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BCG vaccine SSI°: too many errors

The poorly designed packaging of the tuberculosis immunisation BCG vaccine SSI° exposes patients to errors, serious overdoses in particular.

In mid-2015, the French health products safety agency (Agence française des produits de santé, AFSSAPS) published a report of a national pharmacovigilance investigation into errors with the BCG SSI° vaccine between July 2008 and October 2014. This vaccine containing a live attenuated Mycobacterium bovis virus strain is presented in multidose vials containing the equivalent of 10 to 20 doses.

431 drug errors were reported, of which 37 serious errors were analysed.

79 overdoses, 16 of them severe, occurred in 64 children and 15 adults. In 29 cases, an entire vial was injected, i.e. 20 times the dose for 13 infants under the age of one, and 10 times the dose for 3 children aged between 1 and 5. These overdoses resulted in 10 patients having to undergo preventive antibiotic tuberculosis treatment. An abscess appeared in 10 patients following the injection of the overdose. In more than 50% of the cases, the outcome is unknown.

The packaging of BCG SSI° is poorly designed and can expose patients to errors with severe consequences. The design defects are chiefly: the presentation in multidose vials; the need for the product to be reconstituted and for several manipulations before injection; the 1 ml syringe supplied for administering the vaccine with a capacity for 10 to 20 times the dose to be injected; a complicated intradermal injection technique.

This damage was foreseeable and the report is now public. It is up to the pharmaceutical company to improve the packaging as a matter of urgency, and it is up to the health authorities to apply strong pressure on them to do so, to protect infants.

©Prescrire 1 March 2016

"BCG Vaccine SSI°: numerous errors" Prescrire Int 2016; 25 (169): 72. (Pdf, subscribers only).
Download the full review.
Pdf, subscribers only

See also:

BCG SSI°: adverse
effects still reported
Prescrire Int 2009;
18 (101): 124. 
Pdf, subsribers only

SSI° BCG vaccine:
avoidable adverse effects
Prescrire Int 2007;
16 (91): 200 - 201.
Pdf, subscribers only