Safety and Immunogenicity of BNT162b2 in Antiretroviral Therapy-Treated People With HIV.

Publication date: Jul 01, 2026

People with human immunodeficiency virus (HIV) are at increased risk of severe COVID-19 and are recommended for priority vaccination. We investigated the safety and immunogenicity of a 2-dose regimen of the mRNA vaccine BNT162b2 in people with HIV (PWH) on antiretroviral therapy (ART). Safety, reactogenicity, and immunogenicity data were obtained from PWH on ART ≥16 years enrolled in the phase 1/2/3 BNT162-02 trial/C4591001 (NCT04368728) between September and November 2020, which randomized participants (1:1) to receive BNT162b2 or placebo. Immunogenicity was also investigated in a substudy of the open-label phase 1/2 BNT162-01 trial (NCT04380701) in PWH aged 18-85 years and age- and sex- matched HIV-negative controls enrolled February to March 2021. In total, 201 PWH were included from the BNT162-02 trial. Higher rates of local and systemic reactions were reported during the 7 days following both doses by participants administered BNT162b2 versus participants administered placebo, most notably pain at injection site, fatigue, headache, and chills. Most reactions were mild to moderate in severity. No serious adverse events occurred up to 1 month post-dose 2. Spike protein-binding and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody responses were elicited in participants who received BNT162b2 and remained above prevaccination baseline levels through 6 months post-dose 2. In the BNT162-01 trial, all PWH (N = 15) seroconverted, with BNT162b2-induced SARS-CoV-2 neutralization titers and longitudinal T-cell responses similar to those observed in the HIV-negative cohort. Primary 2-dose vaccination with BNT162b2 in PWH was well tolerated and immunogenic with sustained responses up to 6 months, supporting vaccination in this priority population.

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