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.

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