FOI release
Yellow Card Fatal Outcome Reports in Under-18s Following COVID-19 Vaccination
Case reference FOI2026/00615
Received 8 June 2026
Published 10 August 2026
Request
I write to make a request under the Freedom of Information Act 2000. Background In December 2025, the United States Food and Drug Administration's (FDA) Office of Biostatistics and Pharmacovigilance completed a structured case-level causality review of 96 paediatric death reports submitted to the Vaccine Adverse Event Reporting System following COVID-19 vaccination. That review applied the World Health Organization (WHO)–Uppsala Monitoring Centre (UMC) causality assessment framework to each individual case, drawing on medical records, autopsy reports, pathology findings, and follow-up information. The findings were released into the public domain via a United States Senate disclosure in May 2026, and their authenticity has been confirmed by an HHS official. I am conducting independent research into comparative post-market pharmacovigilance practice across medicines regulators, with particular reference to the MHRA, FDA, and European Medicines Agency. The MHRA's statutory obligation to conduct rigorous benefit-risk assessment of authorised medicinal products, and to disclose the basis and limitations of that assessment, provides the domestic regulatory standard against which the question raised by this request is framed. Duty to Confirm or Deny If the MHRA does not hold any of the information requested below, I ask that you confirm that position in writing, as the absence of an equivalent structured review is itself material to comparative research in this area. Information Requested 1. Whether the MHRA has conducted, or commissioned, any structured case-level causality review of Yellow Card fatal outcome reports in individuals aged under 18 years following COVID-19 vaccination, applying a recognised causality assessment framework (such as the WHO-UMC framework or equivalent). 2. If such a review has been conducted: (a) the date or date range of the review; (b) the total number of Yellow Card fatal outcome reports reviewed; (c) the causality classifications assigned, expressed by category (certain, probable/likely, possible, unlikely, unassessable or equivalent); (d) the vaccine products and, where available, the age range of cases reviewed; and (e) whether the review has been published or is otherwise in the public domain, and if so, where. 3. If no such structured review has been conducted: whether the MHRA has assessed paediatric fatal outcome reports following COVID-19 vaccination by any other systematic methodology, and if so, what that methodology was and what its outputs were. Clarification I am not requesting the underlying individual case records. I am requesting the existence and outputs of any structured aggregate causality review, and the methodology applied. I look forward to your acknowledgement of this request and your response within the statutory 20 working days under the Freedom of Information Act 2000.
Response
See attached
Documents
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