Moderna files for authorization of COVID vaccine in teens ages 12-17
Moderna has filed for emergency use authorization with the FDA for its COVID-19 vaccine for use in US teens ages 12 to 17.
“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.”
Moderna’s COVID vaccine is currently authorized for people ages 18 and older.
Last month, Moderna released results from a Phase 2/3 trial of more than 3,700 children ages 12 to 17 in the United States. Data from blood tests showed that the COVID 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 got the COVID vaccine got sick with COVID-19, starting 14 days after their second dose, which is when you are considered to be fully vaccinated.
Four of the children who received the placebo in the trial tested positive for COVID-19, according to Moderna.
The company has already filed for younger-age vaccine authorization in Canada and Europe and Moderna plans to continue to file with other regulatory agencies around the world.
On May 10, Pfizer received authorization for people as young as 12 to use its COVID-19 vaccine.
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