- Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S.
- Novavax’s vaccine is the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19
GAITHERSBURG, MD, USA I August 30, 2024 I Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Novavax’s vaccine is included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024.
Pre-filled syringes of the vaccine will be available in thousands of locations, including retail and independent pharmacies and regional grocers, following the Center for Biologics Evaluation and Research release of vaccine batches.
“Today’s authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “Our updated vaccine targets JN.1, the ‘parent strain’ of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.”
In June, the CDC’s Advisory Committee on Immunization Practices voted unanimously in favor of a universal recommendation for the use of 2024-2025 COVID-19 vaccines authorized under EUA or approved by Biologics License Application in individuals aged six months and older, regardless of specific viral strains.1 As discussed at the June 2024 U.S. FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to target JN.1, the parent strain of the most common currently circulating variants.2,3 Novavax filed for JN.1 in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization to target the JN.1 lineage this fall.2,4,5
The EUA was based on non-clinical data that showed Novavax’s updated vaccine provides protection and 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.
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 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 (NVX-CoV2373) 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
- U.S. Centers for Disease Control and Prevention. Variant Proportions [Data set]. In COVID Data Tracker. 2024. Available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
- U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Summary Minutes. June 5, 2024. Available at: https://www.fda.gov/media/180732/download.
- 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.
- European Medicines Agency. EMA confirms its recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024-2025. July 19, 2024. Available at: https://www.ema.europa.eu/en/documents/other/ema-confirms-its-recommendation-update-antigenic-composition-authorised-covid-19-vaccines-2024-2025_en.pdf.
- 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.
SOURCE: Novavax
Post Views: 5,530
- Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S.
- Novavax’s vaccine is the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19
GAITHERSBURG, MD, USA I August 30, 2024 I Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Novavax’s vaccine is included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024.
Pre-filled syringes of the vaccine will be available in thousands of locations, including retail and independent pharmacies and regional grocers, following the Center for Biologics Evaluation and Research release of vaccine batches.
“Today’s authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “Our updated vaccine targets JN.1, the ‘parent strain’ of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.”
In June, the CDC’s Advisory Committee on Immunization Practices voted unanimously in favor of a universal recommendation for the use of 2024-2025 COVID-19 vaccines authorized under EUA or approved by Biologics License Application in individuals aged six months and older, regardless of specific viral strains.1 As discussed at the June 2024 U.S. FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to target JN.1, the parent strain of the most common currently circulating variants.2,3 Novavax filed for JN.1 in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization to target the JN.1 lineage this fall.2,4,5
The EUA was based on non-clinical data that showed Novavax’s updated vaccine provides protection and 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.
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 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 (NVX-CoV2373) 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
- U.S. Centers for Disease Control and Prevention. Variant Proportions [Data set]. In COVID Data Tracker. 2024. Available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
- U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Summary Minutes. June 5, 2024. Available at: https://www.fda.gov/media/180732/download.
- 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.
- European Medicines Agency. EMA confirms its recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024-2025. July 19, 2024. Available at: https://www.ema.europa.eu/en/documents/other/ema-confirms-its-recommendation-update-antigenic-composition-authorised-covid-19-vaccines-2024-2025_en.pdf.
- 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.
SOURCE: Novavax
Post Views: 5,530
