Yellow fever vaccine: stronger precautions to minimise risk of serious and fatal reactions

26 November 2019

Article: 53/4706

In April 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) disclosed two 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), which resulted in strengthened recommendations to minimise vaccine-associated risks.

A joint letter from Health Protection Scotland (HPS), MHRA, National Travel Health Network and Centre (NaTHNaC), and Public Health England (PHE) was sent on 21 November 2019 to UK yellow fever vaccination centres to inform them of the recommendations.

The following measures should be utilised to minimise risk in those with weakened immune systems, in particular those aged 60 years or older or 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.
    • Vaccination should not be given for travel to areas in which vaccination is generally not recommended by the World Health Organization (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 manufacturer’s patient information leaflet should be given to everyone receiving a yellow fever vaccine as part of the travel consultation.

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 MHRA advised they are updating 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,as this will support rapid identification and referral for treatment of YEL-AND and YEL-AVD.

In addition, MHRA are producing a standardised pre-vaccination screening checklist and a patient group direction (PGD) template.

More information for health professionals can be found on the TRAVAX website.

Source: MHRA, 21 November 2019