Overview
- The FDA's Vaccines and Related Biological Products Advisory Committee voted 8 to 0 with one abstention on Thursday to recommend a monovalent XFG formulation and sent the advice to the FDA for final sign-off.
- CDC briefings presented to the panel showed XFG and its descendants accounted for more than half of U.S. infections in early May, driving the push to update next season's shots.
- Moderna, Pfizer-BioNTech and Sanofi/Novavax told the panel they can supply XFG-targeted doses, with Moderna saying it could meet mid-August timelines and others ready to start production on approval.
- Company data showed XFG-adapted vaccines produce strong neutralizing antibodies against JN.1-family variants but offer more limited neutralization of the distinct BA.3.2 lineage; BA.3.2-adapted shots improved BA.3.2 neutralization at the expense of JN.1 coverage.
- Advisers warned that falling genomic sequencing and delayed data sharing make strain prediction harder and that a court stay over CDC advisory appointments plus recent FDA leadership turnover leave final approval and policy steps uncertain.