Effectiveness of the BNT162b2mRNA COVID-19 vaccine in patients with hematological neoplasms in a nationwide mass vaccination setting

Abstract

Evidence regarding the effectiveness of COVID-19 vaccine in patients with impaired immunity is limited. Initial observations suggest a lower humoral response in these patients. We evaluated the relative effectiveness of the mRNA BNT162b2 vaccine in patients with hematological neoplasms compared with matched controls. Data on patients with hematological neoplasms after 2 vaccine doses were extracted and matched 1:1 with vaccinated controls. Subpopulation analyses focused on patients receiving therapy for hematological neoplasm, patients without treatment who were only followed, and recipients of specific treatments. The analysis focused on COVID-19 outcomes from days 7 through 43 after the second vaccine dose in these areas: documented COVID-19 infection by polymerase chain reaction; symptomatic infection; hospitalizations; severe COVID-19 disease; and COVID-19-related death. In a population of 4.7 million insured people, 32 516 patients with hematological neoplasms were identified, of whom 5017 were receiving therapy for an active disease. Vaccinated patients with hematological neoplasms, compared with vaccinated matched controls, had an increased risk of documented infections (relative risk [RR] 1.60, 95% CI 1.12-2.37); symptomatic COVID-19 (RR 1.72, 95% CI 1.05-2.85); COVID-19-related hospitalizations (RR 3.13, 95% CI 1.68-7.08); severe COVID-19 (RR 2.27, 95% CI 1.18-5.19); and COVID-19-related death (RR 1.66, 95% CI 0.72-4.47). Limiting the analysis to patients on hematological treatments showed a higher increased risk. This analysis shows that vaccinated patients with hematological neoplasms, in particular patients receiving treatment, suffer from COVID-19 outcomes more than vaccinated individuals with intact immune system. Ways to enhance COVID-19 immunity in this patient population, such as additional doses, should be explored.

Graphical abstract

Figure 1.

Flowchart diagram of the study.

Figure 2.

COVID-19 outcomes of all vaccinated patients with hematological neoplasms vs controls. Kaplan-Meier curves of outcomes: COVID-19 infection, symptoms, hospitalizations, severe disease, and death, respectively. The blue curve represents vaccinated patients; red curve represents vaccinated controls. The Kaplan-Meier curve covers the 64 days from the first vaccination dose, whereas the analysis and the data in the tables correspond to days 7 to 43 from the second vaccination dose (days 28-64 from the first dose). Note that in all outcomes, the patients with hematological neoplasms fared worse.

Figure 2.

COVID-19 outcomes of all vaccinated patients with hematological neoplasms vs controls. Kaplan-Meier curves of outcomes: COVID-19 infection, symptoms, hospitalizations, severe disease, and death, respectively. The blue curve represents vaccinated patients; red curve represents vaccinated controls. The Kaplan-Meier curve covers the 64 days from the first vaccination dose, whereas the analysis and the data in the tables correspond to days 7 to 43 from the second vaccination dose (days 28-64 from the first dose). Note that in all outcomes, the patients with hematological neoplasms fared worse.

Figure 2.

COVID-19 outcomes of all vaccinated patients with hematological neoplasms vs controls. Kaplan-Meier curves of outcomes: COVID-19 infection, symptoms, hospitalizations, severe disease, and death, respectively. The blue curve represents vaccinated patients; red curve represents vaccinated controls. The Kaplan-Meier curve covers the 64 days from the first vaccination dose, whereas the analysis and the data in the tables correspond to days 7 to 43 from the second vaccination dose (days 28-64 from the first dose). Note that in all outcomes, the patients with hematological neoplasms fared worse.

Figure 3.

COVID-19 outcomes of vaccinated patients receiving treatment of the hematological neoplasms vs controls. Kaplan-Meier curves of the same outcomes demonstrated in Figure 2, with blue and red curves representing vaccinated patients and vaccinated controls, respectively. The difference (RR) between the patient and control groups is even more prominent than that represented in Figure 2.

Figure 3.

COVID-19 outcomes of vaccinated patients receiving treatment of the hematological neoplasms vs controls. Kaplan-Meier curves of the same outcomes demonstrated in Figure 2, with blue and red curves representing vaccinated patients and vaccinated controls, respectively. The difference (RR) between the patient and control groups is even more prominent than that represented in Figure 2.

Figure 3.

COVID-19 outcomes of vaccinated patients receiving treatment of the hematological neoplasms vs controls. Kaplan-Meier curves of the same outcomes demonstrated in Figure 2, with blue and red curves representing vaccinated patients and vaccinated controls, respectively. The difference (RR) between the patient and control groups is even more prominent than that represented in Figure 2.