– Novavax’s updated protein-based XBB COVID vaccine induced neutralizing responses against emerging subvariants, including EG.5.1 and XBB.1.16.6
GAITHERSBURG, Md., Aug. 22, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, announced today that its candidate for Updated protein-based XBB COVID vaccine induced neutralizing antibody responses to subvariants EG.5.1 and XBB.1.16.6 in small animal and non-human primate studies. Variants of the XBB sublineage are overwhelmingly responsible for the majority of current COVID cases in the US and the European Union.1, 2
“Our data have shown that Novavax’s protein-based COVID vaccine induces broadly neutralizing responses against XBB subvariants, including EG.5.1 and XBB.1.16.6,” said Filip Dubovsky, Novavax President of Research and Development. “We are very confident in our updated COVID vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall.”
Non-clinical data previously showed that Novavax’s 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 be applicable to drift-forward variants. .3 Novavax is in the process of submitting applications for its XBB.1.5 COVID vaccine candidate to regulatory authorities around the world.
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
Authorized UseNovavax COVID-19 adjuvanted vaccine 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 people 12 years of age or older. Novavax adjuvanted COVID-19 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 or older for whom an FDA-licensed vaccine. The bivalent COVID-19 mRNA booster vaccine is not affordable or clinically appropriate, and for persons 18 years of age or older who choose to receive the adjuvanted Novavax COVID-19 vaccine because they would not otherwise receive a booster dose of the vaccine against COVID-19.
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, reactions related to lymphadenopathy, 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 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 potential impact and the scope of Novavax and NVX -CoV2373 and its candidate XBB variants to address vaccine access, population protection, efficacy, intended use of safety, and expected delivery of the NVX-CoV2373 and XBB candidate vaccines 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
References
1.Centers for Disease Control and Prevention (CDC). (2023). Variant Proportions [Data set]. In COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/
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