This request is based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the
Preliminary safety data from the trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to
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