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1054828

	registered interest
	date	04/02/2019
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Yellow Fever: Vaccination
	house id	1
	legislature	25259 pref label House of Commons
	question text	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.
	tabling member constituency	Gravesham
	tabling member printed	Adam Holloway
	uin	216211
	answer	answer is ministerial correction date of answer 12/02/2019 answer text <p>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.</p><p> </p><p>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.</p><p> </p><p>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.</p><p> </p><p>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.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 216210 216213 question first answered 12/02/2019 17:04:11 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	1522 label Biography information for Adam Holloway

1054830

	registered interest
	date	04/02/2019
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Yellow Fever: Vaccination
	house id	1
	legislature	25259 pref label House of Commons
	question text	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.
	tabling member constituency	Gravesham
	tabling member printed	Adam Holloway
	uin	216213
	answer	answer is ministerial correction date of answer 12/02/2019 answer text <p>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.</p><p> </p><p>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.</p><p> </p><p>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.</p><p> </p><p>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.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 216210 216211 question first answered 12/02/2019 17:04:11 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	1522 label Biography information for Adam Holloway