A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds

Medientyp: E-Artikel
Titel: A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds
Beteiligte: Usdan, Lisa; Patel, Sohil; Rodriguez, Hector; Xu, Xia; Lee, Dung-Yang; Finn, Daniel; Wyper, Hayley; Lowry, Francine S; Mensa, Federico J; Lu, Claire; Cooper, David; Koury, Kenneth; Anderson, Annaliesa S; Türeci, Özlem; Şahin, Uğur; Swanson, Kena A; Gruber, William C; Kitchin, Nicholas; Andrews, Charles; Arora, Samir; Brandon, Donald; Cannon, Kevin; Chalhoub, Fadi; Christensen, Shane; [...]
Erschienen: Oxford University Press (OUP), 2023
Erschienen in: Clinical Infectious Diseases (2023)
Sprache: Englisch
DOI: 10.1093/cid/ciad718
ISSN: 1058-4838; 1537-6591
Schlagwörter: Infectious Diseases ; Microbiology (medical)
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Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>Protection against contemporary severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants requires sequence-adapted vaccines.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>In this ongoing phase 2/3 trial, 12–17-year-olds (n = 108), 18–55-year-olds (n = 313), and &gt;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], &gt;1), and noninferiority with respect to seroresponse rates (LB of 2-sided 95% CI for rate difference, greater than −5%), for Omicron BA.4/BA.5 were assessed in &gt;55-year-olds versus original BNT162b2 as a second booster. Noninferiority with respect to neutralizing titer level (LB of 2-sided 95% CI for GMR, &gt; 0.67) and seroresponse rate (LB of 2-sided 95% CI for rate difference, greater than −10%) of Omicron BA.4/BA.5 immune response for BNT162b2-Omi.BA.4/BA.5 in 18–55 versus &gt;55-year-olds was assessed.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>One month after vaccination in &gt;55-year-olds, the model-adjusted GMR of Omicron BA.4/BA.5 neutralizing titers for the BNT162b2-Omi.BA.4/BA.5 versus BNT162b2 groups (2.91 [95% CI, 2.45–3.44]) demonstrated the superiority of BNT162b2-Omi.BA.4/BA.5. Adjusted difference in the percentages of &gt;55-year-olds with seroresponse (26.77% [95% CI, 19.59–33.95]) showed noninferiority of BNT162b2-Omi.BA.4/BA.5 to BNT162b2. Noninferiority of BNT162b2-Omi.BA.4/BA.5 in 18–55-year-olds compared with &gt;55-year-olds was met for model-adjusted GMR and seroresponse. Geometric mean titers in 12–17-year-olds increased from baseline to 1 month after vaccination. The BNT162b2-Omi.BA.4/BA.5 safety profile was similar to the profiles for booster doses of bivalent Omicron BA.1-modified BNT162b2 and original BNT162b2 reported in previous studies.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Based on immunogenicity and safety data up to 1 month after vaccination in participants who previously received 3 original BNT162b2 doses, a BNT162b2-Omi.BA.4/BA.5 30-µg booster has a favorable benefit-risk profile.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trials Registration</jats:title> <jats:p>NCT05472038</jats:p> </jats:sec>

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