Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
College of Medicine, University of Cincinnati, Cincinnati, Ohio.
Pediatrics. 2022 Feb 1;149(2). doi: 10.1542/peds.2021-054578.
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.
美国食品和药物管理局（FDA）于 2021 年 8 月 23 日批准辉瑞-生物技术公司的冠状病毒疾病 2019 疫苗（Comirnaty）的生物制品许可申请，为超出目前生物制品许可申请（16 岁及以上）或紧急使用授权（12 至 15 岁）年龄范围的儿童进行标签外疫苗接种打开了大门。尽管在 FDA 批准的剂量、条件或人群之外为患者开处方通常是合法的，并且在儿科中很常见，但 FDA、疾病控制和预防中心以及美国儿科学会已建议不要对冠状病毒疾病 2019 疫苗进行标签外处方。有几篇评论文章考虑了这样一种情况，即父母在其年龄组获得批准或授权之前，要求其 11 岁有特殊医疗需求的孩子的儿科医生为其开疫苗。第一篇评论文章考虑了对患者、家庭、提供者和社会的潜在益处和风险，强调了年轻患者未知的风险以及获得充分知情同意的必要性。第二篇评论文章描述了评估标签外处方的算法和原则，并认为目前将 Comirnaty 标签外用于 12 岁以下儿童的益处并不超过风险。第三篇评论文章讨论了伦理和法律问题，最终呼吁联邦机构消除向目前缺乏授权的年龄组儿童提供疫苗的法律障碍。
