Understanding FDA-Approved Labeling and CDC Recommendations for Use of Vaccines

Details

• Alternative Title:
  Pediatrics
• Personal Author:
  Meissner, H. Cody ; Farizo, Karen ; Pratt, Douglas ; Pickering, Larry K. ; Cohn, Amanda C.
• Description:
  Adherence to recommendations for the use of licensed vaccines ensures maximum individual and societal benefits from the national immunization program. The US Food and Drug Administration (FDA) licenses a vaccine once it determines that data submitted by the manufacturer reveal that the vaccine is safe and effective for its intended use. For each US-licensed vaccine, the FDA-approved prescribing information contains detailed information for health care providers to ensure safe and effective use. Centers for Disease Control and Prevention recommendations for the use of a licensed vaccine often are based on additional considerations, such as disease epidemiology, public acceptance, vaccine supply, and cost. Our objective in this article is to explain the reasons for the differences between FDA-approved prescribing information and Centers for Disease Control and Prevention recommendations for vaccine use.
• Subjects:
  Drug Approval Humans Practice Guidelines As Topic Product Labeling Vaccines
• Source:
  Pediatrics. 142(3)
• Pubmed ID:
  30139807
• Pubmed Central ID:
  PMC8988052
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Name as Subject:
  Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration.
• Place as Subject:
  United States
• Volume:
  142
• Issue:
  3
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:dc74d19f9398f78a55111d990655122c6ce959c0c5aeca0c2871256b2884831d
• Download URL:
  https://stacks.cdc.gov/view/cdc/116093/cdc_116093_DS1.pdf
• File Type:
  [PDF - 62.46 KB ]