Novavax starts late-stage COVID-19 vaccine trial in U.S.

 

• Novavax (NASDAQ:NVAX) announces that it has initiated the Phase 3 study for its COVID-19 vaccine candidate in the U.S. and Mexico.
• The study, involving 30,000 volunteers aged 18 years and older, will evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in a randomized, placebo-controlled, observer-blinded trial, conducted in 155 sites.
• Two-third of subjects will randomly receive two intramuscular injections of the vaccine, administered 21 days apart, with one-third receiving the placebo. The company has designed the study to evaluate the vaccine candidate’s impact on a diverse population: More than 25% of subjects are 65 years old or older, and more than 15% comprises black/African American.
• Confirmed by PCR tests, the trial’s primary endpoint will be the prevention of symptomatic COVID-19, and the key secondary endpoint will be the prevention of symptomatic moderate or severe COVID-19.
• Adjuvanted with the proprietary, Saponin-based Matrix-M™ to enhance the immune response, NVX-CoV2373 is a protein-based vaccine candidate manufactured from the genetic sequence of SARS-CoV-2.
• Late last month, Novavax announced it completed the enrollment in the U.K.-based pivotal Phase 3 trial with results expected in 1Q 2021.
• https://seekingalpha.com/news/3647534-novavax-starts-late-stage-covidminus-19-vaccine-trial-in-u-s