Pfizer and BioNTech Report Positive Phase 3 Results for LP.8.1-Adapted COVID-19 Vaccine

Pfizer and BioNTech Report Positive Phase 3 Results for LP.8.1-Adapted COVID-19 Vaccine

By, Admin 9 September 2025

Pfizer Inc. and BioNTech SE announced positive topline results from an ongoing phase 3 trial cohort evaluating their LP.8.1-adapted monovalent Comirnaty (COVID-19 Vaccine, mRNA) 2025–2026 Formula. The study focused on adults aged 65+ and adults 18–64 with at least one risk factor for severe COVID-19.

Key Findings from the Trial

  • Robust immune response:
    - 14 days post-vaccination, neutralizing antibody titers against LP.8.1 increased >4-fold compared to pre-vaccination levels in both age groups.
  • Study size: 100 participants:
    -     50 aged 65+
    - 50 aged 18–64 with risk factors.
  • Prior vaccination:
    - All had received the KP.2-adapted vaccine at least six months earlier.
    - None had received other COVID-19 vaccines or had COVID-19 infection since then.
  • Safety profile:
    - Consistent with previous studies.
    - No new safety concerns reported.

Why It Matters

  • Reinforces pre-clinical findings that supported FDA approval of the LP.8.1-adapted vaccine.
  • Shows strong immune responses against multiple circulating sublineages of SARS-CoV-2.
  • Provides early guidance for prescribers ahead of the 2025–2026 vaccination period.
  • Complements, but does not replace, FDA post-marketing study commitments.

Pfizer-BioNTech COVID-19 Vaccine: Global Impact

  • 5 billion doses distributed worldwide to date.
  • Continues to show favourable safety and efficacy supported by:
    - Clinical and preclinical data.
    - Real-world evidence.
    - Pharmacovigilance monitoring.
    - Robust manufacturing data.
  • Based on BioNTech’s proprietary mRNA technology.
  • BioNTech holds marketing authorizations for Comirnaty and its adapted vaccines in:
    - United States
    - European Union
    - United Kingdom
    - Other global markets

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