The US Food and Drug Administration (FDA) approval of the biologics license application for the Pfizer-BioNTech coronavirus disease 2019 vaccine (Comirnaty) on August 23, 2021, opened the door to the off-label vaccination of children younger than the age range currently covered by either the biologics license application (16 years old and older) or the emergency use authorization (12 to 15 years old). Although prescribing medications at doses, for conditions, or in populations other than those approved by the FDA is generally legal and is common in pediatrics, the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics have recommended against off-label prescription of the coronavirus disease 2019 vaccine. Several commentaries consider a case in which parents ask their child's pediatrician to prescribe the vaccine for their 11-year-old with special health care needs before approval or authorization in her age group. The first commentary considers the potential benefits and risks to the patient, as well as to the family, the provider, and society, emphasizing the unknown risks in younger patients and the need for adequate informed consent. The second commentary describes an algorithm and principles for evaluating off-label prescribing and argues that the current benefits of prescribing Comirnaty off label to children <12 do not outweigh the risks. The third commentary addresses ethical and legal issues, ultimately calling on federal agencies to remove legal barriers to making the vaccine available to children in age groups that currently lack authorization.

中文翻译：

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儿童 COVID-19 疫苗的标签外处方：临床、伦理和法律问题。

美国食品药品监督管理局（FDA）于2021年8月23日批准辉瑞-BioNTech 2019冠状病毒病疫苗（Comirnaty）的生物制剂许可申请，为目前年龄范围以下儿童的标签外疫苗接种打开了大门生物制品许可申请（16 岁及以上）或紧急使用授权（12 至 15 岁）涵盖。尽管按照 FDA 批准的剂量、条件或在人群中开药通常是合法的，并且在儿科中很常见，但 FDA、疾病控制和预防中心和美国儿科学会建议不要关闭2019年冠状病毒病疫苗的标签处方。一些评论考虑了父母问孩子的情况 的儿科医生在她的年龄组批准或授权之前为他们的 11 岁有特殊医疗保健需求的孩子开出疫苗。第一条评论考虑了对患者以及家庭、提供者和社会的潜在益处和风险，强调了年轻患者的未知风险和充分知情同意的必要性。第二条评论描述了评估标签外处方的算法和原则，并认为目前对 12 岁以下的儿童开出标签外的 Comirnaty 的好处并没有超过风险。第三条评论涉及道德和法律问题，最终呼吁联邦机构消除法律障碍，以使目前缺乏授权的年龄组的儿童能够获得疫苗。