NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) and BioNTech SE (BNTX) reported positive topline results from an ongoing Phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-g dose of the LP.8.1-adapted monovalent COMIRNATY, or COVID-19 Vaccine, mRNA, 2025-2026 Formula in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19. The preliminary data showed a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination.
The companies noted that the clinical findings reinforce pre-clinical data that supported the recent FDA approval of the LP.8.1-adapted COVID-19 vaccine. The study was conducted to provide additional information about immunological effects of the vaccine and is not intended to replace the post marketing commitments requested by the FDA.
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