BALTIMORE — The University of Maryland School of Medicine (UMSOM) this week began an expansion of its adult Novavax clinical trial.
They have now added teens age 12-17 years old as the next group to be studied as part of the school’s broad portfolio of work addressing the COVID-19 pandemic.
The clinical trial began just as the U.S. Food and Drug Administration announced it has expanded the Emergency Use Authorization for the Pfizer vaccine for adults to now include adolescents 12-15 years old.
Just as with the adult vaccines – in which more than one vaccine is needed to help the U.S. and the world reach a level of normalcy not seen since early 2020 – more than one pediatric vaccine will be needed to fully vaccinate children and teens worldwide.
The expansion of the PREVENT-19 clinical trial will assess safety, efficacy, and immunogenicity of NVX-CoV2373, Novavax’s recombinant protein vaccine candidate against COVID-19, in up to 3,000 12-17 year olds who will be seen at up to 75 sites across the U.S.
Study participants will randomly receive either the Novavax vaccine candidate or a placebo in two doses given 21 days apart.
Two-thirds of participants will receive the vaccine, and one third will receive placebo.
Participants will be monitored for up to two years after receiving the second dose. A blinded crossover will occur later in the study, ensuring that all study participants eventually receive active vaccines.