特朗普政府本周一发布行政令,要求在90天内制定方案将麻腮风(MMR)疫苗从联合注射拆分为单独注射,并错开与其他疫苗的接种时间 [1]。这一举措遭到公共卫生专家的强烈反对。
目前美国FDA批准的麻疹、腮腺炎和风疹疫苗均为联合制剂,自20世纪70年代初以来一直是标准做法 [1]。若按照行政令要求拆分,儿童原本需要两次接种的MMR疫苗将需要六次就医 [1]。前FDA疫苗主管杰西·古德曼表示,设计、建造和获得联邦批准新疫苗厂通常需要约五年时间 [1]。默克公司在声明中指出:"迄今为止,没有已发表的科学证据表明将联合MMR疫苗分离为三个单独注射有任何益处" [1]。
Johns Hopkins公共卫生学院专家安娜·德宾博士认为:"没有充分的理由支持这一政策,这是很糟糕的公共卫生政策" [1]。专家们警告,这项政策将给父母、医疗提供者和制药企业带来前所未有的财务和后勤挑战。制药企业需要重启数十年未生产的单独疫苗,建设新工厂,耗资数千万美元且耗时数年 [1]。值得注意的是,该行政令不具有法律约束力,白宫和FDA不能强制制药企业开发新疫苗,仅州政府有权要求学童接种 [1]。
President Trump announced an executive order Monday requiring a plan to separate combined vaccines, particularly the MMR vaccine protecting against measles, mumps, and rubella, and to stagger their administration over extended timelines [1]. The directive mandates that such a plan be developed within 90 days [1].
Currently, all measles, mumps, and rubella vaccines approved by the FDA are administered as a combined shot, a standard practice since the early 1970s [1]. Under the proposed approach, the two-dose MMR schedule—given at age one and after age four—would expand to six separate medical visits if the three components were administered individually [1]. Public health experts have strongly opposed the plan, with no scientific evidence supporting benefits from separating the vaccines [1]. Merck, a major vaccine manufacturer, stated that "to date, there is no published scientific evidence demonstrating any benefit to separating the combined MMR vaccine into three individual injections" [1].
Implementing such a policy would present unprecedented logistical and financial obstacles. Pharmaceutical companies would need to restart production of individual vaccines that have not been manufactured for decades, construct new facilities, and secure federal approval—a process typically requiring approximately five years according to former FDA vaccine chief Jesse Goodman [1]. The costs would amount to tens of millions of dollars. Dr. Anna Durbin of Johns Hopkins School of Public Health characterized the policy as "very bad public health policy," noting there is "no sufficient reason to support" it [1].
However, the executive order carries no legal force; neither the White House nor the FDA can compel pharmaceutical companies to develop new vaccines [1]. Only state governments possess the authority to mandate school vaccination requirements [1].