The new framework represents a balanced, evidence-based approach that ensures timely access for vulnerable populations while demanding rigorous scientific proof of benefit for low-risk individuals. This policy shift will help restore public trust in vaccines by requiring gold-standard data and acknowledging that a one-size-fits-all approach may no longer be appropriate given widespread immunity from prior vaccination and infection.
This overly restrictive policy will unnecessarily limit vaccine access for people who want protection, potentially leaving millions of healthy Americans vulnerable. The extensive safety and effectiveness data already collected from hundreds of millions of doses should be sufficient, and requiring new placebo-controlled trials raises ethical concerns given COVID-19's continued threat of hospitalization and death.
There is a 34% chance that there will be two or more COVID-19 hospitalization waves in the United States in at least one of the 2028 and 2029 respiratory disease seasons, according to the Metaculus prediction community.