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Strengthened Recommendations to Minimise Risk of Serious and Fatal Reactions to Yellow Fever Vaccination

22 November 2019

In April 2019 the Medicines and Healthcare products Regulatory Agency (MHRA) disclosed 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril). In response, a Yellow Fever Vaccine Expert Working Group was convened by the Commission on Human Medicines (CHM). This has resulted in strengthened recommendations to minimise risk.

The following measures should be utilised to minimise risk in those with weakened immune systems, and in particular those aged 60 years or older and anyone who has had their thymus removed.

  • In people aged 60 years or older, due to a higher risk of life-threatening side effects, the vaccine should be given only when there is a significant and unavoidable risk of acquiring yellow fever infection, such as travel to an area where there is a current or periodic risk of yellow fever transmission
    • Vaccine should NOT be given for travel to areas in which vaccination is ‘generally not recommended’ by WHO.
  • Only healthcare professionals specifically trained in benefit-risk evaluation of yellow fever vaccine should administer the vaccine, following their individualised assessment of a person’s travel itinerary and suitability to receive the vaccine
  • The vaccine should NOT be administered to people:
    • who have had their thymus gland removed for any reason
    • who are taking biological drugs that are immunosuppressive or immunomodulating
    • who have a first-degree family history of YEL-AVD or YEL-AND following vaccination that was not related to a known medical risk factor (i.e. in case of an unidentified genetic predisposition).
  • The manufacturer’s patient information leaflet should be given to everyone receiving a yellow fever vaccine as part of the travel consultation.

The MHRA have also advised they are updating and producing:

  • The summary of product characteristics and patient information leaflet. This will include information about the early signs and symptoms of these severe side effects, so that vaccinees know to urgently seek medical attention if these side effects are suspected – this will support rapid identification and referral for treatment of YEL-AND and YEL-AVD.
  • A standardised pre-vaccination screening checklist - further information and advice to follow from Health Protection Scotland and  National Travel Health Network and Centre in England.
  • A patient group direction (PGD) template.

If there is any doubt about individual suitability for yellow fever vaccine, delay vaccination and seek specialist advice from the Travel and International Health Team of Health Protection Scotland via the clinical advice line 0141 300 1130 (available Monday and Wednesday 14:00 – 16:00 and Friday 09:30 – 11:30).

Further information can be accessed using the following links: