Full Press Release Details
Novavax's Nuvaxovid 2025-2026 Formula
COVID-19 Vaccine Approved in the U.S.
GAITHERSBURG, Md., August 27, 2025 -
Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration has approved the Nuvaxovid 2025-2026
Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one
underlying condition that puts them at high risk for severe outcomes from COVID-19.
"With today's approval, we will work
with our partner Sanofi to provide access to a protein-based, non-mRNA COVID-19 vaccine for eligible individuals this fall," said
John C. Jacobs, President and Chief Executive Officer, Novavax.
Clinical and preclinical data have previously
shown that Nuvaxovid is safe and effective for the prevention of COVID-19.1,2 Both clinical and preclinical data from Nuvaxovid
confirm 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 vast majority of COVID-19 infections globally are caused by variants within
Sanofi is leading commercialization efforts for
Nuvaxovid and Novavax is eligible to receive ongoing tiered royalties from sales of the vaccine.
VACCINE AUTHORIZATION (U.S.)
Nuvaxovid is a vaccine indicated for active immunization
to prevent COVID-19 caused by SARS-CoV-2 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one
underlying condition that puts them at high risk for severe outcomes from COVID-19.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
reported (>10%) solicited adverse reactions were injection site tenderness, injection site pain, injection site redness, headache,
muscle pain, fatigue, malaise, joint pain, fever and nausea/vomiting.
To report suspected adverse reactions, contact
Novavax, Inc. at 1-844-668-2829 or the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov.
Nuvaxovid is 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
in pre-filled syringes and is stored at 2 to 8 C, enabling the use of existing vaccine supply and cold chain channels.
About Matrix-M Adjuvant
Matrix-M is Novavax's 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.
It is clinically proven to induce potent, durable and broad immune responses with an acceptable safety and tolerability profile and allows
use of a lower dose of antigen that is still effective.4 Matrix-M is sustainably harvested and manufactured and has the potential
to enhance existing and new vaccines. When combined with the Company's recombinant, protein-based nanoparticles, this technology
platform is the basis of Novavax's expanding pipeline.
Novavax, Inc. (Nasdaq: NVAX) tackles some of
the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based
nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access
to its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond,
and forging new partnerships and collaborations with other companies. Please visit novavax.com and LinkedIn for more information.
Forward-Looking Statements
Statements herein relating to the future of Novavax,
its operating plans and prospects, the efficacy, safety and intended utilization of Novavax's COVID-19 vaccine, the possible receipt
of tiered royalties from vaccine sales the immunogenic response of its vaccine technology against variant strains and the scope, are
forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that
could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include,
without limitation, challenges or delays related to the requested postmarketing commitment; antigenic drift or shift in the SARS-CoV-2
spike protein, challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements,
including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty
obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability
of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for a JN.1 protein-based
COVID-19 vaccine or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution
or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling
and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified
in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations"
sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by the information identified in the
"Risk Factors" section in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each as filed with the
Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained
in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov
and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press
release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business
is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors and others should
give careful consideration to these risks and uncertainties.