SHIELD-Utah Study Shows Novavax's COVID-19 Vaccine Induces Lower Reactogenicity Symptoms Compared to mRNA
Rhea-AI Summary
Novavax (NVAX) has announced preliminary results from the SHIELD-Utah study comparing its COVID-19 Vaccine (2024-2025 Formula) targeting the JN.1 strain with Pfizer-BioNTech's mRNA vaccine. The real-world study, conducted between September-December 2024, demonstrated significantly lower reactogenicity in Novavax recipients.
Key findings show Novavax recipients experienced an average of 1.7 symptoms versus 2.8 in Pfizer-BioNTech recipients. Only 24.2% of Novavax recipients reported Grade 2 or higher symptoms compared to 43.8% for Pfizer-BioNTech. Local reactogenicity events were 12.5% lower in Novavax recipients.
The study, conducted at University of Utah Health with 219 Novavax and 369 Pfizer-BioNTech recipients, also revealed reduced impact on daily activities. Novavax recipients reported fewer hours of missed work (0.7 vs 1.4h) and less productivity impact (0.8 vs 2.4h) compared to Pfizer-BioNTech recipients.
Positive
- Lower frequency and severity of side effects compared to competitor's vaccine
- Reduced impact on work productivity (0.8h vs 2.4h lost)
- Lower rate of Grade 2+ symptoms (24.2% vs 43.8%)
- 12.5% fewer local reactogenicity events than competitor
Negative
- Smaller study group for Novavax (219) compared to Pfizer-BioNTech (369)
- Results are preliminary, full publication pending
News Market Reaction
On the day this news was published, NVAX declined 0.31%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Preliminary data showed Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine
- Full results will be submitted for publication later this year
"The risk of side effects or reactogenicity has been shown to be a major decision factor for those opting to get vaccinated. Our findings of lower frequency and intensity of reactogenicity symptoms from the protein-based COVID-19 vaccine observed in SHIELD-
As in previous studies, the SHIELD study found health care workers who received the Novavax vaccine reported significantly fewer reactogenicity events than Pfizer-BioNTech recipients. On average, Novavax recipients experienced 1.7 symptoms versus 2.8 systemic symptoms in Pfizer-BioNTech recipients;
"Today's results add to an increasing body of research underscoring the tolerability of Novavax's COVID-19 vaccine," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. "Our protein-based nanoparticles and Matrix-M® adjuvant are the foundation of our COVID-19 vaccine. Our new R&D pipeline is focused on delivering more assets built on this powerful technology platform, including the use of our Matrix M adjuvant, which has been associated with a favorable tolerability profile."
SHIELD-
About Novavax
Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most significant health challenges by leveraging its scientific expertise in vaccines and its cutting-edge technology platform, which includes protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy is focused on building new and diversified partnerships via the out-licensing of its technology platform and vaccine assets earlier in the development process. These strategic collaborations are fueled by smart investments in a growing early-stage pipeline starting with the Company's core expertise in infectious disease and potentially expanding into other disease areas. 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 updated combined annual Research & Development and Selling, General and Administrative expense target for FY 2025, the potential for its COVID-19-Influenza Combination (CIC) and stand-alone influenza trial to be used for accelerated approval and the timing of updates related thereto, 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 2024-2025 formula 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, 2023, 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
240-720-7804
media@novavax.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/shield-utah-study-shows-novavaxs-covid-19-vaccine-induces-lower-reactogenicity-symptoms-compared-to-mrna-302428227.html
SOURCE Novavax, Inc.
FAQ
What are the key findings of the SHIELD-Utah study for Novavax's COVID-19 vaccine (NVAX)?
How many participants were included in the 2024 SHIELD-Utah study for NVAX?
What is the impact of Novavax's COVID-19 vaccine on work productivity compared to Pfizer's?
When was the SHIELD-Utah study for NVAX conducted?
What healthcare professionals participated in the NVAX SHIELD-Utah study?
