Trial reportVaccine2022
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.
Trial report in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04368728 (A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS), which is not on this map. Cited by 40 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of sars-cov-2 rna vaccine candidates against covid-19 in healthy individuals
Who cites it
40 citing papers in PubMed, 4 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Vaccines for preventing infections in adults with haematological malignancies.The Cochrane database of systematic reviews · 2025Pooled it
- Vaccines for preventing infections in adults with solid tumours.The Cochrane database of systematic reviews · 2025Pooled it
- Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023Pooled it
- Seroconversion rate after COVID-19 vaccination in patients with solid cancer: A systematic review and meta-analysis.Human vaccines & immunotherapeutics · 2022Pooled it
- Review
- Vaccination Against Respiratory Infections in Adults with Cancer: A Concise Guide for Clinicians.Vaccines · 2026Review
- Safety, Immunogenicity, and Efficacy of COVID-19 Vaccines in Radiation-Oncology Patients: A Systematic Review and Meta-Analysis.Vaccines · 2025Review
- Incidence of dynamic seroconversion in subjects received the first dose of the SARS-COV-2 vaccine (AstraZeneca, Moderna and Pfizer) in Kinshasa, Democratic Republic of Congo: prospective cohort study.BMC infectious diseases · 2025Article
- Article
- Integration of 101 machine learning algorithm combinations to unveil m6A/m1A/m5C/m7G-associated prognostic signature in colorectal cancer.Scientific reports · 2025Article
- An approach to COVID‑19 and oncology: From impact, staging and management to vaccine outcomes in cancer patients: A systematic review and meta‑analysis.Experimental and therapeutic medicine · 2025Article
- Robust genome and cell engineering via in vitro and in situ circularized RNAs.Nature biomedical engineering · 2025Article
- Current Advances in Nanocarriers for Cancer Therapy.International journal of nanomedicine · 2025Review
- Vaccination for solid organ transplanted patients: Recommendations, efficacy, and safety.World journal of transplantation · 2024Review
- The Novavax Heterologous Coronavirus Disease 2019 Booster Demonstrates Lower Reactogenicity Than Messenger RNA: A Targeted Review.The Journal of infectious diseases · 2024Review
- Effectiveness of COVID-19 vaccines against severe COVID-19 among patients with cancer in Catalonia, Spain.Nature communications · 2024Article
- Cancer Care During the COVID-19 Pandemic: A Retrospective Study From a Najran Oncology Center.Cureus · 2024Article
- Strategies to reduce the risks of mRNA drug and vaccine toxicity.Nature reviews. Drug discovery · 2024Review
- Vaccination status, incidence of adverse events, and awareness of COVID-19 vaccine among outpatients undergoing chemotherapy.Journal of pharmaceutical health care and sciences · 2024Article
- Lyophilization process optimization and molecular dynamics simulation of mRNA-LNPs for SARS-CoV-2 vaccine.NPJ vaccines · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIndividuals 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
methodsBetween 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.
resultsAt 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.
conclusionIn 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.