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20h ago

FDA Advisers Back JN.1-Based COVID Boosters for Fall Amid New Access Rules

The panel's unanimous vote coincides with new FDA policies restricting booster eligibility for healthy individuals under 65 without additional trials.

A staff member prepares a vaccine at Martin Luther King, Jr. Community Hospital in Los Angeles in 2020.

Overview

  • The FDA's vaccine advisory committee unanimously recommended continuing with JN.1-based COVID-19 vaccines for the 2025 fall booster campaign.
  • Under new FDA rules, healthy individuals under 65 will require additional placebo-controlled trials for updated vaccine approvals, potentially delaying access.
  • High-risk groups, including adults 65 and older and those with underlying medical conditions, remain exempt from the new trial requirements.
  • Some panelists supported updating to the newer LP.8.1 variant for improved future coverage, but concerns about access influenced the decision to retain JN.1.
  • FDA officials acknowledged uncertainty regarding final eligibility criteria and are working with manufacturers to finalize implementation details.