Quality issues prompt Sanofi typhoid vaccine recall
pharmafile | October 3, 2012 | News story | Manufacturing and Production |Â Â Sanofi, Typhen Vi, recallÂ
Sanofi has recalled several lots of its typhoid fever vaccine Typhim Vi on fears that a quality defect could compromise the efficacy of the product.
Typhim Vi is indicated for active immunisation against typhoid fever caused by Salmonella enterica serovar typhi in people aged two years or older.
Some stocks of the polysaccharide vaccine have been pulled off the market on the back of out-of-specification (OOS) test results, which suggest the vaccine may not have enough antigen to be sufficiently potent. The root cause of the OOS test results is being investigated by the firm.
An FDA notice indicates that five lots of Typhim Vi in prefilled syringes and one lot of 20-dose vials are affected by the recall in the US, while the Department of Health in Hong Kong recently ordered a total recall of all product on the market.
In a letter sent to healthcare professionals in the US, Sanofi said the recall was initiated in consultation with the FDA “because of potential lower potency of the vaccine against typhoid fever due to a lower antigen content (i.e., an antigen content below the official pharmacopeia specification limit) in some lots of vaccine”.
The company stressed that there are no safety concerns for people who have already received a Typhim Vi vaccine from the recalled lots, and also said it does not expect any shortages in the US marketplace because alternative vaccine products are available.
An alternative typhoid fever vaccine from Crucell called Vivotif is available on the US market, according to Sanofi.
Typhim Vi is an important public health product and last year became the first vaccine to be granted World Health Organization (WHO) prequalification status, a key requirement for the procurement of medicines by UNICEF and other United Nations agencies like the Pan American Health Organization (PAHO) Revolving Fund.
Phil Taylor
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