- New safety and immunogenicity data for the COVID-19-Influenza Combination vaccine candidate Phase 1/2 trial will be presented
- New data will be presented for Novavax' COVID-19 vaccine supporting its use as a homologous and heterologous booster in adults aged 18 and older and adolescents aged 12 through 17
- Updated Phase 3 PREVENT-19 data and new Study 307: Lot Consistency data will reinforce COVID-19 vaccine's benefits as an adult heterologous booster
GAITHERSBURG, Md., Oct. 10, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, will present new safety and immunogenicity data from the first Phase 1/2 COVID-Influenza Combination (CIC) dose-finding trial evaluating its CIC vaccine candidate at the World Vaccine Congress (WVC) Europe, October 11 to 14, 2022. Data from the Phase 3 PREVENT-19 trial and from Study 307: Lot Consistency evaluating the protein-based Novavax COVID-19 vaccine (NVX-CoV2373) as a booster both in adults aged 18 and older and in adolescents aged 12 through 17 will also be presented.
"Data presented at WVC will show the continued momentum of our COVID-19 vaccine as a booster and also provide insight into our COVID-19-Influenza Combination vaccine candidate's immunogenicity, safety, and optimal dose," said Gregory Glenn, M.D., President of Research and Development at Novavax. "Novavax is focused on developing innovative vaccines built on a well-established technology and we are committed to building a portfolio of best-in-class vaccines across multiple infectious disease areas."
In addition to the data presentations, Dr. Glenn will participate in a keynote panel to discuss the future of COVID-19 vaccines and next steps in addressing the pandemic.
The future of COVID vaccination in the human population – What's the end game and how do we exit from the public health emergency?
October 12, 2022
8:30 – 9:30am (CEST)
Paving the way for Protein: Novavax's COVID-19 Vaccine as a Booster, Variant-adapted
October 12, 2022
05:00 – 5:30pm (CEST)
Update on Novavax Investigational Influenza vaccine and COVID-19-INFLUENZA Combination Vaccine development
October 13, 2022
2:30 – 3:00pm (CEST)
For more information, visit the World Vaccine Congress Europe 2022 website.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine has received authorization from multiple regulatory authorities globally, including the U.S. Food and Drug Administration, the European Commission, and the WHO. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional populations and indications such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating its COVID-19-Influenza Combination vaccine candidate in a Phase 1/2 clinical trial, its quadrivalent influenza investigational vaccine candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and connect with us on LinkedIn.
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including an Omicron strain based vaccine and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal Influenza Combination investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety intended utilization, and the expected administration of NVX-CoV2373 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 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; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; 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' Annual Report on Form 10-K for the year ended December 31, 2021 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.
Erika Schultz | 240-268-2022
Ali Chartan or Giovanna Chandler | 202-709-5563
SOURCE Novavax, Inc.