Journal Article

Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals ≥12 Years Old: A Phase 2/3 Trial

Belanger, Todd, Lu, Claire, Mensa, Federico, Gayed, Juleen, Gurtman, Alejandra, Zou, Jing, Hu, Yanping, Anderson, Annaliesa S., Diya, Oyeniyi, Koury, Kenneth, Lowry, Francine S., Xie, Xuping, Şahin, Uǧur, Modjarrad, Kayvon, Türeci, Özlem, Bangad, Vishva, Xu, Xia, Kitchin, Nicholas, Cutler, Mark, Cooper, David, Swanson, Kena A.

2024

Overview

Vaccination remains an important mitigation tool against COVID-19. We report 1-month safety and preliminary immunogenicity data from a substudy of an ongoing, open-label, phase 2/3 study of monovalent Omicron XBB.1.5-adapted BNT162b2 (single 30-μg dose). Healthy participants ≥12 years old (N = 412 (12–17 years, N = 30; 18–55 years, N = 174; >55 years, N = 208)) who previously received ≥3 doses of a US-authorized mRNA vaccine, the most recent being an Omicron BA.4/BA.5-adapted bivalent vaccine ≥150 days before study vaccination, were vaccinated. Serum 50% neutralizing titers against Omicron XBB.1.5, EG.5.1, and BA.2.86 were measured 7 days and 1 month after vaccination in a subset of ≥18-year-olds (N = 40) who were positive for SARS-CoV-2 at baseline. Seven-day immunogenicity was also evaluated in a matched group who received bivalent BA.4/BA.5-adapted BNT162b2 in a previous study (ClinicalTrials.gov Identifier: NCT05472038). There were no new safety signals; local reactions and systemic events were mostly mild to moderate in severity, adverse events were infrequent, and none led to study withdrawal. The XBB.1.5-adapted BNT162b2 induced numerically higher titers against Omicron XBB.1.5, EG.5.1, and BA.2.86 than BA.4/BA.5-adapted BNT162b2 at 7 days and robust neutralizing responses to all three sublineages at 1 month. These data support a favorable benefit-risk profile of XBB.1.5-adapted BNT162b2 30 μg. ClinicalTrials.gov Identifier: NCT05997290

• Publisher: MDPI AG,MDPI
• Subject: Age / BNT162b2 / booster / Child health services / Consent / COVID-19 / COVID-19 vaccines / Demographic aspects / Drug dosages / FDA approval / Immunogenetics / Immunogenicity / International organizations / Menstruation / mRNA / Multisystem inflammatory syndrome in children / Myocarditis / Neutralizing / Pericarditis / Review boards / Risk assessment / Robustness (mathematics) / Safety / Safety and security measures / SARS-CoV-2 / Severe acute respiratory syndrome coronavirus 2 / Testing / vaccine / Vaccines / variant-adapted