FDA Expands Eligibility for COVID-19 Vaccine Boosters

The U.S. Food and Drug Administration (FDA) recently amended the emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines.  The FDA is now authorizing use of a single booster dose for all individuals 18 years of age and older at least six months after completion of the primary vaccination series of the Pfizer-BioNTech or Moderna COVID-19 Vaccines or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.  This amended authorization “is based on the FDA’s analysis of immune response data that supported use in the previously authorized populations for boosters.”  Pfizer and Moderna “are conducting post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis.”  The U.S. Centers for Disease Control and Prevention and FDA also “have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety concerns.”