https://www.ema.europa.eu/en/documents/scientific-discussion/m-m-rvaxpro-epar-scientific-discussion_en.pdf<\/a><\/p>Priorix was approved before public assessment reports were a requirement. The EPAR for M-M-RVaxPro contains a general summary of the manufacturing information that was provided during the assessment process; however, the specific details of the manufacturing process are confidential.<\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4065", "label" : {"_value" : "Biography information for Dame Jackie Doyle-Price"}
}
, "answeringMemberConstituency" : {"_value" : "Thurrock"}
, "answeringMemberPrinted" : {"_value" : "Jackie Doyle-Price"}
, "dateOfAnswer" : {"_value" : "2019-07-25", "_datatype" : "dateTime"}
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, "answeringDeptShortName" : {"_value" : "Health and Social Care"}
, "answeringDeptSortName" : {"_value" : "Health and Social Care"}
, "date" : {"_value" : "2019-07-23", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "MMR Vaccine"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
}
], "questionText" : "To ask the Secretary of State for Health and Social Care, what steps he is taking to help ensure (a) transparency and (b) accountability in the process of manufacturing the MMR vaccine.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/1522", "label" : {"_value" : "Biography information for Adam Holloway"}
}
, "tablingMemberConstituency" : {"_value" : "Gravesham"}
, "tablingMemberPrinted" : [{"_value" : "Adam Holloway"}
], "uin" : "280999"}
, {"_about" : "http://data.parliament.uk/resources/1054826", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/1054826/answer", "answerText" : {"_value" : "
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>
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>
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>
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>"}
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, "date" : {"_value" : "2019-02-04", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Yellow Fever: Vaccination"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
}
], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/1522", "label" : {"_value" : "Biography information for Adam Holloway"}
}
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, "tablingMemberPrinted" : [{"_value" : "Adam Holloway"}
], "uin" : "216210"}
, {"_about" : "http://data.parliament.uk/resources/1054828", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/1054828/answer", "answerText" : {"_value" : "
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>
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>
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>
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>"}
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}
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, "dateOfAnswer" : {"_value" : "2019-02-12", "_datatype" : "dateTime"}
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, {"_value" : "216213"}
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, "date" : {"_value" : "2019-02-04", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Yellow Fever: Vaccination"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
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], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/1522", "label" : {"_value" : "Biography information for Adam Holloway"}
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, "tablingMemberPrinted" : [{"_value" : "Adam Holloway"}
], "uin" : "216211"}
, {"_about" : "http://data.parliament.uk/resources/1054830", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/1054830/answer", "answerText" : {"_value" : "
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>
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>
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>
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>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4065", "label" : {"_value" : "Biography information for Dame Jackie Doyle-Price"}
}
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, "date" : {"_value" : "2019-02-04", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Yellow Fever: Vaccination"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
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], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/1522", "label" : {"_value" : "Biography information for Adam Holloway"}
}
, "tablingMemberConstituency" : {"_value" : "Gravesham"}
, "tablingMemberPrinted" : [{"_value" : "Adam Holloway"}
], "uin" : "216213"}
, {"_about" : "http://data.parliament.uk/resources/1054839", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/1054839/answer", "answerText" : {"_value" : "
The Medical Research Council has an active study to assess the safety and immunogenicity of yellow fever vaccine dose sparing strategies for campaign and programmatic use. The study seeks to determine whether using a fractional dose of the normal yellow fever vaccine in infants provides sufficient protection against yellow fever compared with the normal dose of vaccine and whether altering the route of administration affects vaccine safety.<\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4065", "label" : {"_value" : "Biography information for Dame Jackie Doyle-Price"}
}
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, "answeringMemberPrinted" : {"_value" : "Jackie Doyle-Price"}
, "dateOfAnswer" : {"_value" : "2019-02-12", "_datatype" : "dateTime"}
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]}
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, "answeringDeptShortName" : {"_value" : "Health and Social Care"}
, "answeringDeptSortName" : {"_value" : "Health and Social Care"}
, "date" : {"_value" : "2019-02-04", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Yellow Fever: Vaccination"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
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], "questionText" : "To ask the Secretary of State for Health and Social Care, what information he holds on research into safer alternatives to the Stamaril vaccine; and if the Government will provide funding for such research.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/1522", "label" : {"_value" : "Biography information for Adam Holloway"}
}
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, "tablingMemberPrinted" : [{"_value" : "Adam Holloway"}
], "uin" : "216216"}
, {"_about" : "http://data.parliament.uk/resources/1054841", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/1054841/answer", "answerText" : {"_value" : "
Holders of marketing authorisations are responsible for on-going monitoring of the safety of the medicinal products they place on the market. Additionally, the safety profile of all medicinal products is continually reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) to determine whether there are new risks, if risks have changed, and if any additional risk minimising measures or other regulatory action is required.<\/p>
<\/p>
Since 2012 it has been a legal requirement for both marketing authorisation holders and medicines regulators to monitor the effectiveness of all such risk minimising measures to determine whether they have had the desired effect. Depending on the findings, further action to minimise risk may be taken.<\/p>
<\/p>
Recent reviews of the impact of regulatory interventions have been conducted by the MHRA and across the European regulatory network, and further evaluation of the effectiveness of the regulatory regimen in the European Union is ongoing.<\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4065", "label" : {"_value" : "Biography information for Dame Jackie Doyle-Price"}
}
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, "answeringMemberPrinted" : {"_value" : "Jackie Doyle-Price"}
, "dateOfAnswer" : {"_value" : "2019-02-12", "_datatype" : "dateTime"}
, "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"}
, "questionFirstAnswered" : [{"_value" : "2019-02-12T16:53:58.243Z", "_datatype" : "dateTime"}
]}
, "answeringDeptId" : {"_value" : "17"}
, "answeringDeptShortName" : {"_value" : "Health and Social Care"}
, "answeringDeptSortName" : {"_value" : "Health and Social Care"}
, "date" : {"_value" : "2019-02-04", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Drugs: Side Effects"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
}
], "questionText" : "To ask the Secretary of State for Health and Social Care, whether he has made a recent assessment of the effectiveness of the regulatory regime in ensuring that drug companies continuously take steps to minimise the risks from their products.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/1522", "label" : {"_value" : "Biography information for Adam Holloway"}
}
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, "tablingMemberPrinted" : [{"_value" : "Adam Holloway"}
], "uin" : "216217"}
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