- Novavax is set to deliver the monovalent protein-based XBB COVID vaccine in accordance with the FDA VRBPAC recommendation for the fall
GAITHERSBURG, Md., June 16, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company promoting protein-based vaccines with its novel Matrix-M™ adjuvant, participated in the Committee meeting today Vaccine and Related Biological Products Advisory (VRBPAC) to the US Food and Drug Administration (FDA) resulting in a unanimous vote recommending upgrading the current composition of the COVID vaccine to a monovalent XBB lineage.
"Novavax expects to be ready for commercial delivery of a protein-based monovalent XBB COVID vaccine this fall in line with today's VRBPAC recommendation," said John C. Jacobs, Novavax President and CEO. "In partnership with regulators and public health authorities, Novavax has been developing and manufacturing this vaccine candidate, and as we move closer to harmonizing guidelines from the FDA, the World Health Organization and the European Medicines Agency , we believe we are in a better position to offer an alternative vaccine option to people around the world."
Novavax presented data at the VRBPAC meeting supporting the recommendation to vaccinate this fall with a monovalent XBB strain. Data from Novavax showed that its XBB.1.5 COVID vaccine candidate induced functional immune responses for variants XBB.1.5, XBB.1.16, and XBB.2.3, indicating a broad response that could potentially apply to drift-forward variants. .
Novavax will seek updated FDA labeling for its XBB COVID vaccine candidate with the goal of making it available and affordable on par with other COVID vaccines.
Authorized 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 who a vaccine licensed by the FDA. The mRNA bivalent COVID-19 booster vaccine is not affordable or clinically appropriate, and for people 18 years and older who elect to receive the adjuvanted Novavax COVID-19 vaccine because they would not otherwise receive a dose booster of a vaccine against COVID-19.
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 Contraindications Do 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 adjuvanted vaccine. 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 the Novavax 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 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, influenza, and combined COVID and influenza. Visit novavax.com and LinkedIn for more information.
Forward-Looking Statements Statements in this document relating to the future of Novavax, its operating plans and outlook, the continued development of NVX-CoV2373, XBB variant vaccine candidates, the scope, timing, and outcome of future filings and regulatory actions, the impact potential and scope of Novavax and NVX-CoV2373 and their XBB candidate variants to address vaccine access, population protection, efficacy, intended use of safety, and expected delivery of NVX-CoV2373 and XBB candidate vaccines they 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, among others, 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 and subsequent Quarterly Reports on Form 10-Q, 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.
Contacts: Investors Erika Schultz 240-268-2022ir@novavax.com
MediaAli Chartan240-720-7804media@novavax.com
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