Novavax Receives Full Marketing Authorization for Prototype COVID … – Novavax Investor Relations

GAITHERSBURG, Md., Oct. 18, 2023 /PRNewswire/ --Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for individuals aged 12 and older for active immunization to help prevent COVID-19.

"Full marketing authorization of our prototype COVID-19 vaccine in the U.K. is a stepping stone to enable authorization of updated strains of our vaccine in the future," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We are working with the MHRA to provide the information needed for the rapid review of our updated protein-based non-mRNA COVID-19 vaccine as an important step to ensuring access to vaccine options in the U.K. this coming vaccination season."

Authorization was based on two Phase 3 trials, PREVENT-19 conducted in the U.S. and Mexico and a Phase 3 trial in the U.K., as well as a Phase 2a/b trial in South Africa. In these trials, Novavax demonstrated the efficacy and safety of its prototype vaccine as a primary series in individuals aged 12 and older, and the immunogenicity and safety of the vaccine as a booster in individuals aged 18 and older.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/or search for MHRA Yellow Card in the Google Play or Apple App Store. When reporting please include the vaccine brand and batch/Lot number if available.

i. Additional efficacy and safety data are being collected.

Trade Name in the U.S.The trade name Nuvaxovid has not been approved by the U.S. Food and DrugAdministration.

Important Safety Information: U.K.

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

About Nuvaxovid (NVX-CoV2373) NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2 to 8C, enabling the use of existing vaccine supply and cold chain channels.

About the PREVENT-19 Phase 3 TrialThe PRE-fusion protein subunitVaccineEfficacyNovavaxTrial COVID-19 (PREVENT-19) was a randomized, placebo-controlled, observer-blinded Phase 3 trial conducted in the U.S. and Mexico to evaluate the efficacy and safety of NVX-CoV2373 as a primary series and as a booster in adults and adolescents to prevent SARS-CoV-2 infection. As a primary series, the primary endpoint was the first occurrence of polymerase chain reaction (PCR)-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second dose in 29,960 adult participants aged 18 and older at baseline without protocol violations prior to illness. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Full results of the trial were published in the New England Journal of Medicine.

About the NVX-CoV2373 U.K. Phase 3 TrialThe primary endpoint in this phase 3, randomized, observer-blinded, placebo-controlled trial conducted in the United Kingdom (U.K.), was first occurrence of confirmed COVID-19 with onset at least seven days after the second vaccination. The trial enrolled 14,039 adult participants aged 18 and older. Full results were published in the New England Journal of Medicine.

About Matrix-M Adjuvant When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

About Novavax Novavax, Inc. (Nasdaq:NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases.Novavax, a global company based inGaithersburg,Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovativenanoparticletechnology andNovavax'spatentedMatrix-Madjuvant to enhance the immune response. Focused on the world's most urgent health challenges,Novavaxis currently evaluating vaccines for COVID-19, influenza and COVID-19 and influenza combined. Please visitnovavax.comandLinkedInfor more information.

Forward-Looking StatementsStatements herein relating to the future ofNovavax, its operating plans and prospects,the scope, timing and outcome of future regulatory filings and actions.Novavaxcautions 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; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability ofNovavaxto pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for its product candidates, including future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges;and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections ofNovavax'sAnnual Report on Form 10-K for the year endedDecember 31, 2022and 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 atwww.sec.govandwww.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.

CONTACTSInvestorsErika Schultz240-268-2022 [emailprotected]

MediaAli Chartan 240-720-7804 [emailprotected]

SOURCE NOVAVAX, INC

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Novavax Receives Full Marketing Authorization for Prototype COVID ... - Novavax Investor Relations