SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

iStock, klenger Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma. BioNTech shares dropped as much as 8% Friday morning to around $103 per share after the Germany-based company said it would discontinue a mid-stage colorectal cancer trial of its highly anticipated personalized mRNA cancer immunotherapy. “BioNTech’s termination of the Phase 2 trial in resected colorectal cancer is a clear setback,” BMO Capital Markets wrote in a note to analysts Friday morning. “We expect the termination to reduce confidence in autogene cevumeran and raise questions about whether vaccine-induced immune responses can prevent recurrence without concurrent checkpoint inhibition or chemotherapy.” Last week, Moderna and Merck reported positive data from a Phase 3 trial of their own personalized mRNA cancer vaccine intismeran autogene, but the regimen also included the larger partner’s blockbuster checkpoint inhibitor Keytruda. In their trial, participants taking the combination lived longer without melanoma returning, meeting the study’s primary endpoint of recurrence-free survival. Cancer Moderna stock nearly doubles as Merck-partnered mRNA cancer vaccine meets Phase 3 goal Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA. August 19, 2026 · 3 min read · Nick Paul Taylor Read more BioNTech’s trial, conversely, was not showing evidence of efficacy. An Independent Data Safety Monitoring Board (DSMB) recommended discontinuing the trial due to futility, according to a Friday press release from BioNTech. Dubbed BNT122-01, the study evaluated whether autogene cevumeran given as monotherapy could help prevent disease recurrence in high-risk patients with colorectal cancer (CRC). The “futility boundary” was crossed in October 2025, the company noted, but at the time the DSMB determined that “the data were not sufficiently mature to support reliable conclusions regarding efficacy, and that follow-up time was insufficient to evaluate the trial’s primary endpoint.” Based on the data now available, the DSMB “identified a numerical imbalance in overall survival between treatment arms in this specific patient population” and said further continuation of the trial was unlikely to change the efficacy outcome. BioNTech is also investigating autogene cevumeran in the Phase 2 IMcode003 trial, along with Roche’s checkpoint inhibitor Tecentriq and chemotherapy, for pancreatic ductal adenocarcinoma (PDAC). Data presented in April from a small Phase 1 trial in this indication showed that nearly 90% of trial participants whose immune systems responded to the vaccine were still alive up to six years after receiving the last treatment, according to Memorial Sloan Kettering Cancer Center. Because the vaccine is not given as a monotherapy for PDAC, BMO said the read-through of the canceled trial to BioNTech’s broader program “is negative but limited.” Still, the analysts continued, the CRC trial discontinuation “represents a clear setback for the company’s individualized neoantigen therapy platform.” BioNTech’s news is a blow to a resurgent mRNA space still celebrating the Phase 3 win for Merck and Moderna’s own cancer vaccine in melanoma. In addition to the clinical win, the space also saw movement on the regulatory side. On Aug. 5—exactly a year after the Department of Health and Human Services slashed $500 million in funding from mRNA-based programs—Moderna won FDA approval for its flu vaccine, mFLUVISA. The greenlight was a redeeming moment for Moderna, after the agency refused to review its original application in February. And this week, the FDA greenlit updated mRNA-based vaccines for the 2026-27 season: Moderna’s mNexspike and Spikevax, and Pfizer and BioNTech’s Comirnaty, along with Novavax’s protein-based Nuvaxovid.

COVID-19 remains a public health challenge, particularly among older adults and high-risk populations 1 Novavax's partners are ready to bring its protein-based, non-mRNA vaccine with a favorable tolerability pro global markets, providing an important option for healthcare providers and patients GAITHERSBURG, Md. , Aug. 28, 2026 /PRNewswire/ -- Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major markets including the U.S., European Union (EU) and Japan. These approvals position Novavax to continue earning royalties on net sales in these markets this season. "We believe our partners Sanofi and Takeda are well-positioned for this commercial season. Sanofi has an expanded U.S. marketing campaign and launches in additional international markets, and under Takeda's leadership, Nuvaxovid ® has become the second-leading COVID-19 vaccine in one of the world's largest healthcare markets," said John C. Jacobs, President and Chief Executive Officer, Novavax. "With these approvals, Novavax is eligible for continued royalties on partner sales without carrying commercial infrastructure of our own, a testament to the value creation of our business model." COVID-19 continues to present a meaningful public health challenge, particularly among older adults and other high-risk populations. Novavax is committed to working with its partners to ensure a protein-based, non-mRNA vaccine option is available for the fall season. Results from Sanofi's Phase 4 COMPARE study – a large head-to-head evaluation of Nuvaxovid and a next-generation mRNA COVID-19 vaccine – demonstrated Nuvaxovid's favorable tolerability profile, an important consideration for healthcare providers and patients when making informed vaccine choices. Sanofi, Novavax's largest partner, leads Nuvaxovid commercial activities across most major markets and looks to be positioned for a robust 2026-2027 season, expanding the vaccine's commercial reach through broader activities in the U.S. and launches in Germany, Canada and other international markets from 2026 onward. Novavax is eligible to receive ongoing royalties from sales of the vaccine per their 2024 collaboration and license agreement (CLA). Takeda commercializes Nuvaxovid in Japan. In the 2025-2026 season, Nuvaxovid was the second-most used COVID-19 vaccine in Japan, with delivery volumes and the number of sites receiving the vaccine increasing significantly year over year. Under the CLA terms announced in May 2025, Novavax earns annual milestones tied to regulatory approvals and royalties on net sales each season. About Nuvaxovid ™ Nuvaxovid is formulated to target the XFG variant. It is a protein-based vaccine made by creating copies of the surface spike protein of the 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 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. 2 The Company's recombinant, protein-based nanoparticles are combined with its Matrix-M adjuvant, constituting the basis of Novavax's expanding pipeline. About Novavax 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 its Matrix-M adjuvant and protein-based nanoparticles. The Company's corporate growth strategy is designed to deliver value via three key strategic pillars: partnering its technology, targeted and capital-efficient R&D innovation and a lean and efficient operating model. This includes maximizing impact through partnerships for its marketed products (Nuvaxovid, R21/Matrix-M), Matrix technology and R&D assets. 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 possible achievement and timing of achievement of milestone and receipt of royalties under the collaboration and licensing agreements with Sanofi and Takeda, and our partners' ability to launch products and operate effectively in U.S. and international markets, 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, 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, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions; challenges or delays in obtaining commercial adoption and market acceptance of its COVID-19 vaccine or any COVID-19 variant strain containing formulation; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; 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, 2025, and subsequent Quarterly Reports on Form 10-Q, 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 and , 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. Contacts: Investors Naina Zaman 240-410-5353 ir@novavax.com Media Yvonne Sprow 844-264-8571 media@novavax.com References CDC. (2025). People with Certain Medical Conditions and COVID-19 Risk Factors, Updated June 11, 2025. Available from: . Accessed August 24, 2026. Stertman L. et al.; The Matrix-M™ adjuvant: A critical component of vaccines for the 21st century. Hum Vaccin Immunother. 2023 Dec 31;19(1):2189885. doi: 10.1080/21645515.2023.2189885. View original content to download multimedia: SOURCE Novavax, Inc.