Other safety alerts
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| The United Kingdom: Yellow fever vaccine (Stamaril) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed and those 60 years and older |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that it has recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril). Due to an increased risk of life-threatening reactions, the vaccine must not be given to anyone with a medical history of thymus dysfunction or who is immunosuppressed. In addition, extreme caution must be used and a careful risk assessment conducted before vaccination of people aged 60 years and older due to a substantially increased risk of such adverse reactions in this age group.
In recent months, MHRA has been notified of 2 fatal adverse reactions to yellow fever vaccine. In one case, the vaccine was given to a person with a history of thymectomy following a thymoma (a contraindication in the product information). In another case, the vaccine was given to a 67-year-old with no other known risk factors. Both patients died shortly after vaccination due to suspected yellow fever vaccine-associated viscerotropic disease (YEL-AVD). YEL-AVD is a recognised adverse reaction that resembles severe yellow fever infection. The global reporting rate is around 1 case in every 1 million people vaccinated, with thymus disease, immunosuppression, and an age of 60 years and older increasing the risk. Another serious risk of vaccination is vaccine-associated neurotropic disease (YEL-AND), which can occur at a similar rate and with the same risk factors. YEL-AND can present with a variety of neurological manifestations.
MHRA is in the process of reviewing the benefit-risk balance of yellow fever vaccine and measures to minimise risks in the light of these cases and the latest scientific data. MHRA will update guidance, as necessary.
When a person presents for yellow fever immunisation, it is important that healthcare professionals clearly discuss with them the individual risks and benefits of the vaccine based on their specific travel itinerary. Sufficient time should be set aside to ensure that the person is immune competent and has no contraindications to the vaccine, including a review of full medical history and any available medical records. Any potential history of thymus disease or thymus removal should be specifically queried. Any decision to administer the vaccine to a person aged 60 years and older must be based on a significant and unavoidable risk of acquiring yellow fever infection. Provision of the Patient Information Leaflet would provide a helpful basis for this discussion with potential vaccinees. Risk assessment checklists should also be used to ensure checks have been completed and patients have been assessed for immunocompetence (in line with local and organisational requirements).
Healthcare professionals are reminded:
- As with any live attenuated vaccine, yellow fever vaccine must not be given to people who may be immunosuppressed.
- Yellow fever vaccine is contraindicated in people with a history of thymus dysfunction (including myasthenia gravis and thymoma).
- Yellow fever vaccine is contraindicated in people who have had their thymus gland removed (thymectomy).
- In people aged 60 years and older, the vaccine should only be given when it is considered that there is a significant and unavoidable risk of acquiring yellow fever infection.
- Professionals who administer yellow fever vaccine must be familiar with any contraindications and special precautions before proceeding with immunization.
- If there is any doubt as to whether a person who is due to receive yellow fever vaccine may be immunosuppressed, immunisation should be deferred until specialist advice has been sought.
- Protocols and checklists should be strengthened to avoid inappropriate administration that can lead to severe and possibly fatal adverse effects.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/yellow-fever-vaccine-stamaril-and-fatal-adverse-reactions-extreme-caution-needed-in-people-who-may-be-immunosuppressed-and-those-60-years-and-older
In Hong Kong, Stamaril Pasteur (Yellow Fever) Vaccine (HK-40600) is registered by Sanofi-Aventis Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received one case of adverse event following Stamaril vaccination. The case was reported to the DH as a case of yellow fever vaccine-associated viscerotropic disease (YEL-AVD). The case had a few clinical features compatible with YEL-AVD. However, according to the opinion of the World Health Organization (WHO) Yellow Fever Initiative, it cannot be concluded that this case was a definite case of YEL-AVD.
The local product insert states that the drug should not be used in patients who have a poor or weakened immune system or have a history of problems with their thymus gland or have had their thymus gland removed. The product insert also includes warnings and precautions for patients who are over 60 years old. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Apr 17, 2019
Issued at HKT 17:45
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