GAITHERSBURG, Md., July 6, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global developer of protein-based vaccines with its novel Matrix-M™ adjuvant, has received Authorization from the European Commission Marketing Authorization (MA) in the European Union (EU) for Nuvaxovid™ (NVX-CoV2373). This decision comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a favorable opinion for full marketing authorisation. The vaccine is now fully licensed for use as a primary series in individuals 12 years and older and as a booster dose in adults 18 years and older for the prevention of COVID-19. Nuvaxovid initially received a conditional marketing authorization in the EU for these indications.
According to John C. Jacobs, Chairman and CEO of Novavax, "This marketing authorization sets the stage for all future regulatory approvals of updated versions of our COVID vaccine, a necessity to ensure we can quickly get our vaccine to people in In addition to the EU, we are preparing to apply for full approval in the US, as well as other markets, and are committed to ensuring that protein-based options are available worldwide. remains an integral part of public health measures."
The Phase 3 PREVENT-19 trial demonstrated the reassuring safety profile of Nuvaxovid, as well as its efficacy as a primary series in adults, immunogenicity and safety as a booster dose in adults, and efficacy and safety as a primary series in individuals from 12 years old.
Novavax's COVID vaccine is licensed for use in more than 40 markets worldwide.
US trade name The trade name Nuvaxovid™ has not yet been approved by the US Food and Drug Administration (FDA).
Use of Novavax COVID-19 Vaccine, Adjuvanted in the United States Novavax COVID-19 Vaccine, Adjuvanted Vaccine has not been approved or licensed by the United States FDA, but has been cleared for emergency use by the FDA, under an Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19) as a primary series in individuals 12 years of age and older. Novavax COVID-19 Vaccine, Adjuvanted Vaccine is also licensed to provide a first booster dose at least 6 months after completion of primary vaccination with a licensed or approved COVID-19 vaccine to persons 18 years of age and older for for whom an FDA-licensed mRNA bivalent COVID-19 booster vaccine is not affordable or clinically appropriate, and for individuals 18 years of age and older who elect to receive the adjuvanted, adjuvanted COVID-19 vaccine from Novavax because they otherwise otherwise they would not receive a booster dose of a COVID-19 vaccine.
Emergency use of this product is only authorized for the duration of a statement that circumstances exist that warrant emergency use authorization of the medical product under Section 564(b)(1) of the FD Act
IMPORTANT SAFETY INFORMATION ContraindicationsDo not administer Novavax COVID-19 vaccine, adjuvanted to individuals with a known history of a severe allergic reaction (eg, anaphylaxis) to any component of Novavax COVID-19 vaccine, adjuvanted.
Warnings and Precautions Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following administration of Novavax COVID-19 vaccine, adjuvanted. Monitor recipients of the adjuvanted Novavax COVID-19 vaccine for the occurrence of immediate adverse reactions in accordance with Centers for Disease Control and Prevention (CDC) guidelines.
Myocarditis and Pericarditis: Data from clinical trials provide evidence of an increased risk of myocarditis and pericarditis following administration of Novavax COVID-19 vaccine, adjuvanted (see EUA full prescribing information). The CDC has published considerations related to myocarditis and pericarditis after vaccination, including vaccination of persons with a history of myocarditis or pericarditis ( https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim -considerations-us.html
Syncope (fainting): may occur in association with the administration of injectable vaccines. Procedures must be in place to prevent injury from fainting.
Impaired Immunocompetence: Immunosuppressed individuals, including individuals receiving immunosuppressive therapy, may have a decreased immune response to Novavax COVID-19 vaccine, adjuvanted.
Limitations of Vaccine Efficacy: The adjuvanted Novavax COVID-19 vaccine may not protect all vaccine recipients.
Adverse reactions Adverse reactions reported in clinical trials following administration of adjuvanted Novavax COVID-19 vaccine include injection site pain/tenderness, fatigue/general 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 after administration of the adjuvanted Novavax COVID-19 vaccine outside of clinical trials.
Additional adverse reactions, some of which may be serious, may manifest with the more widespread use of the Novavax COVID-19 vaccine, adjuvanted.
Reporting of Adverse Events and Vaccine Administration Errors The vaccine 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):
Complete and Submit VAERS Reports Online: For further assistance with VAERS reporting, call 1-800-822-7967. Reports must include the words "Novavax COVID-19 Vaccine, USA Adjuvanted" in the report description section.
To the extent possible, please report adverse events to Novavax, Inc. using the following contact information or providing a copy of the VAERS form to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax number: 1- 888-988-8809, Phone number: 1-844-NOVAVAX (1-844-668-2829).
Click to view Novavax's COVID-19 Vaccine, Adjuvanted, Fact Sheet for Healthcare Providers Administering the Vaccine (Vaccine Providers), and Full EUA Prescribing Information.
Click to view the fact sheet for recipients and caregivers.
About Nuvaxovid™ (NVX-CoV2373) NVX-CoV2373 is a protein-based vaccine created by creating copies of the SARS-CoV-2 surface spike protein that causes COVID. Using 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 amplifies the immune response. The vaccine is packaged as a ready-to-use liquid formulation and stored at 2-8°C, allowing use of existing cold chain and vaccine supply channels.
About the Phase 3 PREVENT-19 Trial The Vaccine Efficacy Novavax Trial COVID-19 PRE-fusion protein subunit (PREVENT-19) was a randomized, placebo-controlled, observer-blind, Phase 3 trial conducted in the United States and Mexico to evaluate the efficacy and safety of NVX-CoV2373 as a primary series and as a booster in adults and adolescents to prevent SARS-CoV-2 infection. As the primary series, the primary endpoint was the first onset of symptomatic COVID-19 (mild, moderate, or severe) confirmed by polymerase chain reaction (PCR) with onset at least 7 days after the second dose in 29,960 Adult participants 18 years and older at baseline with no pre-illness protocol violations. A secondary endpoint was prevention of PCR-confirmed moderate or severe symptomatic COVID-19. The full results of the trial have been published in the New England Journal of Medicine.
The pediatric expansion of the trial evaluated 2,247 adolescents aged 12 to 17 years in the United States. Results of the expansion were announced in February 2022. The adult booster expansion of the trial evaluated a single booster dose of the vaccine in adult participants approximately six months after their two-dose primary vaccination series. The results of the expansion were announced in October 2022.
About Matrix-M™ Adjuvant When added to vaccines, Novavax's proprietary saponin-based Matrix-M adjuvant enhances the immune system response, making it stronger, broader and longer lasting. 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 better health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax, a global company headquartered in Gaithersburg, Maryland, USA, offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology, and Novavax's proprietary Matrix-M adjuvant to enhance the immune response. Focused on the world's most pressing health challenges, Novavax is currently evaluating vaccines for COVID, flu, and combined COVID and flu. Visit novavax.com and LinkedIn for more information.
Forward-Looking Statements The statements contained herein concern the future of Novavax, its operational plans and prospects, the ongoing development of NVX-CoV2373, NVX-CoV2515 and the Omicron-based/Parental-based bivalent vaccine, a COVID combination vaccine candidate. Investigational -19-Influenza, Investigational Quadrivalent Influenza Vaccine Candidate, Scope, Timing, and Outcome of Future Submissions and Regulatory Action, Additional Global Authorizations of NVX-CoV2373 for Use in Adults and adolescents, and as a reinforcement, the evolution of the COVID-19 pandemic, the potential impact and scope of Novavax and NVX-CoV2373 in addressing access to vaccines, the protection of populations, the efficacy, the safety of the intended use and 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 such statements. These risks and uncertainties include, but are not limited to, challenges to satisfy, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy authorities. applicable regulations; difficulty in obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax's ability to follow planned regulatory pathways; unforeseen challenges or delays in conducting clinical trials; challenges in meeting contractual requirements under agreements with multiple commercial, government, and other entities; 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, 2022, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place undue reliance on any forward-looking statements contained in this press release. We encourage you to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. Forward-looking statements in this press release speak only as of the date hereof, and we do not undertake any obligation to update or revise any such statements. Our business is subject to material risks and uncertainties, including those mentioned above. Investors, potential investors and others should carefully consider these risks and uncertainties.
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