Regulatory PathRegulatory requirements compared

Active substance

Yellow fever vaccine

Open in the medicines table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
YF-VAX00428833109648 PFU / 0.5 MLPOWDER FOR SOLUTION · SUBCUTANEOUSSANOFI VACCINES CANADA LTD.

WHO WHO Model List of Essential Medicines (2025)

  • 19.3. Immunologicals > Vaccines · core
    Need for immunization against certain single viral diseases
    All vaccines should comply with the WHO requirements for biological substances.

Safety signals and safety-related labeling changes

  • MHRA 16 Nov 2021 Yellow fever vaccine (Stamaril): new pre-vaccination checklist
    A standardised pre-vaccination checklist has been introduced to ensure the yellow fever vaccine is indicated for the intended travel destination and to enable vaccinators to identify existing contraindications or precautions in individuals before vaccination.
  • MHRA 21 Nov 2019 Yellow fever vaccine: stronger precautions in people with weakened immunity and in those aged 60 years or older
    The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions. Key recommendations include new and updated contraindications and strengthened precautions to protect those with a weakened immune systems (including for people aged 60 years or older) and standardised risk-benefit evaluation procedures across UK yellow fever vaccination centres to ensure that people only receive the vaccine after a thorough risk assessment.

All safety entries for yellow fever vaccine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.