Red Hand Letter on Leaking Syringes in Some GSK Vaccines
Important information about leaking syringes with some Glaxo SmithKline vacc ines Affected vaccines: Boostrix, Boostrix Polio, Engerix-B, Havrix, Infanrix hexa, Menjugate, Priorix, Priorix-Tetra, Tetanol Pur, Twinrix (adult and pediatric), Varilrix.Leaking syringes have been reported with the above vaccines in the course of vaccine preparation or administration In Europe, this affects 2.6 per 100.000 doses, with a range of 2-10 per 100,000 doses in the 5 most commonly affected countries, although the absolute incidence of fluid leakage is not known and may be higher. Leakage does not pose a risk to the sterility of the vaccine. The potential risk of fluid leakage from the syringe is that it could theoretically result in under-dosing of the vaccine and inadequate vaccine protection in vaccinated individuals. Pharmacovigilance data show no evidence that the observed fluid leaks resulted in vaccine failure (lack of efficacy) or other patient safety risks. If the leak occurs during reconstitution of the lyophilized vaccine, the affected syringe should be discarded. If leakage occurs during injection of the vaccine, it is up to the physician to decide whether individuals who have been vaccinated with a lower dose than the standard amount of vaccine should be vaccinated a second time. Consideration should be given to both the potential benefits and potential risk of adverse effects of further vaccination, as well as the potential risk of reduced vaccine protection if vaccination is not repeated. Local recommendations for managing potential vaccine underdoses should be followed. All health care workers are encouraged to report complaints regarding product quality, administration errors, and suspected adverse reactions. more information:
Queries (technical)
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
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Communications Management AGES/BASG
E-mail: presse-basg@basg.gv.at
