FDA clears updated COVID vaccines for high-risk groups

The FDA approved updated mRNA vaccines from Pfizer and Moderna, plus a non-mRNA shot from Sanofi, targeting current strains. The shots are authorized for older adults and those with underlying conditions, with availability in coming days. A CDC advisory panel's legal limbo may affect insurance coverage requirements.

The approvals cover three distinct vaccine platforms, with Moderna's shot authorized for the broadest age range at 6 months and older, while Pfizer's applies to those 5 and up, and Sanofi's to ages 12 and above. CDC surveillance data shows coronavirus infections rising or likely rising in 47 states as of mid-August, though overall transmission levels remain low.

The regulatory decision arrives amid an unusual procedural gap: a federal court invalidated the appointments of CDC advisory panel members made by Health Secretary Robert F. Kennedy Jr., leaving the committee unable to issue standard eligibility recommendations. That absence removes the typical requirement for insurers to cover the vaccines, potentially complicating patient access even as manufacturers prepare to ship doses to pharmacies and clinics within days.