Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Vaccine Candidates Showed Robust Immune Responses and Were Well Tolerated in Initial Cohort of a Phase 3 Trial
- Both vaccine candidates showed robust immune responses with 2.4-5.7-fold increase over baseline
- Excellent safety profile with over 98% of adverse events being mild or moderate
- Successful comparison against established products Nuvaxovid and Fluzone HD
- Results support previous Phase 2 data findings
- Trial was not powered for statistical significance
- Company needs to secure partners to advance development
- Additional clinical trials will be required for registration
Insights
Novavax reports positive early Phase 3 data for both COVID-19-Influenza combo and standalone flu vaccines, pursuing partnerships for continued development.
Novavax's interim Phase 3 results demonstrate encouraging progress for both their COVID-19-Influenza Combination (CIC) and standalone trivalent influenza vaccine candidates. The data shows robust immune responses with 2.4-5.7-fold increases over baseline for all tested antigens, comparable to already licensed products Nuvaxovid and Fluzone HD. This is particularly noteworthy as combination vaccines represent a significant market opportunity by offering simplified immunization against multiple pathogens.
The safety profile appears solid with over 98% of adverse events classified as mild or moderate, consistent with previous trials. However, investors should note several important limitations: this was a descriptive trial not powered for statistical significance, involved only approximately 2,000 adults aged 65+, and represents just an initial cohort of the larger Phase 3 program.
Most critically, Novavax explicitly states they're pursuing partnering opportunities for further development rather than advancing independently. This suggests potential resource constraints or strategic focus on other programs. The company frames these results as building on previous Phase 2 data and informing partnership discussions, indicating they're seeking external support before committing to the costly full registrational Phase 3 program needed for regulatory approval. This measured approach reflects both the promising data and Novavax's practical need to prioritize resource allocation in the competitive vaccine landscape.
- Both vaccine candidates induced robust immune responses across all antigens tested
- No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials
- Novavax continues to pursue partnering opportunities to advance further development of these programs
"Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. "This data set adds to findings from our Phase 2 trial and will help inform discussions with potential partners."
Both stand-alone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline). Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators. Nearly all (>
This descriptive trial was designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older. This trial was not adequately powered to demonstrate statistical significance. These results build on previous Phase 2 data.
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 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, its partnerships, and the potential for its CIC and stand-alone influenza vaccine to be used with a partner in a registrational Phase 3 program, 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 pursuing additional partnership opportunities; 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; challenges or delays in conducting clinical trials or studies for its product candidates; challenges or delays in obtaining regulatory authorization for its product candidates, including for future COVID-19 variant strain changes, its CIC vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; 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; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan; challenges in obtaining commercial adoption and market acceptance of its updated COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; 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, 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 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.
Contacts:
Investors
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.
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