SILVER SPRING, Maryland. – The U.S. Food and Drug Administration (FDA) on Monday amended the emergency use authorization to expand the use of a single Pfizer booster dose to include use in individuals 12 and older.
The FDA determined that the protective health benefits of a single booster dose of the Pfizer vaccine will provide continued protection against COVID-19 and the associated risks that can occur, including hospitalization.
The decision was backed by real-world safety data that included results from more than 6,300 children in Israel, ages 12 through 15, who received the third shot. The FDA says there are no new safety concerns following a booster in this age of the population.
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said FDA Commissioner Janet Woodcock, M.D.
