The Food and Drug Administration on Monday expanded the emergency use authorization of Pfizer-BioNTech’s Covid-19 vaccine to include 12- to 15-year-olds.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D.
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
The two-dose vaccine is already authorized for use in people 16 and older.
However, the Centers for Disease Control and Prevention’s vaccine advisory committee is scheduled to meet this Wednesday to review the vaccine for kids. If approved by the CDC, adolescents could start receiving the vaccine as soon as this week.
In late March, the companies had said that the vaccine was found to be 100% effective in a clinical trial of more than 2,000 adolescents. They also said the vaccine showed a “robust” antibody response in the children, exceeding those in an earlier trial of older teens and young adults. Side effects were generally consistent with those seen in adults, they added.
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