ArticleVaccines2026
A Study to Investigate the Safety and Immunogenicity of Monovalent Omicron LP.8.1-Adapted BNT162b2 COVID-19 Vaccine in Adults ≥ 65 Years of Age and High-Risk Adults 18-64 Years of Age (Preliminary Results).
Article in Vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07069309 (A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED VARIANT-ADAPTED VACCINE CANDIDATE), which is not on this map. Not yet cited in PubMed.
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A phase 3 protocol to investigate the safety, tolerability, and immunogenicity of bnt162b2 rna-based variant-adapted vaccine candidate(s) against sars-cov-2 in participants 12 through 64 years of age considered at higher risk of severe covid-19, and participants ≥65 years of age
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18 authors.
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Abstract
BACKGROUND/
objectivesThis study evaluated the Omicron LP.8.1 variant-adapted BNT162b2 mRNA vaccine (LP.8.1-adapted BNT162b2).
methodsThis analysis is part of an ongoing phase 3 open-label study evaluating the immunogenicity, safety, and tolerability of LP.8.1-adapted BNT162b2. Reported here are descriptive 2-week post-vaccination results in 18-64 -year-olds at high risk of severe COVID-19 and in ≥65-year-olds who received the Omicron KP.2-adapted COVID-19 vaccine ≥ 6 months previously. Primary immunogenicity endpoints included neutralizing antibody geometric mean titers (GMTs) against LP.8.1 and KP.2 at 2 weeks after vaccination and geometric mean fold rises from baseline to 2 weeks after vaccination. Results were compared with a historical control group of adults who received KP.2-adapted BNT162b2 in a previous study. Tolerability and safety were also assessed.
resultsOverall, 104 participants received LP.8.1-adapted BNT162b2 (18-64-year-olds,
conclusionsAfter 2 weeks of follow-up, and in a small sample size, LP.8.1-adapted BNT162b2 was immunogenic in ≥65-year-olds and ≥18-year-olds at high risk of severe COVID-19. The safety and tolerability profile for LP.8.1-adapted BNT162b2 was consistent with the current US prescribing information for BNT162b2 and that of other variant-adapted BNT162b2 vaccines (Clinicaltrials.gov Identifier: NCT07069309, registered 16 July 2025).
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