FDA Approves Novavax's Nuvaxovid™ for High-Risk Groups

By Greg Peters • Thursday, August 28 10:24 • Permanent Link

Novavax, Inc. (NASDAQ: NVAX) has announced the approval of the Nuvaxovid™ 2025-2026 formula by the U.S. Food and Drug Administration for the prevention of COVID-19 in individuals aged 65 and older, as well as those aged 12 through 64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The Nuvaxovid™ vaccine is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season. Novavax's President and CEO, John C. Jacobs, has highlighted that the company will be working with its partner, Sanofi, to provide access to this vaccine for eligible individuals.

Clinical and preclinical data have previously shown that Nuvaxovid is safe and effective for the prevention of COVID-19, and that the JN.1 strain vaccination induces immunity across currently circulating JN.1 lineage strains, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7, and XEC. As of July 2025, the majority of COVID-19 infections globally are caused by variants within the JN.1 strain.

Sanofi is leading commercialization efforts for Nuvaxovid, and Novavax is eligible to receive ongoing tiered royalties from sales of the vaccine. The vaccine is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in the specified age groups.

The most commonly reported (>10%) solicited adverse reactions to the vaccine were injection site tenderness, injection site pain, injection site redness, headache, muscle pain, fatigue, malaise, joint pain, fever, and nausea/vomiting.

Nuvaxovid is a protein-based vaccine formulated to target the JN.1 variant, made by creating copies of the surface spike protein of SARS-CoV-2. Novavax's unique recombinant nanoparticle technology and the Matrix-M® adjuvant enhances and broadens the immune response. The vaccine is stored at 2° to 8°C.

Matrix-M® is Novavax’s proprietary adjuvant, clinically proven to induce potent, durable, and broad immune responses with an acceptable safety and tolerability profile.

Novavax, Inc. (NASDAQ: NVAX) aims to optimize its existing partnerships and expand access to its technology platform through research and development innovation, organic portfolio expansion in infectious disease and beyond, as well as forging new partnerships and collaborations with other companies.

This approval marks a significant milestone in the ongoing efforts to combat the COVID-19 pandemic, providing a new option for individuals at high risk for severe outcomes from the virus. Today the company's shares have moved 1.07% to a price of $7.58. For the full picture, make sure to review NOVAVAX INC's 8-K report.

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