biostudies-literatureUnknown78(5)Usdan L<h4>Background</h4>Protection against contemporary severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants requires sequence-adapted vaccines.<h4>Methods</h4>In this ongoing phase 2/3 trial, 12-17-year-olds (n = 108), 18-55-year-olds (n = 313), and >55-year-olds (n = 306) who previously received 3 original BNT162b2 30-µg doses, received a fourth dose (second booster) of 30-µg bivalent original/Omicron-BA.4/BA.5-adapted BNT162b2 (BNT162b2-Omi.BA.4/BA.5). For comparisons with original BNT162b2, participants were selected from another phase 3 trial. Immunologic superiority 1 month after vaccination, with respect to 50% neutralizing titers (lower bound [LB] of 2-sided 95% confidence interval [CI] for geometric mean ratio [GMR], >1), and noninferiority with respect to seroresponseClinical infectious diseases : an official publication of the Infectious Diseases Society of America1194-1203https://www.ebi.ac.uk/biostudies/studies/S-EPMC11093671biostudies-literatureA Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds.PMC11093671Sahin UStacey HRodriguez HChristensen SAndrews CTureci ODavis MWyper HMurray AMartin EEssink BFortmann SPatel SMiller DVarano SChu LKoury KAnderson ASFragoso VUsdan LLee DYMensa FJLu CRaad GFinn DLowry FSChalhoub FCannon KHeller RFitz-Patrick DSenders SHaggag AArora SLucasti CPeterson JJennings THartman ACooper DPickrell PWadsworth LKitchin NBrandon DXu XC4591044 Study GroupSwanson KAGruber WCfalseA Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds.<h4>Background</h4>Protection against contemporary severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants requires sequence-adapted vaccines.<h4>Methods</h4>In this ongoing phase 2/3 trial, 12-17-year-olds (n = 108), 18-55-year-olds (n = 313), and >55-year-olds (n = 306) who previously received 3 original BNT162b2 30-µg doses, received a fourth dose (second booster) of 30-µg bivalent original/Omicron-BA.4/BA.5-adapted BNT162b2 (BNT162b2-Omi.BA.4/BA.5). For comparisons with original BNT162b2, participants were selected from another phase 3 trial. Immunologic superiority 1 month after vaccination, with respect to 50% neutralizing titers (lower bound [LB] of 2-sided 95% confidence interval [CI] for geometric mean ratio [GMR], >1), and noninferiority with respect to seroresponse2024-01-01T00:00:00Z2024 May2026-06-02T21:23:23.757Z2026-04-20T03:14:19.925ZS-EPMC110936713801602110.1093/cid/ciad718