29 June 2009

Reporting suspected yellow fever vaccine-associated neurologic disease (YEL-AND) or suspected yellow fever vaccine-associated viscerotropic disease (YEL-AVD)

The risk of YEL-AND and YEL-AVD is estimated to be approximately 5 cases per million doses administered [1]. This risk increases in those aged 60 years and older [2]. These serious post-vaccine adverse events have only been reported in first time vaccinees [1].

YEL-AND begins on average 14 days (range 4 to 23 days) following vaccination. Patients can present with headache and fever with worsening neurological deficit, including confusion and coma. Guillain-Barré syndrome has been reported [3, 4]. Nearly all cases recover.

YEL-AVD begins shortly after vaccination (median 4 days, range 2-8 days). Symptoms initially include fever, headache and myalgias, and can progress to hypotension, hepatitis, multi-organ failure and death [3].

The safety profiles of all medicinal products marketed in the UK are subject to continuous monitoring by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Marketing Authorisation Holder. To support these activities health professionals are requested to report the following adverse events that occur following vaccination with yellow fever vaccine:

All cases of confirmed or suspected YEL-AND or YEL-AVD

All other serious adverse events, which include those that are fatal, life threatening, disabling or incapacitating, result in or prolong hospitalisation, congenital abnormalities, or are medically significant.

Report these serious adverse events to:

1. Medicines and Healthcare Regulatory products Regulatory Agency via the yellow card system at: http://www.mhra.gov.uk/Safetyinformation/Reportingsafety

problems/Reportingsuspectedadversedrugreactions/index.htm

2. Sanofi Pasteur MSD UK through their online Adverse Event Reporting Form at: http://www.spmsd.co.uk/doc.asp?catid=427&docid=806 or by calling the Pharmacovigilance Department on 01628 785291

3. National Travel Health Network and Centre (NaTHNaC) via the telephone advice line on 0845 602 6712

References

1. Cetron MS, Marfin AA, Julian KG et al. Yellow fever vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP).  MMWR 2002:51(No.RR-17):1-10

2. Khromava AY, Eidex RB, Weld LH et al. Yellow fever vaccine: an updated assessment of advanced age as a risk factor for serious adverse events. Vaccine 2005:23:3256-63

3. Barnett E. Yellow fever: epidemiology and prevention. CID 2007;44:850-7.

4. McMahon AW, Eidex RB, Marfin AA et al. Neurologic disease associated with 17D-204 yellow fever vaccination: a report of 15 cases. Vaccine 2007; 25:1727-34

Further reading

• Pulendran B, Miller J, Querec TD, et al. Case of yellow fever vaccine--associated viscerotropic disease with prolonged viremia, robust adaptive immune responses, and polymorphisms in CCR5 and RANTES genes. J Infect Dis 2008;198:500-7.
• Kitchener S. Viscerotropic and neurotropic disease following vaccination with the 17D yellow fever vaccine, ARILVAX®. Vaccine 2004; 22:2103-5
• Centers for Disease Control and Prevention. Notice to readers: Fever, jaundice and multiple organ system failure associated with 17D-derived yellow fever vaccination, 1996-2001. MMWR 2001; 3 August; 50(30): 643-5. Available at: http://www.cdc.gov/mmwr//preview/mmwrhtml/mm5030a3

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