Yellow Fever Vaccine
Indications
Registered South African indications:
- Active immunisation against yellow fever in:
- Persons living in, travelling to or passing through an area where there is a current or periodic risk of yellow fever transmission
- Persons moving from an endemic to a potentially receptive non-endemic area
- Laboratory workers handling potentially infectious materials
Contraindications (ZA)
Registered South African contraindications
- Hypersensitivity to the active ingredient or any of its excipients
- History of severe allergic reaction to egg or chicken proteins or after previous administration of the vaccine or a vaccine containing the same components
- Moderate or severe febrile or acute illness
- Congenital or acquired immune deficiency that impairs cellular immunity, including those receiving immunosuppressive therapies, chemotherapy, high doses of systemic corticosteroids (e.g. daily dose of 20mg or 2mg/kg body mass of prednisone or equivalent for 2 weeks or more, or daily dose of 40mg or more of prednisone for more than 1 week), any other medicines including biologicals with known immunosuppressive or immunomodulating properties, radiotherapy, cytotoxic medicines or any other condition which may result in immunocompromised status
- History of thymus dysfunction (including myasthenia gravis, thymoma) or thymectomy (for any reason)
- Thymectomy or thymic disease has been identified as potentially influencing the development of yellow fever vaccine-associated viscerotropic disease
- History of thymus dysfunction prior to administering yellow fever vaccine should be determined. Alternative means of prevention in such patients are to be considered - Symptomatic HIV-infected individuals
- Asymptomatic HIV infection when accompanied by evidence of impaired immune function
- Children <6 months old due to the risk of encephalitis
Contraindications
Contraindications registered in other jurisdictions
- Hypersensitivity to the active ingredient or any of its excipients
- Hypersensitivity to eggs or chicken proteins
- Severe hypersensitivity reactions (e.g. anaphylaxis) after a previous dose of any yellow fever vaccine
- Immunosuppression, whether congenital or acquired. This includes individuals receiving immunosuppressive therapies such as treatment with high-dose systemic corticosteroids (e.g. daily dose of 20mg or 2mg/kg body weight of prednisone or equivalent for 2 weeks or more or daily dose of 40mg or more of prednisone for more than 1 week), any other medicinal products including biologicals with known immunosuppressive properties, radiotherapy, cytotoxic drugs, or any other condition which may result in immunocompromised status
- History of thymus dysfunction (including myasthenia gravis, thymoma)
- Thymectomy (for any reason)
- Symptomatic HIV infection
- Asymptomatic HIV infection when accompanied by evidence of impaired immune function
- Moderate or severe febrile illness or acute illness
- Children <6 months
Warnings & precautions
- Pregnancy
- Breastfeeding
- Renal impairment
- Hepatic impairment
- Elderly
- Intravascular injection
- Bleeding disorders
- Congenital or acquired immunodeficiency
- Children 6-9 months
Adult dosage (ZA)
Forms avail. in SA and covered in this monograph: vac
South African registered indications and dosages
Active immunisation against yellow fever in:
- Persons living in, travelling to or passing through an area where there is a current or periodic risk of yellow fever transmission
- Persons moving from an endemic to a potentially receptive non-endemic area
- Laboratory workers handling potentially infectious materials
- IM/SC: Primary vaccination: 0.5ml, as a single dose of the reconstituted vaccine; Provides protection for at least 10 years and may be life long protection; Re-vaccination: Repeat dose, as required
Yellow fever vaccine should only be given to individuals who are or will be at risk of yellow fever infection or those needing to meet International Health Regulations (IHR). Before vaccination, identify those potentially at higher risk for adverse reactions following vaccination
For the latest yellow fever vaccine guidelines, check the WHO website or national health authorities' resources. To be officially recognized, the vaccine must be given at a WHO-approved centre by a qualified health professional and registered on an International Certificate of Vaccination from the Department of Health. Certificate validity follows IHR guidelines i.e shall extend for the life of the person vaccinated, starting 10 days after the initial vaccination and immediately post-revaccination. Re-vaccination may be needed in individuals who had an insufficient immune response after primary vaccination if they continue to be at risk for yellow fever virus infection. Re-vaccination may also be required, depending on local official recommendations
Method of administration
The vaccine, once reconstituted, can be given either intramuscularly or subcutaneously. Preferred injection site for intramuscular administration in adults is the deltoid muscle
Do not give the yellow fever vaccine via intravascular injection
The yellow fever vaccine should not be mixed with other injectable vaccines or medicinal products. If given alongside other injections, use separate syringes and injection sites, ideally on different limbs
Paediatric dosage (ZA)
Paed. forms avail. in SA and covered in this monograph: vac
South African registered indications and dosages
Active immunisation against yellow fever in:
- Persons living in, travelling to or passing through an area where there is a current or periodic risk of yellow fever transmission
- Persons moving from an endemic to a potentially receptive non-endemic area
- Laboratory workers handling potentially infectious materials
- Younger than 6 months: Contraindicated
- Between 6-9 months: Not recommended for use, except in specific circumstances and in accordance with available official recommendations, in which case the dose is the same as in children 9 months and older
- Older than 9 months: See adult dosage
Yellow fever vaccine should only be given to individuals who are or will be at risk of yellow fever infection or those needing to meet International Health Regulations (IHR). Before vaccination, identify those potentially at higher risk for adverse reactions following vaccination
For the latest yellow fever vaccine guidelines, check the WHO website or national health authorities' resources. To be officially recognized, the vaccine must be given at a WHO-approved centre by a qualified health professional and registered on an International Certificate of Vaccination from the Department of Health. Certificate validity follows IHR guidelines i.e shall extend for the life of the person vaccinated, starting 10 days after the initial vaccination and immediately post-revaccination. Re-vaccination may be needed in individuals who had an insufficient immune response after primary vaccination if they continue to be at risk for yellow fever virus infection. Re-vaccination may also be required, depending on local official recommendations
Method of administration
The vaccine, once reconstituted, can be given either intramuscularly or subcutaneously.
Preferred injection sites for intramuscular administration:
- Anterolateral aspect of the thigh for children 9-11 months old
- Anterolateral aspect of the thigh (or deltoid if muscle mass allows) for children 12-35 months old
- Deltoid muscle for older children (36 months and above)
Do not give the yellow fever vaccine via intravascular injection
The yellow fever vaccine should not be mixed with other injectable vaccines or medicinal products. If given alongside other injections, use separate syringes and injection sites, ideally on different limbs
Pregnancy & lactation
Pregnancy
- Caution; not recommended
- No animal developmental and reproductive studies have been conducted with Yellow Fever Vaccine and the potential risk for humans is unknown
- Data on a limited number of exposed pregnancies indicate no adverse effects of the Yellow Fever Vaccine on pregnancy or the health of the fetus/newborn child
- Nevertheless, the Yellow Fever Vaccine should be given to pregnant women only when clearly needed and only after careful consideration of the potential risks and benefits
Breastfeeding
- Caution; not recommended
- As there is a probable risk of transmission of the vaccine virus strain to the infants from breast-feeding mothers, Yellow Fever Vaccine should not be given to nursing mothers unless when clearly needed such as during an outbreak control, and following an assessment of the risks and benefits
Fertility
- No information available
Renal impairment
- Caution; no information available
Hepatic impairment
- Caution; no information available
Elderly
- Caution; no dose adjustment recommended
Adverse reactions
Central Nervous System Disorders
- Drowsiness
- Headache
- Dizziness
- Paresthesia
- Irritability
- Crying
- Asthenia
Respiratory Disorders
- Rhinitis
Gastrointestinal Disorders
- Nausea and vomiting
- Abdominal pain
- Diarrhea
Endocrine and Metabolic Disorders
- Loss of appetite
Musculoskeletal Disorders
- Myalgia
- Arthralgia
Skin and Subcutaneous Tissue Disorders
- Rash
- Pruritus
- Urticaria
- Injection site reaction
Immune, Blood and Lymphatic System Disorders
- Lymphadenopathy
- Anaphylactoid reaction
- Pyrexia
- Influenza-like illness
Interactions
- Immunosuppressant therapy
- Anticoagulants
Monitoring
None routine
Mechanism of action
Yellow fever vaccine is a live vaccine that offers active immunization against yellow fever infection.
Dosage forms
- Vaccine
Formulation
Injection 0.5ml
- Stamaril (Sanofi) originator
References
1. PI - STAMARIL, powder and solvent for suspension for injection, Live, attenuated yellow fever virus strain 17D-204, Sanofi-aventis south africa (pty) ltd - DATE OF REVISION OF THE TEXT 13 December 2021 Downloaded online 25 Oct 2023 [https://trello.com/c/d1ZIe756/1800-yellow-fever-vaccine-vac-drupal-id-14802] 2. https://www.medicines.org.uk/emc/medicine/9846 (23/03/2017_Sanofi_Stamaril_inj) 3. https://drive.google.com/drive/folders/1h6arnzJPpZexgjrl9pMM6e6KoKGaR0Ug (9/10/2006_Sanofi_Stamaril_vac) 4. https://www.uptodate.com/contents/yellow-fever-vaccine-drug-information?source=search_result&search=yellow%20fever&selectedTitle=2~117 5. https://www.drugs.com/pregnancy/yellow-fever-vaccine.html 6.SmPC: Stamaril powder and solvent for suspension for injection in pre-filled syringe, Sanofi Pasteur: Last updated 9 Sept 2019; updated 16 April 2020, [https://www.medicines.org.uk/emc/product/1683] 7. Dr Irhuma. Updates for Yellow Fever Vaccine [https://trello.com/c/rMS5bjHg/321-list-of-hot-monographs-1]. Dated 26 November 2019. Updated 16 April 2020. 8. Porphyria information: Yellow Fever Vaccine. Updated 16 April 2020 from http://porphyriadrugs.com/ (APF) 9. SmPC - Stamaril powder and solvent for suspension for injection in pre-filled syringe - Summary of Product Characteristics Updated 15-Feb-2021 - Sanofi Pasteur Downloaded online 25 October 2023 [https://www.medicines.org.uk/emc/product/1683] 10. SAIDS - Stamaril - Medication Check - Drug Free Sport - Downloaded online 25 Oct 2023 [https://drugfreesport.org.za/online-medication-check/]
Brands & products
1 product · cached snapshot- Stamaril
VACVaccine· 1 product
from R435.17| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Stamaril | 1000 iu/0.5ml | 0.5 | Sanofi Aventis South Africa (Pty) Ltd | R435.17 |
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.