Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) reported topline Phase 3 results for their LP.8.1-adapted monovalent COMIRNATY (2025-2026 Formula) in high-risk adults.
Among 100 participants, the vaccine generated a ≥4-fold increase in neutralizing antibodies against the LP.8.1 sublineage within 14 days, with a safety profile consistent with prior formulations. All participants had previously received the KP.2-adapted vaccine at least six months earlier.
In August, Health and Human Services Secretary Robert F. Kennedy Jr. announced on social media that the emergency use authorizations for COVID-19 vaccines have now been rescinded.
The Food and Drug Administration (FDA) has approved a supplemental BLA for the LP.8.1-adapted vaccine in adults 65+ and individuals 5–64 with underlying conditions. To date, more than 5 billion doses of Pfizer-BioNTech COVID-19 vaccines have been distributed worldwide.
Price Action: PFE stock is down 2.25% at $24.32, and BNTX stock is down 8.33% at $103.10 at the last check on Monday.
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