Novavax Reports 2nd Quarter 2022 Financial Results and Operational Highlights.

GAITHERSBURG, Md: Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the second quarter ended June 30, 2022.

"We are pleased with our progress since the start of the second quarter, which importantly included delivering our vaccine to the U.S. market with immunizations underway," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With over 23 million doses delivered since the start of the third quarter, we are distributing our vaccine globally and have gained positive momentum as we move into the remainder of 2022 and into 2023. Through continued expansions to our label for adolescents and boosting and our vaccine's competitive product profile, we are confident it will play an important role in the long-term COVID-19 landscape."

Second Quarter 2022 and Recent Highlights

Progressed COVID-19 Global Regulatory Strategy

Received Emergency Use Authorization (EUA) from United States (U.S.) Food and Drug Administration (FDA) with label expansion underway, marking first protein-based COVID-19 vaccine available for use domestically

Authorized for primary series in adults 18 and older with unanimous recommendation received from U.S. Centers for Disease Control and Prevention (CDC)

Planned submission for boosting data from PREVENT-19 Phase 3 trial in August of 2022

Nuvaxovid or Covovax authorized in 43 countries for primary series in adults 18 and older, with additional label expansions received and underway in several geographies

Authorized for boosting in adults 18 and older in Japan, Australia and New Zealand

Nuvaxovid filings completed in the European Union (EU), Great Britain and Switzerland

Authorized for primary series in adolescents aged 12 through 17 in the EU, India, Australia, Japan and Thailand

Nuvaxovid filings completed to the World Health Organization (WHO), Great Britain, Canada, Switzerland, New Zealand and Taiwan

Expect to file for authorization of Omicron-containing vaccine with U.S. FDA in the fourth quarter of 2022

COVID-19 Vaccine Manufacturing and Distribution

Delivered over 73 million doses of Nuvaxovid and Covovax globally to date, including 23 million doses since the start of the third quarter 2022, reflecting strong momentum for the remainder of 2022

Secured order from U.S. government for 3.2 million initial doses under existing...

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