PR97494

GAITHERSBURG, Md., Aug. 20, 2022 /PRNewswire=KYODO JBN/ --

--Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in

the U.S.

--Doses of the Novavax COVID-19 Vaccine, Adjuvanted are now available and

primary series immunizations for adolescents can begin once a policy

recommendation from the CDC is received

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

and commercializing next-generation vaccines for serious infectious diseases,

today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has

received expanded emergency use authorization (EUA) from the U.S. Food and Drug

Administration (FDA) to provide a two-dose primary series for active

immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe

acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12

through 17.

Logo - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg

"Having more vaccine options for use in both adults and adolescents, like the

Novavax COVID-19 Vaccine, Adjuvanted will hopefully help increase vaccination

rates, particularly as we prepare for ongoing surges of COVID-19 with the start

of fall and the back-to-school season," said Stanley C. Erck, President and

Chief Executive Officer, Novavax. "We hope that our vaccine, developed using an

innovative approach to recombinant protein vaccine technology, may have a

special role in adolescent vaccination based on parents' and caregivers'

familiarity with protein-based vaccines used in other disease areas."

The FDA EUA decision was based on data from the ongoing pediatric expansion

(https://c212.net/c/link/?t=0&l=en&o=3626522-1&h=3854266283&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3585705-1%26h%3D3028641640%26u%3Dhttps%253A%252F%252Fir.novavax.com%252F2022-02-10-Novavax-Announces-Positive-Results-of-COVID-19-Vaccine-in-Pediatric-Population-of-PREVENT-19-Phase-3-Clinical-Trial%26a%3Dpediatric%2Bexpansion&a=pediatric+expansion) of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years

across 75 sites in the U.S., to evaluate the safety and effectiveness of the

Novavax COVID-19 Vaccine, Adjuvanted. In pediatric expansion, the vaccine

achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95%

CI: 37.55%, 92.45%) overall at a time when the Delta variant was the

predominant circulating SARS-CoV-2 strain in the U.S. The efficacy analysis was

supported by assessment of antibody titers that were shown to be higher in

adolescents than in young adults.

Safety data from the pediatric expansion showed the vaccine to be generally

well-tolerated. Serious and severe adverse reactions (AR) were low in number

and balanced between vaccine and placebo groups, and not considered related to

the vaccine. Local and systemic reactogenicity was generally lower than or

similar to adults, after the first and second dose. No new safety signal was

observed through the placebo-controlled portion of the study. Among

participants 12 through 17 years of age, solicited ARs following administration

of any dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection site

pain/tenderness (75.0%), headache (56.9%), fatigue/malaise (57.9%), muscle pain

(49.0%), nausea/vomiting (19.9%), joint pain (16.2%), fever (16.9%), injection

site swelling (8.0%), and injection site redness (7.5%). Most were

mild-to-moderate in severity and lasted less than two days.

The next step for the vaccine is a policy recommendation for use from the

Centers for Disease Control and Prevention (CDC). Doses (https://c212.net/c/link/?t=0&l=en&o=3626522-1&h=1202429836&u=https%3A%2F%2Fir.novavax.com%2F2022-07-11-U-S-Government-Secures-3-2-Million-Doses-of-Novavax-COVID-19-Vaccine&a=Doses) of the Novavax COVID-19 Vaccine, Adjuvanted are available for use in

adolescents upon the CDC's recommendation.

In July 2022 the U.S. FDA had granted EUA (https://c212.net/c/link/?t=0&l=en&o=3626522-1&h=3784108957&u=https%3A%2F%2Fir.novavax.com%2F2022-07-13-U-S-FDA-Grants-Emergency-Use-Authorization-for-Novavax-COVID-19-Vaccine%2C-Adjuvanted-for-Individuals-Aged-18-and-Over&a=EUA) for a two-dose primary series in adults aged 18 and older, followed by a

recommendation (https://c212.net/c/link/?t=0&l=en&o=3626522-1&h=3600652057&u=https%3A%2F%2Fir.novavax.com%2F2022-07-19-U-S-CDC-Advisory-Committee-Unanimously-Recommends-Novavax-COVID-19-Vaccine%2C-Adjuvanted-as-a-Primary-Series-for-Individuals-Aged-18-and-Older&a=recommendation) from the CDC Advisory Committee on Immunization Practices, and endorsement (https://c212.net/c/link/?t=0&l=en&o=3626522-1&h=1140185259&u=https%3A%2F%2Fir.novavax.com%2FU-S-Centers-for-Disease-Control-and-Prevention-Endorses-Advisory-Committee-on-Immunization-Practices-Recommendation-for-Novavax-COVID-19-Vaccine%2C-Adjuvanted&a=endorsement) from the CDC.

This project has been supported in part with federal funds from the Department

of Health and Human Services (HHS); the Administration for Strategic

Preparedness and Response; Biomedical Advanced Research and Development

Authority (BARDA), through the Department of Defense Joint Program Executive

Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)

under contract number MCDC2011-001.

Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.

The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by

the US Food and Drug Administration (FDA), but has been authorized for

emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a

two-dose primary series to individuals 12 years of age and older to prevent

Coronavirus Disease 2019 (COVID-19).

The emergency use of this product is only authorized for the duration of the

declaration that circumstances exist justifying the authorization of emergency

use of the medical product under Section 564(b)(1) of the FD&C Act unless the

declaration is terminated or authorization revoked sooner.

Authorized Use

The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an

Emergency Use Authorization (EUA) to provide a two-dose primary series for

active immunization to prevent coronavirus disease 2019 (COVID-19) caused by

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12

years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with

a known history of a severe allergic reaction (e.g., anaphylaxis) to any

component of the Novavax COVID-19 Vaccine, Adjuvanted.

Warnings and Precautions

Management of Acute Allergic Reactions: Appropriate medical treatment to manage

immediate allergic reactions must be immediately available in the event an

acute anaphylactic reaction occurs following administration of the Novavax

COVID-19 Vaccine, Adjuvanted. Monitor the Novavax COVID-19 Vaccine, Adjuvanted

recipients for the occurrence of immediate adverse reactions according to the

Centers for Disease Control (CDC) and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis: Clinical trials data provide evidence for

increased risks of myocarditis and pericarditis following administration of the

Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information).

Syncope (fainting): May occur in association with administration of injectable

vaccines. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence: Immunocompromised persons, including individuals

receiving immunosuppressant therapy, may have a diminished immune response to

the Novavax COVID-19 Vaccine, Adjuvanted.

Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted

may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions reported in clinical trials following administration of the

Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness,

fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection

site redness, injection site swelling, fever, chills, injection site pruritus,

hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and

pericarditis.

Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been

reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted

outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent

with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.

Reporting Adverse Events and Vaccine Administration Errors

The vaccination provider enrolled in the federal COVID-19 Vaccination Program

is responsible for mandatory reporting of the following to the Vaccine Adverse

Event Reporting System (VAERS):

    --  vaccine administration errors whether or not associated with an adverse

        event,

    --  serious adverse events (irrespective of attribution to vaccination),

    --  cases of Multisystem Inflammatory Syndrome (MIS), in adults and

        children, and

    --  cases of COVID-19 that results in hospitalization or death.

Complete and submit reports to VAERS online: For further assistance with

reporting to VAERS, call 1-800-822-7967. The reports should include the words

"Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the

report.

To the extent feasible, report adverse events to Novavax, Inc. using the

following contact information or by providing a copy of the VAERS form to

Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809,

Telephone Number: 1-844-NOVAVAX (1-844-668-2829).

Please click to see the Novavax COVID-19 Vaccine, Adjuvanted Fact Sheet for

Healthcare Providers Administering Vaccine (Vaccination Providers) and EUA Full

Prescribing Information. ( https://www.fda.gov/media/159897/download )

Please click to see the Fact Sheet for Recipients and Caregivers

(https://c212.net/c/link/?t=0&l=en&o=3626522-1&h=4115483347&u=https%3A%2F%2Fnovavax.widen.net%2Fs%2Fx5p5tqsdgw%2Fus-eua-fact-sheet-recipients&a=Fact+Sheet+for+Recipients+and+Caregivers).

About NVX-CoV2373 (Novavax' COVID-19 Vaccine, Adjuvanted)

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. NVX-CoV2373 contains purified protein antigen and can neither

replicate, nor can it cause COVID-19.

NVX-CoV2373 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°- 8° Celsius, enabling the use of existing vaccine

supply and cold chain channels. Use of the vaccine should be in accordance with

official recommendations.

The PREVENT-19 trial of NVX-CoV2373 is being conducted with support from the

U.S. government, including the Department of Defense, BARDA, part of the Office

of the Assistant Secretary for Preparedness and Response at the HHS, and the

National Institute of Allergy and Infectious Diseases, part of the National

Institutes of Health at HHS. BARDA is providing up to $1.75 billion under a

Department of Defense agreement (number MCDC2011-001). JPEO-CBRND is also

providing funding of up to $45.7 million under a separate agreement. To date,

the U.S. government has agreed to order 3.2 million doses of NVX-CoV2373 under

these existing agreements. Novavax and the U.S. government will determine the

timing, pricing, and amounts for delivery of any additional NVX-CoV2373 doses.

Novavax intends to pursue additional U.S. procurement of both NVX-CoV2373 doses

and other potential formulations.

Novavax has established partnerships for the manufacture, commercialization and

distribution of NVX-CoV2373 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. NVX-CoV2373, the company's

COVID-19 vaccine, has received authorization from multiple regulatory

authorities globally, including the FDA, European Commission and the World

Health Organization. The vaccine is currently under review by multiple

regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is

also currently evaluating a COVID-seasonal influenza combination vaccine

candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and

NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is

also evaluating 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/ ).

*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle

influenza vaccine candidate produced by Novavax. This investigational candidate

was evaluated during a controlled phase 3 trial conducted during the 2019-2020

influenza season.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and

prospects, its partnerships, the potential for subsequent orders from the U.S.

government for additional doses of NVX-CoV2373 and other potential

formulations, the timing of clinical trial results, the ongoing development of

NVX-CoV2373, including an Omicron strain based vaccine and bivalent

Omicron-based / original strain based vaccine, a COVID-seasonal 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, 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 of NVX-CoV2373, 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;

unanticipated challenges or delays in conducting clinical trials; 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

SOURCE: Novavax, Inc.