Nuvaxovid

• Novavax has secured significantly improved financial terms in its amended collaboration agreement with Takeda for Nuvaxovid, including upfront payments, seasonal milestones, and ongoing royalties. • The strengthened partnership ensures continued availability of Nuvaxovid, a protein-based non-mRNA COVID-19 vaccine, in Japan's pharmaceutical market, the third largest globally. • This agreement validates Novavax's technology platform featuring protein-based nanoparticles and proprietary Matrix-M adjuvant, supporting the company's strategy to become a preferred partner through strategic collaborations.

The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.

• Novavax reported significant revenue decline with Q4 sales dropping to $88 million from $291 million year-over-year, reflecting diminishing COVID-19 vaccine demand and strategic repositioning. • The company is transforming from a vaccine manufacturer to a technology platform company, focusing on partnerships and licensing its Matrix-M adjuvant technology to major pharmaceutical firms. • Strategic cost-cutting measures aim to reduce annual expenses by 80% to $250 million by 2027, while a partnership with Sanofi could yield $175 million upon FDA full authorization of their COVID vaccine.

• The European Commission and 15 EU countries have initiated a joint procurement for protein-based COVID-19 vaccines, providing alternatives to mRNA vaccines for the 2024 vaccination campaigns. • Four COVID-19 vaccines are currently authorized in the EU: two mRNA-based (Comirnaty and Spikevax) and two protein-based (Nuvaxovid and Bimervax), with adapted versions targeting newer variants. • The European Medicines Agency has approved multiple adapted vaccines for autumn 2024, including Comirnaty JN.1, Spikevax JN.1, and Nuvaxovid JN.1, with Bimervax JN.1 under current assessment.

• Novavax's updated COVID-19 vaccine NVX-CoV2601, targeting the Omicron XBB.1.5 variant, demonstrated a 5.8-fold higher neutralizing antibody response compared to the original vaccine in a Phase 2/3 study. • The trial involving 332 adults showed 64% seroresponse rate for NVX-CoV2601 versus 7% for the original vaccine, with a favorable safety profile including mainly mild injection site reactions. • The study results support the value of strain-matched vaccine updates, suggesting improved protection against current COVID-19 variants for previously mRNA-vaccinated individuals.