TY - JOUR
T1 - Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults
T2 - Single-Arm Substudy from a Phase 2/3 Trial
AU - Diya, Oyeniyi
AU - Gayed, Juleen
AU - Lowry, Francine S.
AU - Ma, Hua
AU - Bangad, Vishva
AU - Mensa, Federico
AU - Zou, Jing
AU - Xie, Xuping
AU - Hu, Yanping
AU - Cutler, Mark
AU - Belanger, Todd
AU - Cooper, David
AU - Xu, Xia
AU - Mogg, Robin
AU - Türeci, Özlem
AU - Şahin, Uǧur
AU - Swanson, Kena A.
AU - Modjarrad, Kayvon
AU - Anderson, Annaliesa S.
AU - Gurtman, Alejandra
AU - Kitchin, Nicholas
N1 - Publisher Copyright:
© Pfizer Inc 2025.
PY - 2025/8
Y1 - 2025/8
N2 - Introduction: COVID-19 continues to cause substantial health burden, particularly among vulnerable populations. Vaccines remain a vital tool in preventing severe disease outcomes. As the causative pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve; therefore, updates may be needed to closely match COVID-19 vaccine composition to predominant circulating lineages to confer optimal protection. Methods: In this cohort from a substudy of an ongoing phase 2/3 trial, 102 healthy adults (18‒55 and > 55 years of age, n = 51 each) were vaccinated with Omicron KP.2-adapted BNT162b2. Serum neutralizing titers against Omicron KP.2, JN.1, and KP.3 were assessed before and through 1 month after vaccination. Immunogenicity in KP.2-adapted BNT162b2 recipients was compared with participants who received JN.1-adapted BNT162b2 in an earlier cohort of this substudy. Local reactions and systemic events through 7 days and adverse events (AEs) through 1 month are reported. Results: One month after vaccination, KP.2-adapted BNT162b2-elicited neutralizing titers against Omicron KP.2, JN.1, and KP.3 were numerically higher than those induced by JN.1-adapted BNT162b2. Geometric mean fold rises from before to 1 month after vaccination were numerically higher in those who received KP.2-adapted BNT162b2 compared with those who received JN.1-adapted BNT162b2 (9.4 vs. 6.8 for KP.2; 7.8 vs. 5.7 for JN.1; 9.2 vs. 7.0 for KP.3). Percentages of participants with seroresponses were numerically higher against KP.2 after KP.2-adapted BNT162b2 than JN.1-adapted BNT162b2 (75% vs. 65%) and similar against JN.1 and KP.3 for both vaccines (69% vs. 67% for JN.1; 74% vs. 73% for KP.3). Local reactions and systemic events were all mild to moderate in severity, AEs were infrequent, and no serious AEs or AEs leading to withdrawal were reported. Conclusions: Collectively, these immunogenicity, safety, and tolerability data support administration of KP.2-adapted BNT162b2 to protect against contemporaneous circulating lineages. ClinicalTrials.gov Identifier: NCT05997290.
AB - Introduction: COVID-19 continues to cause substantial health burden, particularly among vulnerable populations. Vaccines remain a vital tool in preventing severe disease outcomes. As the causative pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve; therefore, updates may be needed to closely match COVID-19 vaccine composition to predominant circulating lineages to confer optimal protection. Methods: In this cohort from a substudy of an ongoing phase 2/3 trial, 102 healthy adults (18‒55 and > 55 years of age, n = 51 each) were vaccinated with Omicron KP.2-adapted BNT162b2. Serum neutralizing titers against Omicron KP.2, JN.1, and KP.3 were assessed before and through 1 month after vaccination. Immunogenicity in KP.2-adapted BNT162b2 recipients was compared with participants who received JN.1-adapted BNT162b2 in an earlier cohort of this substudy. Local reactions and systemic events through 7 days and adverse events (AEs) through 1 month are reported. Results: One month after vaccination, KP.2-adapted BNT162b2-elicited neutralizing titers against Omicron KP.2, JN.1, and KP.3 were numerically higher than those induced by JN.1-adapted BNT162b2. Geometric mean fold rises from before to 1 month after vaccination were numerically higher in those who received KP.2-adapted BNT162b2 compared with those who received JN.1-adapted BNT162b2 (9.4 vs. 6.8 for KP.2; 7.8 vs. 5.7 for JN.1; 9.2 vs. 7.0 for KP.3). Percentages of participants with seroresponses were numerically higher against KP.2 after KP.2-adapted BNT162b2 than JN.1-adapted BNT162b2 (75% vs. 65%) and similar against JN.1 and KP.3 for both vaccines (69% vs. 67% for JN.1; 74% vs. 73% for KP.3). Local reactions and systemic events were all mild to moderate in severity, AEs were infrequent, and no serious AEs or AEs leading to withdrawal were reported. Conclusions: Collectively, these immunogenicity, safety, and tolerability data support administration of KP.2-adapted BNT162b2 to protect against contemporaneous circulating lineages. ClinicalTrials.gov Identifier: NCT05997290.
KW - BNT162b2
KW - Booster
KW - COVID-19
KW - Lineage
KW - Omicron KP.2
KW - SARS-CoV-2 vaccine
KW - Sublineage
KW - Variant adapted
UR - https://www.scopus.com/pages/publications/105009890056
UR - https://www.scopus.com/pages/publications/105009890056#tab=citedBy
U2 - 10.1007/s40121-025-01185-4
DO - 10.1007/s40121-025-01185-4
M3 - Article
C2 - 40591130
AN - SCOPUS:105009890056
SN - 2193-8229
VL - 14
SP - 1973
EP - 1987
JO - Infectious Diseases and Therapy
JF - Infectious Diseases and Therapy
IS - 8
ER -