Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection.

Breakage at the flange and/or hub of the syringe, resulting in lacerations or needle puncture wounds, have been reported for Vaxneuvance suspension for injection in pre-filled syringe.

Further investigation has revealed that this is related to a component issue. While corrective and preventive actions have been implemented to address this defect, all Vaxneuvance syringes currently on the market have the potential for these defects.

To reduce the potential risk of injury to the patient, caregiver and/or healthcare professional, it is recommended that the glass syringe be carefully inspected for breakage before use and the dose discarded if breakage is observed or suspected prior to use of Vaxneuvance.

The Direct Healthcare Professional Communication is available in "Related Documents".