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FDA Approves Novavax COVID Vaccine

FDA Approves Novavax COVID Vaccine

PWOnlyIAS

May 20, 2025

FDA Approves Novavax COVID Vaccine

The U.S. Food and Drug Administration has approved the Biologics License Application (BLA) for Novavax’s COVID-19 vaccine called Nuvaxovid™ for active immunization. 

About Nuvaxovid™

  • Nuvaxovid (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. 
    • The non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus
  • Technology: Nuvaxovid uses Novavax’s unique recombinant nanoparticle technology with  Novavax’s Matrix-M® adjuvant enhancing and broadening the immune response. 
    • Novavax’s Matrix-M is its proprietary adjuvant that can be added to a vaccine or medicine to stimulate a stronger immune response and is currently used in globally approved vaccines.
  • Feature: The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°.
  • In Use: Nuvaxovid has been available for use in the U.S. under Emergency Use Authorization since July 2022.
    • It has full market approvals in the European Union, United Kingdom, Japan, Canada, Australia, Taiwan and Singapore.

About JN.1 Variant of COVID 19

  • JN.1 is a descendant of the BA.2.86 (Pirola) strain which is a sublineage of the Omicron strain.
  • WHO Recognition: The JN.1 variant was labelled as the Variant of Interest by the WHO in December 2023.
  • Mutations: The variant features approximately 30 mutations allowing for the easier spread of the virus and escaping immunity from vaccines or past infections.
    • The variant features a unique mutation in the spike protein (the part of the virus that binds to human cells). 
  • Spread: The JN.1 variant remains the most common SARS-CoV-2 variant across all four WHO regions with sequence shares of,
    • 93.9% in the Western Pacific region (WPR), 85.7% in the South East Asia region (SEAR), 94.7% in the European region (EUR), and 93.2% in the region of the Americas (AMR)
  • Vaccines Targeting JN.1 Variant: The XBB.1.5 monovalent COVID-19 vaccines has been specifically designed to target the XBB.1.5 subvariant of Omicron. Examples of the vaccines in use are,
    • Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax (both mRNA-based, approved in the US, EU, Canada, Australia, and others)
    • Novavax’s Nuvaxovid (protein subunit, approved in the EU)
    • Zapomeran (Kostaive), a self-amplifying mRNA vaccine approved in Japan and the EU.
    • Covovax XBB.1.5 monovalent booster is the only COVID-19 vaccine in India.

About Recombinant Nanoparticle Technology

  • Recombinant technology of nanoparticles is an emerging technology to produce nanoparticulate systems composed of recombinant macromolecules, such as proteins. 
  • Recombinant Proteins: The technique enables the use of genetic material from target pathogens to create highly purified, specific recombinant proteins.
    • Nanoparticles: The recombinant spike proteins are then organised in a nanoparticle which helps the immune system recognize that target protein from different angles.
  • Significance: The technology helps train the immune system to develop protective antibodies that can help prevent illness.
  • The Novavax vaccine against SARS-CoV-2 uses this technology.

Also Read
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UDAAN PRELIMS WALLAH
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Quick Revise Now !
UDAAN PRELIMS WALLAH
Comprehensive coverage with a concise format
Integration of PYQ within the booklet
Designed as per recent trends of Prelims questions
हिंदी में भी उपलब्ध

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