Drugs List

Therapeutic Indications

Uses

Yellow fever - prophylaxis

Active immunization for preventing yellow fever in persons:

Travelling to, passing through or living in an endemic area.

Travelling to any country that requires and international Certificate of Vaccination for entry (which may or may not depend on the previous itinerary).

Handling potentially infectious materials (e.g. laboratory workers).

In order to comply with vaccine regulations and to be officially recognised, yellow fever vaccine must be administered at an approved World Health Organisation (WHO) vaccination centre and registered on an International Certificate of Vaccination. The yellow fever vaccine certificate (ICVP) will be valid for the duration of the life of the person vaccinated (WHO, 2016).

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book.

Administration

For subcutaneous or intramuscular injection only.

A single dose should be given by subcutaneous injection. This is the preferred route of administration.

The intramuscular route may be used if this is in accordance with official recommendations.

For intramuscular use, the recommended injection sites are the anterolateral aspect of the thigh in children less than 12 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 12 months through 35 months of age or the deltoid muscle in children from 36 months of age onwards and adults.

Contraindications

Acute illness
Children under 6 months
Febrile disorder
Immunosuppression
Asymptomatic HIV infection with evidence of impaired immune function
History of thymus dysfunction
Immunodeficiency syndromes
Myasthenia gravis
Symptomatic HIV infection
Thymectomy
Thymoma

Precautions and Warnings

Children aged 6 to 9 months
First degree family history of neurotropic disease post vaccination
First degree family history of viscerotropic disease post vaccination
Patients over 60 years
Breastfeeding
Coagulopathy
HIV infection without clinical manifestation
Pregnancy
Thrombocytopenia

Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Postpone immunisation if there is active or suspected infection
Immunise at least 10 days before entering endemic area
Postpone therapy for 1 month in patients who have had systemic steroids
Vaccine may not be effective in 100% of patients
Allow disinfecting agents to evaporate before administering vaccine
Do not mix with other drugs or substances
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Advise patient to seek medical help if neurotropic disease symptoms occur
Advise patient to seek medical help if viscerotropic disease symptoms occur
May affect results of some laboratory tests
Follow national immunisation guidelines

Immunosuppression
If the immunosuppression is temporary, vaccination should be delayed until the immune function has recovered. In patients who have received systemic corticosteroids for 14 days or more, it is advisable to delay vaccination until at least one month after completing the course.

HIV infection
There are limited data to determine the immunological parameters that might differentiate persons who could be safely vaccinated and who might mount a protective immune response from those in whom vaccination could be both hazardous and ineffective. Therefore, if an asymptomatic HIV-infected person cannot avoid travel to an endemic area, available official guidance should be taken into account when considering the potential risks and benefits of vaccination.

Children born to HIV positive mothers
HIV infected children aged at least 6 months who are potentially in need of protection against yellow fever should be referred to a specialist paediatric team for advice on whether or not to vaccinate.

Elderly (aged 60 years and older)
Persons aged 60 years and older may have an increased risk of serious and potentially fatal adverse reactions when compared to other age groups. These adverse reactions include systemic and neurological reactions persisting more than 48 hours, YEL-AVD and YEL-AND. Therefore, the vaccine should only be given to those who have a significant risk of acquiring yellow fever.

Yellow Fever Vaccine-Associated Neurotropic Disease (YEL-AND)
Very rare cases of yellow fever vaccine-associated neurotropic disease (YEL-AND) has been reported following vaccination, with sequelae or with a fatal outcome. Most cases have been reported with an onset within 30 days of the primary vaccination. The risk appears to be higher in those aged over 60 years and below 9 months of age (including infants exposed to vaccine through breastfeeding) although cases have also been reported in other age groups. Congenital or acquired immunodeficiency has also been recognised as a potential risk factor.

Yellow Fever Vaccine-Associated Viscerotropic Disease (YEL-AVD)
Very rarely, yellow fever vaccine-associated viscerotropic disease (YEL-AVD) has been reported. The mortality rate has been around 60%. Most cases of YEL-AVD have been in primary vaccinees with onset within 10 days of vaccination. The risk appears to be higher in those aged over 60 years although cases have also been reported in other age groups. History of thymus dysfunction has also been recognised as a potential risk factor.

Simultaneous administration of live vaccines
Doses of inactivated vaccines can be administered at any interval before, after, or at the same time as a live vaccine and vice versa. Live vaccines can also be administered at any time before or after each other with the exception of MMR where a 28-day minimum interval period should be kept between the administration of MMR and yellow fever vaccine. The reason is that co-administration of these two vaccines can lead to sub-optimal antibody responses to yellow fever, mumps and rubella antigens. Where protection is required rapidly then the two vaccines should be given at any interval. An additional dose of MMR should be considered and re-vaccination with the yellow fever vaccine can also be considered on a case by case basis for those at on-going risk.

Pregnancy and Lactation

Pregnancy

Use yellow fever vaccine with caution during pregnancy.

The manufacturer does not recommend using yellow fever vaccine during pregnancy. The vaccine should be given to pregnant women only when clearly needed and only after careful consideration of the potential risks and benefits. Pregnant women should be advised not to travel to a high risk area. Yellow fever is a serious infectious disease with high morbidity and mortality. Reinforcing immunisation should be offered to those women who continue to be at risk and received their initial yellow fever vaccination during pregnancy.

At the time of writing there is limited published information regarding the use of yellow fever vaccine during pregnancy. Potential risks are unknown.

Lactation

Use yellow fever vaccine with caution during breastfeeding.

Manufacturer does not recommend breastfeeding unless when clearly needed such as during outbreak control, and following an assessment of the risk and benefits. Being a live attenuated vaccine, there is a potential risk of transmission of the vaccine virus strain to the infant from the breastfeeding mother. Exposure to yellow fever vaccine via breast milk would not increase the risk to an infant who also receives the vaccination.
The risk of developing neurotropic disease (YEL-AND) appears to be higher in infants younger than 9 months of age exposed to vaccine through breastfeeding.

Studies indicates that in up to 80 to 100% of cases, the 17D vaccine virus is no longer present in maternal serum 10 to 13 days following vaccination (Hale 2014). This would suggest that breastfeeding posses little risk to an infant 10 to 13 days after immunisation.

Side Effects

Abdominal pain
Anaphylactoid reaction
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Convulsions
Crying
Decreased appetite
Diarrhoea
Dizziness
Drowsiness
Haematoma (injection site)
Headache
Hypersensitivity reactions
Induration (injection site)
Influenza-like symptoms
Irritability
Lethargy
Local pain (injection site)
Lymphadenopathy
Myalgia
Nausea
Paraesthesia
Pruritus
Pyrexia
Rash
Rhinitis
Stinging, redness and swelling at injection site
Swelling (injection site)
Syncope
Urticaria
Vomiting
Yellow fever vaccine - associated neurotropic disease
Yellow fever vaccine - associated viscerotropic disease

Presentation

Vaccine containing live attenuated 17D strain of yellow fever virus.

Drugs List

Therapeutic Indications

Uses

Yellow fever - prophylaxis

Active immunization for preventing yellow fever in persons:

Travelling to, passing through or living in an endemic area.

Travelling to any country that requires and international Certificate of Vaccination for entry (which may or may not depend on the previous itinerary).

Handling potentially infectious materials (e.g. laboratory workers).

In order to comply with vaccine regulations and to be officially recognised, yellow fever vaccine must be administered at an approved World Health Organisation (WHO) vaccination centre and registered on an International Certificate of Vaccination. The yellow fever vaccine certificate (ICVP) will be valid for the duration of the life of the person vaccinated (WHO, 2016).

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book.

Dosage

Adults

Children

Administration

For subcutaneous or intramuscular injection only.

A single dose should be given by subcutaneous injection. This is the preferred route of administration.

The intramuscular route may be used if this is in accordance with official recommendations.

For intramuscular use, the recommended injection sites are the anterolateral aspect of the thigh in children less than 12 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 12 months through 35 months of age or the deltoid muscle in children from 36 months of age onwards and adults.

Contraindications

Acute illness
Children under 6 months
Febrile disorder
Immunosuppression
Asymptomatic HIV infection with evidence of impaired immune function
History of thymus dysfunction
Immunodeficiency syndromes
Myasthenia gravis
Symptomatic HIV infection
Thymectomy
Thymoma

Precautions and Warnings

Children aged 6 to 9 months
First degree family history of neurotropic disease post vaccination
First degree family history of viscerotropic disease post vaccination
Patients over 60 years
Breastfeeding
Coagulopathy
HIV infection without clinical manifestation
Pregnancy
Thrombocytopenia

Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Postpone immunisation if there is active or suspected infection
Immunise at least 10 days before entering endemic area
Postpone therapy for 1 month in patients who have had systemic steroids
Vaccine may not be effective in 100% of patients
Allow disinfecting agents to evaporate before administering vaccine
Do not mix with other drugs or substances
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Advise patient to seek medical help if neurotropic disease symptoms occur
Advise patient to seek medical help if viscerotropic disease symptoms occur
May affect results of some laboratory tests
Follow national immunisation guidelines

Immunosuppression
If the immunosuppression is temporary, vaccination should be delayed until the immune function has recovered. In patients who have received systemic corticosteroids for 14 days or more, it is advisable to delay vaccination until at least one month after completing the course.

HIV infection
There are limited data to determine the immunological parameters that might differentiate persons who could be safely vaccinated and who might mount a protective immune response from those in whom vaccination could be both hazardous and ineffective. Therefore, if an asymptomatic HIV-infected person cannot avoid travel to an endemic area, available official guidance should be taken into account when considering the potential risks and benefits of vaccination.

Children born to HIV positive mothers
HIV infected children aged at least 6 months who are potentially in need of protection against yellow fever should be referred to a specialist paediatric team for advice on whether or not to vaccinate.

Elderly (aged 60 years and older)
Persons aged 60 years and older may have an increased risk of serious and potentially fatal adverse reactions when compared to other age groups. These adverse reactions include systemic and neurological reactions persisting more than 48 hours, YEL-AVD and YEL-AND. Therefore, the vaccine should only be given to those who have a significant risk of acquiring yellow fever.

Yellow Fever Vaccine-Associated Neurotropic Disease (YEL-AND)
Very rare cases of yellow fever vaccine-associated neurotropic disease (YEL-AND) has been reported following vaccination, with sequelae or with a fatal outcome. Most cases have been reported with an onset within 30 days of the primary vaccination. The risk appears to be higher in those aged over 60 years and below 9 months of age (including infants exposed to vaccine through breastfeeding) although cases have also been reported in other age groups. Congenital or acquired immunodeficiency has also been recognised as a potential risk factor.

Yellow Fever Vaccine-Associated Viscerotropic Disease (YEL-AVD)
Very rarely, yellow fever vaccine-associated viscerotropic disease (YEL-AVD) has been reported. The mortality rate has been around 60%. Most cases of YEL-AVD have been in primary vaccinees with onset within 10 days of vaccination. The risk appears to be higher in those aged over 60 years although cases have also been reported in other age groups. History of thymus dysfunction has also been recognised as a potential risk factor.

Simultaneous administration of live vaccines
Doses of inactivated vaccines can be administered at any interval before, after, or at the same time as a live vaccine and vice versa. Live vaccines can also be administered at any time before or after each other with the exception of MMR where a 28-day minimum interval period should be kept between the administration of MMR and yellow fever vaccine. The reason is that co-administration of these two vaccines can lead to sub-optimal antibody responses to yellow fever, mumps and rubella antigens. Where protection is required rapidly then the two vaccines should be given at any interval. An additional dose of MMR should be considered and re-vaccination with the yellow fever vaccine can also be considered on a case by case basis for those at on-going risk.

Pregnancy and Lactation

Pregnancy

Use yellow fever vaccine with caution during pregnancy.

The manufacturer does not recommend using yellow fever vaccine during pregnancy. The vaccine should be given to pregnant women only when clearly needed and only after careful consideration of the potential risks and benefits. Pregnant women should be advised not to travel to a high risk area. Yellow fever is a serious infectious disease with high morbidity and mortality. Reinforcing immunisation should be offered to those women who continue to be at risk and received their initial yellow fever vaccination during pregnancy.

At the time of writing there is limited published information regarding the use of yellow fever vaccine during pregnancy. Potential risks are unknown.

Lactation

Use yellow fever vaccine with caution during breastfeeding.

Manufacturer does not recommend breastfeeding unless when clearly needed such as during outbreak control, and following an assessment of the risk and benefits. Being a live attenuated vaccine, there is a potential risk of transmission of the vaccine virus strain to the infant from the breastfeeding mother. Exposure to yellow fever vaccine via breast milk would not increase the risk to an infant who also receives the vaccination.
The risk of developing neurotropic disease (YEL-AND) appears to be higher in infants younger than 9 months of age exposed to vaccine through breastfeeding.

Studies indicates that in up to 80 to 100% of cases, the 17D vaccine virus is no longer present in maternal serum 10 to 13 days following vaccination (Hale 2014). This would suggest that breastfeeding posses little risk to an infant 10 to 13 days after immunisation.

Side Effects

Abdominal pain
Anaphylactoid reaction
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Convulsions
Crying
Decreased appetite
Diarrhoea
Dizziness
Drowsiness
Haematoma (injection site)
Headache
Hypersensitivity reactions
Induration (injection site)
Influenza-like symptoms
Irritability
Lethargy
Local pain (injection site)
Lymphadenopathy
Myalgia
Nausea
Paraesthesia
Pruritus
Pyrexia
Rash
Rhinitis
Stinging, redness and swelling at injection site
Swelling (injection site)
Syncope
Urticaria
Vomiting
Yellow fever vaccine - associated neurotropic disease
Yellow fever vaccine - associated viscerotropic disease

Effects on Laboratory Tests

Yellow fever vaccine can induce false positive results with laboratory and/or diagnostic tests for other flavivirus related diseases such as dengue or Japanese encephalitis.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: June 2020.

Reference Sources

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Stamaril. Sanofi Pasteur MSD Ltd. Revised September 2019.

Immunisation against infectious disease - The Green Book.
Available at www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book#the-green-book

MHRA Drug Safety Update November 2019
Available at: https://www.mhra.gov.uk
Last accessed: 17 February 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 June 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Yellow fever vaccine. Last revised: 31 October 2018.
Last accessed: 14 February 2020.