Novavax Announces Deliveries of Its COVID-19 Vaccine to European Union Member States

GAITHERSBURG, Md., Feb. 23, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines against serious infectious diseases, today announced the first doses of Nuvaxovid™ COVID -19 vaccines (recombinant, with adjuvant) have started shipping to member states of the European Union (EU). Nuvaxovid, also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine authorized for use in Europe.

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Permitted use of Nuvaxovid™ in the European Union

The European Commission has granted conditional marketing authorization for Nuvaxovid™ COVID-19 vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people aged 18 and over.

Important Safety Information

  • Nuvaxovid™ is contraindicated in people with hypersensitivity to the active substance or to any of the excipients
  • Cases of anaphylaxis have been reported with the administration of COVID-19 vaccines. Appropriate medical treatment and monitoring should be available in the event of an anaphylactic reaction
  • Anxiety-related reactions including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination in response to needle injection. It is important that precautions are in place to avoid injury from fainting
  • Vaccination should be postponed in persons with severe acute febrile illness or acute infection
  • Administer Nuvaxovid with caution to people receiving anticoagulant therapy or those with thrombocytopenia or any bleeding disorder (such as haemophilia) as bleeding or bruising may occur after intramuscular administration in these people.
  • The effectiveness of Nuvaxovid may be lower in immunocompromised people
  • The duration of protection offered by the vaccine is unknown as it is still determined by ongoing clinical trials
  • Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccinees
  • The most common adverse reactions observed in clinical studies (frequency category of very common ≥ 1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and discomfort.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with the patented saponin-based Matrix-M™ adjuvant of Novavax to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains a purified protein antigen and cannot replicate or cause COVID-19.

Novavax’s COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination schedule provides for two doses of 0.5 ml (5 mcg of antigen and 50 mcg of Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored between 2° and 8° Celsius, allowing the use of existing vaccine supply channels and the cold chain. The use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, marketing and distribution of NVX-CoV2373 worldwide. The existing clearances leverage Novavax’s manufacturing partnership with the Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’s global supply chain.

About Matrix-M™ Adjuvant

Novavax’s patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating entry of antigen-presenting cells into the injection site and enhancing antigen presentation in the injection site. local lymph nodes, thereby stimulating the immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved global health through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address pressing global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional clearance from several regulatory authorities around the world, including the European Commission and the World Health Organization. The vaccine is also under review by several regulatory bodies around the world. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a combined COVID-seasonal influenza vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its experimental quadrivalent influenza vaccine candidate. These candidate vaccines incorporate Novavax’s proprietary saponin-based Matrix-M™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.

Forward-looking statements

The following statements regarding Novavax’s future, business plans and prospects, partnerships, ongoing development of NVX-CoV2373, including a combination COVID-seasonal influenza vaccine candidate with NanoFlu, its investigational vaccine candidate quadrivalent influenza, the scope, timing and outcome of future regulatory filings and actions, including Novavax’s plans to submit global regulatory filings for an NVX-CoV2373 pediatric indication during the first quarter of 2022, and to complete the existing authorizations with data from additional Novavax global supply chain manufacturing sites, the potential impact of Novavax and NVX-CoV2373 on vaccine access, pandemic control and population protection , the efficacy, safety, and intended use of NVX-CoV2373, as well as the expected delivery of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. These risks and uncertainties include the challenges of meeting, alone or with partners, various product safety, efficacy and characterization requirements, including those related to process qualification and test validation, necessary to meet applicable regulatory authorities; difficulty in obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax’s ability to pursue anticipated regulatory pathways; difficulties in meeting contractual requirements under agreements with multiple commercial, governmental and other entities; and other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place significant reliance on any forward-looking statements contained in this press release. We encourage you to read our SEC filings, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date hereof, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those mentioned above. Investors, potential investors and others should pay particular attention to these risks and uncertainties.

Source: Novavax

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