GAITHERSBURG, Md. , Nov. 8, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company committed to the advancement and commercialization of next-generation vaccines for serious infectious diseases, announced the primary effects of its Phase 3 booster trial for SARS-CoV-2 (COVID-19) rS variant vaccines that appear the company’s BA. 1 vaccine candidate (NVX-CoV2515) met the number one strain replacement criterion. Data demonstrate that neutralizing responses of the BA. 1 vaccine candidate in Americans not exposed to COVID-19 were superior to those of the prototype vaccine (NVX-CoV2373), allowing a transfer to a new vaccine variant, if necessary (see Figure 1).
In addition, the knowledge shows no merit for the bivalent Novavax vaccine candidate over BA. 1 or the prototype candidate vaccine in the general trial population. Immunoglobulin G (IgG) antibody responses opposed to BA. 1 and prototype strains showed similar responses in the 3 vaccine teams (prototype [n=273], candidate vaccine BA. 1 [n=279] and bivalent vaccine – prototype candidate BA. 1 [n=277]). * Importantly, for the BA. 5 strain (which is structurally similar to BA. 1), pseudoneutralization responses demonstrated that there is no merit for BA. 1 or bivalent vaccine applicants over the vaccine. prototype. **
Overall, knowledge showed that the prototype vaccine induced a broad immune reaction opposite to the original prototype strains, BA. 1 and BA. 5. The prototype vaccine induced physically potent IgG reactions against BA. 1 and the corresponding prototype strain. * The pseudoneutralization reactions opposed to BA. 5 for the prototype vaccine were comparable to those induced through the BA vaccine. 1 and bivalent vaccine applicants were more consistent. *
“Today’s effects show that our booster vaccine prototype induces cross-reactions to a wide variety of variants with the potential to protect against strains in the long term. This is a feature of our vaccine generation and shows the relevance of our existing vaccine prototype. as a reminder even as the COVID-19 landscape continues to evolve,” said Gregory M. Glenn, M. D. , president of Research and Development at Novavax. “Our vaccine, which provides a broad immune reaction even against evolving variants, presents a forward-looking strategy to protect against COVID-19 now and in the long term. “
When administered as a timing (fourth dose), all 3 formulations of the vaccine were also well tolerated, according to the well-established protection profile of the prototype vaccine. 71%, bivalent 65%). The maximum non-unusual systemic symptoms requested were fatigue and malaise (BA. 1 45%, prototype 41%, bivalent 45%), headache (BA. 1 38%, prototype 35%, bivalent 36%), muscle pain (BA. 1 25%, prototype 24%, bivalent 24%) and joint pain (BA. 1 10%, prototype 11%, bivalent 6%), with most reactions being mild or moderate.
Figure 1: Mean geometric proportion of BA. 1 wild-type neutralizing responses (day 14) of the organization examined in participants not infected in the past
Group comparisons
Neutralizing antibodies to BA. 1
Prototype BA. 1 vaccine
From bivalent vaccine to prototype
Bivalent vaccine to BA. 1 vaccine
Geometric Relationship (GMR)
1. 6
1. 2
0,7
95% GMR range
1. 31, 2. 03
0,94, 1,44
0,57, 0,89
* IgG responses are statistically significant. ** Objectively tailored analysis shown with a validated test.
About the Omicron Phase 3 Trial The Novavax Omicron Phase 3 trial is a randomized, two-part, observer-blinded trial to compare Omicron subvariant vaccine candidates. NVX-CoV2515 (BA. 1) and bivalent (NVX-CoV2373 subvariant Omicron NVX-CoV2515) were compared with NVX-CoV2373 in older adults aged 18 to 64 years vaccinated in the past with 3 doses of mRNA vaccine. All formulations come with the Matrix-M adjuvant to expand the immune response. The assay compares reactogenicity and immune responses to the 3 formulations. The trial’s number one endpoints come with immune response measures, and its secondary endpoints include additional measures of immune responses and protective measures. The trial plans to recruit 2090 older adults aged 18 to 64 at 19 sites in Australia.
About NVX-CoV2373NVX-CoV2373 is a protein-based vaccine designed from the genetic series of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’s generation of recombinant nanoparticles to generate an antigen. derived from the coronavirus spike protein and is formulated with Novavax’s patented saponin-based Matrix-M adjuvant for immune reaction and stimulating higher levels of neutralizing antibodies. NVX-CoV2373 comprises a purified protein antigen and cannot reflect or cause COVID-19.
The vaccine is packaged as ready-to-use liquid formula in a vial containing ten doses. The vaccination schedule consists of two doses of 0. 5 ml (5 mcg antigen and 50 mcg Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored between 2° and 8° Celsius, so it is imaginable to use the existing vaccine source channels and the bloodless chain. The use of the vaccine deserves to be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, marketing and distribution of the vaccine worldwide. The existing approvals leverage Novavax’s production partnership with the Serum Institute of India, the world’s largest vaccine manufacturer by volume. These will then be complemented by knowledge from other Novavax production sites. global chain of sources.
About the Matrix-M adjuvant Novavax’s patented saponin-based Matrix-M adjuvant demonstrated a potent and well-tolerated effect by stimulating the access of antigen-presenting cells at the injection site and presenting the antigen to local lymph nodes, thereby stimulating the immune response.
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a biogeneration company advancing global fitness through the discovery, progression and commercialization of cutting-edge vaccines to save you from serious infectious diseases. The company’s proprietary recombinant generation platform harnesses the power and speed of genetic engineering to successfully produce highly immunogenic nanoparticles designed to address pressing global fitness needs. The Novavax COVID-19 vaccine has gained approval from several regulatory governments around the world, including the US Food and Drug Administration, the European Commission and the World Health Organization. The vaccine is lately undergoing review through various regulatory agencies around the world, being added for other populations and indications, such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also lately comparing its combined influenza and COVID-19 vaccine candidate (CIC) in a phase 1/2 clinical trial, its investigational quadrivalent influenza vaccine candidate and a strain-based vaccine. Omicron (NVX-CoV2515), as well as a bivalent Omicron-based/parent strain-based vaccine. These candidate vaccines incorporate Novavax’s proprietary saponin-based Matrix-M adjuvant for immune reaction and stimulate higher levels of neutralizing antibodies.
For more information, visit www. novavax. com and connect with us on LinkedIn.
Forward-Looking StatementsDetailed statements regarding Novavax’s long-term, business plans and outlook, timing of clinical trial effects, continued progression of NVX-CoV2373, addition of NVX-CoV2515, and Omicron-based bivalent vaccine /original strain, the CIC investigational vaccine candidate, the scope, timing and end results of long-term submissions and regulatory actions, adding Novavax’s plans to supplement existing authorizations with knowledge of production sites of the global chain of origin of Novavax, the additional global authorizations of NVX-CoV2373 for use in adults and adolescents, and as a reminder, the potential impact and success of Novavax and NVX-CoV2373 in the fight against access to vaccines, the pandemic control and coverage of populations, efficacy, protection, and use and administration statements of NVX-CoV2373 are decl prospective plots. Novavax cautions that such forward-looking statements are subject to threats and uncertainties that may cause actual effects to differ materially from those expressed or implied by such statements. These threats and uncertainties include, but are not limited to, difficulties in assembly, alone or with partners, various defense needs, efficacy and product characterization, adding the like to procedural qualification and validation. testing, as required to satisfy applicable regulatory authorities; unforeseen difficulties or delays in conducting clinical trials; difficulty obtaining scarce cloth and raw supplies; resource limitations, adding human capital and production capacity, on Novavax’s ability to adhere to expected regulatory pathways; difficulties in assembling control needs under agreements with multiple commercial, governmental and other entities; and other known threat items 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 fiscal year ended December 31, 2021 and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). Investors are cautioned against placing significant reliance on the forward-looking statements contained in this press release. We invite you to read our SEC filings, available at www. sec. gov and www. novavax. com, for a discussion of these and other threats and uncertainties. The forward-looking statements contained in this press release speak only as of the date hereof, and we do not assume any legal responsibility to update or revise any of the statements. Our business is subject to truly extensive threats and uncertainties, in addition to those discussed above. Investors, potential investors, and others deserve to pay special attention to those threats and uncertainties.
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