Novavax, Inc. today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted.
GAITHERSBURG, Md., Aug. 15, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older. “It’s important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Based on the data presented to the FDA’s VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants.” This application for EUA is supported by data from Novavax’ Phase 3 PREVENT-19 trial conducted in the United States and Mexico, and from the UK-sponsored COV-BOOST Phase 2 trial. As part of an open-label booster phase of the PREVENT-19 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants at least six months after their primary two-dose vaccination series of the Novavax COVID-19 Vaccine, Adjuvanted. The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series Phase 3 clinical trials. In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted induced a significant antibody response when used as a heterologous third booster dose. In the PREVENT-19 trial, following the booster, local and systemic reactions had a median duration of approximately two days. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of the Novavax COVID-19 Vaccine, Adjuvanted, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose. In the U.S., the FDA granted EUA, followed by a positive recommendation from the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), and endorsement from the CDC for a two-dose primary series in adults aged 18 and older in July. Doses of the Novavax COVID-19 Vaccine, Adjuvanted have been available for use in the U.S. since July. This project has been supported in part with federal funds from the Department of Health and Human Services (HHS); the Administration for Strategic 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 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 IMPORTANT SAFETY INFORMATION Contraindications Warnings and Precautions 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 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 Errors
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 the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) The Novavax COVID-19 Vaccine, Adjuvanted is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. The PREVENT-19 trial is being conducted with support from the U.S. government, including the Department of Defense, BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the HHS, and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement (number MCDC2011-001). JPEO-CBRND is also providing funding of up to $45.7 million under a separate agreement. To date, the U.S. government has agreed to order 3.2 million doses of the Novavax COVID-19 Vaccine, Adjuvanted. Novavax and the U.S. government will determine the timing, pricing, and amounts for delivery of any additional doses. Novavax intends to pursue additional U.S. procurement of both the Novavax COVID-19 Vaccine, Adjuvanted doses and other potential formulations. Novavax has established partnerships for the manufacture, commercialization, and distribution of the Novavax COVID-19 Vaccine, Adjuvanted worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain. About Matrix-M™ Adjuvant About Novavax For more information, visit www.novavax.com and connect with us on LinkedIn. *NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season. Forward-Looking Statements Contacts: Investors Erika Schultz | 240-268-2022 Media Ali Chartan or Giovanna Chandler | 202-709-5563 View original content to download multimedia:https://www.prnewswire.com/news-releases/novavax-submits-application-to-the-us-fda-for-emergency-use-authorization-for-novavax-covid-19-vaccine-adjuvanted-as-a-booster-in-adults-aged-18-and-older-301605447.html SOURCE Novavax, Inc. | ||
Company Codes: NASDAQ-NMS:NVAX |