Other safety alerts
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| The United Kingdom: Yellow fever vaccine: stronger precautions in people with weakened immunity and in those aged 60 years or older |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that the Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions. Key recommendations include new and updated contraindications and strengthened precautions to protect those with a weakened immune systems (including for people aged 60 years or older) and standardised risk-benefit evaluation procedures across UK yellow fever vaccination centres to ensure that people only receive the vaccine after a thorough risk assessment.
Two risks unique to yellow fever vaccine are viscerotropic disease (YEL-AVD) and neurotropic disease (YEL-AND), which both resemble yellow fever infection. These are very rare but can be fatal. These risks are more likely to occur in certain groups, particularly people with a weakened immune system, people without a thymus, and people aged 60 years or older. The risks of YEL-AND and YEL-AVD are estimated to be up to 1 per 100,000 primary vaccinees, although this may be up to 4-times greater in those aged 60 years or older.
Cases of neurotropic disease (YEL-AND) have been reported in primary vaccinees with an onset within 30 days of vaccination. The risk appears to be higher in people older than 60 years and younger than 9 months of age (including infants exposed to vaccine through breastfeeding), although cases have been also reported in other age groups. Congenital or acquired immunodeficiency has also been recognised as a potential risk factor. YEL-AND may manifest as high fever with headache that may progress to include 1 or more of confusion, lethargy, encephalitis, encephalopathy, and meningitis. Other neurological signs and symptoms have been reported and include convulsions, Guillain-Barré syndrome, and focal neurological deficits.
Cases of viscerotropic disease (YEL-AVD; formerly described as febrile multiple organ-system failure) have been reported following vaccination with yellow fever vaccine, some of which have been fatal. In most cases reported, the onset of signs and symptoms was within 10 days of vaccination. Initial signs and symptoms of AVD are non-specific and may include pyrexia, myalgia, fatigue, headache and hypotension, potentially progressing quickly to liver dysfunction with jaundice, muscle cytolysis, thrombocytopenia, and acute respiratory and renal failure.
Healthcare professionals are advised:
- Yellow fever vaccine is a highly effective vaccine to protect against life-threatening yellow fever infection; however, strict adherence to contraindications and precautions is essential to reduce the risk of very rare but potentially fatal adverse reactions.
- A letter from MHRA, Public Health England, National Travel Health Network and Centre, and Health Protection Scotland has been sent to UK yellow fever vaccination centres to inform them of the recommendations and that changes will be made to the product information and standardised pre-vaccination screening tools. Please find below the recommendations listed in the letter:
• In people aged 60 years or older, due to a higher risk of life-threatening side effects, the vaccine should be given only when there is a significant and unavoidable risk of acquiring yellow fever infection, such as travel to an area where there is a current or periodic risk of yellow fever transmission. This would exclude travel to areas in which vaccination is ‘generally not recommended’ by WHO.
• Only healthcare professionals specifically trained in benefit-risk evaluation of yellow fever vaccine should administer the vaccine, following their individualised assessment of a person’s travel itinerary and suitability to receive the vaccine
• Do not administer the vaccine to people who have had their thymus gland removed for any reason; who are taking biological drugs that are immunosuppressive or immunomodulating; and who have a first-degree family history of YEL-AVD or YEL-AND following vaccination that was not related to a known medical risk factor (i.e. in case of an unidentified genetic predisposition).
- Every vaccinee should be advised to seek emergency medical attention if they develop signs or symptoms of very rare YEL-AND or YEL-AVD and should receive the manufacturer’s patient information leaflet as part of the travel consultation.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/yellow-fever-vaccine-stronger-precautions-in-people-with-weakened-immunity-and-in-those-aged-60-years-or-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.
Related news was previously issued by the MHRA and was posted on the Drug Office website on 17 Apr 2019. In light of the updated contraindications and strengthened precautions in MHRA’s announcement, letters to inform local healthcare professionals will be issued; and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Nov 22, 2019
Issued at HKT 17:30
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