Overview
- Senate investigators on Wednesday released an interim report and held a hearing that allege Biden-era health officials sidelined an FDA analyst whose work flagged more potential COVID-19 vaccine safety issues.
- Dr. Ana Szarfman used a regression‑adjusted method built to fix “masking” in the VAERS database, where reports on one product can hide signals for another, and with statistician Dr. William DuMouchel reported about 25 previously undetected signals including sudden cardiac death, Bell’s palsy, and pulmonary infarction.
- Internal emails cited in the report show FDA leaders urged colleagues to discuss her work off email, told her in May 2021 to hold off on analyses, and by September 2021 to cease and desist over concerns her outputs could fuel anti‑vaccination rhetoric.
- The report says FDA and CDC later cut back weekly safety summaries, and a 2022 CDC email suggested Freedom of Information Act requests may have driven the decision to stop sharing those outputs.
- Witnesses at the hearing included two researchers and a COVID-19 survivor, while Democrats noted that statistical signals trigger follow‑up work rather than prove causation and pointed to large studies that found no increase in long‑term mortality among vaccinated people.