Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in people living with HIV-1

Clin Microbiol Infect. 2021 Dec;27(12):1851-1855. doi: 10.1016/j.cmi.2021.07.031. Epub 2021 Aug 24.


Objectives: The immunogenicity and safety of the Pfizer-BioNTech BNT162b2 mRNA vaccine in people living with human immunodeficiency virus type 1 (PLWH) are unknown. We aimed to assess the immunogenicity and safety of this vaccine in PLWH.

Methods: In this prospective open study, we enrolled 143 PLWH, aged ≥18 years, who attended our clinic and 261 immunocompetent health-care workers (HCWs). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor binding domain (RBD) IgG and neutralizing antibodies were measured. Adverse events, viral load and CD4 cell counts were monitored.

Results: At a median of 18 days (interquartile range 14-21 days) after the second dose, anti-RBD-IgG was positive in 139/141 (98%) PLWH. Among HCWs, 258/261 (98.9%) developed anti-RBD-IgG at a median of 26 days (interquartile range 24-27 days) after the second dose. Following the second dose, immune sera neutralized SARS-CoV-2 pseudo-virus in 97% and 98% of PLWH and HCWs, respectively. Adverse events were reported in 60% of PLWH, mainly pain at the injection site, fatigue and headache. AIDS-related adverse events were not reported. Human immunodeficiency virus load increased in 3/143 (2%) patients from <40 copies/mL to ≤100 copies/mL. CD4+ T-cell count decreased from a geometric mean of 700 cells/μL (95% CI 648-757 cells/μL) to 633.8 cells/μL (95% CI 588-683 cells/μL) (p < 0.01).

Conclusions: BNT162b2 mRNA vaccine appears immunogenic and safe in PLWH who are on antiretroviral therapy with unsuppressed CD4 count and suppressed viral load.

Keywords: BNT162b2; Coronavirus disease 2019; Human immunodeficiency virus; Immunogenicity; Vaccination.

MeSH terms

  • Adult
  • Anti-HIV Agents / therapeutic use
  • Antibodies, Neutralizing / blood
  • Antibodies, Viral / blood
  • BNT162 Vaccine / immunology*
  • CD4 Lymphocyte Count
  • COVID-19* / prevention & control
  • HIV Infections* / complications
  • HIV Infections* / drug therapy
  • HIV-1
  • Humans
  • Immunoglobulin G / blood
  • Prospective Studies


  • Anti-HIV Agents
  • Antibodies, Neutralizing
  • Antibodies, Viral
  • Immunoglobulin G
  • BNT162 Vaccine