A review of the yellow fever vaccine (Stamaril) carried out by the Commission on Human Medicines (CHM) has found that, for most people, the balance of benefits and possible side effects of the vaccine remains overwhelmingly favourable. However, it recommends that further precautions should be taken in people with weakened immunity and in those aged 60 years or older.
A letter from the Medicines and Healthcare products Regulatory Agency (MHRA), the National Travel Health Network and Centre, Public Health England and Health Protection Scotland (HPS) has been circulated to yellow fever vaccination centres to advise them of the CHM’s recommendations.
An article in the MHRA’s safety bulletin, Drug Safety Update, has also been published to inform other healthcare professionals.
The CHM recommendations strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions. Key recommendations include new and updated information on who shouldn’t receive the vaccine and additional precautions to protect risk groups.
Yellow fever is a life-threatening viral infection carried by mosquitoes in some tropical countries. It is essential for anyone travelling to an area where there is a risk of infection to take steps to reduce the risk. The yellow fever vaccine is highly effective and it is the best way to protect those at risk of disease during travel.
Dr Philip Bryan, Vaccine Safety Lead at the MHRA, said:
“Yellow fever is a deadly disease. Vaccination is highly effective and remains the best form of protection. The possible side effects of yellow fever vaccine are mostly mild and short-lasting, and not everyone will experience them.
“But there is a very rare risk of life-threatening side effects and the vaccine is not suitable for everyone, such as those who may have a weakened immune system because of drugs they are taking, or illnesses they have or have had in the past. Additionally, people aged 60 years or over should only receive the vaccine if there is a significant and unavoidable risk of yellow fever infection during their travel.
“Patient safety is our highest priority and the MHRA is now working to communicate the Commission’s recommendations to health care professionals.”
Notes to Editor
The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care.
The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM’s functions are set out in regulation 10 of the Human Medicines Regulations 2012 (SI 2012/1916). The MHRA acts as secretariat to the Commission on Human Medicines.