Moderna will expand the size of its Covid-19 vaccine trial in younger children, the company said Monday, and will not seek emergency use authorization for the vaccine in that age group until later this year or early next year.
"We are actively discussing a proposal with the FDA. The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events," Moderna spokesperson Ray Jordan said in a statement to CNN.Parents are hesitant to vaccinate children, but pediatricians might be the keyThe original size of the trial was 6,750 children ages 6 months to 12 years. Moderna did not say how many additional children the trial will now include.
Pfizer has said it expects initial results of the Phase 2/3 trials in September for children 5 to 11, and results for younger children shortly after.Many parents are eager to vaccinate younger children as schools prepare to open for in-person learning in the fall. Pfizer vaccine is currently authorized for people as young as 12, but there's no vaccine available for younger children.
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