Lewis Benjamin P
J Am Pharm Assoc (2003). 2025 Aug 1:102492. doi: 10.1016/j.japh.2025.102492.
Robert M.Califf, MD, Commissioner of the Food and Drug Administration (FDA), noted at the end of his term that misinformation was a priority during his tenure; however, COVID-19 vaccines have dissuaded people from getting the vaccine and contributed to preventable deaths. The Incoming Secretary of the Department of Health and Human Services, Robert F. Kennedy, Jr. (RFK Jr.), which includes the FDA, has now stated that there aren't sufficient vaccine safety studies, falsely asserted the government doesn't have good vaccine safety monitoring, and that we don't have good science on almost everything, including vaccines. Additionally, he refused to acknowledge the scientific consensus that childhood vaccines (e.g., MMR) do not cause autism. Pharmaceutical sponsors study vaccines in clinical trials under an Investigational New Drug Application (IND), which extensively tests vaccines, analyzing thousands of subjects' data for safety and efficacy. Many vaccines have been available for years without reported safety concerns. Conducting comprehensive clinical trials, monitoring, and reporting vaccine safety data is considered good science. Effective communication about vaccines is crucial as we become increasingly interconnected through world travel, social media, and the internet. Providing accurate information and fostering trust that supports good clinical and scientific knowledge prevents confusion from unsupported statements, such as social media, that can create misinformation. The FDA approves the official prescribing information and fact sheet for vaccines, ensuring they are accurate and well-documented to prevent misinformation. Responsible health science communication must be correct, transparent, and inclusive to the public. Vaccination is a fundamental principle of public health, and clear communication is the basis of mitigating vaccine hesitancy, misinformation, and disinformation. Without this, misinformation will erode the foundation of public health.
美国食品药品监督管理局(FDA)专员罗伯特·M·卡利夫医学博士在其任期结束时指出,错误信息是他任期内的一个优先事项;然而,新冠疫苗却使人们不愿接种疫苗,导致了可预防的死亡。即将上任的卫生与公众服务部部长罗伯特·F·肯尼迪(小罗伯特·F·肯尼迪),该部门包括FDA,现已表示没有足够的疫苗安全性研究,错误地声称政府没有良好的疫苗安全性监测,而且我们几乎对所有事情,包括疫苗,都没有可靠的科学依据。此外,他拒绝承认关于儿童疫苗(如麻疹、腮腺炎、风疹联合疫苗)不会导致自闭症的科学共识。制药赞助商在新药临床试验申请(IND)下的临床试验中研究疫苗,该申请对疫苗进行了广泛测试,分析了数千名受试者的数据以评估安全性和有效性。许多疫苗已经上市多年,没有报告过安全问题。进行全面的临床试验、监测和报告疫苗安全数据被认为是良好的科学做法。随着我们通过世界旅行、社交媒体和互联网变得越来越相互关联,关于疫苗的有效沟通至关重要。提供准确信息并建立支持良好临床和科学知识的信任,可以防止社交媒体等无根据言论造成的混乱,这些言论可能会制造错误信息。FDA批准疫苗的官方处方信息和情况说明书,确保其准确且有充分记录,以防止错误信息。负责任的健康科学传播必须正确、透明且面向公众。疫苗接种是公共卫生的基本原则,清晰的沟通是缓解疫苗犹豫、错误信息和虚假信息的基础。没有这一点,错误信息将侵蚀公共卫生的基础。