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.
【저자키워드】 COVID-19, Efficacy, Vaccine, Safety, BNT162b2, malignancy, 【초록키워드】 BNT162b2 vaccine, COVID-19 vaccine, therapy, Trial, Hospitalization, fatigue, COVID-19 pandemic, Cancer, Infection, clinical trials, outcomes, Randomized, clinical, death, incidence rate, Melanoma, Efficacy and safety, Placebo, Follow-up, placebo-controlled, BNT162b2 mRNA, Prostate, neoplasm, Neoplasms, immunosuppressive, Safe, high risk, Participants, individual, participant, unblinding, follow-up time, MOST, Pyrexia, Injection-site pain, reported, receiving, excluded, AEs, baseline, observer-blinded, placebo recipient, reactogenicity event, were excluded, 【제목키워드】 randomized clinical trial, COVID-19 vaccine, BNT162b2 mRNA, Phase 3, participant, subgroup analysis,