Novavax confirms the examination by the European Medicines Agency of the conditional marketing authorization application for the COVID-19 vaccine

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GAITHERSBURG, Md., Nov. 17, 2021 / PRNewswire / – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines against serious infectious diseases, today announced that the European Medicines Agency (EMA) has started its assessment of a conditional marketing authorization (CMA) application for the COVID-19 vaccine from Novavax, which will be marketed in the European Union under the name Nuvaxovid ™ brand. The EMA statement can be viewed here.

“Today’s announcement from the EMA brings Novavax closer to our goal of ensuring broad global access to our protein-based COVID-19 vaccine across Europe,” said Stanley C. Erck, President and CEO of Novavax. “Novavax looks forward to providing an additional vaccine option in Europe, based on a proven and well-understood technology platform, and thanks the European Commission for its continued partnership and confidence in our COVID-19 program. “

The company announced earlier this month that it has completed the submission of all data and modules required by the EMA for the regulatory assessment of NVX-CoV2373, Novavax’s recombinant nanoparticle-based COVID-19 vaccine. with Matrix-M ™ adjuvant. The EMA has indicated that its assessment will proceed on an accelerated schedule, with an advisory potentially issued in a few weeks.

The chemistry, manufacturing and controls (CMC) dataset submitted to the EMA and other global regulatory agencies is based on Novavax’s manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume. It will then be supplemented with data from additional manufacturing sites in Novavax’s global supply chain.

The Novavax / IBS vaccine recently received Emergency Use Authorization (EUA) in Indonesia and the Philippines, and companies have also filed for Emergency Authorization in India and an Emergency Use List. (EUL) to the World Health Organization (WHO). Novavax has also announced regulatory filings for its vaccine in the UK, Australia, New Zealand, Canada and with the WHO. In addition, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax plans to submit the complete package to the US FDA by the end of the year. The brand name NuvaxovidTM has not been authorized by the US FDA.

About NVX-CoV2373 Phase 3 TrialsNVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a UK trial that demonstrated 96.4% efficacy against the original viral strain, 86.3% against the Alpha variant (B.1.1 .7) and an overall efficiency of 89.7%; and the PREVENT-19 trial in the United States and Mexico which demonstrated 100% protection against moderate and severe disease and an overall efficacy of 90.4%. It was generally well tolerated and elicited a strong antibody response.

About NVX-CoV2373NVX-CoV2373 is a protein-based vaccine candidate designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with Matrix-M ™ adjuvant patented saponin from Novavax to improve the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains a purified protein antigen and cannot replicate or cause COVID-19.

Novavax’s COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination schedule requires two doses of 0.5 ml (5 micrograms of antigen and 50 micrograms of Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored between 2 ° and 8 ° Celsius, which allows the use of existing vaccine supply and cold chain channels.

About Matrix-M ™ Adjuvant Novavax’s patented saponin-based Matrix-M ™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating entry of antigen-presenting cells into the injection site and improving antigen presentation in the injection site. local lymph nodes, thereby strengthening the immune response.

About NovavaxNovavax, 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 combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet urgent global health needs. Novavax is conducting advanced clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu ™, its quadrivalent nanoparticle influenza vaccine, has achieved all of the major goals of its pivotal Phase 3 clinical trial in the elderly. Both vaccine candidates incorporate Novavax’s proprietary saponin-based Matrix-M ™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with on Twitter and LinkedIn.

Forward-looking statementsThe following statements relating to the future of Novavax, including Novavax’s plans to supplement its CMC dataset submitted to the EMA with data from additional manufacturing sites in Novavax’s global supply chain, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties which could cause actual results to differ materially from those expressed or implied by these statements. These risks and uncertainties include challenges in meeting, alone or with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and test validation, necessary to meet applicable regulatory authorities; resource constraints, including human capital and manufacturing capacity, on Novavax’s ability to follow planned regulatory pathways; and the other risk factors identified in the “Risk factors” and “Management’s analysis and analysis of the financial position and operating results” sections of Novavax’s annual report on form 10-K for the year ended December 31, 2020 and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place significant reliance on any forward-looking statements contained in this statement. 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 statement speak only as of the date of this document, and we assume no obligation to update or revise any statements. Our business is subject to substantial risks and uncertainties, including those mentioned above. Investors, potential investors and others should carefully consider these risks and uncertainties.

Contacts:

Investors Novavax, Inc. Erika Schultz | [email protected]

Solebury TroutAlexandra Roy | [email protected]

Media Alison Chartan | 240-720-7804 Laura Keenan Lindsey | [email protected]

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SOURCE Novavax, Inc.



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