Country for PR: United States
Contributor: PR Newswire New York
Wednesday, November 09 2022 - 01:51
Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster
GAITHERSBURG, Md., Nov. 8, 2022 /PRNewswire-AsiaNet/ --

-- The Novavax BA.1 vaccine candidate met its primary strain-change endpoint 
allowing for development of variant vaccines, if necessary
-- Novavax' prototype vaccine induced broad immune response against original 
Wuhan, BA.1, and BA.5 strains
-- The trial showed no benefit for a bivalent vaccine utilizing Novavax' 
recombinant protein/adjuvant technology

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing 
and commercializing next-generation vaccines for serious infectious diseases, 
today announced topline results from its Phase 3 Boosting Trial for the 
SARS-CoV-2 rS Variant Vaccines (COVID-19) showing that the Company's BA.1 
vaccine candidate (NVX-CoV2515) met the primary strain-change endpoint. The 
data demonstrate that the BA.1 vaccine candidate neutralizing responses in 
those not previously exposed to COVID-19 were greater than those of the 
prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if 
necessary (see chart 1).

Additionally, data show no benefit for the Novavax bivalent vaccine candidate 
compared to the BA.1 vaccine candidate or prototype vaccine in the overall 
trial population. Immunoglobulin G (IgG) antibody responses against BA.1 and 
prototype strains showed similar responses across the three vaccine groups 
(prototype [n=273], BA.1 vaccine candidate [n=279], and bivalent – prototype + 
BA.1 vaccine candidate [n=277]).* Importantly, for the BA.5 strain (which is 
structurally similar to BA.1), pseudoneutralization responses demonstrated that 
there was no benefit for the BA.1 or bivalent vaccine candidates compared to 
the prototype vaccine.**

Overall, the data demonstrated that the prototype vaccine induced a broad 
immune response against original prototype, BA.1, and BA.5 strains. The 
prototype vaccine induced robust IgG responses to both BA.1 and the matched 
prototype strain.* Pseudoneutralization responses against BA.5 for the 
prototype vaccine were comparable to those induced by the more closely 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," said 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 were similarly well-tolerated, consistent with the 
well-established safety profile of the prototype vaccine. The most common local 
solicited symptom was pain/tenderness (BA.1 69%, prototype 71%, bivalent 65%). 
The most common systemic solicited symptoms 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 the majority of reactions being mild or 

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

                                        Group Comparisons

    Neutralizing   BA.1 vaccine to     Bivalent vaccine to  Bivalent vaccine to
     antibodies    prototype vaccine    prototype vaccine      BA.1 vaccine
     for BA.1

     Ratio (GMR)         1.6                    1.2                 0.7

    GMR 95% 
     Interval        1.31, 2.03             0.94, 1.44          0.57, 0.89

*IgG responses are not statistically significant.
**Fit-for-purpose analysis 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 evaluate Omicron subvariant vaccine candidates. NVX-CoV2515 (BA.1) and 
bivalent (NVX-CoV2373 + Omicron subvariant NVX-CoV2515) vaccine candidates were 
compared to NVX-CoV2373 in adults aged 18 to 64 previously vaccinated with 
three doses of mRNA vaccines. All formulations include the Matrix-M(TM) 
adjuvant to enhance and broaden the immune response. The trial is evaluating 
the reactogenicity and immune responses to all three formulations. The trial's 
primary endpoints include measures of immune response, and its secondary 
endpoints include additional measurements of immune responses and safety 
measures. The trial plans to enroll 2,090 adults aged 18 to 64 across 19 sites 
in Australia.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of 
the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The 
vaccine was created using Novavax' recombinant nanoparticle technology to 
generate antigen derived from the coronavirus spike protein and is formulated 
with Novavax' patented saponin-based Matrix-M(TM) adjuvant to enhance the 
immune response and stimulate high levels of neutralizing antibodies. 
NVX-CoV2373 contains purified protein antigen and can neither replicate, nor 
can it cause COVID-19.

The vaccine is packaged as a ready-to-use liquid formulation in a vial 
containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg 
antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The 
vaccine is stored at 2”degrees”- 8”degrees” Celsius, enabling the use of 
existing vaccine supply and cold chain channels. Use of the vaccine should be 
in accordance with official recommendations.  

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 manufacturer by volume. They will later be supplemented with 
data from additional manufacturing sites throughout Novavax' global supply 

About Matrix-M(TM) Adjuvant
Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and 
well-tolerated effect by stimulating the entry of antigen-presenting cells into 
the injection site and enhancing antigen presentation in local lymph nodes, 
boosting immune response.

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 COVID-19-Influenza 
Combination (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.

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Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and 
prospects,   the timing of clinical trial results, the ongoing development of 
NVX-CoV2373, including NVX-CoV2515 and bivalent Omicron-based / original strain 
based vaccine, the CIC 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 and 
intended utilization and 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; 
unanticipated challenges or delays in conducting clinical trials; 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; 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 and, 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 

Erika Schultz | 240-268-2022

Ali Chartan or Giovanna Chandler | 202-709-5563

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Source - Novavax, Inc.