Vaccine recalled in UK still available in Ireland

A typhoid vaccine recalled in Britain because of concerns about its effectiveness has remained on the Irish market.

Batches of Typhim Vi were recalled in Britain last Monday amid fears that patients given the vaccine were not fully protected against the potentially life-threatening disease.

The British Medicines and Healthcare Products Regulatory Agency also issued a drug alert to healthcare professionals advising them that the manufacturer, Sanofi Pasteur MSD, had recalled 16 batches of Typhim Vi.

However, no such alert was issued by the Irish Medicines Board. In a statement, the IMB said the issue “is not a safety concern”.

The British recall related to concerns about the effectiveness of the vaccine in some syringes distributed from Jan 7 following filling problems in the manufacturing process. The British agency said as a result “some patients who have been vaccinated with Typhim Vi may not be fully protected against the disease”.

Dr Graham Fry, director of the Tropical Medical Bureau which has 22 clinics in Ireland, said they had known about the typhoid situation for some time and had not used Typhim Vi “for quite a few weeks”.

“We have sourced the oral vaccine and have used this for our patients where necessary though supplies are very limited,” Dr Fry said.

“There is a combined hepatitis A/typhoid vaccine which is unaffected by the current typhoid situation.”

Dr Fry said he couldn’t say why the IMB had not instructed Sanofi Pasteur MSD to undertake a product recall “but certainly the vaccine distribution by Sanofi ceased in Ireland overnight once the problem was identified internationally”.

Dr Fry said he understood there had not been a requirement in Britain to revaccinate patients because even though optimal antibody protection may have been compromised, the feeling was that some cover would have been generated by the administered vaccine.

The IMB said revaccination was not currently recommended, and that travellers are advised to take food and water hygiene precautions when visiting areas where typhoid is prevalent.

The IMB also said once replacement stock becomes available, affected batches on the Irish market would be recalled.

The IMB said it was working closely with the manufacturers to secure replacement stocks, and that the estimated arrival date is today.

Dr Fry said they had been told they would have fresh stock by tomorrow. The IMB said a recall prior to the arrival of replacement stock would result in the unavailability of any typhoid vaccine for certain groups.

“This is in line with the approach that has been taken in the UK and other impacted European markets,” the IMB said.

Typhoid is a bacterial disease of humans transmitted through contaminated food and water. Approximately 10 cases are notified in Ireland each year.