Discrepancies Between US Food and Drug Administration Vaccine Licensure Indications and Advisory Committee on...

In the United States, the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA) is responsible for licensure of vaccines. The Advisory Committee on Immunization Practices (ACIP) is a federal advisory committee that provides guidance to the Centers for Disease Control and Prevention (CDC) on use of vaccines. Discrepancies between FDA licensure indications and ACIP/CDC vaccine recommendations exist, challenging health care providers. The objectives of this study were: (1) to categorize differences between FDA vaccine licensure indications and ACIP/CDC vaccine recommendations for vaccines; and (2) to assess knowledge, attitudes, and practices of pediatricians, family physicians, and obstetrician-gynecologists regarding their understanding of differences.

Information was extracted from FDAvaccine package inserts, and corresponding information was collected for ACIP/CDC vaccine recommendations (2000-2014) for vaccines in the childhood and adult immunization schedules. Surveys regarding knowledge of discrepancies were distributed electronically to members of the Georgia chapters of the American Academy of Pediatrics (GA-AAP) and the American Academy of Family Physicians (GA-AAFP), and the national American College of Obstetricians and Gynecologists (ACOG) in 2014.

Differences were identified in 20 instances: differences in age group indications were identified in 6, in dosing administration schedules in 4, and in immunocompromised hosts and pregnant women in 10. We received 145 (8.5%) responses from GA-AAP, 237 (9.5%) from GA-AAFP, and 869 (1.5%) from national ACOG members. A total of 105 (72%) GA-AAP respondents reported that they follow AAP recommendations and 168 (71%) GA-AAFP respondents follow ACIP recommendations. GA-AAP and GA-AAFP respondents generally were not aware of data the FDA considers for vaccine licensure or data that pharmaceutical company representatives are permitted to discuss. Respondents remain current with vaccine recommendations through review of materials from professional organizations, the CDC, and package inserts; Continuing Medical Education; and information from pharmaceutical representatives. A total of 780 (90%) ACOG respondents had no concerns regarding routinely recommended reduced diphtheria toxoid and acellular pertussis vaccines (n = 730 [84%]) and influenza during pregnancy vaccines (n = 852 [98%]) to pregnant patients. However, these findings must be interpreted within the context of a low overall ACOG survey response rate.

Education regarding existence of and reasons for discrepancies between FDA licensure of and ACIP/CDC recommendations for vaccines and reasons for these differences could optimize immunization delivery.