《英国医学杂志》调查引争议：独立医学联盟称CDC与FDA曾被警告疫苗安全工具会漏检信号
华盛顿10月6日——据独立医学联盟（IMA）10月5日发布的声明，该组织引用《英国医学杂志》（The BMJ）上周发表的调查报道称，美国疾病控制与预防中心（CDC）与食品药品监督管理局（FDA）在新冠mRNA疫苗上市初期所依赖的一项数据挖掘方法，曾被内部提示无法标记心肌炎等严重事件，两机构随后仍以「无信号」对外说明安全性。IMA称，已呼吁国会与司法部就此展开调查。以上为该组织与报道的一方说法。
IMA主席约瑟夫·瓦隆（Joseph Varon）在声明中表示，FDA官员早在2021年2月就收到过改良方法的提示。报道涉及的技术细节是：CDC曾承诺使用两种分析方法，其中比例报告比（PRR）直至2022年才实际运行；而两机构共同依赖的另一种方法，在FDA内部周报中从未对心肌炎、心包炎与耳鸣发出过信号。
需要说明的是，上述内容是调查报道与倡议组织的主张，CDC与FDA是否认可以及完整回应，应以两机构正式文件为准；疫苗的总体获益—风险评估结论，也应以监管机构与同行评议研究的最新版本为准。本站仅作新闻事实转述，不作医学结论，读者接种决策请咨询医生并查阅CDC官方接种建议页面。
信息来源：独立医学联盟10月5日声明，引述The BMJ调查报道。
图片来源：GNU Health vaccines — Meanmicio / CC BY-SA 4.0 (via Openverse)
BMJ Investigation Sparks Dispute: Medical Alliance Says CDC and FDA Were Warned Safety Tool Missed Signals
WASHINGTON, Oct. 6 — The Independent Medical Alliance (IMA), a national coalition of independent physicians and clinicians, said on Oct. 5 that a BMJ investigation published last week documented that CDC and FDA officials relied on a data mining method they had been told could not flag myocarditis and other serious events from the two mRNA COVID vaccines, and then pointed to the lack of alerts as evidence the products were safe. The IMA said it has called for congressional and Justice Department investigations. The account above is the position of the organization and the report it cites.
IMA president Dr. Joseph Varon said an FDA medical officer warned leadership in February 2021 and brought an updated method to fix the flaw. The technical details alleged are that the CDC did not run one of its two promised analyses, proportional reporting ratios, until 2022, and that the method both agencies chose to rely on never signaled for myocarditis, pericarditis or tinnitus in the FDA weekly reports the BMJ reviewed.
These are claims by an investigative report and an advocacy organization. The CDC's and FDA's formal positions should be taken from the agencies' own documents, and overall benefit-risk assessments from regulators and peer-reviewed research. This article reports the dispute as news and draws no medical conclusion; readers should consult their physicians and the CDC's official recommendation pages for vaccination decisions.
Source: Independent Medical Alliance statement, Oct. 5, citing The BMJ investigation.
Photo: GNU Health vaccines — Meanmicio / CC BY-SA 4.0 (via Openverse)
图片来源：图：位于亚特兰大的美国疾病控制与预防中心（CDC）总部大楼。摄影：James Gathany（CDC），公有领域，取自 Wikimedia Commons
