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“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 Dr. Janet Woodcock on granting emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to those 12-year-old and older.

Published on

may 10, 2021

  • "The issuance of an EUA is not an FDA approval (licensure) of a vaccine." The FDA makes clear in this statement the "emergency use authorization" allows use of the vaccine during a health emergency, which is different than a full approval of the vaccine.
  • The FDA says the safety data included more than 2200 pre-teens and teenagers enrolled in a clinical trial - about half received the vaccine and the other half received a placebo.
  • "More than half of the participants were followed for safety for at least two months following the second dose."
  • Those in their early teens experienced some of the same side-effects as those 16-years-old and older - including more pronounced soreness, aches, and fever after the second dose.
  • Why It Matters: Some health officials believe vaccinated young adults is a necessary step towards ending the pandemic; others disagree and believe an emergency use authorization for a portion of the population not severely impacted by COVID-19 may not be appropriate.

Read the press release HERE

Developing Story: More context coming soon on SmartHER News.

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