Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
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.
Answered by Jackie Doyle-Price
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.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
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.
Answered by Jackie Doyle-Price
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.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will commission research into new vaccines for yellow fever in the event that Sanofi Pasteur does not undertake research into its yellow fever vaccine.
Answered by Caroline Dinenage
The Department’s National Institute for Health Research (NIHR) welcomes funding applications for research into any aspect of human health, including the development of cheaper vaccines. These applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality. In all disease areas, the amount of NIHR funding depends on the volume and quality of scientific activity.
The NIHR and the Medical Research Council both have a wide portfolio of research activity in vaccines which cover clinical trials for new vaccines, new technologies, ways of improving uptake and cost effectiveness.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
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.
Answered by Jackie Doyle-Price
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.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits on including yellow fever in the list of vaccines under the Vaccine Damage Payment Act 1979 for which compensation may be paid.
Answered by Steve Brine
The Vaccine Damage Payment Scheme (VDPS) is not a compensation scheme. There is no assessment of what losses were actually suffered. It provides a one off tax-free lump sum payment, currently £120,000, to successful claimants and is one part of the wide range of support and help available to severely disabled people in the United Kingdom.
The VDPS is primarily designed to cover adverse reactions for vaccination in the child immunisation programme which is a Government initiative to protect the community from infectious disease and does not include travel vaccines.
The Scheme is being kept under review if further inclusions are thought necessary.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of changing the provisions of the Vaccine Damage Payment compensation scheme so that people who suffer a psychiatric injury as a result of an adverse event involving a vaccine can also be fairly compensated for the effects of (a) loss of earnings, (b) the stigma of mental illness and (c) incarceration.
Answered by Steve Brine
The Department for Work and Pensions administers the Vaccine Damage Payment Scheme (VDPS) on our behalf.
The VDPS is not a compensation scheme. There is no assessment of what losses were actually suffered. It provides a one off tax-free lump sum payment, currently £120,000, to successful claimants and is one part of the wide range of support and help available to severely disabled people in the United Kingdom.
This Scheme is not designed as an alternative to litigation and does not prejudice the right of the injured person to pursue a claim against the manufacturer of the vaccine for compensation.
To qualify for a VDPS payment, the applicant has to meet two legal tests:
- establishing, on a balance of probabilities, that the disablement was caused by a vaccination covered by the VDPS; and
- the resulting disablement is severe disablement (60% or more), assessed on the same basis as for the Industrial Injuries Disablement Benefit Scheme.
Disablement is the overall effect of the disability arising from a loss of faculty caused by the vaccine. It is an assessment of the effects of the medical condition, not an assessment of the condition itself. The effects may be physical or mental or both. The level of disablement is made by comparison of the disabled person to a person of the same age and sex whose physical and mental condition is normal.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
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.
Answered by Jackie Doyle-Price
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.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
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.
Answered by Jackie Doyle-Price
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.
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.
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.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has any plans to make ketamine available on the NHS for people with treatment-resistant depression.
Answered by Steve Brine
There are no current plans to make ketamine routinely available on the National Health Service for people with treatment-resistant depression. To be prescribed routinely within the NHS, the manufacturer of a ketamine-based medicine would need to apply for and be granted a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication.
Ketamine is currently only licenced by the MHRA as an anaesthetic for diagnostic and surgical procedures in adults and children.
Asked by: Adam Holloway (Conservative - Gravesham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, whether the new NHS Indemnity cover for GPs will be extended to GPs working or willing to work for the NHS, who despite being cleared by the GMC and the Medical Practitioners Tribunal Service had been declined indemnity by the traditional three indemnity organisations.
Answered by Philip Dunne
The Secretary of State announced on 12 October 2017 that the Government is planning to develop a state-backed indemnity scheme for general practice in England, subject to further work on relevant issues.
We envisage the scheme would provide clinical negligence cover to providers of general practitioner (GP) services (e.g. GP contractors out-of-hours providers of GP services) through which the activities of individual GPs would be covered from the point the scheme is established. It would be available to all contractors who provide primary medical services: General Medical Services, Primary Medical Service and Alternative Provider Medical Services plus any other integrated urgent care delivered through NHS Standard Contracts. The cover would include the activities of practice staff including other medical professionals working for the practice in the provision of these contracted services, and students/trainees working in this area.
Decisions have yet to be made about inclusion of doctors working in other public sector settings including prisons and the Ministry of Defence. We are working with GPs and their representatives, other providers of primary medical services and practice staff to develop the scheme and its scope so as to work best for general practice, and for patients.