US FDA Grants Emergency Use Authorization to Novavax 2024-2025 Formula Covid-19 Vaccine

US FDA Grants Emergency Use Authorization to Novavax 2024-2025 Formula Covid-19 Vaccine

By, Admin 2 September 2024

US FDA grants Emergency Use Authorization to Novavax 2024-2025 Formula Covid-19 vaccine to prevent Covid-19 in individuals aged 12 and older

Overview

Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced the Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the US 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 US Centers for Disease Control and Prevention (CDC) on June 27, 2024.

Pre-filled Syringes Availability

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.

Words from CEO: Novavax

  • "Today's authorization enables Novavax to launch our updated Covid-19 vaccine in the US 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.""

CDC's Advisory Committee on Covid-19 Vaccines

  • In June, the CDC's Advisory Committee on Immunization Practices voted unanimously in favour 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. 
  • As discussed at the June 2024 US 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. 
  • Novavax filed for JN.1 in line with guidance from the US FDA, European Medicines Agency (EMA) and the World Health Organization to target the JN.1 lineage this fall.

Non-clinical Data Behind EUA

  • The EUA 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. 
  • 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 Covid-19 Vaccine: Approvals

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.

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.

Novavax: Indication

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.

About 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. 
  • 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, Inc.

  • Novavax, Inc. promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. 
  • Novavax, a global company based in Gaithersburg, Maryland, US, 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.