Moderna seeks FDA authorization for COVID-19 vaccine for people ages 12 to 17
Moderna has filed with the US Food and Drug Administration for emergency use authorization for its COVID-19 vaccine for people ages 12 to 17, according to a news release from the company.
Moderna’s COVID-19 vaccine is currently authorized for people ages 18 and older.
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 showed that the vaccine produced an immune response that was equivalent to earlier findings in adults. In that trial, initial observations found that none of the children who received the vaccine got sick with COVID-19 starting 14 days after their second dose. Four of the children who received the placebo tested positive for COVID-19.
The company has already filed for younger-age vaccine authorization with regulators in Canada and Europe.
Pfizer received authorization for people as young as 12 to use its coronavirus vaccine on May 10. Days later, it was recommended for use by the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, and CDC Director Dr. Rochelle Walensky accepted the recommendation.
Although younger people are much less likely to become seriously ill with COVID-19, Walensky warned recently that in the month before the Pfizer vaccine was authorized for people as young as 12, the agency observed “troubling data” about adolescents hospitalized with severe COVID-19. And, younger people can spread the virus to older and more vulnerable people.
The other COVID-19 vaccine available for use in the United States, made by Johnson & Johnson, is currently authorized for for people ages 18 and older.
