FDA Authorizes Pfizer's COVID Vaccine For Kids Ages 12 To 15
By Bill Galluccio
May 10, 2021
The U.S. Food and Drug Administration has granted an emergency use authorization for Pfizer's COVID-19 vaccine to be given to children between the ages of 12 and 15.
The Centers for Disease Control and Prevention's vaccine advisory committee will meet on Wednesday (May 13) to review the data and decide if the vaccine can be distributed. If they approve the vaccine, which is widely expected, vaccinations for that age group could begin by the end of the week.
"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," Acting FDA Commissioner Janet Woodcock said in a statement. "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."
Pfizer said its vaccine had an efficacy of 100% in children ages 12 to 15 in a clinical trial with more than 2,000 participants. The drugmaker said that adolescents experienced similar side effects as adults, including injection site pain, fatigue, headache, muscle pain, chills, fever, and nausea.
Pfizer is expecting to be granted approval to distribute the vaccine to children under the age of 12 by the end of the year. In an earnings report released on May 4, Pfizer said it expects to apply for emergency use authorization in young children in September and infants in November.
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