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1141380

registered interest
date	23/07/2019
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	MMR Vaccine: Safety
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps he is taking to maintain and improve pharmacovigilance in relation to the MMR vaccine.
tabling member constituency	Gravesham
tabling member printed	Adam Holloway
uin	280998
answer	answer is ministerial correction date of answer 25/07/2019 answer text <p>As with all vaccines and medicines, the safety of the Measles, Mumps and Rubella (MMR) vaccine remains under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA uses all available sources of evidence in pharmacovigilance, including regular review of suspected adverse reactions submitted through the Yellow Card Scheme, data from clinical and epidemiological studies, the medical literature and information from pharmaceutical companies and other worldwide regulatory authorities. The MHRA’s processes and data analysis systems are regularly evaluated to ensure optimal performance in monitoring the safety of vaccines and medicines.</p><p>The balance of benefits and risks of MMR vaccine remains overwhelmingly favourable.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 25/07/2019 16:35:38 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	1522 label Biography information for Adam Holloway

1141381

registered interest
date	23/07/2019
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	MMR Vaccine
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	Gravesham
tabling member printed	Adam Holloway
uin	280999
answer	answer is ministerial correction date of answer 25/07/2019 answer text <p>Two Measles, Mumps and Rubella (MMR) vaccines are licensed for use in the United Kingdom: M-M-RVaxPro and Priorix. Both vaccines are on the National Health Service’s routine immunisation schedule. The quality, safety and efficacy of both M-M-RVaxPro and Priorix have been evaluated before they were given a Marketing Authorisation in Europe, and the Marketing Authorisation Holder for each vaccines is legally required to submit periodic safety update reports to the regulator, which are documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The sites at which the products are manufactured are also required to undergo periodic inspections to ensure that they comply with Good Manufacturing Practices. Each batch of vaccines is tested by an official medicines control laboratory (OMCL). OMCL testing is independent of and in addition to the manufacturer’s testing. These procedures ensure that the MMR vaccines available in the UK are safe and efficacious and that the manufacturers/Marketing Authorisation holders are held accountable for their products.</p><p>A European Public Assessment Report (EPAR) for M-M-RVaxPro is available at the following link:</p><p><a href="https://www.ema.europa.eu/en/documents/scientific-discussion/m-m-rvaxpro-epar-scientific-discussion_en.pdf" target="_blank">https://www.ema.europa.eu/en/documents/scientific-discussion/m-m-rvaxpro-epar-scientific-discussion_en.pdf</a></p><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> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 25/07/2019 16:38:57 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	1522 label Biography information for Adam Holloway

1054826

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 representations to Sanofi Pasteur on undertaking new research into the risks of adverse events, including psychosis, from using the vaccine Stamaril.
tabling member constituency	Gravesham
tabling member printed	Adam Holloway
uin	216210
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 216211 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

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

1054839

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 information he holds on research into safer alternatives to the Stamaril vaccine; and if the Government will provide funding for such research.
tabling member constituency	Gravesham
tabling member printed	Adam Holloway
uin	216216
answer	answer is ministerial correction date of answer 12/02/2019 answer text <p>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> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 12/02/2019 16:59:08 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	1522 label Biography information for Adam Holloway

1054841

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	Drugs: Side Effects
house id	1
legislature	25259 pref label House of Commons
question text	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.
tabling member constituency	Gravesham
tabling member printed	Adam Holloway
uin	216217
answer	answer is ministerial correction date of answer 12/02/2019 answer text <p>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> </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> </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> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 12/02/2019 16:53:58 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	1522 label Biography information for Adam Holloway