Moderna seeks FDA authorization for COVID vaccine for children ages 12 to 17
Moderna has officially requested that the US Food and Drug Administration approve emergency use authorization for its COVID-19 vaccine for children ages 12 to 17, according to a news release from the company, CNN reports.
The vaccine is currently authorized for people ages 18 and older and CNN notes that the company also filed for younger-age vaccine authorization with regulators in Canada and Europe.
A competing vaccine by Pfizer has already received authorization for vaccine use in individuals as young as 12.
Last month, Moderna released results from a Phase 2/3 trial of 3,732 children ages 12 to 17 in the United States; blood tests revealed that the vaccine triggered an immune response that was equivalent to earlier findings in adults.
During the trial, initial observations revealed that none of the children who received the vaccine became sick with COVID-19 starting 14 days after their second dose. However, four of the children who received the placebo tested positive for COVID-19.
The third US-approved COVID-19 vaccine, produced by Johnson & Johnson, is currently authorized for for people ages 18 and older.
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