Preserving public confidence

摘要

On April 23, 2008, the Philadelphia Inquirer obtained and posted on their website the official report of the US Food and Drug Administration's (FDA) inspection of Merck's manufacturing facility in Montgomery County (PA, USA). The report detailed a catalogue of 49 separate failures over the past 2 years in processes that affect the quality and sterility of vaccines produced at the factory, including the new quadrivalent Human papillomavirus (HPV) vaccine (Gardasil). Because the HPV vaccine is given prophylactically to children and adolescents, the vaccine has to be safe, and perceived to be so by the general public, if there is to be widespread uptake of the vaccine. The process failures at the facility include sterility issues, equipment maintenance and sanitation, data recording, packaging, and quality control. Specific failures associated with the manufacture of the HPV vaccine were leaks in the production line that fills vials with the vaccine and leaks in syringes dispensing the vaccine-both of which could cause contamination. The FDA report also criticised Merck for failing to re-inspect batches of the HPV vaccine that have caused serious adverse reactions. However, perhaps more alarmingly, the document notes Merck's failure to correct defects in their processes.