FDA authorizes Pfizer vaccine for kids ages 12 to 15

Collaborator: Rachael Schuit
Published: 05/11/2021, 1:29 AM
Edited: 05/11/2021, 1:09 PM

(WASHINGTON D.C.) The Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) for Pfizer's COVID-19 vaccine on Monday to include kids between the ages of 12 and 15.

“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," said Acting FDA Commissioner Janet Woodcock, M.D. "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.”

According to the FDA, 1.5 million cases of COVID-19 in people between the ages of 11 and 17 were reported to the Centers for Disease Control (CDC) between March 1, 2020 to April 30, 2021. 

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”

The FDA says the possible benefits of anyone as young as 12 receiving the Pfizer vaccine, outweigh known and potential risks. 

In a clinical trial, 1,131 adolescents between the ages of 12 and 15 received the Pfizer vaccine. 

According to the FDA, side effects reported from this clinical trial were similar to those from the clinical trial with people ages 16 and older. 

The FDA says the side effects that were reported the most by the clinical trial participants that were between the ages 12 and 15 were pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain. 

The side effects typically lasted between one and three days. 


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