title: Opinion on adventitious agents testing for vaccines: why do we worry so much about adventitious agents in vaccines?
abstract: The manner in which viral vaccines are produced in a biological system makes them vulnerable to microbial contamination. Considerable effort is expended to avoid such contamination and to detect it if it occurred. Is this effort warranted, efficient, scientifically sound, and rational? When asked for my opinion on these matters, I agreed to discuss the basis and historical context for why we do what we do and proffer opinion on what we might do instead or in addition, as we look forward to the inclusion of new strategies and methods in our arsenal. Being an advocate of the 3 R's policy, I invite a re-examination of the traditional in vivo methods in particular. I also advocate for a risk-based approach consistent with "Quality by Design" as a more scientific and rational means of addressing these issues. In the end, vaccinologists need to reassure the public that the vaccines they or their children receive are safe and pure and that all reasonable measures are taken to safeguard them.
authors.affiliation: CAPT USPHS, USNIH/NIAID/DAIDS, Bethesda, MD 20892, United States. rsheets@niaid.nih.gov
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Sheets
mesh_terms: D000818:Animals; D004340:Drug Contamination / Q000517:prevention & control*; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000592:standards; D006801:Humans; D018570:Risk Assessment; D014765:Viral Vaccines / Q000009:adverse effects*
chemical_list: D014765:Viral Vaccines