By Fineline Cube 
Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) today announced that the United States Food and Drug Administration (FDA) has approved a new indication for their LP.8.1‑adapted monovalent COVID‑19 vaccine (COMIRNATY LP.8.1). The product is now authorized for use in adults aged 65 and older and in individuals aged 5‑64 who have at least one underlying condition that places them at high risk for severe COVID‑19 outcomes.
FDA‑Guided Sublineage Selection
- LP.8.1 was chosen as the preferred sublineage for a JN.1‑lineage‑based monovalent vaccine, in line with FDA recommendations for the 2025‑fall U.S. rollout.
- The vaccine will begin shipping immediately, becoming available in pharmacies, hospitals, and clinics nationwide within days.
Global Reach and Proven Safety
- Over five billion doses of the Pfizer/BioNTech COVID‑19 vaccine have been distributed worldwide.
- Extensive real‑world evidence, clinical trials, non‑clinical studies, pharmacovigilance data, and robust manufacturing records continue to support the vaccine’s favorable safety and efficacy profile.
Product and Regulatory Overview
| Item | Details |
|---|---|
| Technology | BioNTech’s proprietary mRNA platform |
| Co‑development | Pfizer & BioNTech |
| Marketing Authorization | BioNTech holds approval in the U.S., EU, UK, and other markets; emergency use authorizations elsewhere |
| New Indication | Adults ≥ 65 & 5‑64 with high‑risk conditions |
The approval underscores the ongoing commitment of Pfizer and BioNTech to adapt their mRNA technology to evolving viral variants and to protect the most vulnerable populations.-Fineline Info & Tech