As part of a phase three trial of the Novavax, Inc. COVID-19 vaccine, NVX-CoV2373, up to 3,000 volunteers between 12 and 17 years old will be dosed at up to 75 sites across the United States to determine potential pediatric applications.
While the number of vaccines for adults has been growing, the world has largely put the question of COVID-19 vaccines for children on the backburner. Early on, this was due to scientific consensus that children were not in as much danger with regard to the disease. Novavax wants to be part of closing that final gap, and as such, the PREVENT-19 trial will evaluate the efficacy, safety, and immunogenicity alike for this vaccine among adolescents.
“Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic,” Dr. Gregory Glenn, president of research and development at Novavax, said.
For the trial, participants will be given either the vaccine candidate by intramuscular injection or a placebo. In either case, they will be given two doses, administered 21 days apart. After six months, the participants will return and reverse what they are given to guarantee all receive an active vaccine. Participants will then be monitored for up to two years after that final dose.
At the 21st annual World Vaccine Congress, the trial was also discussed through both a presentation and panel discussion.