Severe Acute Respiratory Syndrome

GAITHERSBURG, MD, USA I October 9, 2024 I Novavax, Inc. (Nasdaq: NVAX ), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission granted Marketing Authorization for Novavax’s updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU). This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). Authorization was based on non-clinical data that showed Novavax’s updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1. 1 In clinical trials, the most common adverse reactions associated with Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise. Novavax’s vaccine is also authorized for use in the U.S. , and is in line with guidance from the U.S. Food and Drug Administration (FDA), EMA and the World Health Organization to target the JN.1 lineage this fall. 2-5 AUTHORIZED USE IN THE U.S. Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been approved or licensed by the FDA but has been authorized for emergency use by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted. The EUA of this product will remain in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the authorization is revoked sooner. VACCINE AUTHORIZATION (U.S.) Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. IMPORTANT SAFETY INFORMATION Contraindications Warnings and Precautions Adverse Reactions Solicited adverse reactions included: Injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling and fever. Reporting Adverse Events and Vaccine Administration Errors The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html , by calling 1-800-822-7967 or send an email to info@vaers.org. About the Novavax COVID-19 2024-2025 Formula (NVX-CoV2705) NVX-CoV2705 is an updated version of Novavax’s prototype COVID-19 vaccine formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax’s unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax’s Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels. About Matrix-M™ Adjuvant When added to vaccines, Novavax’s patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable. 3 The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. About Novavax Novavax, Inc. (Nasdaq: NVAX ) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. The Company’s portfolio includes its COVID-19 vaccine and its pipeline includes COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. In addition, Novavax’s adjuvant is included in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information. References SOURCE: Novavax

GAITHERSBURG, Md., Oct. 9, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU). This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). Authorization was based on non-clinical data that showed Novavax's updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1 In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise. Novavax's vaccine is also authorized for use in the U.S., and is in line with guidance from the U.S. Food and Drug Administration (FDA), EMA and the World Health Organization to target the JN.1 lineage this fall.2-5 AUTHORIZED USE IN THE U.S. Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been approved or licensed by the FDA but has been authorized for emergency use by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted. The EUA of this product will remain in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the authorization is revoked sooner. VACCINE AUTHORIZATION (U.S.) Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. IMPORTANT SAFETY INFORMATION Contraindications Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted. Warnings and Precautions Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the Novavax COVID-19 Vaccine, Adjuvanted. Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted. Syncope (fainting): may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting. Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted. Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients. Adverse Reactions Solicited adverse reactions included: Injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling and fever. Reporting Adverse Events and Vaccine Administration Errors The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at , by calling 1-800-822-7967 or send an email to [email protected]. About the Novavax COVID-19 2024-2025 Formula (NVX-CoV2705) NVX-CoV2705 is an updated version of Novavax's prototype COVID-19 vaccine formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels. About Matrix-M™ Adjuvant When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable.3 The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. About Novavax Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The Company's portfolio includes its COVID-19 vaccine and its pipeline includes COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information. Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, the immunogenic response of its vaccine technology against variant strains including JN.1 lineage viruses, and the scope, timing and outcome of future regulatory filings and actions, including any EMA or FDA recommendations, the expectation to have unit dose vials available in select European countries this fall season, 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 such statements. These risks and uncertainties include, without limitation, antigenic drift or shift in the SARS-CoV-2 spike protein, challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for a JN.1 protein-based COVID-19 vaccine or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those 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 year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: Investors Luis Sanay, CFA 240-268-2022 [email protected] Media Giovanna Chandler 240-720-7804 [email protected] References Kaku Y, Uriu K, Okumura K; Genotype to Phenotype Japan (G2P-Japan) Consortium, Ito J, Sato K. Virological characteristics of the SARS-CoV-2 KP.3.1.1 variant. Lancet Infect Dis. 2024;24(10):e609. doi:10.1016/S1473-3099(24)00505-X U.S. Centers for Disease Control and Prevention. Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States. September 6, 2024. Available at: . U.S. Centers for Disease Control and Prevention. CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season. June 27, 2024. Available at: . World Health Organization. Statement on the antigen composition of COVID-19 vaccines. April 26, 2024. Available at: . European Medicines Agency. ETF recommends updating COVID-19 vaccines to target new JN.1 variant. April 30, 2024. Available at: . SOURCE Novavax, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VANCOUVER, BC, Oct. 8, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (the "Company") is pleased to announce that it has engaged Rajkannan Rajagopalan, PhD, as Advisor for development and production of the Company's DPX™ formulations. Dr. Rajagopalan has a PhD in Pharmaceutical Chemistry/Physical Chemistry, with over 20 years of experience in nanoparticles formulation development for biomolecules (peptides, proteins, nucleic acids, VLPs, mAbs) delivery to treat cancer, infectious diseases and autoimmune disorders. Most recently, Dr. Rajagopalan was Senior Director of Formulation Development at IMV, Inc., where he developed DPX-based vaccines to treat breast, ovarian, bladder and hard to reach cancers; and DPX-based RSV, Anthrax, ZIKA, Ebola, Tuberculosis and SARS infectious disease vaccines, as well as VLP-encapsulated DPX vaccines to treat Malaria and RSV infections. He also developed the DPX formulations for SurMAGE and KRAS/BRAS antigens to treat bladder and colorectal cancers, and formulation technology to deliver multiple peptides (up to 25 neoantigens) in a single DPX formulation for personalized cancer treatment, and an emulsion technology to co-deliver both small molecules chemotherapeutics and antibodies together for cancer treatments. In addition, Dr. Rajagopalan established that DPX technology can be used as a thermostable platform for vaccines with the inclusion of right additives (sugars and biodegradable polymers). Dr. Rajagopalan holds multiple patents to treat cancer and infectious diseases using DPX technology for the delivery of peptides, proteins, nucleic acids and small molecules. Dr. Rajagopalan currently works for Toralgen Inc., as VP Formulation/Manufacturing and Scientific Development, overseeing the formulation development and CMC activities for the oral delivery of GLP-1 peptides and mAbs. Kenneth Kovan, BioVaxys President & Chief Operating Officer, stated, "We are very pleased to significantly expand our internal capabilities with the addition of Dr. Rajagopalan. He is a significant addition to our team, where in the near term he will assist with development of DPX formulations for our peanut allergy vaccine program with McMaster University, our planned preclinical studies of DPX/mRNA vaccines, as well as continued Phase 1 studies in oncology and infectious disease and expansion into new opportunities with DPX. As Dr. Rajagopalan was instrumental in the development of liposomes-based vaccine technology licensed to SpayVac and Zoetis for animal vaccines, he will be a tremendous help for our two current licensees. Dr. Rajagopalan will also help BioVaxys establish its own non-GLP clinical supply facility for production of DPX formulations." Dr. Rajagopalan joins Brittany Davison, a Chartered Professional Accountant and owner of Davison CPA Consulting Inc., as an Advisor with BioVaxys from the former IMV, Inc. where she previously served as Chief Accounting Officer and Acting Chief Financial Officer. About BioVaxys Technology Corp. BioVaxys Technology Corp. () is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© "neoantigen" tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization for food allergy, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company's clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX™ platform, and is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, and BVX-0918, a personalized immunotherapeutic vaccine using its proprietary HapTenix© "neoantigen" tumor cell construct platform for refractive late-stage ovarian cancer. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. Logo: ON BEHALF OF THE BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +740 358 0555 Email: [email protected] Cautionary Statements Regarding Forward Looking Information This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties. The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. SOURCE BioVaxys Technology Corp. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED