BALTIMORE (WJZ) -- The University of Maryland School of Medicine began the expansion of clinical trials for the Novavax COVID-19 vaccine in teenagers aged 12 through 17 this week.
The clinical trials began just as the U.S. Food and Drug Administration announced the extension of the Emergency Use Authorization for the Pfizer vaccine to now include those ages 12 and up. However, just as with the adult vaccine, more than one pediatric will be needed to fully vaccine children and teens across the globe.
The expansion of the PREVENT-19 study will evaluate the safety, effectiveness and immunity of the Novavax vaccine. The clinical trials will include participants aged 12 through 17 who will been seen at 75 sites across the United States.
Participants will randomly receive the Novavax vaccine or placebo in two doses given 21 days apart. Two thirds of the group will receive the vaccine and one third will receive the placebo. Participants will be monitored for up to 2 years after receiving the second dose.
A blinded crossover will take place later in the study to ensure all participants receive active vaccines.
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