Evidence on vaccine effectiveness (VE) of 2025-26 COVID-19 vaccines is limited. We estimated VE of BNT162b2 LP.8.1-adapted vaccine among non-immunocompromised adults [≥]65 years through December 2025 using linked claims and immunization registry data from two U.S. states. VE against COVID-19-related ED/UC encounters was 48% (95% CI:19, 66).
L. Zambrano, T. Yu, J. Mateus et al.· medRxiv· 0 citations
BACKGROUND
Data on effectiveness of COVID-19 vaccinations during the 2024-2025 respiratory season are limited, particularly among those with underlying medical conditions (UMC). We estimated BNT162b2 KP.2 vaccine effectiveness (VE) against COVID-19-associated hospital admission, emergency department (ED), and urgent care (UC) visits in two U.S. states.
METHODS
Retrospective cohort study of non-immunocompromised adults living in Louisiana or California, with ≥1 year prior continuous enrollment in insurance plans contributing to the HealthVerity claims database beginning August 22, 2024. The effectiveness of BNT162b2 KP.2 vaccine (2024-2025 formulation, hereafter referred to as BNT162b2), measured as a time-varying exposure against hospital admission, ED, or UC encounters with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code U07.1 was calculated as 1 - adjusted hazard ratio using Cox proportional hazard models adjusted for age group, sex, state, insurance payor, presence or absence of UMCs, and pre-index healthcare utilization. Stratifications included those aged 65 years and older, those aged 18-64 years with UMCs, and those aged 18-64 years without UMCs.
RESULTS
The cohort included 6,256,421 individuals (93% California, 7% Louisiana); 330,565 (5%) received the BNT162b2 vaccine. Vaccinated individuals were older and had more comorbidities, wellness visits, and prior influenza vaccination. Overall, 66% of the study population had ≥1 UMC; the most prevalent conditions were obesity (25%), history of immunocompromised conditions (23%), and mental health conditions (19%). COVID-19-related encounter rates for ED, UC or hospitalization were lower among vaccinated compared to unvaccinated persons (25.1 vs 36.3 per 100,000 person-months). Among all adults, VE was 37% against hospitalization, 12% against ED/UC encounters, and 16% against ED/UC/hospitalization encounters. Results were similar across age groups and UMCs.
CONCLUSIONS
BNT162b2 provided protection against COVID-19-associated outcomes of ED, UC or hospitalization among non-immunocompromised U.S. adults, including those with UMCs, over the course of the 2024-2025 respiratory virus season, supporting continued vaccine recommendations.
REGISTRATION
This study was posted on clinicaltrials.gov prior to analyses (NCT06923137).
Tara Ahi, K. Andersen, J. Mateus et al.· Vaccine· 0 citations
KP.2-adapted BNT162b2 COVID-19 vaccine provided significant protection against emergency department, urgent care, and inpatient encounters for COVID-19 in children.
K. Andersen, Tara Ahi, Maria D. McColgan et al.· Jornal de Pediatria· 0 citations