GAITHERSBURG, Md. , Feb. 13, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company committed to advancing and advertising next-generation vaccines for serious infectious diseases, today announced an amendment to its existing agreement with the U. S. Department of Health and Human Services (HHS). The U. S. Department of Defense, in collaboration with the Department of Defense, to supply up to 1. 5 million doses of the Novavax COVID-19 vaccine, with adjuvant (NVX-CoV2373). access to Novavax vaccine and progression of vials of smaller doses, variety of strains according to U. S. Food and Drug Administration recommendations. An elegant transition to the advertising market.
“This agreement recognizes the need to provide other Americans with a diverse portfolio of COVID-19 vaccines and underscores the importance of Novavax’s partnership with the U. S. government. “We are in the U. S. to ensure the continuation of a protein-based option as part of public health measures. “said John C. Jacobs, president and chief executive officer of Novavax. “We look forward to continuing our collaboration with the U. S. government. “We are looking forward to the U. S. in the progress of our COVID-19 vaccine to meet the needs of the FDA and advertising visitors for the upcoming 2023/2024 vaccination campaign. “
This contract will reflect the continued efforts of the U. S. government. The U. S. Department of Health and Prevention is in the U. S. to make Novavax’s protein-based vaccine freely available to states, jurisdictions, federal pharmaceutical partners, and federally licensed fitness centers.
Novavax’s adjuvanted COVID-19 vaccine obtained emergency use authorization from the U. S. FDA. booster dose at least six months after the final touch of immunization number one with a legal or approved COVID-19 vaccine Americans 18 years of age and older for whom an FDA-legal or clinically appropriate bivalent COVID-19 mRNA booster vaccine should not be had, and Americans 18 years of age and older who choose to receive the Novavax COVID-19 vaccine, with adjuvant, as they would not otherwise get a booster dose of a COVID-19 vaccine.
This contract is supported through the federal budget allocated in the past through HHS, the Strategic Preparedness and Response Administration and the Biomedical Advanced Research and Development Authority, through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under contract number W15QKN. -16-9-1002, assignment number CDCM2011-001.
Use of the Novavax COVID-19 vaccine, with adjuvant in the United States) to save you from coronavirus disease 2019 (COVID-19) as a number one series in Americans 12 years of age and older. The Novavax COVID-19 adjuvant vaccine is also legal to deliver a booster first dose at least 6 months after completion of the number one immunization with a legal or approved COVID-19 vaccine for Americans 18 years of age and older for whom a legal FDA The bivalent COVID-19 mRNA booster vaccine is not available or clinically appropriate, and Americans 18 and older who choose to receive the Novavax COVID-19 vaccine, with adjuvant, as they would not otherwise get a booster dose of a COVID-19 vaccine.
Emergency use of this product is permitted during the declaration of lifestyles of cases that warrant emergency use authorization of the medical product under Section 564(b)(1) of the FD Act.
The Novavax COVID-19 vaccine, adjuvant vaccine is legal for use under an Emergency Use Authorization (EUA) to supply a number one two-dose series for active immunization to save you from coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Americans 12 years of age and older. 19 vaccine for Americans 18 years and older for whom a legal FDA The bivalent COVID-19 mRNA booster vaccine is not available or clinically appropriate, and Americans 18 and older who choose to get the Novavax COVID-19 vaccine, adjuvanted, as they would not otherwise get a booster dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATIONE-indicaAdminister the adjuvanted Novavax COVID-19 vaccine to people with a known history of a severe allergic reaction (p. e. g. , anaphylaxis) to any component of the Novavax COVID-19 vaccine, with adjuvant.
Warnings and precautions Management of acute allergic reactions: The appropriate medical remedy to manage rapid allergic reactions should be available immediately in case of an acute anaphylactic reaction after the management of the Novavax COVID-19 vaccine, with adjuvant. Monitor the Novavax COVID-19 vaccine, adjuvanted recipients for immediate adverse occasions according to Centers for Disease Control (CDC) and Proccasionion guidelines.
Myocarditis and pericarditis: Clinical trial data provide evidence of an increased threat of myocarditis and pericarditis following adjuvanted management of the Novavax COVID-19 vaccine (see full U. S. prescribing information). CDC has published considerations for myocarditis and pericarditis after vaccination, adding to vaccinate others with a history of myocarditis or pericarditis (https://www. cdc. gov/vaccines/covid-19/clinical-considerations/interim-considerations-us. htmlmyocarditis-pericarditis).
Syncope (fainting): may occur in combination with monitoring injectable vaccines. Procedures should be in place to prevent you from fainting.
Impaired immunocompetence: Immunocompromised individuals, in addition to those receiving immunosuppressive therapy, may have a decreased immune reaction to the Novavax COVID-19 vaccine, with adjuvant.
Limitations of vaccine efficacy: Novavax COVID-19, adjuvanted vaccine possibly not all vaccine recipients.
Adverse reactions Adverse reactions reported in clinical trials after adjuvanted Novavax COVID-19 vaccine management come with 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, anaphylaxis, paresthesia and hypoesthesia have been reported following treatment with the Novavax COVID-19 vaccine, with adjuvant in outdoor clinical trials.
Additional side effects, some of which could be serious, could occur with more widespread use of the Novavax COVID-19 vaccine, with adjuvant.
Reporting adverse events and errors in vaccine handling
Complete and submit VAERS reports online: For help with VAERS reports, call 1-800-822-7967. The reports come with the words “Novavax COVID-19 Vaccine, Adyuvated USA” in the description segment of the report.
If possible, report adverse occasions to Novavax, Inc. using the following touch form or offering a copy of the VAERS form to Novavax, Inc. Website: www. NovavaxMedInfo. com, Fax: 1-888-988-8809, Phone: 1-844-NOVAVAX (1-844-668-2829).
To view the Novavax COVID-19 vaccine, the adjuvant fact sheet for health care providers administering the vaccine (vaccine providers), and full U. S. prescribing information.
Click to view the beneficiary and caregiver sheet.
About NVX-CoV2373 (Novavax COVID-19 vaccine, with adjuvant) 19 disease. The vaccine was created using Novavax’s generation of recombinant nanoparticles to generate an antigen derived from the coronavirus spike protein and is formulated with Novavax’s patented saponin-based Matrix-M adjuvant to react immune and stimulate the highest levels of neutralizing antibodies. The vaccine contains a purified protein antigen and cannot reflect or cause COVID-19.
The vaccine is packaged as a ready-to-use liquid formula and stored between 2° and 8° Celsius, allowing the use of existing vaccine source channels and bloodless chain. The use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, marketing and distribution of its vaccine worldwide. The existing approvals leverage Novavax’s production partnership with the Serum Institute of India, the world’s largest vaccine manufacturer by volume. Subsequently, they will be complemented by knowledge of other Novavax production sites. worldwide chain of sources.
About the Matrix-M adjuvant Novavax’s patented saponin-based Matrix-M adjuvant demonstrated a potent and well-tolerated effect by stimulating antigen presenting cell access at the injection site and antigen presentation in local lymph nodes, thereby stimulating the immune response.
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a biogeneration company that advances advanced global fitness through the discovery, progression and commercialization of cutting-edge vaccines to save you from serious infectious diseases. The company’s proprietary recombinant generation platform harnesses the power and speed of genetic engineering to successfully produce highly immunogenic nanoparticles designed to address urgent global fitness needs. The Novavax COVID-19 vaccine has gained approval from multiple regulatory governments around the world, including the US FDA, the European Commission, and the World Health Organization. The vaccine is currently being reviewed through various regulatory agencies around the world, and is being added for other indications and populations, such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also recently comparing its COVID-19 combination influenza vaccine (CIC) candidate, its investigational quadrivalent influenza vaccine candidate, and a vaccine based on the Omicron strain. (NVX-CoV2515), as well as a bivalent format based on Omicron/founded vaccine parent strain. These vaccine candidates incorporate Novavax’s proprietary saponin-based Matrix-M adjuvant for the immune response and stimulate the highest levels of neutralizing antibodies.
For more information, visit www. novavax. com and connect with us on LinkedIn.
Forward-Looking Statements Detailed statements regarding Novavax’s long-term, operating plans and customers, its partnerships, the outlook for upcoming US government orders NVX-CoV2373, NVX-CoV2515, and a strain-based bivalent vaccine original/based on Omicron, CIC vaccine candidate, investigational quadrivalent influenza vaccine candidate, scope, timing and effects of long-term introductions and regulatory actions, plus Novavax plans to complement existing authorizations with information from other production sites in the Novavax global supply chain, additional global authorizations of NVX-CoV2373 for use in adults and adolescents, and as a reminder, the potential impact and success of Novavax and NVX-CoV2373 in access to vaccines, expansion of vaccination rates, control of the pandemic and protection of people, efficacy, safety Safety, Intended Use, and Intended Management of NVX-CoV2373 and the CIC Vaccine Candidate Are Forward-Looking Statements Array Novavax cautions that such forward-looking statements are subject to threats and uncertainties that may cause actual effects to differ materially from those expressed or implied by those statements. These threats and uncertainties include, but are not limited to, difficulties in assembly, alone or with partners, various safety, efficacy, and product characterization needs, as well as the likes of qualification and validation procedures. testing, as required to satisfy applicable regulatory authorities; difficulty in obtaining scarce raw materials and supplies; resource constraints, adding human capital and production capacity, on Novavax’s ability to adhere to expected regulatory pathways; unforeseen difficulties or delays in conducting clinical trials; difficulties in assembling control needs under agreements with multiple commercial, governmental and other entities; and other known threat items 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, 2021 and upcoming 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 invite you to read our SEC filings, available at www. sec. gov and www. novavax. com, for a discussion of these and other threats and uncertainties. Forward-looking statements contained in this press release speak only as of the date hereof, and we do not assume any legal responsibility to update or revise any forward-looking statements. Our business is subject to really extensive threats and uncertainties, in addition to those discussed above. Investors, potential investors and others deserve to pay special attention to these threats and uncertainties.
contacts:InvestorsErika Schultz | 240-268-2022ir@novavax. com
MediaAli Chartan and Giovanna Chandler | 202-709-5563media@novavax. com
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