Stamaril

Department of Health and Social Care written question – answered on 12th February 2019.

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Photo of Adam Holloway Adam Holloway Conservative, Gravesham

To ask the Secretary of State for Health and Social Care, if he will make representations to Sanofi Pasteur on undertaking new research into the risks of adverse events, including psychosis, from using the vaccine Stamaril.

Photo of Adam Holloway Adam Holloway Conservative, Gravesham

To ask the Secretary of State for Health and Social Care, what representations he has made to Sanofi Pasteur on ensuring that new technology is developed to eliminate the risks of adverse events, including psychosis, from the use of the vaccine Stamaril.

Photo of Adam Holloway Adam Holloway Conservative, Gravesham

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of including psychosis in the list of potential side effects published on the use of Stamaril as a vaccine for yellow fever.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

As with all vaccines and medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) closely monitors the safety of Stamaril yellow fever vaccine. The MHRA takes advice from the Government's independent scientific advisory body, the Commission on Human Medicines, when evaluating the risks and benefits of medicines and vaccines.

The Marketing Authorisation Holder for Stamaril, Sanofi Pasteur, has statutory obligations to continuously monitor the safety, and balance of benefits and risks, of the vaccine.

The potential risks of Stamaril are described in the prescribing information, the Summary of Product Characteristics, and the information for vaccine recipients, the Patient Information Leaflet. A recognised, very rare risk of Stamaril vaccine is Yellow Fever Vaccine-Associated Neurotropic Disease, known as YEL-AND. Whilst the symptoms of YEL-AND can include confusion and acute focal neurological deficits (e.g. affecting motor co-ordination), this is not typically associated with psychosis or other long-term psychiatric disorders.

Further to other recent reports of serious suspected adverse reactions in United Kingdom travellers, the MHRA is in the process of further reviewing the balance of benefits and risks of Yellow Fever vaccine, which will include an analysis of neuropsychiatric events.

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