Yellow fever occurs in tropical and sub-tropical regions of Africa and South and Central America. There is no risk of transmission in the United Kingdom (UK) from imported cases of yellow fever since the mosquito vector does not occur in the UK. Therefore, there are no current plans make this vaccine available on the National Health Service.

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.

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.

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.

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.

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.

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.

FCO officials have been in direct contact with the Angolan Government and Angolan Embassy in London on yellow fever. Although we are unable to provide direct assistance given the UK regulations around yellow fever supplies, the Department for International Development are directly funding Gavi, the Vaccine Alliance, and as its largest donor is providing £1.44 billion for 2016-2020. Gavi is supporting Angola’s response through the International Coordination Group’s (ICG) Revolving Fund. Angola has already received 7 million doses from the ICG to respond to the outbreak. We also provide central funding to the WHO, who have been running a vaccination campaign in Luanda province.

The Government recognises the Yellow Fever outbreak in Angola as being of serious concern, with risks of international spread through non-immunised travellers. Government departments are collaborating to monitor the situation closely, including within affected and at-risk countries where the UK has a presence. We are also working with the World Health Organisation, Gavi (the vaccine alliance) and other international partners to support their work to control the outbreak, including through large-scale vaccination campaigns. The UK has financed one quarter of the Yellow Fever vaccine doses provided to the global stockpile in 2016. More than 10.5million people in Angola and nearly 2million people in DRC have already been vaccinated in response to the outbreak.

This Government’s assessment is that the national response to the yellow fever outbreak in Angola is growing in strength with support from the international community and the strategic use of donated vaccines. To date surrounding countries have not suffered related outbreaks and exported yellow fever cases to China, Kenya and the Democratic Republic of Congo have been managed effectively.

The United Kingdom is supporting the national vaccination campaign in Angola through its core funding to Gavi, the Vaccine Alliance, and to the World Health Organisation. The international response has provided 7.3 million doses of yellow fever vaccine to Angola to respond to the outbreak.

The British Embassy in Luanda has been in close contact with the Government of Angola and the World Health Organisation regarding the current outbreak of yellow fever. The UK is the largest donor to Gavi (the Vaccine Alliance) and is providing £1.44 billion for 2016-2020. Gavi is supporting Angola’s response through the International Coordination Group’s Revolving Fund. We understand that Angola has received 7 million doses from the International Coordination Group to respond to the outbreak. The UK is also supporting vaccinations for yellow fever in Luanda through the World Health Organisation.

The manufacturer, Sanofi Pasteur MSD, has experienced temporary manufacturing issues which have led to supply problems with its single dose yellow fever vaccine, “Stamaril”. The company is at present unable to confirm when normal supply will resume.

Officials have been working with the company and the National Travel Health Network and Centre to help ensure that people are able to obtain yellow fever vaccine. No other company has a United Kingdom marketing authorisation for this product. However travel clinics have access to supplies of yellow fever vaccine which are licensed in other countries. Under the Medicines legislation, doctors in the UK can prescribe unlicensed medicines to meet the needs of individual patients on their own responsibility.

Reports of suspected adverse drug reactions (ADRs) are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme. It is important to note that a Yellow Card report is not proof of a side effect occurring, but merely a suspicion by the reporter that the vaccine may have been the cause.

Suspected reactions of psychiatric disorders reported to the MHRA each year since Stamaril yellow fever vaccine was licensed are summarised in the following table.

*One report unless stated in brackets

The Yellow Card scheme is open to anyone in the United Kingdom who wishes to report a suspected ADR, regardless of their profession. However, the MHRA does not routinely receive information on a suspected ADR report on whether the individual concerned is a member of the armed forces or any other profession.

Although yellow fever vaccines have not typically been associated with psychosis, very rarely yellow fever vaccine-associated neurotropic disease has been reported following vaccination, symptoms of which include high fever with headache that may progress to include one or more of the following: confusion, encephalitis/encephalopathy, meningitis, focal neurological deficits, or Guillain-Barré syndrome.

This potential risk is described in the product information for Stamaril. Yellow fever is a serious and potentially fatal disease, and the balance of benefits and risks for Stamaril remains positive. As with all medicines and vaccines on the UK market, the MHRA keeps the safety of the yellow fever vaccine under close review.

The Sudanese Federal Ministry of Health (FMOH) recently notified the World Health Organisation (WHO) of a yellow fever outbreak affecting twelve localities in West and South Kordofan states. According to WHO, between 3 October and 24 November 2013, a total of 44 suspected cases of yellow fever including 14 deaths were reported from this outbreak.

We are deeply concerned about the outbreak of yellow fever in Darfur. The latest report from the World Health Organisation suggests that 497 people have been infected, with 124 deaths. Sudan has been allocated 2.4 million vaccines from the International Co-ordinating Group on Vaccine

and the vaccination campaign started on 20 November 2012. The UK has contributed to the vaccination campaign through its support to the Central Emergency Response Fund. We will continue to monitor the situation closely.