Regulatory Focus™ > News Articles > Sanofi Pasteur Recalls Vaccine in UK after Efficacy Concerns Raised

Sanofi Pasteur Recalls Vaccine in UK after Efficacy Concerns Raised

Posted 09 October 2012 | By Alexander Gaffney, RAC 

UK regulators with the Medicines and Healthcare products Regulatory Agency (MHRA) have issued a drug alert to healthcare practitioners warning them of a recall involving Sanofi Pasteur MSD's typhoid vaccine, Typhim Vi.

In its 8 October warning, MHRA said while the vaccine remained safe, concerns had been raised about the product's effectiveness against typhoid, and the agency urged all patients who recently traveled abroad and remained "unwell" to seek medical attention.

In a "Dear Healthcare Professional" letter posted on MHRA's website, Sanofi said it was recalling 16 batches of Typhim Vi manufactured between March 2011 and September 2012 due to concerns about out-of-specification antigen levels which could lead to consumers being, "Insufficiently protected against typhoid."

"Not all doses in these batches are affected, but it is not possible to predict who may have received the affected doses," explained Sanofi.

The company also said it was unable to determine when normal distribution of the product would resume in the UK, but expected all stock of the drug would be removed from the market by the end of October. The vaccine should be available again at some point in early 2013, it predicted.

The BBC reports more than 720,000 patients in the UK could be more susceptible to typhoid than previously believed, though it noted that revaccinations were not recommended.

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