Discrepancies Between US Food and Drug Administration Vaccine Licensure Indications and Advisory Committee on Immunization Practices Recommendations: Provider Knowledge and Attitudes.

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. METHODS: 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. FINDINGS: 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 a...
Source: Clinical Therapeutics - Category: Drugs & Pharmacology Authors: Tags: Clin Ther Source Type: research