Recommendation follows U.S. FDA Emergency Use Authorization for the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary series FDA has determined that first vaccine lot has met all release specifications and is acceptable for use under Emergency Use Authorization Novavax expects to ship doses to the U.S. Government-designated distribution center in the coming days Novavax' vaccine is the first FDA-authorized and ACIP-recommended protein-based COVID-19 vaccine in the U.S. GAITHERSBURG, Md., July 20, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the use of the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary seriesin individuals aged 18 and older. The recommendation follows the Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA). ACIP will submit its recommendation to the Director of theCDCfor review and endorsement. "We think vaccine choice is important, particularly as we expect to see ongoing surges of COVID-19 and work to increase vaccination rates," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With demonstrated efficacy and a reassuring safety profile, our vaccine is the country's first protein-based option." The Committee based its recommendation on use in individuals aged 18 and older on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled 29,960 participants aged 18 years and older in the U.S. andMexico. In the trial, the Novavax COVID-19 Vaccine, Adjuvanted demonstrated 90.4% efficacy (95% confidence interval [CI], 83.8% to 94.3%; P<0.001) with a reassuring safety profile. Among participants 18 through 64 years of age, solicited adverse reactions (ARs) following administration of any dose of the vaccine, were injection site pain/tenderness (82.2%), fatigue/malaise (62.0%), muscle pain (54.1%), headache (52.9%), joint pain (25.4%), nausea/vomiting (15.6%), injection site redness (7.0%), injection site swelling (6.3%), and fever (6.0%). In participants 65 years of age, solicited ARs following administration of any dose of the vaccine were injection site pain/tenderness (63.4%), fatigue/malaise (39.2%), muscle pain (30.2%), headache (29.2%), joint pain (15.4%), nausea/vomiting (7.3%), injection site swelling (5.3%), injection site redness (4.8%), and fever (2.0%). In addition to the FDA EUA, the Novavax COVID-19 vaccinehas received conditional authorization for use in individuals aged 18 and older from multiple regulatory agencies worldwide, including the European Commission(EC), and Emergency Use Listing from the World Health Organization. This project has been supported in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number MCDC2011-001. Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S. The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a two-dose primary series to individuals 18 years of age and older to prevent Coronavirus Disease 2019 (COVID-19). The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Authorized Use The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 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 to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Novavax COVID-19 Vaccine, Adjuvanted. Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines. Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information). 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 Adverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis. Myocarditis, pericarditis, and anaphylaxis have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted. Reporting Adverse Events and Vaccine Administration ErrorsThe vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS): vaccine administration errors whether or not associated with an adverse event, serious adverse events (irrespective of attribution to vaccination), cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that results in hospitalization or death. Complete and submit reports to VAERS online: https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report. To the extent feasible, report adverse events to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829). Please click to see the Novavax COVID-19 Vaccine, Adjuvanted Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers) and EUA Full Prescribing Information. About NVX-CoV2373 (Novavax' COVID-19 Vaccine, Adjuvanted) NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matri