Considerations for unblinding individual study participants during vaccine trials

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Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or “pseudo unblinding,” in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization.

Original languageEnglish (US)
Pages (from-to)3399-3402
Number of pages4
Issue number22
StatePublished - May 22 2023


  • Adverse events
  • Regulatory guidance
  • Unblinding
  • Vaccine
  • Vaccine safety
  • Vaccine trials

ASJC Scopus subject areas

  • Molecular Medicine
  • General Immunology and Microbiology
  • General Veterinary
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases


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