Health Canada – Several GlaxoSmithKline Inc. vaccines: Potential Risk of Underdosing

Audiences

Healthcare professionals including family physicians, pediatricians, pharmacists, nurses, nurse practitioners, physicians’ assistants, and those working in travel clinics.

Key messages

• This information is applicable to the following vaccines: BOOSTRIX, BOOSTRIX-POLIO, ENGERIX-B, HAVRIX, HAVRIX Junior, INFANRIX-IPV, INFANRIX-IPV/HIB, INFANRIX-hexa, TWINRIX and TWINRIX Junior (see section “Products affected*”).
• Leakages have occurred from ceramic coated tip (CCT) syringes used for several GlaxoSmithKline Inc. vaccines in Canada.  The leakages occurred at the connection of the syringe tip and the needle hub during vaccine preparation or administration at an approximate rate of 3 per 100,000 syringes distributed. The integrity of the syringe and sterility of the contents were not compromised. 
• Administration of vaccines from leaking syringes can result in a potential risk of underdosing, that may leave patients inadequately protected from disease after vaccination (see section “Information for healthcare professionals”). 
• Healthcare professionals are advised:
  • not to use the syringe when the leakage occurs during reconstitution of lyophilized vaccines. 
  • when the leakage occurs during vaccine injection and the individual received less than the standard dose, the decision to revaccinate should take into account both the potential benefits and risks associated with administering a repeated dose (see section “Information for healthcare professionals”). 
• GlaxoSmithKline Inc. has been working with Health Canada to provide information regarding the leaking syringes for vaccines and the corrective actions implemented. The introduction of improved CCT syringes on the Canadian market is anticipated in 2018. However, both improved and affected CCT syringes are expected to be on the market until the end of 2019, the estimated time for using up the potentially affected syringes.

Issue

There have been reports of leakage from CCT syringes used for several GlaxoSmithKline Inc. vaccines during vaccine preparation or administration. Although the leakage does not pose a concern for the vaccine sterility, there is a potential risk of underdosing associated with administration of a vaccine from a leaking syringe that may leave patients inadequately protected from disease after vaccination.