Yellow fever vaccine: Stamaril – additional robust precautions for specific patient groups

Following very rare fatal adverse reactions after administration of the yellow fever vaccine, Stamaril, the MHRA has issued additional strengthened patient safety recommendations

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new drug safety update highlighting additional robust precautions for  yellow fever (YF) vaccine (Stamaril) administration in individuals aged 60 years and over and those with weakened immune systems following recent reports of fatal adverse reactions.  The MHRA issued a drug safety update in April 2019 which advised healthcare professionals of the risks of using the YF vaccine in the above patient groups; these recommendations have been strengthened and updated.

In addition to the information that was issued in the previous drug safety update, all healthcare professionals should be aware of the following advice in relation to the YF vaccine, Stamaril:

• It is very effective in protecting against yellow-fever infection, which can be fatal; however it is crucial that healthcare professionals adhere strictly to cautions and contraindications to minimise the risk of very rare, but possibly fatal, adverse reactions
• The Commission on Human Medicines (CHM) has conducted a risk/benefit review of the vaccines and issued recommendations to reinforce risk-minimisation measures; these have been sent to all UK YF vaccination centres via a letter from organisations such as the MHRA and Public Health England:
  • The recommendations include added and updated contraindications, increased precautions for use in patients aged 60 years and over and standardised risk/benefit analysis procedures for UK YF vaccination centres to ensure individuals only receive a vaccine after a rigorous risk assessment

• Healthcare professionals who administer YF vaccine should be specifically trained in risk/benefit analysis; a risk assessment should be conducted prior to vaccine administration
  • The traveller’s medical history, details of the travel itinerary, immune status and potential contraindications should be discussed
  • A patient information leaflet should be given to every traveller being vaccinated
  • All YF vaccine recipients should be advised to seek emergency medical care if they experience signs/symptoms of highly rare neurotropic disease (YEL-AND) or viscerotropic disease (YEL-AVD)
• Healthcare professionals, including pharmacists, who administer YF vaccine must:
  • Understand the contraindications and special precautions prior to administration –from the Summary of Product Characteristics for Stamaril
  • Be familiar with the YF Vaccine Centre code of practice
• Suspected side effects during vaccination and any medication error which has resulted in harm should be reported to the MHRA via the Yellow Card Scheme

Pharmacists administering the YF vaccine against a Patient Group Direction (PGD) must follow the terms of the PGD and contact the PGD provider where appropriate.

For further information on this or any other query, please contact the NPA Pharmacy Services team on 01727 891 800 or email pharmacyservices@npa.co.uk.

 Produced by the NPA Pharmacy Services team November 2019.