Overview

• The FDA approved new formulations from Pfizer-BioNTech, Moderna and Novavax for 2025–26 but restricted eligibility to adults 65+ and people with qualifying medical conditions.
• Pfizer’s emergency authorization for children under 5 was revoked, leaving Moderna as the only mRNA option for the youngest children, limited to those with high-risk conditions.
• Company specifics include Pfizer for ages 5–64 at high risk and all 65+, Moderna for 6 months–64 at high risk and all 65+, and Novavax for 12–64 at high risk and all 65+.
• CDC guidance has not yet been issued after changes to its advisory panel, and insurers have offered mixed signals on payment, with Kaiser Permanente pledging full coverage.
• Pfizer said shipments begin immediately and Moderna expects availability within days, with shots updated to target the LP.8.1 subvariant.