Particle.news

Download on the App Store

FDA Approves LP.8.1 COVID Boosters, Limits Routine Use to Seniors and High-Risk Patients

Uncertainty over CDC guidance now clouds insurance coverage.

Overview

  • Shots from Pfizer, Moderna and Novavax won FDA clearance for broad use in adults 65 and older, with access for younger people restricted to those with at least one qualifying medical condition.
  • Labeling specifics: Pfizer is cleared for ages 5–64 at high risk, Moderna for 6 months–64 at high risk, and Novavax for 12–64 at high risk; all three are fully available to those 65 and older.
  • The FDA revoked several pandemic-era EUAs, including Pfizer’s authorization for children under 5, leaving Moderna as the only option for ages 6 months to 5 and only for children with serious health problems.
  • The updated vaccines target the LP.8.1 subvariant within the JN.1 family, with Pfizer shipping immediately and Moderna expecting availability within days, while Novavax anticipates doses in early fall.
  • Coverage and rollout remain unsettled as a reconstituted CDC advisory panel has yet to issue recommendations, insurers weigh reimbursements, pharmacists face verification limits, and patients not deemed high-risk may face out-of-pocket costs of roughly $140–$150; major medical groups including the AAP and IDSA are urging broader access.