Novavax will begin dosing children and adolescent participants in the ongoing phase 3 clinical trial review for NVX-CoV2373, the company’s investigational COVID-19 vaccine, for the prevention of the pandemic virus.
The biotechnology vaccine company announced Monday morning that the North American-based PREVENT-19 pivotal trial will start a new treatment arm of up to 3,000 adolescents ages 12-17 at 75 sites across the US. The younger participants will be included in the company’s assessment of the efficacy, safety and immunogenicity of NVX-CoV2373 against COVID-19.
New pediatric and adolescent patients will be split 2: 1 into either NVX-CoV2373 or placebo over 2 doses administered 21 days apart. The researchers plan to perform a blind crossover 6 months after initiation to ensure that all participants receive the active vaccine. Safety results will be observed in participants for up to 2 years.
The study vaccine is currently being evaluated in a few pivotal Phase 3 studies: PREVENT-19 and a UK study that previously showed 100% prevention against severe COVID-19, 96.4% efficacy against the original SARS-CoV-2 strain, 86 , 3% efficacy against the B.1.1.7 variant and 89.7% overall efficacy.
In addition, researchers have been conducting a few phase 2 studies since August 2020. The first has shown 100% prevention against serious diseases and 48.6% efficacy against the South African variant, among South African participants. The second, a phase 1/2 continuation in the US and Australia, is underway.
PREVENT-19 started in December 2020. Its early successes, as well as that of international studies, in adult participants lead Novavax to believe there is great hope for protecting children and adolescents from COVID-19.
“By expanding our PREVENT-19 clinical trial, we hope to build on the encouraging safety and efficacy data generated to date in adults for our vaccine candidate and play an important global role in offering vaccination to so many Possibly people around the world age groups to end the suffering caused by the pandemic, ”said Gregory M. Glenn, MD, chair of Research and Development at Novavax, in a statement.