operates within the biotechnology industry, specializing in the research and development of vaccines.

When was Novavax founded and where is it headquartered?

Novavax was founded in 1987 and is headquartered in Gaithersburg, Maryland, United States. This location serves as its global headquarters and houses its Vaccines Innovation Campus.

How is Novavax traded on the stock market?

Novavax is a publicly traded company and its stock is listed on the Nasdaq under the ticker symbol NVAX. Its ISIN (International Securities Identification Number) is US6700024010.

What were Novavax's main areas of vaccine development prior to 2020?

Before 2020, Novavax scientists concentrated on developing experimental vaccines for influenza and respiratory syncytial virus (RSV). They also worked on vaccines for Ebola and other emerging infectious diseases.

How did the company's focus shift in 2020?

In 2020, Novavax redirected its efforts to concentrate on the development and approval of its NVX-CoV2373 vaccine, which is designed to prevent COVID-19.

What is the name of Novavax's COVID-19 vaccine?

Novavax's COVID-19 vaccine is known by the brand name Nuvaxovid, and its development candidate designation is NVX-CoV2373. It is a protein subunit vaccine.

What is the Matrix-M platform and when did Novavax acquire it?

The Matrix-M is a proprietary immune-stimulating saponin-based immunologic adjuvant platform. Novavax acquired this platform in June 2013 through the purchase of the Swedish company Isconova AB, subsequently renaming it Novavax AB.

What was the purpose of the ResVax vaccine candidate?

ResVax was Novavax's vaccine candidate aimed at stimulating resistance to Respiratory Syncytial Virus (RSV) infection. It was designed for both adult and infant populations, with a particular focus on maternal immunization to protect infants.

What were the outcomes of the early clinical trials for ResVax?

In March 2015, Novavax completed a Phase I trial for its Ebola vaccine candidate and a Phase II study for its RSV vaccine, which would become ResVax. The RSV trial showed encouraging results regarding efficacy against RSV infection.

What challenges did Novavax face with the ResVax vaccine trials?

In 2016, Novavax's Phase III Resolve trial for ResVax failed, leading to a significant drop in its stock price. A Phase II adult trial also showed stimulation of antigenicity but failed in efficacy. In 2019, late-stage clinical testing of ResVax failed for a second time, impacting investor confidence and leading to a reverse stock split.

What is NanoFlu and what was its development status?

NanoFlu is a quadrivalent influenza vaccine developed by Novavax. It successfully completed Phase II clinical trials in 2019 and received fast track designation from the U.S. FDA in January 2020 to proceed to Phase III trials, which were completed in March 2020.

How is Novavax financed?

Novavax is financed through a combination of public and private investors. Approximately 50% of its free float shares are held by institutional investors.

What significant research grants has Novavax received?

In 2015, Novavax received a research grant of US$89 million from the Bill and Melinda Gates Foundation to support the development of its RSV vaccine for infants via maternal immunization. Additionally, the Coalition for Epidemic Preparedness Innovations (CEPI) provided funding, including US$384 million in May 2020 and an earlier US$4 million in March 2020, to support the development and manufacturing of its COVID-19 vaccine candidate.

What was the nature of the U.S. government's funding for Novavax?

In July 2020, Novavax was awarded a US$1.6 billion loan from the United States government through the Operation Warp Speed program. This funding was intended to cover the testing, commercialization, and production of a potential coronavirus vaccine in the U.S., aiming for 100 million doses by January 2021.

What is the technological basis of Novavax's COVID-19 vaccine, NVX-CoV2373?

NVX-CoV2373 is a protein subunit vaccine. It contains the spike protein of the SARS-CoV-2 virus, the virus that causes COVID-19, and utilizes Novavax's Matrix-M adjuvant.

What efficacy did Novavax's COVID-19 vaccine demonstrate in its Phase III trials?

In January 2021, Novavax released Phase III trial data showing its vaccine had 89% efficacy against COVID-19 and provided strong immunity against new variants. A later Phase 3 trial in the US and Mexico, announced in June 2021, showed an overall efficacy of 90.4%.

How did Novavax's COVID-19 vaccine perform against the Omicron variant?

In December 2021, Novavax announced that its vaccine demonstrated an immune response against the Omicron variant. While the antibody response was four times lower than against the original variant, a third dose significantly increased neutralizing antibodies against Omicron by 73.5 times.

Which regulatory bodies have granted authorization or approval for Novavax's COVID-19 vaccine?

Novavax's Nuvaxovid vaccine has received emergency use authorization (EUA) or conditional marketing authorization from several bodies, including the National Agency of Drug and Food Control of Indonesia, the World Health Organization (WHO) for emergency use, the European Medicines Agency (EMA) for conditional marketing authorization, Health Canada, and the U.S. Food and Drug Administration (FDA) for emergency use authorization. It also received provisional approval from Australia's Therapeutic Goods Administration (TGA).

Covovax is the brand name under which Novavax's COVID-19 vaccine is marketed in India, co-developed with the Serum Institute of India (SII). It is also supplied to the COVAX program for distribution to low and middle-income countries.

What role did Takeda Pharmaceutical Company play regarding Novavax's vaccine in Japan?

In September 2021, Japan's Ministry of Health, Labour and Welfare agreed to purchase 150 million doses of Novavax's vaccine candidate (TAK-019), with Takeda Pharmaceutical Company set to manufacture and distribute it upon regulatory approval.

What is the significance of the European Commission's full marketing authorization for Nuvaxovid?

In July 2023, the European Commission granted full marketing authorization for Novavax's Nuvaxovid vaccine. This allows its use as a primary series for individuals aged 12 and older and as a booster dose for adults aged 18 and older, establishing a basis for future approvals in other markets.

How has the Novavax COVID-19 vaccine been updated to address new variants?

In October 2023, the FDA amended the Emergency Use Authorization (EUA) for Novavax's vaccine to include a formulation updated with the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 for individuals aged 12 and above. In October 2024, a vaccine targeting the JN.1 strain was authorized in the European Union.

What is the current status of Novavax's full licensure for its COVID-19 vaccine in the United States?

As of April 2025, Novavax was still pursuing full licensure for its COVID-19 vaccine in the United States. The company submitted a Biologics License Application (BLA) to the FDA, which requested an additional clinical trial before granting approval.

What is the latest FDA approval status for Novavax's COVID-19 vaccine in the US?

In May 2025, Novavax received FDA approval for its COVID-19 vaccine, Nuvaxovid. This approval covers adults aged 65 and older, as well as individuals aged 12 through 64 who have at least one underlying medical condition that increases their risk for severe COVID-19 outcomes.

What is the role of Novavax's proprietary vaccine adjuvants?

Novavax develops proprietary immune-stimulating saponin-based immunologic adjuvants through its Swedish subsidiary, Novavax AB. The Matrix-M adjuvant is a key component used in Novavax's approved COVID-19 vaccine, NVX-CoV2373, to enhance the immune response.

What financial results did Novavax report for 2023?

In 2023, Novavax reported revenue of US$983.7 million, which represented a decrease compared to previous periods. The company also reported having 1,541 employees in 2022.

What strategic changes has Novavax made to its operations?

Between 2022 and 2024, Novavax scaled back its operations by approximately $1 billion, reducing its focus on research and development. In December 2024, the company sold its Czech manufacturing facility to Novo Nordisk for $200 million.

What was the significance of Novavax's partnership with Sanofi?

In October 2024, Novavax entered into a $1.2 billion partnership with Sanofi. This agreement allows Sanofi to utilize Novavax's Matrix-M adjuvant for its own product development.

What is the primary function of an adjuvant in a vaccine?

An adjuvant is a substance added to a vaccine to help create a stronger immune response in the person receiving the vaccine. It essentially boosts the vaccine's effectiveness.

What is the significance of the Matrix-M adjuvant for Novavax's vaccines?

The Matrix-M adjuvant is a key proprietary technology for Novavax, used to enhance the immunogenicity of its vaccines, including its COVID-19 vaccine, NVX-CoV2373.

What does it mean for a company to be publicly traded?

A publicly traded company is one whose shares are bought and sold on a stock exchange, such as the Nasdaq. This allows the general public to invest in the company.

What is a 'fast track designation' from the FDA?

A fast track designation is a process by which the U.S. Food and Drug Administration (FDA) expedites the review and development of drugs or vaccines intended to treat serious conditions and fill unmet medical needs. It allows for more frequent communication between the FDA and the sponsor.

What is a protein subunit vaccine?

A protein subunit vaccine is a type of vaccine that uses only specific pieces of the pathogen, such as its proteins, to stimulate an immune response. This is in contrast to vaccines that use weakened or inactivated versions of the whole pathogen.

What is the purpose of a reverse stock split?

A reverse stock split is a corporate action in which a company reduces the number of its outstanding shares, often to increase the share price. This is sometimes done to meet minimum share price requirements for stock exchange listings, like the Nasdaq.

What is the difference between emergency use authorization (EUA) and full marketing authorization for a vaccine?

Emergency Use Authorization (EUA) allows for the use of unapproved medical products or unapproved uses of approved medical products during public health emergencies. Full marketing authorization, also known as licensure, is a more comprehensive review process that grants permanent approval for a product's use based on demonstrated safety and efficacy.

What is the role of the Coalition for Epidemic Preparedness Innovations (CEPI)?

CEPI is a global partnership that finances and coordinates the development of vaccines against emerging infectious diseases. It provided significant funding to Novavax for its COVID-19 vaccine development.

What is Operation Warp Speed?

Operation Warp Speed was a U.S. government initiative launched in 2020 to accelerate the development, manufacturing, and distribution of COVID-19 vaccines and therapeutics. Novavax received substantial funding from this program.

What does it mean for a vaccine to be 'provisional approval'?

Provisional approval, as granted by Australia's TGA, is a regulatory pathway that allows for the use of a medicine or vaccine based on promising early-stage data, with the expectation that further data will confirm its safety and efficacy. It is often used during public health crises.

What is the significance of WHO prequalification for a vaccine?

WHO prequalification signifies that a vaccine meets international standards for quality, safety, and efficacy. This status is crucial for vaccines intended for use in global health programs, such as the COVAX initiative, enabling their distribution in lower-income countries.

What is the purpose of clinical trials, such as Phase I, II, and III?

Clinical trials are research studies performed on people to evaluate the safety and efficacy of new medical treatments, including vaccines. Phase I trials typically assess safety in a small group, Phase II expands on safety and efficacy in a larger group, and Phase III confirms efficacy and monitors side effects in a very large group before regulatory approval.

SARS-CoV-2 is the specific virus that causes the disease known as COVID-19. Novavax's NVX-CoV2373 vaccine is designed to provide immunity against this virus.

What is the significance of a company having a 'website' listed in its profile?

A company's website serves as its official online presence, providing information about its products, services, history, and contact details. It is a primary channel for communication with the public, investors, and potential partners.

What does 'area served: Worldwide' indicate for Novavax?

Indicating 'Worldwide' as the area served means that Novavax's products, particularly its vaccines, are intended for distribution and use globally, not limited to a specific country or region.

What is the role of a CEO in a company like Novavax?

The Chief Executive Officer (CEO) is the highest-ranking executive in a company, responsible for overall management, strategic decisions, and operations. John Jacobs holds this position at Novavax.

What is the function of the R&D department in a biotechnology company?

The Research and Development (R&D) department in a biotechnology company like Novavax is responsible for discovering, developing, and testing new products, such as vaccines. Ruxandra Draghia-Akli leads this crucial area for Novavax.

What is the significance of a company's revenue figure?

Revenue represents the total income generated by a company from its business activities, typically from the sale of goods or services. It is a key indicator of a company's financial performance and market presence.

What does the number of employees indicate about a company?

The number of employees reflects the size and operational capacity of a company. A larger workforce often suggests more extensive operations, research, manufacturing, or sales activities.

What is the purpose of an ISIN?

An ISIN (International Securities Identification Number) is a unique code assigned to securities like stocks and bonds, facilitating international trading and identification. Novavax's ISIN is US6700024010.

What does 'public company' mean in the context of Novavax?

Being a 'public company' means that Novavax's shares are available for purchase by the general public on a stock exchange, allowing for public investment and ownership.

What is the significance of the 'infobox-caption' for the image of the Novavax building?

The infobox caption, 'Novavax headquarters in Gaithersburg,' identifies the location depicted in the accompanying image as the main administrative center for the company.

Novavax Wiki: Novavax: Pioneering Vaccine Innovation in Biotechnology

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Company Overview

Corporate Identity

Novavax, Inc. is a prominent American biotechnology company headquartered in Gaithersburg, Maryland. Established in 1987, it operates as a public entity, traded on the Nasdaq under the ticker symbol NVAX. The company's core mission revolves around the development of vaccines designed to combat serious infectious diseases globally.

Technological Focus

Novavax specializes in creating vaccines using advanced technologies, including protein subunit vaccines and proprietary immune-stimulating adjuvant platforms like Matrix-M. Their research and development efforts have historically targeted influenza and respiratory syncytial virus (RSV), alongside emerging threats such as Ebola and, critically, COVID-19.

Financial Snapshot

As of the latest reporting period (2023), Novavax generated revenue of approximately US$983.7 million. The company employs a significant workforce, with 1,541 individuals recorded in 2022, reflecting its substantial operational scale in the biotechnology sector.

Historical Trajectory

Strategic Acquisitions

In June 2013, Novavax significantly bolstered its technological capabilities by acquiring the Swedish company Isconova AB. This acquisition brought the innovative Matrix-M adjuvant platform under Novavax's umbrella, integrating it as Novavax AB, which would prove crucial for future vaccine development.

Navigating Challenges (ResVax)

Novavax faced considerable setbacks with its respiratory syncytial virus (RSV) vaccine candidate, ResVax. Despite early promising Phase I and II trial results, late-stage Phase III trials in 2016 and 2019 failed to meet efficacy endpoints. These failures led to significant stock price drops, workforce reductions, and strategic restructuring efforts to refocus on market-ready products and new clinical trials.

Advancing Influenza Vaccine (NanoFlu)

The company's quadrivalent influenza vaccine, NanoFlu, demonstrated success in Phase II clinical trials by 2019. It received fast track designation from the U.S. FDA in January 2020, paving the way for Phase III trials, which were completed in March 2020, positioning NanoFlu as a key product candidate.

COVID-19 Vaccine Development

NVX-CoV2373: The Candidate

In January 2020, Novavax announced the development of NVX-CoV2373, a protein subunit vaccine candidate designed to elicit immunity against SARS-CoV-2. This vaccine utilizes the virus's spike protein, produced in insect cells, and is formulated with the Matrix-M adjuvant.

Clinical Efficacy and Approvals

Phase III trials reported high efficacy rates, with overall efficacy reaching 90.4% in US/Mexico trials by June 2021. The vaccine, branded as Nuvaxovid, received emergency use authorization (EUA) in various regions, including the European Union (December 2021), Canada (February 2022), Australia (January 2022), and the United States (July 2022). It also received WHO emergency use listing, facilitating its distribution through the COVAX program.

Variant Response and Boosters

Data released in late 2021 indicated that Nuvaxovid generated an immune response against the Omicron variant. A third dose significantly boosted neutralizing antibody levels, demonstrating the vaccine's adaptability and potential effectiveness against evolving strains of the virus. The vaccine has since been updated to target specific variants, such as XBB.1.5 and JN.1.

Proprietary Adjuvants

The Matrix-M Platform

Novavax develops proprietary immune-stimulating saponin-based immunologic adjuvants through its Swedish subsidiary, Novavax AB. The flagship adjuvant, Matrix-M, is a key component in Novavax's vaccine formulations, including its COVID-19 vaccine.

Matrix-M is derived from the bark of the Quillaja saponaria tree. It is formulated with cholesterol and phospholipid. This adjuvant is designed to enhance the immune response by stimulating the production of antibodies and cellular immunity, thereby increasing vaccine efficacy. Research has shown its ability to enhance immunogenicity in various vaccine types, including protein-based and viral vector vaccines.

Strategic Partnerships

The Matrix-M technology has attracted significant interest and investment. The Bill & Melinda Gates Foundation provided substantial grants to support Novavax's RSV vaccine development using this adjuvant. Furthermore, Novavax entered a $1.2 billion partnership with Sanofi in October 2024, allowing Sanofi to leverage the Matrix-M adjuvant for its own product pipeline.

Financial Landscape

Funding and Investment

Novavax's operations are supported by a mix of public and private investment, with a notable portion of its free float shares held by institutional investors. The company has secured significant funding through research grants and government contracts, including substantial support from the Bill & Melinda Gates Foundation and the U.S. government's Operation Warp Speed program.

Operational Adjustments

In recent years, Novavax has undertaken strategic operational adjustments, including scaling back operations by approximately $1 billion between 2022 and 2024, with a reduced emphasis on research and development. The company also divested its Czech manufacturing facility to Novo Nordisk in December 2024 for $200 million, signaling a strategic refocusing of its business operations.

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Novavax: Advancing Global Health

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Company Overview ℹ️

🏢 Corporate Identity

🔬 Technological Focus

📊 Financial Snapshot

Historical Trajectory 📈

🔗 Strategic Acquisitions

⚠️ Navigating Challenges (ResVax)

🚀 Advancing Influenza Vaccine (NanoFlu)

COVID-19 Vaccine Development 🦠

🔬 NVX-CoV2373: The Candidate

📊 Clinical Efficacy and Approvals

🛡️ Variant Response and Boosters

Proprietary Adjuvants ✨

🧪 The Matrix-M Platform

🤝 Strategic Partnerships

Financial Landscape 💰

🏦 Funding and Investment

📉 Operational Adjustments

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📜 Important Notice

Dive in with Flashcard Learning!

Company Overview

Corporate Identity

Technological Focus

Financial Snapshot

Historical Trajectory

Strategic Acquisitions

Navigating Challenges (ResVax)

Advancing Influenza Vaccine (NanoFlu)

COVID-19 Vaccine Development

NVX-CoV2373: The Candidate

Clinical Efficacy and Approvals

Variant Response and Boosters

Proprietary Adjuvants

The Matrix-M Platform

Strategic Partnerships

Financial Landscape

Funding and Investment

Operational Adjustments

Teacher's Corner

True or False?

Test Your Knowledge!

Gamer's Corner

Discover other topics to study!

References

Feedback & Support

Disclaimer

Important Notice