Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial

Stephen J Thomas, John L Perez, Stephen P Lockhart, Subramanian Hariharan, Nicholas Kitchin, Ruth Bailey, Katherine Liau, Eleni Lagkadinou, Özlem Türeci, Ugur Şahin, Xia Xu, Kenneth Koury, Samuel S Dychter, Claire Lu, Teresa C Gentile, William C Gruber, Stephen J Thomas, John L Perez, Stephen P Lockhart, Subramanian Hariharan, Nicholas Kitchin, Ruth Bailey, Katherine Liau, Eleni Lagkadinou, Özlem Türeci, Ugur Şahin, Xia Xu, Kenneth Koury, Samuel S Dychter, Claire Lu, Teresa C Gentile, William C Gruber

Abstract

Introduction: Individuals with an underlying malignancy have high risk of poor COVID-19 outcomes. In clinical trials, COVID-19 vaccines were safe and efficacious against infection, hospitalization, and death, but most trials excluded participants with cancer. We report results from participants with a history of past or active neoplasm (malignant or benign/unknown) and up to 6 months' follow-up post-dose 2 from the placebo-controlled, observer-blinded trial of the 2-dose BNT162b2 mRNA COVID-19 vaccine.

Patients and methods: Between July 2020-January 2021, 46,429 participants aged ≥ 12 years were randomized at 152 sites in 6 countries. Healthy participants with pre-existing stable neoplasm could participate; those receiving immunosuppressive therapy were excluded. Data are reported for participants, aged ≥ 16 years for safety and ≥ 12 years for efficacy, who had any history of neoplasm at baseline (data cut-off: March 13, 2021). Adverse-event (AE) data are controlled for follow-up time before unblinding and reported as incidence rates (IRs) per 100 person-years follow-up.

Results: At baseline, 3813 participants had a history of neoplasm; most common malignancies were breast (n = 460), prostate (n = 362), and melanoma (n = 223). Four BNT162b2 and 71 placebo recipients developed COVID-19 from 7 days post-dose 2; vaccine efficacy was 94.4% (95% CI: 85.2, 98.5) after up to 6 months' follow-up post-dose 2. This compares favorably with vaccine efficacy of 91.1% in the overall trial population after the same follow-up. AEs were reported at IRs of 95.4(BNT162b2) and 48.3 (placebo) per 100 person-years. Most common AEs were reactogenicity events (injection-site pain, fatigue, pyrexia). Three BNT162b2 and 1 placebo recipients withdrew because of vaccine-related AEs. No vaccine-related deaths were reported.

Conclusion: In participants with past or active neoplasms, BNT162b2 vaccine has a similar efficacy and safety profile as in the overall trial population. These results can inform BNT162b2 use during the COVID-19 pandemic and future trials in participants with cancer. Clinical trial number: NCT04368728.

Keywords: BNT162b2; COVID-19; Efficacy; Malignancy; Safety; Vaccine.

Conflict of interest statement

Declaration of Competing Interest SJT: investigator on Pfizer COVID-19 vaccine trials, single consulting engagement and ad hoc advisory board member for Pfizer; JLP, SPL, SH, NK, RB, KL, XX, KK, SSD, CL, WCG: employees of Pfizer and hold Pfizer stock/stock options; EL, OT, US: employees of BioNTech; TG: nothing to disclose.

Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

Figures

Fig. 1
Fig. 1
Mode of action of the BNT162b2 vaccine. APC = antigen presenting cell; LNP = lipid nanoparticles; mRNA = messenger ribonucleic acid; modRNA = modified ribonucleic acid; UTR = untranslated region.
Fig. 2
Fig. 2
Confirmed COVID-19 occurrence at least 7 days after the second vaccine dose among participants with A) any history of past or active neoplasm (malignancy or benign/unknown tumor) at baseline, and B) the overall trial population (evaluable efficacy population; participants with or without evidence of previous infection). CI = confidence interval; COVID-19 = coronavirus disease 2019; VE = vaccine efficacy.

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