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CURRENT ADR NETWORK REPORT

Leaking vaccine syringes from GlaxoSmithKline

On preparing the six-in-one vaccine, INFANRIX HEXA, in 2016, a paediatrician noticed that liquid was leaking between the syringe and the needle. A complaint was subsequently lodged with the supplier, GlaxoSmithKline (GSK; NETWORK report 17.481). Although both GSK and the Paul-Ehrlich-Institut (PEI) had been aware of the problem of leaking syringes as far back as 2015, the company rejected the complaint on the grounds that "no leakage was observed" on testing with GSK needles (1). The leakiness also affects other vaccines provided by the supplier (2).* However, GSK did inform the medical profession as recent as April 2018, apparently at the insistence of the European Medicines Agency (EMA) (3). Improved syringes should be available since early 2018 onwards. However, GSK does not intend to recall faulty batches as this might compromise vaccine provision. It is therefore presumed that potentially leaking syringes will continue to be dispensed until late 2019. According to the company, between 2 and 10 syringes in 100,000 have been reported as leaking (2), but we assume the number of unreported cases to be considerable. Up to 100 µl "or more" can be lost from a leaking syringe (2). When requested by arznei-telegramm, GSK announced that if a syringe leaks during vaccine preparation, a replacement should be requested, free of charge, from the dispensing pharmacy (3). However, reference to the replacement procedure is not included in the communication sent to healthcare professionals (2). If a leak is detected during the vaccination process, sterility is guaranteed but the reduced dose may not be sufficient to ensure a complete immune response. In this case, GSK is leaving it to doctors to decide whether or not revaccination is required, and refers to US and UK recommendations (2). In the USA (4), doctors are advised to revaccinate in the event of leakage. According to the UK recommendation (5), if under-dosing is suspected, revaccination should be carried out as soon as possible, preferably on the same day. If this is not feasible, a minimal interval of four weeks should elapse before reinjecting live vaccines (5). With several vaccines, it is impossible to choose preparations from other suppliers because of the lack of alternatives, e.g. as with INFANRIX or TETANOL PUR. The argument that recall of the defective batches could lead to a shortage of vaccines for the general public highlights the vulnerability of our health care system: In the event of drug shortages, important medicines obtained from only one or a handful of suppliers may not be available in sufficient quantities (see a-t 2015; 46: 81-2 and 2018; 49: 14-5).

1GSK: letter dated 8 Nov. 2016
2GSK: letter to health professionals dated 3 Apr. 2018; http://www.a-turl.de/?k=anza
3GSK: letter dated 20 April 2018
4CDC: Epidemiology and Prevention of Vaccine-Preventable Diseases ("Pink Book") - “Vaccine Administration‘, as at Nov. 2016; http://www.a-turl.de/?k=ecku
5Health Protection Agency: Vaccine incident guidance; March 2012; http://www.a-turl.de/?k=hmde
* In addition to INFANRIX HEXA, BOOSTRIX, BOOSTRIX POLIO, ENCEPUR, ENGERIX B, FENDRIX, HAVRIX, INFANRIX, INFANRIX IPV + HIB, TETANOL PUR and TWINRIX are also affected (2).

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