New England Journal of Medicine Publishes Novavax' NanoFlu Clinical Trial Data

• NanoFlu^TM Phase 1/2 trial data published in a peer-reviewed letter to the editor in The New England Journal of Medicine
• NanoFlu demonstrates significantly improved immune responses against a panel of homologous and drifted A(H3N2) influenza viruses compared to leading licensed egg-based, high-dose flu vaccine in older adults
• Phase 2 trial of quadrivalent NanoFlu expected to begin in third quarter of 2018

GAITHERSBURG, Md., June 13, 2018 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that The New England Journal of Medicine (NEJM) published a peer-reviewed letter to the editor detailing the positive results from Novavax' Phase 1/2 clinical trial in older adults comparing its Matrix- M(TM) adjuvanted nanoparticle seasonal influenza vaccine candidate (NanoFlu) to the leading licensed egg-based, high-dose influenza vaccine (IIV3-HD). The letter is available online at www.nejm.org/doi/full/10.1056/NEJMc1803554.

"We are pleased to be able to share the detailed data from the NanoFlu Phase 1/2 clinical trial with the broader scientific community," said Stanley C. Erck, President and Chief Executive Officer of Novavax, Inc. "The low effectiveness of seasonal influenza vaccines, and in particular the A(H3N2) component of the vaccine, during the 2017-2018 season emphasizes the need for a more effective vaccine. Our non-egg-based, recombinant nanoparticle vaccine, when coupled with Matrix-M, potentially offers broader protection against rapidly evolving drift strain variants. We believe this addresses important public health challenges caused by influenza and offers a significant advantage over current influenza vaccines."

In February 2018, Novavax reported the positive top-line results from the NanoFlu Phase 1/2 clinical trial in older adults. Details of the data, as published in this letter, include that NanoFlu in comparison to IIV3-HD induced:

• Hemagglutination inhibition (HAI) immune responses that were 28 to 64% greater against the homologous and four generations of drifted wild-type A(H3N2) influenza strains; and
• Higher HAI responses against the homologous A(H1N1) strain and comparable responses against the homologous B/Brisbane strain.

"These results showcase the potential benefit NanoFlu could have for older adults, a population challenged by poor immune responses. This population faces an urgent unmet medical need for a more effective flu vaccine, as highlighted by the severe flu season of 2017-2018," said Dr. Vivek Shinde, Executive Director, Clinical Development at Novavax and lead author of the letter. "We look forward to advancing this vaccine into the planned Phase 2 clinical trial of quadrivalent NanoFlu in the third quarter of 2018."