The U.S. Food and Drug Administration Monday lowered the age that people can receive the Pfizer COVID-19 vaccine in the United States to 12. The vaccine was authorized for use in ages 16 and up in December.
In a statement on the FDA’s website, the agency’s acting commissioner Dr. Janet Woodcock called the authorization “a significant step in the fight against the COVID-19 pandemic.” The action, she wrote, “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.”
FDA officials sought to assure parents and guardians that the FDA undertook a rigorous and thorough review of all available data when making its decision.
“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,” says the director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks.
The FDA determined the potential benefits of the vaccine in those 12 years of age and older “outweigh the known and potential risks.”
More than a million adolescent cases reported
From March 1, 2020, through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention. Children and adolescents generally experience milder COVID-19 symptoms as compared to adults.
The Pfizer vaccine will be available to younger teens and children as a series of two doses, three weeks apart, the same dosage and dosing regimen for those 16 years of age and older.
The Centers for Disease Control and Prevention’s federal vaccine advisory committee, the Advisory Committee on Immunization Practices (known as ACIP), is scheduled to vote on whether to recommend the shot for 12- to 15-year-olds at an emergency meeting on Wednesday, May 12.
For more on the vaccine’s benefits and risks, view the updated FDA Fact Sheets for vaccination providers and recipients and caregivers.
