Hastings Cent Rep. 2021 Nov;51(6):27-32. doi: 10.1002/hast.1296. Epub 2021 Nov 8.
When the U.S. Food and Drug Administration fully approved the Pfizer-BioNTech Covid-19 vaccine for people sixteen and older, questions arose. Parents, pediatricians, and the media wondered whether Covid-19 vaccines could be used off-label-and whether they should be. The American Academy of Pediatrics cautioned against pediatric off-label use of the vaccine, and the vaccine provider agreement from the Centers for Disease Control and Prevention appears to prohibit it. After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of a blanket prohibition on off-label pediatric Covid-19 vaccination, as it limits clinician ability to provide care they may determine to be clinically and ethically appropriate. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests.
当美国食品和药物管理局（FDA）全面批准辉瑞-生物科技公司（Pfizer-BioNTech）的新冠疫苗用于 16 岁及以上人群时，出现了一些问题。家长、儿科医生和媒体想知道新冠疫苗是否可以超说明书使用，以及是否应该这样做。美国儿科学会（AAP）警告不要在儿科中进行疫苗的超说明书使用，疾病控制与预防中心（CDC）的疫苗提供者协议似乎也禁止这种做法。在简要说明超说明书使用的伦理和法律先例之后，我们根据个体的获益、风险和可用替代方案，对儿科超说明书新冠疫苗接种的伦理可允许性和需要考虑的因素进行了分析。我们的分析对全面禁止儿科超说明书新冠疫苗接种的做法提出了伦理质疑，因为这限制了临床医生提供他们可能认为在临床和伦理上合适的治疗的能力。与此同时，我们的分析也承认，新冠疫情带来了一些群体层面的伦理问题，这些问题有时与个人的健康利益相冲突。
