Yellow fever vaccine (Stamaril): new pre-vaccination checklist - GOV.UK

Advice for healthcare professionals:

• yellow fever vaccine is a highly effective vaccine to protect against life-threatening yellow fever infection; for most people the balance between the benefits and possible side effects of the vaccine remains overwhelmingly favourable
• adherence to contraindications (for example, in people with immunosuppression or thymus dysfunction or thymectomy) and precautions (in people aged 60 years or older, infants aged 6 months to 9 months, and pregnant or breastfeeding women) is essential to reduce the risk of very rare but potentially fatal adverse reactions – see 2019 Drug Safety Update on safety measures
• use the new checklist in vaccination consultations to ensure systematic evaluation of benefits and risks for individual travellers
• the checklist is not a replacement for the full travel health risk assessment by a qualified practitioner and additional checklists or materials may also be used prior to vaccination, depending on clinical guidance
• provide the Patient Information Leaflet and advise patients of the need to seek emergency medical attention if they develop signs or symptoms of a severe reaction following vaccination
• report suspected adverse reactions to the yellow fever vaccine to the Yellow Card Scheme.

Benefits of the yellow fever vaccine

Yellow fever is a life-threatening viral infection and protective measures against the disease are essential for anyone travelling to an area where there is a risk of infection. Yellow fever vaccine (Stamaril) is highly effective and is the best way to protect those at risk of disease during travel.

Yellow fever vaccine must only be administered in a registered Yellow Fever Vaccination Centre by registered healthcare professionals who have completed the yellow fever training programme run by National Travel Health Network and Centre (NaTHNaC) in England, Wales and Northern Ireland or Public Health Scotland.

Very rare adverse reactions associated with yellow fever vaccine

For most people, the balance between the benefits and possible side effects of the vaccine remains overwhelmingly favourable. However, because the vaccine contains a live, weakened strain of the yellow fever virus, adherence to contraindications and precautions is essential to reduce the risk of serious side effects, especially in patients with contraindications due to immunosuppression (congenital or acquired) or thymus dysfunction or removal.

Very rare cases of yellow fever vaccine-associated viscerotropic disease (YEL-AVD) and yellow fever vaccine-associated neurotropic disease (YEL-AND) are important identified risks associated with the yellow fever vaccine. In 2018 to 2019, two events of YEL-AVD with a fatal outcome were reported after yellow fever vaccination in UK. These events led the Commission on Human Medicines to introduce a series of recommendations to strengthen measures to minimise these risks.

These recommendations included a letter sent to vaccination clinics in 2019, changes to product information (which have now been made), and a standardised pre-vaccination screening checklist, which has now been agreed by the manufacturer and the MHRA.

Procedures for vaccination clinics

Before administration of the yellow fever vaccine, the Summary of Product Characteristics requires that healthcare professionals must ensure that:

1. Yellow fever vaccination is recommended for the intended destination, based on yellow fever endemic status at the time of the travel or if an International Certificate of Vaccination is required; this information is available from the World Health Organization, NaTHNaC or Public Health Scotland
2. The traveller has no contraindication for vaccination (such as acquired or congenital immunosuppression, including thymus disorders or thymectomy for any reason, and known immunosuppressive therapies, or are infants younger than 6 months) – see full contraindications
3. They have explored and thoroughly assessed the risk factors and precautions as listed in the section 'Special warnings and precautions for use' before vaccine administration (for example, people aged 60 years or older, infants aged 6 months to 9 months, and pregnant or breastfeeding women)
4. The traveller is informed of risks associated with vaccination or non-vaccination following the full risk assessment – it is the healthcare professional's responsibility to ensure the patient understands and accepts the risks before vaccination
5. Vaccinees are advised to seek emergency medical attention if they develop signs or symptoms of YEL-AND or YEL-AVD and receive the manufacturer's Patient Information Leaflet, which lists characteristics of these reactions

The newly introduced Stamaril Yellow Fever vaccine Checklist supports this consultation. However it is not a replacement for the full travel health risk assessment currently undertaken by a qualified practitioner.

Additional checklists or materials may also be used prior to vaccination, depending on clinical guidance of the vaccination centre and the national authority.

Report suspected reactions to vaccines

Please continue to report suspected adverse reactions to the yellow fever vaccine and other medicines to the Yellow Card Scheme.

Submit reports electronically using:

When reporting a suspected reaction to a vaccine, please provide the brand name (or product licence number and manufacturer) and the specific batch number. Additionally, when providing patients with details of the vaccine administered, it is good practice to give them details of the brand and batch number. This will allow patients and carers to report suspected reactions more accurately to the Yellow Card Scheme.

Incidents involving the yellow fever vaccine in England, Wales, and Northern Ireland should be reported to NaTHNaC and incidents in Scotland should be reported to Public Health Scotland.

Any medication errors (for example, vaccination of a contraindicated person) that result in harm should be reported via the Yellow Card Scheme. Medication errors in the absence of harm should be reported via local reporting methods.

Report suspected side effects to medicines, vaccines, medical device and test kit incidents used in coronavirus (COVID-19) testing and treatment using the dedicated Coronavirus Yellow Card reporting site or the Yellow Card app. See the MHRA website for the latest information on medicines and vaccines for COVID-19.

Article citation: Drug Safety Update volume 15, issue 4: November 2021: 1.