Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018)

Abstract

Highlights Comparison of FDA PIs to EMA SmPCs showed little harmonization. Comparison of CDC VISs to EMA PLs showed even less harmonization. No pattern was observed in the number of labeling elements harmonized over time.

The CredibleMeds® list: Usage of QT interval prolonging drugs in Germany and discordances with prescribing information

“…For example, in a recently published study, the comparison between the FDA's and EMA's prescribing information showed little harmonization regarding the labelling of new vaccines. 47 In addition, it was shown that drug labels are updated more frequently in the period after their introduction to the market than later in its product life cycle, which leads to lack of updated information especially for longestablished drugs as well as generic drugs. 43,48 To the best of our knowledge, the FDA and EMA do not have their own official lists published for QT interval prolonging or torsadogenic drugs.…”

A Comparison of FDA and EMA Pregnancy and Lactation Labeling

“…One study evaluated the FDA and the EMA product labeling for new vaccines between 2006 and 2018. 8 The study found that despite the same clinical data being submitted for market authorization, the resulting labeling language is different across nearly all sections of labeling, including indicated populations. Interestingly, one of the labeling elements considered to have the greatest level of harmonization was Pregnancy Assessment, but no details of how this comparison was made were described.…”

“…Two previous studies evaluated the labeling language between the EMA SmPC and the FDA product labeling, although neither specifically sought to address pregnancy and lactation. One study evaluated the FDA and the EMA product labeling for new vaccines between 2006 and 2018 8 . The study found that despite the same clinical data being submitted for market authorization, the resulting labeling language is different across nearly all sections of labeling, including indicated populations.…”

Viewpoint of the European Pediatric Societies over Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Children Younger Than Age 12 Years Amid Return to School and the Surging Virus Variants

“…Vaccines undergo rigorous regulatory approval procedures to ensure their safety, efficacy, and quality 16 . Clinical trials are currently underway for the COVID-19 vaccine in children under 12 years old and is strictly monitored in the US by the Food and Drug Administration (FDA) and in Europe by the European Medicines Agency (EMA) 17 , 18 .…”