FDA licensure of and ACIP recommendations for vaccines

Volume 35, Issue 37, Pages 4825-5080 (5 September 2017)

FDA licensure of and ACIP recommendations for vaccines
Original Research Article
Pages 5027-5036
Larry K. Pickering, Walter A Orenstein, Wellington Sun, Carol J. Baker
Many healthcare providers are not familiar with the Food and Drug Administration (FDA) vaccine licensure process, the Advisory Committee on Immunization Practices (ACIP) vaccine recommendation process, and how FDA vaccine licensure and ACIP recommendations are related. Vaccines for use in the United States military and civilian populations are licensed by the FDA by several potential pathways but use of licensed vaccines in the civilian population should be based on recommendations made by the ACIP. In performing these distinct activities, FDA and ACIP function under different mandates. In this article, we discuss whether the FDA licensure pathways used to approve a vaccine impacts ACIP recommendation categories for vaccines licensed from 2006 to 2016.