Business
Novavax Announces Initiation of Phase 2b/3 Hummingbird™ Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11 Years
GAITHERSBURG, Md., Aug. 4, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing
About this update from Novavax, Inc.
[{"type":"text","content":"GAITHERSBURG, Md., Aug. 4, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the initiation of its Phase 2b/3 Hummingbird™ global clinical trial. The trial will evaluate the safety, effectiveness (immunogenicity), and efficacy of two doses of the Novavax COVID-19 vaccine (NVX-CoV2373) in younger children aged six months through 11 years, followed by a booster at six months after the primary vaccination series.\n\"We are excited to begin the Hummingbird trial to study Nuvaxovid's efficacy in children as young as six months through age 11,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"With a successful trial, we may have the opportunity to offer our COVID-19 vaccine to all age groups aged six months and older for protection against this ongoing pandemic.\"\nThe trial will assess the Novavax COVID-19 vaccine in infants (six through 23 months of age), toddlers (two through five years) and children (six through 11 years). The trial is an age de-escalation trial and age groups will be tested sequentially. Participants have begun dosing in the six to 11-year-old age group. The trial will also have sentinel cohorts in each age group and cohort progression and age-de-escalation will occur after safety review.\nThe trial will seek to enroll 3,600 participants in the US, Mexico, Colombia, Argentina, Spain, UK, South Africa, Philippines, and Brazil. Initial results are expected in Q1 2023.\nAbout the Novavax COVID-19 vaccine (NVX-CoV2373)\nThe Novavax COVID-19 vaccine (NVX-CoV2373) 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. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19. \nThe Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for t...