2023-09-21 11:03:24
Glass Syringes of Pneumococcal Vaccine Vaxneuvance May Break, Causing Potential Injury
21-09-2023, 11:00
Healthcare providers have been advised to exercise caution with the use of the pneumococcal vaccine Vaxneuvance, as the glass pre-filled syringe may be prone to breakage. The Medicines Authority CBG has issued a warning stating that the syringe’s finger grip and/or tip could break, potentially causing cuts or puncture wounds.
To ensure patient safety, healthcare providers are urged to carefully inspect the pre-filled syringe for any fractures before administering the vaccine. If any signs of breakage are visible, the syringe should not be used. However, even if the syringe appears intact, healthcare providers are advised to handle it with care.
Vaxneuvance is a vaccine designed to protect against pneumococcal disease in both children, starting from 6 weeks of age, and adults. The syringe breakage issue is related to a step in the production process, although steps have been taken by the manufacturer to address the problem in future batches. Nevertheless, it is still possible that Vaxneuvance syringes currently on the market may be affected.
In light of this issue, healthcare providers have been provided with specific advice to minimize the risks associated with the use of Vaxneuvance. The vaccine should be administered strictly in accordance with the instructions outlined in the product information. Additionally, healthcare providers are advised to thoroughly examine the syringe for any breaks both inside the packaging and after removal. If any breakage is observed, the syringe should not be used. If the syringe appears intact, it should still be used with caution, without applying excessive force during preparation and administration.
Marketing authorization holder, Merck Sharp & Dohme BV, has taken proactive steps to address this issue. They have sent a letter, known as a Direct Healthcare Professional Communication (DHPC), containing vital risk information to healthcare providers who have used or will use syringes from the affected batch in the near future. This communication was conducted in collaboration with the MEB and the Healthcare and Youth Inspectorate (IGJ).
To ensure the safety of individuals receiving the pneumococcal vaccine Vaxneuvance, it is crucial that healthcare providers adhere to the outlined precautions and carefully assess each syringe for signs of breakage. By taking these measures, the risk of injury can be significantly minimized.]
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