Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the European Union for Use as a Booster for Adults Aged 18 and Older

(Adnkronos) – GAITHERSBURG, Md., Sept. 12, 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 European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) as a homologous and heterologous booster for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for adults aged 18 and older. The approval follows the recommendation made by the European Medicines Agency’s Committee for Medicinal Products for Human Use on September 1, 2022. 

“We are pleased to offer the first protein-based vaccine as both a primary series and booster in the European Union,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “As we continue to explore best practices for managing COVID-19 long term, we have ongoing trials further exploring Nuvaxovid’s efficacy and safety as a booster and preclinical data has indicated that our vaccine induces immune response against Omicron variants, including BA.4/5.” 

The expanded CMA was based on data from Novavax’ Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a robust antibody response when used as a heterologous third booster dose. 

In the Novavax-sponsored trials, following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events (AE), potentially immune-mediated medical conditions, and severe AEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups. 

Nuvaxovid has also been authorized in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is actively under review in other markets. 

The EC previously granted CMA for Nuvaxovid to prevent COVID-19 in adults aged 18 and older in December 2021. Additionally, the EC granted expanded CMA for Nuvaxovid to prevent COVID-19 in adolescents aged 12 through 17 in July 2022. 

Trade Name in the U.S.The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration. 

Important Safety Information 

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) 

Nuvaxovid 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™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19. 

Nuvaxovid 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. 

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid 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 the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 Trials 

The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials. 

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial 240-268-2022ir@novavax.com
 

MediaAli Chartan or Giovanna Chandler

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