– Novavax’s Nuvaxovid™ receives positive CHMP opinion for full marketing authorization for COVID prevention in the EU
GAITHERSBURG, Md., May 29, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company promoting protein-based vaccines with its novel Matrix-M™ adjuvant, announced today that Nuvaxovid™ (NVX -CoV2373) has been recommended for full Marketing Authorization (MA) for use as a primary series in people older than 12 years and as a booster in people older than 18 years for the prevention of COVID-19 in the European Union ( EU) following a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The European Commission will review the CHMP recommendation and is expected to make a final decision on the MS.
“The CHMP’s positive opinion for full marketing authorization of our COVID vaccine brings us one step closer to full authorization and will provide an approval pathway for an updated vaccine in time for the fall,” explained John C. Jacobs, Chairman and CEO of Novavax.
Novavax has demonstrated the efficacy and safety of Nuvaxovid as a primary series, and the immunogenicity and safety of the vaccine as a booster in persons 12 years of age and older in the Phase 3 PREVENT-19 trial, Phase 2 trials, and in real-world trials. .
Novavax’s COVID vaccine is licensed for use in more than 40 markets worldwide. In the EU, Nuvaxovid has been conditionally authorized as a two-dose primary series in adults and adolescents, and as a booster dose in adults.
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 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
Authorized Use Novavax COVID-19 vaccine, adjuvanted 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 by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people older than 12 years. 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 whom a FDA licensed vaccine. 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.
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.
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 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 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 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 an 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 PREVaccineEfficacyNovavaxTrial COVID-19 subunit fusion protein (PREVENT-19) was a Phase 3 randomized, placebo-controlled, observer-blind 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, 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 prospects, the continued development of NVX-CoV2373, its regulatory strategy and approval pathways in relation to NVX-CoV2373 and its COVID-19 vaccines based on variants, scope, timing, and outcome of future submissions and regulatory actions, authorizations in Europe, and additional authorizations worldwide of NVX-CoV2373 for use in adults and adolescents, and as reinforcement, the evolution of the pandemic of COVID-19, the potential impact and scope of Novavax and NVX-CoV2373 to address vaccine access, protection of populations, efficacy, intended use of safety, and expected administration 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, 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: InvestorsErika Schultz 240-268-2022 ir@novavax.com
MediosAli Chartan 240-720-7804 media@novavax.com
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