GAITHERSBURG, MD, USA I October 9, 2024 I Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission granted Marketing Authorization for Novavax’s updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU). This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).
Authorization was based on non-clinical data that showed Novavax’s updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1 In clinical trials, the most common adverse reactions associated with Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.
Novavax’s vaccine is also authorized for use in the U.S., and is in line with guidance from the U.S. Food and Drug Administration (FDA), EMA and the World Health Organization to target the JN.1 lineage this fall.2-5
AUTHORIZED USE IN THE U.S.
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been approved or licensed by the FDA but has been authorized for emergency use by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.
The EUA of this product will remain in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the authorization is revoked sooner.
VACCINE AUTHORIZATION (U.S.)
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications
- Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
Warnings and Precautions
- Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the Novavax COVID-19 Vaccine, Adjuvanted.
- Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted.
- Syncope (fainting): may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
- Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
- Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
Adverse Reactions
Solicited adverse reactions included: Injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling and fever.
Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html, by calling 1-800-822-7967 or send an email to info@vaers.org.
About the Novavax COVID-19 2024-2025 Formula (NVX-CoV2705)
NVX-CoV2705 is an updated version of Novavax’s prototype COVID-19 vaccine formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With 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 broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.
About Matrix-M™ Adjuvant
When added to vaccines, Novavax’s patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable.3 The 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 improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. The Company’s portfolio includes its COVID-19 vaccine and its pipeline includes COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. In addition, Novavax’s adjuvant is included in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information.
References
- Kaku Y, Uriu K, Okumura K; Genotype to Phenotype Japan (G2P-Japan) Consortium, Ito J, Sato K. Virological characteristics of the SARS-CoV-2 KP.3.1.1 variant. Lancet Infect Dis. 2024;24(10):e609. doi:10.1016/S1473-3099(24)00505-X
- U.S. Centers for Disease Control and Prevention. Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States. September 6, 2024. Available at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html.
- U.S. Centers for Disease Control and Prevention. CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season. June 27, 2024. Available at: https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html.
- World Health Organization. Statement on the antigen composition of COVID-19 vaccines. April 26, 2024. Available at: https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines.
- European Medicines Agency. ETF recommends updating COVID-19 vaccines to target new JN.1 variant. April 30, 2024. Available at: https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant.
SOURCE: Novavax
Post Views: 127
GAITHERSBURG, MD, USA I October 9, 2024 I Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission granted Marketing Authorization for Novavax’s updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU). This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).
Authorization was based on non-clinical data that showed Novavax’s updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1 In clinical trials, the most common adverse reactions associated with Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.
Novavax’s vaccine is also authorized for use in the U.S., and is in line with guidance from the U.S. Food and Drug Administration (FDA), EMA and the World Health Organization to target the JN.1 lineage this fall.2-5
AUTHORIZED USE IN THE U.S.
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been approved or licensed by the FDA but has been authorized for emergency use by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.
The EUA of this product will remain in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the authorization is revoked sooner.
VACCINE AUTHORIZATION (U.S.)
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications
- Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
Warnings and Precautions
- Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the Novavax COVID-19 Vaccine, Adjuvanted.
- Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted.
- Syncope (fainting): may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
- Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
- Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
Adverse Reactions
Solicited adverse reactions included: Injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling and fever.
Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html, by calling 1-800-822-7967 or send an email to info@vaers.org.
About the Novavax COVID-19 2024-2025 Formula (NVX-CoV2705)
NVX-CoV2705 is an updated version of Novavax’s prototype COVID-19 vaccine formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With 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 broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.
About Matrix-M™ Adjuvant
When added to vaccines, Novavax’s patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable.3 The 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 improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. The Company’s portfolio includes its COVID-19 vaccine and its pipeline includes COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. In addition, Novavax’s adjuvant is included in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information.
References
- Kaku Y, Uriu K, Okumura K; Genotype to Phenotype Japan (G2P-Japan) Consortium, Ito J, Sato K. Virological characteristics of the SARS-CoV-2 KP.3.1.1 variant. Lancet Infect Dis. 2024;24(10):e609. doi:10.1016/S1473-3099(24)00505-X
- U.S. Centers for Disease Control and Prevention. Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States. September 6, 2024. Available at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html.
- U.S. Centers for Disease Control and Prevention. CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season. June 27, 2024. Available at: https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html.
- World Health Organization. Statement on the antigen composition of COVID-19 vaccines. April 26, 2024. Available at: https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines.
- European Medicines Agency. ETF recommends updating COVID-19 vaccines to target new JN.1 variant. April 30, 2024. Available at: https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant.
SOURCE: Novavax
Post Views: 127
