Novavax Showcases Data from Expanding Vaccine Portfolio at IDWeek 2022

Rhea-AI Summary

Novavax presented new data from its Phase 3 PREVENT-19 trial at IDWeek 2022, highlighting the effectiveness of its COVID-19 vaccine (NVX-CoV2373) as a booster for adults. The study demonstrated significant increases in anti-spike antibody responses, regardless of age or booster intervals (8 or 11 months). Additionally, data from a Phase 1/2 trial on a COVID-19-Influenza Combination vaccine showed positive antibody and T-cell responses against multiple strains. The company's growing vaccine portfolio aims to address global health needs amidst ongoing evaluation by regulatory authorities.

Positive

• Significant improvement in anti-spike antibody responses after booster doses.
• Positive data from Phase 1/2 COVID-19-Influenza Combination vaccine trial.
• Novavax's COVID-19 vaccine has regulatory authorization in multiple regions.

Negative

• None.

• New Phase 3 PREVENT-19 data reinforce the Novavax COVID-19 vaccine's benefits as an adult booster in both younger and older adults, and with varying time intervals for the booster dose
• Phase 1/2 trial data show COVID-19-Influenza Combination vaccine candidate induced antibody and T-cell responses against SARS-CoV-2 and homologous and heterologous influenza strains

GAITHERSBURG, Md., Oct. 20, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, will present new data from the Phase 3 PREVENT-19 trial evaluating its protein-based COVID-19 vaccine (NVX-CoV2373) as a booster in adults, including a breakdown by age and by booster dose interval (8 and 11 months) at IDWeek 2022, October 20 to 22, 2022. Novavax will also present data from the first Phase 1/2 COVID-19-Influenza Combination (CIC) vaccine dose-finding trial.

"At IDWeek 2022, we will share additional insights on the Novavax COVID-19 vaccine as an adult booster dose and show how we are further developing our portfolio with data from the first COVID-19-Influenza Combination vaccine candidate," said Gregory Glenn, M.D., President, Research and Development, Novavax.

New data will be presented from the PREVENT-19 trial, including an evaluation of the effect of age (18 to 64 years, and ≥ 65 years) and schedule on boosted immunologic response. These data showed that following a booster dose, anti-spike antibody and neutralizing responses for the original prototype strain increased significantly relative to pre-boost levels, regardless of the dosing regimen or age group across adult participants. Antibody responses against the more recent Omicron variants, including BA.1, BA.2, and BA.5, approximated those associated with protection in the PREVENT-19 trial. These data will be presented in addition to data shared earlier in the month.

In addition to the data presentations, Novavax is sponsoring a Learning Lounge session, "Using Behavioral Science to Help Understand Vaccine Hesitancy." As a Mentorship Champion of the Infectious Diseases Society of America (IDSA) Foundation, Novavax will also host the Mentorship Luncheon at IDWeek.

"Having a mentoring relationship is one of the main reasons that medical students and residents choose to pursue a career path in infectious diseases," said Stephen E. Peeler, IDSA Foundation, Executive Director. "That is why we are grateful to Novavax for their generous commitment to our growing mentorship program."

Novavax presentations during IDWeek 2022:

Author	Presentation title	Details
Áñez, G	Safety and Immunogenicity of a Booster Dose of Novavax COVID-19 Vaccine, Adjuvanted (NVX- CoV2373) in Adults from the PREVENT-19 Trial in the United States	Late-breaking Oral Presentation October 20, 2022 1:45 - 3:00pm (EDT)
Shinde, V	Safety and Immunogenicity of COVID                 Influenza Combination Vaccine	Poster Presentation October 22, 2022 12:15 – 1:30pm (EDT)
Graves, C                Wolynn, T Wright, W	Using Behavioral Science to Help Understand Vaccine Hesitancy, Presented by Novavax	Learning Lounge Session                October 22, 2022 10:15 – 11:00am (EDT)

For more information, visit the IDWeek 2022 website.

About Novavax
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 World Health Organization. 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 CIC 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.

Forward-Looking Statements
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  NVX-CoV2515, a bivalent Omicron-based / original strain based vaccine, the CIC  and the quadrivalent influenza investigational candidates the scope, timing and outcome of future regulatory filings and actions, including  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.

Contacts:
Investors
Erika Schultz | 240-268-2022
ir@novavax.com 

Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com 

 

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SOURCE Novavax, Inc.

FAQ

What are the new findings from Novavax's PREVENT-19 trial presented at IDWeek 2022?

The new findings indicate significant increases in anti-spike antibody responses after booster doses of the COVID-19 vaccine NVX-CoV2373 across various age groups and booster intervals.

What data was presented regarding the COVID-19-Influenza Combination vaccine at IDWeek 2022?

Data from the Phase 1/2 trial of the COVID-19-Influenza Combination vaccine candidate showed that it induced positive antibody and T-cell responses against SARS-CoV-2 and both homologous and heterologous influenza strains.

How does the Novavax vaccine perform against Omicron variants?

The data suggest that antibody responses against recent Omicron variants closely approximate those associated with protection in the PREVENT-19 trial.

When was the Novavax data presented at IDWeek 2022?

The data were presented at IDWeek 2022, which took place from October 20 to 22, 2022.

What are the implications of the new data for Novavax's vaccine portfolio?

The new data reinforces Novavax's commitment to vaccine development and the potential effectiveness of its candidates in addressing urgent global health issues.