Sanofi Typhoid Vaccine Recalled

The Medicines and Healthcare products Regulatory Agency (MHRA) recently 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 January 7, 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.

Typhim Vi vaccine is used to immunize people against S. typhi, the organism that causes typhoid fever, in those aged two or older.

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.”

“There is no safety concern for individuals who have received a Typhim Vi vaccine dose from a recalled batch,” Health Canada said in a statement.

“The doses were identified as potentially having less antigen, the substance that stimulates the immune system to produce antibodies against the disease.”

The company is not recommending that people go for a booster shot earlier than normally scheduled.

The other primary concern at this point is that there may be a supply shortage due to the recall.

“The recall may lead to a typhoid vaccine shortage,” the notice said.

“The Typhim Vi recall is expected to impact not only Sanofi Pasteur’s worldwide supply of its vaccine, but may also lead to a typhoid vaccine shortage within the next few weeks/months,” Nancy Simpson, director of communications for Sanofi Pasteur, said in an email.

“The company is fully conscious of the public health impact that this recall may cause and is investing all possible means at its disposal to resolve this issue as quickly as possible. The situation may be different from country to country depending on the local presence of typhoid fever manufacturers and on country stock.”

Canada has two other suppliers of typhoid vaccines, the regulator said.

If you received this vaccine, 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.

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