New Working Groups to be Established to Develop Guidance on Digital Apps for Vaccine Safety Data Collection

  • Digital apps have much potential for improving the quality of safety data collected during both pre and post-introduction of new vaccines, including SARS-COV-2 candidate vaccines.Brighton Collaboration (BC) is forming two inter-related working groups (both working together initially) to harmonize this effort as follows:
    • Group A: Clinically-focus on issues like which adverse events following immunizations (AEFI) to include and how to collect this information; building largely on prior BC guidance when possible.
    • Group B: Technology-focus on issues like which app standards to use, incentives for completion, regulatory approval, and privacy.
      Whenever possible, allowances for tiered approaches (e.g., flip vs. smartphone, patient vs. health worker as reporter of AEFI) will be made.

    It is envisioned to have 8-10 subject matter experts for each working group. Expertise in the following areas is sought:

    • Group A: vaccine safety, clinical trials, pharmacovigilance, medical informatics, and others as needed.
    • Group B: medical informatics, digital app development, ontologies, and others as needed.

    We welcome your participation and/or referral of experts willing to work and author a guidance document on a prioritized basis during the next 3-4 months.

    If you are interested, please email your CV to, specifying in subject line: “Interest in Group A: BC Digital Apps Clinical WG” or ““Interest in Group B: BC Digital Apps Technology WG”.