Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster

• The Novavax BA.1 vaccine candidate met its main strain-change endpoint permitting for growth of variant vaccines, if mandatory
• Novavax’ prototype vaccine induced broad immune response towards unique Wuhan, BA.1, and BA.5 strains
• The trial confirmed no profit for a bivalent vaccine using Novavax’ recombinant protein/adjuvant expertise

GAITHERSBURG, Md., Nov. 8, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology firm devoted to creating and commercializing next-generation vaccines for severe infectious illnesses, in the present day introduced topline outcomes from its Phase 3 Boosting Trial for the SARS-CoV-2 rS Variant Vaccines (COVID-19) exhibiting that the Company’s BA.1 vaccine candidate (NVX-CoV2515) met the main strain-change endpoint. The information exhibit that the BA.1 vaccine candidate neutralizing responses in these not beforehand uncovered to COVID-19 had been larger than these of the prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if mandatory (see chart 1).

Additionally, information present no profit for the Novavax bivalent vaccine candidate in comparison with the BA.1 vaccine candidate or prototype vaccine in the general trial inhabitants. Immunoglobulin G (IgG) antibody responses towards BA.1 and prototype strains confirmed related responses throughout the three vaccine teams (prototype [n=273], BA.1 vaccine candidate [n=279], and bivalent – prototype + BA.1 vaccine candidate [n=277]).* Importantly, for the BA.5 pressure (which is structurally just like BA.1), pseudoneutralization responses demonstrated that there was no profit for the BA.1 or bivalent vaccine candidates in comparison with the prototype vaccine.**

Overall, the information demonstrated that the prototype vaccine induced a broad immune response towards unique prototype, BA.1, and BA.5 strains. The prototype vaccine induced strong IgG responses to each BA.1 and the matched prototype pressure.* Pseudoneutralization responses towards BA.5 for the prototype vaccine had been akin to these induced by the extra carefully matched BA.1 vaccine and bivalent vaccine candidates.*

“Today’s results show that use of our prototype vaccine as a booster induces cross-reactive responses to a broad range of variants with the potential to protect against future strains. This is a hallmark of our vaccine technology and shows the suitability of our current prototype vaccine as a booster even as the COVID-19 landscape continues to evolve,” mentioned Gregory M. Glenn, M.D., President of Research and Development, Novavax. “Our vaccine, which provides broad immune response even in the face of evolving variants, presents a potential strategy to protect against COVID-19 now and into the future.”

When given as a second booster dose (fourth dose), all three vaccine formulations had been equally well-tolerated, according to the well-established security profile of the prototype vaccine. The commonest native solicited symptom was ache/tenderness (BA.1 69%, prototype 71%, bivalent 65%). The commonest systemic solicited signs had been fatigue and malaise (BA.1 45%, prototype 41%, bivalent 45%), headache (BA.1 38%, prototype 35%, bivalent 36%), muscle ache (BA.1 25%, prototype 24%, bivalent 24%), and joint ache (BA.1 10%, prototype 11%, bivalent 6%), with the majority of reactions being delicate or reasonable.

Chart 1: Geometric Mean Ratio of BA.1 wild-type Neutralizing Responses (Day 14) Study Arm in Participants Not Previously Infected

*IgG responses should not statistically important.

**Fit-for-purpose evaluation being confirmed with validated assay.

About the Phase 3 Omicron Trial

Novavax’ Phase 3 Omicron trial is a two-part, observer blinded, randomized trial to judge Omicron subvariant vaccine candidates. NVX-CoV2515 (BA.1) and bivalent (NVX-CoV2373 + Omicron subvariant NVX-CoV2515) vaccine candidates had been in comparison with NVX-CoV2373 in adults aged 18 to 64 beforehand vaccinated with three doses of mRNA vaccines. All formulations embody the Matrix-M™ adjuvant to reinforce and broaden the immune response. The trial is evaluating the reactogenicity and immune responses to all three formulations. The trial’s main endpoints embody measures of immune response, and its secondary endpoints embody further measurements of immune responses and security measures. The trial plans to enroll 2,090 adults aged 18 to 64 throughout 19 websites in Australia.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first pressure of SARS-CoV-2, the virus that causes COVID-19 illness. The vaccine was created utilizing Novavax’ recombinant nanoparticle expertise to generate antigen derived from the coronavirus spike protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to reinforce the immune response and stimulate excessive ranges of neutralizing antibodies. NVX-CoV2373 accommodates purified protein antigen and can neither replicate, nor can it trigger COVID-19.

The vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination routine calls for 2 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days aside. The vaccine is saved at 2°- 8° Celsius, enabling the use of present vaccine provide and chilly chain channels. Use of the vaccine needs to be in accordance with official suggestions.  

Novavax has established partnerships for the manufacture, commercialization, and distribution of the vaccine worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine producer by quantity. They will later be supplemented with information from further manufacturing websites all through Novavax’ world provide chain.

About Matrix-M™ Adjuvant

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated impact by stimulating the entry of antigen-presenting cells into the injection website and enhancing antigen presentation in native lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology firm that promotes improved well being globally by means of the discovery, growth, and commercialization of revolutionary vaccines to stop severe infectious illnesses. The firm’s proprietary recombinant expertise platform harnesses the energy and pace of genetic engineering to effectively produce extremely immunogenic nanoparticles designed to handle pressing world well being wants. The Novavax COVID-19 vaccine has obtained authorization from a number of regulatory authorities globally, together with the U.S. Food and Drug Administration, the European Commission, and the World Health Organization. The vaccine is at present below overview by a number of regulatory businesses worldwide, together with for added populations and indications such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax can also be at present evaluating its COVID-19-Influenza Combination (CIC) vaccine candidate in a Phase 1/2 medical trial, its quadrivalent influenza investigational vaccine candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as nicely as a bivalent format Omicron-based / unique strain-based vaccine. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to reinforce the immune response and stimulate excessive ranges of neutralizing antibodies.

For extra data, go to www.novavax.com and join with us on LinkedIn.

Forward-Looking Statements

Statements herein regarding the future of Novavax, its working plans and prospects,   the timing of medical trial outcomes, the ongoing growth of NVX-CoV2373, together with NVX-CoV2515 and bivalent Omicron-based / unique pressure primarily based vaccine, the CIC investigational vaccine candidate, the scope, timing and consequence of future regulatory filings and actions, together with  Novavax’ plans to complement present authorizations with information from the further manufacturing websites in Novavax’ world provide chain, further worldwide authorizations of NVX-CoV2373 to be used in adults and adolescents, and as a booster, the potential impression and attain of Novavax and NVX-CoV2373 in addressing vaccine entry, controlling the pandemic and defending populations, the efficacy, security and meant utilization and administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are topic to quite a few dangers and uncertainties that would trigger precise outcomes to vary materially from these expressed or implied by such statements. These dangers and uncertainties embody, with out limitation, challenges satisfying, alone or along with companions, varied security, efficacy, and product characterization necessities, together with these associated to course of qualification and assay validation, essential to fulfill relevant regulatory authorities; unanticipated challenges or delays in conducting medical trials; issue acquiring scarce uncooked supplies and provides; useful resource constraints, together with human capital and manufacturing capability, on the means of Novavax to pursue deliberate regulatory pathways; challenges assembly contractual necessities below agreements with a number of industrial, governmental, and different entities; and these different threat elements recognized 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-Ok for the 12 months ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We warning buyers to not place appreciable reliance on forward-looking statements contained on this press launch. You are inspired to learn our filings with the SEC, accessible at www.sec.gov and www.novavax.com, for a dialogue of these and different dangers and uncertainties. The forward-looking statements on this press launch converse solely as of the date of this doc, and we undertake no obligation to replace or revise any of the statements. Our business is topic to substantial dangers and uncertainties, together with these referenced above. Investors, potential buyers, and others ought to give cautious consideration to those dangers and uncertainties. 

Contacts:

Investors

Erika Schultz | 240-268-2022

[email protected]

Media

Ali Chartan or Giovanna Chandler | 202-709-5563

[email protected]

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