- US FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults

GAITHERSBURG, Md., Oct. 21, 2022 /PRNewswire/ -- 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 Vaccine -19, adjuvanted (NVX-CoV2373) received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) to provide a first booster dose at least six months after completing the primary vaccination with a licensed or approved COVID-19 vaccine for persons older than 18 years of age for whom the FDA-licensed bivalent mRNA booster vaccine against COVID-19 is not accessible or clinically appropriate, and for persons older than 18-year-olds who choose to receive the Novavax COVID-19 vaccine, adjuvanted because they would not otherwise receive a booster dose of a COVID-19 vaccine.

"The United States now has access to the adjuvanted Novavax COVID-19 vaccine, the first protein-based option, as a booster," said Stanley C. Erck, Chairman and CEO of Novavax. "According to CDC data, nearly 50 percent of adults who received their primary series have not yet received their first booster dose. Offering another vaccine option may help increase COVID-19 booster vaccination rates." 19 for these adults."

The FDA's EUA decision was based on data from the Phase 3 Prevent-19 clinical trial and the UK-sponsored COV-BOOST trial. In the phase 3 trial, a single booster dose of adjuvanted Novavax COVID-19 vaccine was administered to healthy adult participants aged 18 years and older approximately eight to 11 months after their primary series. After a booster dose, antibody levels were significantly increased relative to pre-boost levels, exceeding levels associated with protection in Phase 3 trials. Neutralizing antibodies were also increased 34- to 27-fold compared to neutralizing antibodies. pre-boost levels when boosted at eight or 11 months. In the COV-BOOST trial, adjuvanted Novavax COVID-19 vaccine increased antibody titers when used as a third dose after initial dosing with another licensed COVID-19 vaccine (heterologous boost).

In the trial, after the boost, local and systemic reactions had a mean duration of approximately two days. The incidence of grade 3 or higher events remained relatively low. Safety reports of reactogenicity events showed an increasing incidence across all three doses of Novavax COVID-19 vaccine, adjuvanted, often seen with increased immunogenicity. Among participants older than 18 years of age, solicited adverse reactions after administration of a booster dose of adjuvanted Novavax COVID-19 vaccine were injection site pain/tenderness (81.1%), fatigue / general malaise (63.4%), muscle pain (63.0%), headache (52.9%), joint pain (30.3%), nausea/vomiting (14.7%), injection site swelling (8.4%), injection site redness (6.3%), and fever (6.3%).

The next step for the vaccine is a policy recommendation for use as a first booster from the Centers for Disease Control and Prevention (CDC). Adjuvanted Novavax COVID-19 vaccine doses are available for use in the US pending this final step and can be found on Vaccines.gov.

The Novavax vaccine is also available for use as a booster in adults over 18 years of age in the European Union, Japan, Australia, New Zealand, Switzerland, and Israel. In addition, several countries have policy recommendations that allow the use of the vaccine as a heterologous or homologous booster dose. In the US, the FDA granted the EUA for a two-dose primary series in adults 18 years and older in July and for adolescents 12 to 17 years of age in August. Following these EUAs, the CDC recommended the use of the vaccine as a primary series for both age groups.

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 Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense of the Department of Defense (JPEO-CBRND) under contract number MCDC2011-001.

Use of Novavax COVID-19 Vaccine, Adjuvanted in the US

Novavax COVID-19 Vaccine, Adjuvanted Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA, under a FDA Use Authorization. (USA) to prevent coronavirus disease 2019 (COVID-19) as a primary series for individuals 12 years of age and older. Novavax COVID-19 vaccine, adjuvanted vaccine is also licensed to provide a first booster dose at least 6 months after completion of primary vaccination with a licensed or approved COVID-19 vaccine to persons 18 years of age and older for whom a FDA licensed vaccine. The bivalent mRNA COVID-19 booster vaccine is not accessible or clinically appropriate, and for persons 18 years of age and older who choose to receive the Novavax COVID-19 vaccine, adjuvanted because they would not otherwise receive a dose booster of a vaccine against COVID-19.

Emergency use of this product is only authorized for the duration of the statement that circumstances exist that warrant authorization of emergency use of the medical product under Section 564(b)(1) of the FD Act.

authorized use

Novavax COVID-19 Vaccine, Adjuvanted is licensed 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 the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people over 12 years of age. Novavax COVID-19 vaccine, adjuvanted vaccine is also licensed to provide a first booster dose at least 6 months after completion of primary vaccination with a licensed or approved COVID-19 vaccine to persons 18 years of age and older for whom a FDA licensed vaccine. The bivalent mRNA COVID-19 booster vaccine is not accessible or clinically appropriate, and for persons 18 years of age and older who choose to receive the Novavax COVID-19 vaccine, adjuvanted because they would not otherwise receive a dose booster of a vaccine against COVID-19.

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer Novavax COVID-19, Adjuvanted vaccine to individuals with a known history of a serious allergic reaction (eg, anaphylaxis) to any component of Novavax COVID-19, Adjuvanted vaccine.

Warnings and precautions

Treatment of acute allergic reactions: In the event of an acute anaphylactic reaction following administration of the Novavax COVID-19 vaccine, adjuvanted, appropriate medical treatment should be immediately available to control allergic reactions immediately. Monitor recipients of the Novavax COVID-19 vaccine, adjuvanted for the appearance of immediate adverse reactions according to the link.

Myocarditis and pericarditis: Data from clinical trials provide evidence of an increased risk of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, adjuvanted (see full US Prescribing Information). CDC has published considerations related to myocarditis and pericarditis after vaccination, including vaccination of persons with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations- us.html

Syncope (fainting): May occur in association with the administration of injectable vaccines. Procedures should be established to prevent injury from fainting.

Impaired Immune Competence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a decreased immune response to Novavax COVID-19 vaccine, adjuvanted.

Limitations of Vaccine Efficacy: Novavax COVID-19 vaccine, adjuvanted may not protect all vaccine recipients.

Adverse reactions

Adverse reactions reported in clinical trials following administration of 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, reactions related to lymphadenopathy, myocarditis, and pericarditis.

Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported after administration of Novavax COVID-19 vaccine, adjuvanted outside of clinical trials.

Additional adverse reactions, some of which may be serious, may manifest with more widespread use of Novavax COVID-19 vaccine, adjuvanted.

Reporting of adverse events and vaccine administration errors

The vaccine provider enrolled in the Federal COVID-19 Vaccine Program is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):

Complete and Submit VAERS Reports Online: For more help with VAERS reporting, call 1-800-822-7967. Reports must include the words "Novavax COVID-19 Vaccine, Adjuvanted USA" in the description section of the report.

To the extent possible, please report adverse events to Novavax, Inc. using the contact information below or by providing a copy of the VAERS form to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888 -988-8809, Phone number: 1-844-NOVAVAX (1-844-668-2829).

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About NVX-CoV2373 (Novavax COVID-19 Vaccine, Adjuvant)

NVX-CoV2373 is a protein-based vaccine designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes the COVID-19 disease. The vaccine was created using Novavax's recombinant nanoparticle technology to generate an antigen derived from the spike (S) protein of the coronavirus and is formulated with Novavax's proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate or 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 of antigen and 50 mcg of Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored between 2° and 8° Celsius, which allows the use of existing cold chain and vaccine supply channels. The use of the vaccine must be in accordance with official recommendations.

The NVX-CoV2373 PREVENT-19 trial is being conducted with the support of the United States government, including the Department of Defense, BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response, and the National Institute of Allergy. and Infectious Diseases, part of the HHS National Institutes of Health. BARDA is providing up to $1.75 billion under a Department of Defense agreement (number MCDC2011-001). JPEO-CBRND is also providing financing of up to $45.7 million under a separate agreement. To date, the US government has agreed to order 3.2 million doses of NVX-CoV2373 under these existing agreements. Novavax and the US Government will determine the schedule, price, and quantities for delivery of any additional doses of NVX-CoV2373. Novavax intends to pursue additional procurement in the United States of both NVX-CoV2373 doses and other potential formulations.

Novavax has established partnerships for the manufacturing, marketing and distribution of NVX-CoV2373 around the world. Existing authorizations take advantage of Novavax's manufacturing partnership with the Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented by data from additional manufacturing sites throughout Novavax's global supply chain.

About Matrix-M™ Adjuvant

Novavax's proprietary saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect in stimulating the entry of antigen-presenting cells to the injection site and enhancing antigen presentation in local lymph nodes, thereby increasing the immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that advances global health through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent health needs around the world. Novavax's COVID-19 vaccine has received authorization from multiple regulatory authorities around the world, including the United States, the European Commission and the World Health Organization. The vaccine is under review by multiple regulatory agencies around the world, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a combined seasonal flu-COVID vaccine candidate in a phase 1/2 clinical trial, its investigational quadrivalent flu vaccine candidate, and is also evaluating a vaccine based on the Omicron strain (NVX-CoV2515), as well as a bivalent vaccine based on the Ómicron/original strain. These candidate vaccines incorporate Novavax's 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.

Forward-Looking Statements Statements in this document regarding the future of Novavax, its operating plans and prospects, its partnerships, the possibility of additional doses of NVX-CoV2373 and other possible formulations being ordered by the US government, the timing of the results of clinical trials, the ongoing development of NVX-CoV2373, NVX-CoV2515, and a bivalent vaccine based on the Omicron/original strain, an investigational COVID seasonal influenza vaccine candidate, the scope, schedule, and result of future regulatory filings and actions, including possible approval by the Director of the Centers for Disease Control and Prevention, Novavax's plans to file a biologics license application with the FDA in 2023, Novavax's plans to supplement existing authorizations with data from additional manufacturing sites in Novavax's global supply chain, global clearances additional NVX-CoV2373 for use in adults and adolescents, and as reinforcement, the potential impact and scope of Novavax and NVX-CoV2373 in addressing access to vaccines, pandemic control, and protection of populations, the efficacy, safety, and anticipated use of NVX-CoV2373, and the anticipated 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, but are not limited to, challenges in 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 regulatory authorities. applicable regulations; unforeseen challenges or delays in conducting clinical trials; difficulty obtaining scarce raw materials and supplies; resource limitations, including human capital and manufacturing capacity, on Novavax's ability to follow planned regulatory pathways; challenges in meeting contractual requirements under agreements with multiple commercial, government 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's 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). Investors are cautioned not to place undue reliance on the forward-looking statements contained in this press release. We encourage you to read our SEC filings, 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 material risks and uncertainties, including those listed above. Investors, potential investors and others should carefully consider these risks and uncertainties.

Contacts:

InversoresErika Schultz | 240-268-2022ir@novavax.com

MediosAli Chartan by Giovanna Chandler | 202-709-5563media@novavax.com

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