Vaccine Effectiveness of monovalent BNT162b2 Vaccine in Immunocompromised Patients

Key Points are meant to be a scientific, factual summary of the available information, focusing on monovalent Pfizer- BioNTech COVID-19 Vaccine or mRNA COVID-19 vaccines, as supported by referenced publications within this section. Conclusions should not be drawn from the inclusion or absence of information.

• Immunocompromised (IC) populations may be susceptible to impaired immune response to vaccination and to severe outcomes, such as hospitalization or death. ^1-6 CDC has made updated recommendations for COVID-19 vaccination in individuals 6 months of age and older who are moderately or severely immunocompromised. Please see product labeling and CDC Interim Clinical Considerations for current vaccine dosing regimens and recommendations.⁷

• Vaccine effectiveness (VE) of monovalent BNT162b2 vaccine has been evaluated in Real-World Evidence (RWE) studies of diverse IC populations, including those with a history of malignancy, organ transplantation, immune-mediated disorders, and immunodeficiencies.^{1, 4-6}

• RWE Studies in IC patient populations:

  • Participants with a history of cancer, rheumatologic disorders, immunodeficiencies, and organ transplantation:
    • Three RWE studies conducted in the US described VE of 2^1-3 and 3 doses^{2, 3} of monovalent mRNA vaccines against confirmed COVID-19 infection and hospitalization in immunocompromised (those with solid and hematologic malignancies; rheumatologic or inflammatory disorders; organ or stem cell transplant; other intrinsic immune conditions or immunodeficiencies; HIV infection with and without AIDS; previous splenectomy, and use of immunosuppressive medications) and immunocompetent adults, during a Delta (B.1.617.2) predominant period.¹
    • Vaccine Effectiveness, in % (95% CI), in these populations is summarized below. The listed studies cannot be compared due to differences in study design and methodologies.

• Participants with history of organ transplantation, inflammatory bowel disease (IBD), and immune-mediated inflammatory disease:

  • RWE studies have described VE of monovalent BNT162b2 or other mRNA vaccines in solid organ and islet transplant recipients⁴, in participants with inflammatory bowel disease and exposure to immunosuppressive medications⁵, and in participants with immune-mediated inflammatory diseases⁶. Vaccine Effectiveness, in % (95% CI), in these IC populations, compared to unvaccinated participants, is summarized in the table below. The listed studies cannot be compared due to differences in study design and methodologies.

References: (1) Embi; (2) Tenforde; (3) Tartof; (4) Callaghan;(5) Khan; (6) Widdifield; (7) COVID-19 Vaccines for People Who Are Moderately or Severely Immunocompromised | CDC