FDA Expands Pfizer Booster Use to 16-17 Years-Old

On 12/9/2021, the U.S. Food and Drug Administration (FDA) expanded the use of a single Pfizer-BioNTech COVID-19 Vaccine booster dose to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer vaccine.  Just in mid-November, the FDA authorized the use of a Pfizer or Moderna vaccine booster to all individuals 18 years old or older at least six months after completion of primary vaccination with the Pfizer or Moderna vaccines, or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.  The new amendment of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine was based on FDA’s analysis of immune response data from individuals who received single booster doses.  The analysis found a demonstrated booster antibody response, thereby supporting the expansion of the eligible booster age population.  The U.S. Centers for Disease Control and Prevention and FDA continue to “monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety concerns.”