FDA Authorizes COVID-19 Emergency Use of Vaccines for Children

The U.S. Food and Drug Administration (FDA) recently amended the emergency use authorization (EUA) for the Moderna and Pfizer-BioNTech  COVID-19 vaccines.  The FDA is now authorizing use of these two vaccines in individuals 6 months of age and older.  The FDA “determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.”  The FDA also convened its Vaccines and Related Biological Products Advisory Committee to “help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”  At its June 14-15, 2022 meeting, the Advisory Committee discussed, and voted in support of, the amended EUA for these two vaccines.  “As part of their original EUA requests, both ModernaTX Inc. and Pfizer Inc. submitted plans to continue to monitor the safety of the vaccines as they are used under EUA,” and these plans “have been updated to include the newly authorized populations.”  The FDA and U.S. Centers for Disease Control and Prevention also “have several systems in place to continually monitor COVID-19 vaccine safety and allow for the timely detection and investigation of potential safety concerns.”