Journal Article

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

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

2022

Overview

•We show BNT162b2 vaccine ph or phase 3 data from participants with baseline history of past/active neoplasm.•Efficacy and safety were evaluated through up to 6 months of follow-up post-BNT162b2 dose 2.•BNT162b2 has similar efficacy in those with history of past/active neoplasm as overall population.•BNT162b2 has favorable safety profile in these participants, similar to overall study population.•Results inform real-world use of BNT162b2 during the pandemic and future trials in cancer patients. 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. 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. 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. 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.

• Publisher: Elsevier Ltd,Elsevier Limited,The Authors. Published by Elsevier Ltd
• Subject: Adolescent / Age / Allergy and Immunology / BNT162 Vaccine / BNT162b2 / Breast / breasts / Cancer / Cancer therapies / Child / Clinical trials / Coronaviruses / COVID-19 / COVID-19 infection / COVID-19 Vaccines / Cytotoxicity / death / Efficacy / Fever / Humans / immunosuppression / Immunosuppressive agents / Infections / injection site / Male / Malignancy / Melanoma / mRNA / Neoplasms / pain / Pandemics / Placebos / Population / Prostate / risk / RNA, Messenger / Safety / SARS-CoV-2 / Severe acute respiratory syndrome coronavirus 2 / Steroids / Subgroups / Tumors / Vaccine / Vaccine efficacy / Vaccines