Former FDA acting chief warned against labeling COVID mRNA shots as "safe and effective"

During the pandemic, senior officials repeatedly called the mRNA COVID-19 vaccines "safe and effective," but acting FDA Commissioner Janet Woodcock later revealed she opposed that phrasing. In a May 27, 2021 email to Anthony Fauci and NIH Director Francis Collins, she recounted hearing from healthcare workers experiencing diverse, hard-to-quantify adverse events and suggested a funded study to examine a cohort of these cases.

Woodcock emphasized that while the vaccines' benefits outweigh risks, no drug is completely risk-free, even water can be lethal in excess. She argued the FDA’s press office should avoid the absolute "safe and effective" label. The agency later reaffirmed confidence in the vaccines, but internal documents also noted at least ten child deaths linked to vaccination, according to a letter from former CBER chief Vinay Prasad. Woodcock concluded that science provides facts, not policy decisions, underscoring the need for value judgments beyond data.