F.D.A. Approves The Pfizer-BioNTech COVID-19 Vaccine For Children Aged 12-15

The Acting FDA Commissioner, Janet Woodcock M.D., has called this a “significant step in the fight against the COVID-19 pandemic.”

We’re making bold strides in slowing the spread of COVID-19, as kids between the ages of 12 and 15 may soon be able to receive the Pfizer-BioNTech vaccine. Previously, only those 16 and up were eligible to be vaccinated, with Moderna and Johnson & Johnson exclusively administering the vaccine to those 18 and older. This update only pertains to the Pfizer-BioNTech, as Moderna and Johnson & Johnson (the only approved vaccines in America) are still unavailable to those under the age of 18.

“[The] FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory 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, supporting the vaccine’s use,” The Food and Drug Administration wrote in a public release. The Acting FDA Commissioner, Janet Woodcock M.D. has called this a “significant step in the fight against the COVID-19 pandemic.”

While this news is relieving, the stamp of approval from the F.D.A. is not all that’s needed to move forward with vaccinating preteens and those in their early teen years. The New York Times reports that an advisory committee of the Centers for Disease Control and Prevention (CDC) must also gather soon to analyze data and make recommendations for vaccine usage on this younger crowd. Once the CDC signs off, the vaccine will be available immediately available for the approved age group.

“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,” the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., said in the aforementioned release. “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.”

Photo credit: Mehmet Ali Ozcan/Anadolu Agency via Getty Images

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