|Date:||8 October 2012|
|Subject:||Typhoid vaccine batches recalled by manufacturer Sanofi|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
The Medicines and Healthcare products Regulatory Agency (MHRA) today issued a drug alert to healthcare professionals advising them that the manufacturer Sanofi Pasteur MSD has recalled 16 batches of their typhoid vaccine, Typhim Vi.
This recall is due to concerns about the effectiveness of the vaccine in some syringes distributed from 7 January 2011 following filling problems in the manufacturing process. Therefore some patients who have been vaccinated with Typhim Vi may not be fully protected against the disease.
If you received this vaccine and have recently returned from abroad, and are unwell, you should contact your doctor.
Vaccine is still available and the Department of Health is working with manufacturers to help ensure that current supply problems are resolved as soon as possible.
MHRA Head of Defective Medicines Report Centre, Ian Holloway said:
“There are no concerns over the safety of this vaccine but the recall has taken place because the vaccine may not be as effective as it should be.
“Anyone who has been to a typhoid region of the world and has a fever, abdominal pain and vomiting should contact a healthcare professional. They can also give them information and advice about minimising the risk of getting typhoid.”
Notes to Editor1. The MHRA has today issued a Class 2 Drug Alert to healthcare professional.
Class 2 Drug Alert (Action Within 48 hours): Sanofi Pasteur MSD Limited - Typhim Vi - Typhoid Polysaccharide Vaccine - EL (12)A/33
2. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.