title: Ensuring the optimal safety of licensed vaccines: a perspective of the vaccine research, development, and manufacturing companies.
abstract: Vaccine safety is increasingly a focus for the general public, health care providers, and vaccine manufacturers, because the efficacy of licensed vaccines is accepted as a given. Commitment to ensuring safety of all vaccines, including childhood vaccines, is addressed by the federal government, academia, and industry. Safety activities conducted by the vaccine research, development, and manufacturing companies occur at all stages of product development, from selection and formulation of candidate vaccines through postlicensure studies and surveillance of adverse-event reports. The contributions of multiple interacting functional groups are required to execute these tasks through the life cycle of a product. We describe here the safeguards used by vaccine manufacturers, including specific examples drawn from recent experience, and highlight some of the current challenges. Vaccine-risk communication becomes a critical area for partnership of vaccine companies with government, professional associations, and nonprofit advocacy groups to provide information on both benefits and risks of vaccines. The crucial role of the vaccine companies in ensuring the optimal vaccine-safety profile, often overlooked, will continue to grow with this dynamic arena.
authors.affiliation: Novartis Vaccines and Diagnostics, 350 Massachusetts Ave, Camridge, MA 02139, USA. Niranjan.Kanesa-thasan@novartis.com
authors.forename: Niranjan
authors.initials: N
authors.lastname: Kanesa-thasan
authors.forename: Alan
authors.initials: A
authors.lastname: Shaw
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Stoddard
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Vernon
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D000818:Animals; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004195:Disease Models, Animal; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015195:Drug Design; D004341:Drug Evaluation; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D017589:Immunization Programs / Q000592:standards; D007223:Infant; D008004:Licensure / Q000331:legislation & jurisprudence; D008297:Male; D012106:Research / Q000331:legislation & jurisprudence; D017751:Safety Management; D014481:United States; D014611:Vaccination / Q000331:legislation & jurisprudence; D014612:Vaccines / Q000494:pharmacology*
chemical_list: D014612:Vaccines