UNDATED, MI (WKZO AM/FM) – Monday, the U.S. Food and Drug Administration (FDA) announced that it has approved the use of the Pfizer vaccine in those 12 – 15 years of age.
The FDA amended the Emergency Use Authorization (EUA) originally issued on December 11, 2020 for use in individuals 16 years of age and older.
“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,” Acting FDA Commissioner Janet Woodcock, M.D. said in a statement. “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.”
In a statement, the FDA said it has determined that the Pfizer-BioNTech COVID-19 Vaccine meets the criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks.
The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.
“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,” director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said. “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.”
As part of the original EUA request, Pfizer Inc. submitted a plan to continue monitoring the safety of the vaccine as it is used under EUA. This plan has been updated to include the newly authorized adolescent population.
The full report can be viewed at this link.
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