PR98247

GAITHERSBURG, Md., Oct. 12, 2022 /PRNewswire=KYODO JBN/ --

    -- Homologous boosting with the prototype Novavax COVID-19 vaccine induced

       robust antibody titers for Omicron BA.1, BA.2, and BA.5

    -- Study 307 (Lot Consistency) achieved its primary endpoint, showing that

       three vaccine lots induced a comparable immune response thereby

       demonstrating the consistency of the manufacturing process

    -- A durable immunogenicity response was observed following primary

       vaccination as well as boosting which matched the levels previously

       associated with protection

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing

and commercializing next-generation vaccines for serious infectious diseases,

today presented data from the Phase 3 PREVENT-19 trial and Study 307 (Lot

Consistency) at the World Vaccine Congress Europe 2022. PREVENT-19 data in both

adults aged 18 and older and adolescents aged 12 through 17 showed the

prototype Novavax COVID-19 vaccine (NVX-CoV2373) achieved its pre-specified

immunologic endpoint. Study 307 (Lot Consistency) met its primary endpoint,

showing that three lots of the Novavax COVID-19 vaccine tested as a

heterologous booster induced consistent immune responses in previously

vaccinated adults aged 18 to 49.

"These data further demonstrate the consistent immunogenicity and safety

profile of the Novavax COVID-19 vaccine as a booster, regardless of previous

vaccine history," said Gregory M. Glenn, M.D., President of Research and

Development, Novavax. "These data are an early indication that our vaccine may

be effective against variants such as Omicron. We have ongoing trials further

exploring the Novavax COVID-19 vaccine's potential as an effective booster

against these variants, including BA.4/5, and look forward to sharing these

data."

PREVENT-19 adult and adolescent homologous boosting

In the PREVENT-19 trial, a single homologous booster dose was given to select

adult participants aged 18 and older, approximately eight or 11 months after

their primary series. Following a booster dose, severe acute respiratory

syndrome coronavirus 2 (SARS-CoV-2) anti-spike (anti-S) Immunoglobulin G (IgG;

a type of antibody) levels increased significantly relative to pre-boost

levels, rising above the level correlated with 95% vaccine efficacy in a recent

USG study. Neutralizing antibodies against the prototype strain also increased

by 34- to 27-fold compared to pre-boost levels when boosted at eight or 11

months. Boosting also increased IgG and human angiotensin converting enzyme 2

(hACE2) receptor inhibition antibody levels against Omicron BA.1, BA.2, and

BA.5 variants, with levels that are comparable to those observed in Phase 3

efficacy studies.

In the pediatric expansion of PREVENT-19 which evaluated boosting in

adolescents aged 12 through 17, a single homologous booster dose was evaluated

for anti-S IgG, hACE2 receptor inhibition and neutralization antibody

responses. Following boosting, neutralizing titers were 2.7-fold higher than

those seen with primary vaccination, and a significant boost was observed for

antibody against Omicron BA.1, BA.2, and BA.5.

In both adults and adolescents, a third dose of the Novavax COVID-19 vaccine

decreased the antigenic distance between SARS-CoV-2 variant and prototype virus

strains, suggesting benefit for the prevention of COVID-19 against contemporary

variants such as Omicron. Additionally, in both adults and adolescents, booster

doses were well tolerated, with mostly mild to moderate reactogenicity that was

of short duration.

Study 307 (Lot Consistency) adult homologous and heterologous boosting

Study 307 (Lot Consistency) achieved its primary endpoint, showing that three

lots of the Novavax COVID-19 vaccine induced consistent immune responses in

adults aged 18 to 49. Further, anti-S IgG titers were within the range

previously found to correlate with high efficacy in the PREVENT-19 Phase 3

trial. Safety was also consistent across lots, with no serious related

treatment-emergent adverse events (AE). These findings confirm a consistent

vaccine manufacturing process.

Further, heterologous boosting responses were consistent across participants

who received primary vaccines from Moderna, Pfizer, or Johnson & Johnson, with

IgG levels approximating levels observed in PREVENT-19.

About PREVENT-19

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial |

COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to

evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M

adjuvant in 29,960 participants 18 years of age and over in 119 locations in

the U.S. and Mexico. The primary endpoint for PREVENT-19 was the first

occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19

with onset at least seven days after the second dose in serologically negative

(to SARS-CoV-2) adult participants at baseline. The statistical success

criterion included a lower bound of 95% CI >30%. A secondary endpoint was the

prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both

endpoints were assessed at least seven days after the second study vaccination

in volunteers who had not been previously infected with SARS-CoV-2. In the

trial, NVX-CoV2373 achieved 90.4% efficacy overall. It was generally

well-tolerated and elicited a robust antibody response after the second dose in

both studies. Full results of the trial were published in the New England

Journal of Medicine (

https://c212.net/c/link/?t=0&l=en&o=3674737-1&h=1669937553&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3650790-1%26h%3D2140323749%26u%3Dhttps%253A%252F%252Fwww.nejm.org%252Fdoi%252Ffull%252F10.1056%252FNEJMoa2116185%253Fquery%253Dfeatured_home%26a%3DNew%2BEngland%2BJournal%2Bof%2BMedicine&a=New+England+Journal+of+Medicine

).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled,

observer-blinded trial to evaluate the safety, effectiveness, and efficacy of

NVX-CoV2373 with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17

years of age in 73 locations in the U.S., compared with placebo. In the

pediatric trial, the vaccine achieved its primary effectiveness endpoint

(non-inferiority of the neutralizing antibody response compared to young adult

participants 18 through 25 years of age from PREVENT-19) and demonstrated 80%

efficacy overall at a time when the Delta variant of concern was the

predominant circulating strain in the U.S. Additionally, immune responses were

about two-to-three-fold higher in adolescents than in adults against all

variants studied.

About Study 307 (Lot Consistency)

Study 307 (Lot Consistency) evaluated three different lots of the Novavax

COVID-19 vaccine in approximately 900 adults aged 18 through 49, who received

an initial primary series of the Novavax COVID-19 vaccine or other authorized

or approved vaccines and a subset who had also received a booster shot with an

authorized or approved COVID-19 vaccine at least six months prior. Participants

were boosted with a single dose of the Novavax COVID-19 vaccine. Immunogenicity

and safety were assessed, along with a comparison of IgG levels based on the

vaccine that was used for the primary series. The study achieved its primary

endpoint, showing that three lots of the Novavax COVID-19 vaccine tested

induced consistent immune responses. Further, anti-S IgG titers were within the

range previously found to correlate with high efficacy in the PREVENT-19 Phase

3 trial. Safety was also consistent across lots, with no serious related

treatment-emergent AEs. These findings confirm a consistent vaccine

manufacturing process.

About the Novavax COVID-19 vaccine (NVX-CoV2373)

The Novavax COVID-19 vaccine (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 (S) 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. The Novavax COVID-19 vaccine

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 2degrees- 8degrees 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

chain.

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 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 (

https://www.linkedin.com/company/novavax/ ).

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 and bivalent Omicron-based /

original strain based vaccine, a COVID-seasonal influenza combination

investigational vaccine candidate, its quadrivalent influenza 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, intended utilization, and

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; 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 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 | +1 240-268-2022

ir@novavax.com

Media

Ali Chartan or Giovanna Chandler | +1 202-709-5563

media@novavax.com

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SOURCE: Novavax, Inc.