{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T02:13:46Z","timestamp":1788401626354,"version":"build-2803163510"},"reference-count":48,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T00:00:00Z","timestamp":1776211200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100032339","name":"BioNTech","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100032339","id-type":"DOI","asserted-by":"crossref"}]},{"id":[{"id":"https:\/\/ror.org\/04fbd2g40","id-type":"ROR","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"crossref"}]},{"id":[{"id":"https:\/\/ror.org\/00kkwkq76","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/Objectives: This study evaluated the Omicron LP.8.1 variant-adapted BNT162b2 mRNA vaccine (LP.8.1-adapted BNT162b2). Methods: This 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\u201364 -year-olds at high risk of severe COVID-19 and in \u226565-year-olds who received the Omicron KP.2-adapted COVID-19 vaccine \u2265 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. Results: Overall, 104 participants received LP.8.1-adapted BNT162b2 (18\u201364-year-olds, n = 51; \u226565-year-olds, n = 53). Baseline neutralizing GMTs were higher in LP.8.1-adapted BNT162b2 recipients than in the historical control group of KP.2-adapted BNT162b2 recipients against both sublineages (248 vs. 157 against LP.8.1; 372 vs. 187 against KP.2). Serum-neutralizing LP.8.1 and KP.2 GMTs increased 2 weeks after vaccination with LP.8.1-adapted BNT162b2 (1752 against LP.8.1; 2104 against KP.2) and historical control groups (1555 and 2395, respectively), and across both age groups. Reactogenicity events with LP.8.1-adapted BNT162b2 were generally mild or moderate and occurred at generally similar frequencies in both age groups. Adverse events were reported in 4.8% of participants (all in 18\u201364-year-olds); no serious adverse events were reported. Conclusions: After 2 weeks of follow-up, and in a small sample size, LP.8.1-adapted BNT162b2 was immunogenic in \u226565-year-olds and \u226518-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).<\/jats:p>","DOI":"10.3390\/vaccines14040350","type":"journal-article","created":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T12:25:30Z","timestamp":1776255930000},"page":"350","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A Study to Investigate the Safety and Immunogenicity of Monovalent Omicron LP.8.1-Adapted BNT162b2 COVID-19 Vaccine in Adults \u2265 65 Years of Age and High-Risk Adults 18\u201364 Years of Age (Preliminary Results)"],"prefix":"10.3390","volume":"14","author":[{"given":"Rucha","family":"Dadhe","sequence":"first","affiliation":[{"name":"Pfizer Vaccines, Pfizer Ltd., Marlow SL7 1YL, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juleen","family":"Gayed","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Ltd., Marlow SL7 1YL, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muneeb","family":"Iqbal","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Ltd., Marlow SL7 1YL, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohit","family":"Solan","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Ltd., Marlow SL7 1YL, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Han","family":"Wu","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Collegeville, PA 19426, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2403-1376","authenticated-orcid":false,"given":"Hua","family":"Ma","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Collegeville, PA 19426, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xia","family":"Xu","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Collegeville, PA 19426, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico J.","family":"Mensa","sequence":"additional","affiliation":[{"name":"BioNTech US Inc., Cambridge, MA 02139, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3399-9979","authenticated-orcid":false,"given":"Todd","family":"Belanger","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cooper","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Mogg","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Collegeville, PA 19426, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annaliesa S.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00d6zlem","family":"T\u00fcreci","sequence":"additional","affiliation":[{"name":"BioNTech, 55131 Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"U\u01e7ur","family":"\u015eahin","sequence":"additional","affiliation":[{"name":"BioNTech, 55131 Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pirada Suphaphiphat","family":"Allen","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayvon","family":"Modjarrad","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandra","family":"Gurtman","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4033-9853","authenticated-orcid":false,"given":"Kelly","family":"Lindert","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Cambridge, MA 02139, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,4,15]]},"reference":[{"key":"ref_1","unstructured":"Centers for Disease Control and Prevention (2024, November 25). 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