Novartis Vaccines and Diagnostics, 350 Massachusetts Ave, Camridge, MA 02139, USA.
Pediatrics. 2011 May;127 Suppl 1:S16-22. doi: 10.1542/peds.2010-1722D. Epub 2011 Apr 18.
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.
疫苗安全日益成为公众、医疗保健提供者和疫苗制造商关注的焦点，因为已许可疫苗的功效被认为是既定事实。联邦政府、学术界和行业都致力于确保所有疫苗（包括儿童疫苗）的安全性。疫苗研究、开发和制造公司在产品开发的各个阶段开展安全性活动，从候选疫苗的选择和配方到上市后研究和不良事件报告监测。在产品的整个生命周期中，需要多个相互作用的功能组来执行这些任务。我们在这里描述了疫苗制造商使用的保障措施，包括从最近的经验中提取的具体示例，并强调了一些当前的挑战。疫苗风险沟通成为疫苗公司与政府、专业协会和非营利宣传团体合作的一个关键领域，以提供疫苗的益处和风险信息。疫苗公司在确保最佳疫苗安全概况方面的关键作用经常被忽视，随着这一充满活力的领域的发展，这一作用将继续扩大。
