Key Takeaways
- A packaging issue affecting the sterility of needle soft packs included with Infanrix Hexa pediatric vaccines has been identified.
- The defect involves a small hole in the soft pack, which may compromise the sterility of the needles but does not affect the syringe or vaccine content.
- Healthcare professionals are advised to discard the affected needles and use alternative sterile needles of the same gauge and length.
Healthcare professionals have been alerted to a potential sterility issue with the needle soft packs provided alongside the pediatric vaccine Infanrix Hexa. Infanrix Hexa is a combination vaccine protecting against diphtheria (D), tetanus (T), pertussis (Pa), hepatitis B (HBV), poliomyelitis (IPV), and Haemophilus influenzae type-b (Hib). The packaging defect involves a small hole, approximately 1 mm in diameter, found in the paper section of the needle soft packs. While this defect does not affect the pre-filled syringes or their contents, it may compromise the sterility of the enclosed needles, potentially posing a safety risk to patients.
This issue specifically concerns the 10-dose presentation of Infanrix Hexa, which includes 10 vials, 10 pre-filled syringes, and 20 needles. The defect is not easily visible, making detection difficult. As a precaution, GlaxoSmithKline (GSK), the manufacturer of Infanrix Hexa, has recommended that healthcare professionals immediately discard the affected needles from all impacted batches to avoid any risk to patient safety.
Impact and Recommended Actions for Healthcare Providers
GSK has emphasized that the packaging defect affects only the needle soft packs and not the vaccine syringes or their contents. Therefore, the vaccine itself remains safe for use. However, due to the potential compromise in needle sterility, healthcare providers are instructed to take the following precautionary measures, All needle soft packs included in the impacted batches of Infanrix Hexa should be removed and discarded to prevent the use of potentially non-sterile needles.
Healthcare professionals should replace the discarded needles with other sterile needles of the same gauge and length to ensure safe vaccine administration. It is important to ensure that the replacement needles meet the necessary specifications for safe use in pediatric vaccinations. Healthcare providers should share this information with all relevant personnel within their organization or team to ensure that all affected needle packs are discarded, and appropriate alternative needles are used. It is essential that this communication reaches all healthcare professionals involved in administering the vaccine to prevent any safety issues.
GSK has coordinated with European regulatory authorities and the Agenzia Italiana del Farmaco (AIFA) to ensure that all healthcare professionals are aware of this issue. Although the defect is considered minor, taking these precautionary measures is critical to maintain patient safety during vaccine administration.
Details of the Packaging Defect
The issue was discovered in the needle soft packs provided with certain batches of the 10-dose presentation of Infanrix Hexa. The defect involves a small hole, approximately 1 mm in diameter, in the paper section of the needle pack. While small, this hole could allow contaminants to enter, potentially compromising the sterility of the needle. Given that this defect is not easily detectable, it is crucial to discard the needles from the affected batches as a precautionary step.
Healthcare professionals are reminded that the pre-filled syringes and their contents are unaffected by this packaging issue. The vaccines can still be safely administered using sterile replacement needles, ensuring the continuation of the vaccination program without delays or interruptions.
Next Steps and Communication
GSK has provided direct communication to healthcare professionals, detailing the steps that need to be taken to ensure patient safety. If any healthcare provider has concerns or requires further guidance, they are encouraged to contact GSK or refer to the official communication and related documents, which provide further information about the affected batches and instructions on how to proceed.
This notice is part of GSK’s commitment to ensuring the highest standards of quality and safety in its vaccine products. The company is working closely with regulatory authorities, including AIFA, to monitor the situation and provide ongoing updates if necessary.
Healthcare professionals should remain vigilant and ensure that all necessary steps are taken to prevent any issues related to the sterility of needles provided with Infanrix Hexa. By adhering to the recommendations and discarding affected needles, providers can continue to deliver safe and effective vaccinations to children, protecting them against a range of serious diseases.
Resource: Italian medicines Agecy, October 10, 2024
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