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

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

doi:10.1016/j.vaccine.2021.12.046

Cited by 37 publications

(28 citation statements)

References 46 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Patients enrolled in our study represent a completely different population compared to those included in vaccine registered trials: in Moderna [14] and Pfizer [15] trials just 21% and 20.5% patients, respectively, had at least one comorbidity, median age was respectively 52 and 51.5 years, patients older than 65 years were respectively 25.3% and 22%. Recently a post-hoc subgroup analysis of global phase 3 Comirnaty vaccine study regarding patients with a history of malignancy was performed, but this study included also patients with benign tumors and patients receiving systemic immunosuppressive treatment were excluded [16]. Instead, in our study every patient had a diagnosis of active cancer on treatment, 68.4% of patients had at least one further coexisting condition and 62.3% was older than 65 years.…”

Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

et al. 2022

View full text Add to dashboard Cite

Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.

show abstract

Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

et al. 2022

View full text Add to dashboard Cite

show abstract

“…The most famous non-viral vector used for mRNA vaccine is the lipid nanoparticle-based mRNA delivery system, which has been used for the mRNA vaccine of Covid19 and has been very successful ( 47 , 48 ). LNPs usually consists of an ionizable lipid-like molecule, polyethylene glycol (PEG)-conjugated lipid, cholesterol and a helper phospholipid.…”

Section: Optimization Of the Vectors For Efficient Delivery Of Mrna C...mentioning

confidence: 99%

Potentialities and Challenges of mRNA Vaccine in Cancer Immunotherapy

et al. 2022

View full text Add to dashboard Cite

Immunotherapy has become the breakthrough strategies for treatment of cancer in recent years. The application of messenger RNA in cancer immunotherapy is gaining tremendous popularity as mRNA can function as an effective vector for the delivery of therapeutic antibodies on immune targets. The high efficacy, decreased toxicity, rapid manufacturing and safe administration of mRNA vaccines have great advantages over conventional vaccines. The unprecedent success of mRNA vaccines against infection has proved its effectiveness. However, the instability and inefficient delivery of mRNA has cast a shadow on the wide application of this approach. In the past decades, modifications on mRNA structure and delivery methods have been made to solve these questions. This review summarizes recent advancements of mRNA vaccines in cancer immunotherapy and the existing challenges for its clinical application, providing insights on the future optimization of mRNA vaccines for the successful treatment of cancer.

show abstract

“…In the same way, patients with cancer, comorbidities, or those receiving immunosuppressive therapy have been excluded. The only published RCT including patients with cancer was the BNT162b2 Pfizer/BioNTech mRNA vaccine trial, which recently reported a subgroup analysis of the 3813 patients with a history of cancer (median age 64 years, range 16-91 years), showing an efficacy of 92-94%, with only four cases reported among the 1802 participants who received the vaccine compared with 71 among those who received placebo [8]. This causes clinicians to make recommendations based on the risk-benefit ratio, on extrapolation of RCT data, on subgroup analyses, or on observational studies, particularly in the context of the emergence of novel variants.…”

Section: Considerations On the Role Of Covid-19 Vaccines In Older Pat...mentioning

confidence: 99%

Updated International Society of Geriatric Oncology COVID-19 working group recommendations on COVID-19 vaccination among older adults with cancer

Soto‐Pérez‐de‐Celis

Mislang

Hernández-Favela

et al. 2022

Journal of Geriatric Oncology

View full text Add to dashboard Cite

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

Cited by 37 publications

References 46 publications

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

Potentialities and Challenges of mRNA Vaccine in Cancer Immunotherapy

Updated International Society of Geriatric Oncology COVID-19 working group recommendations on COVID-19 vaccination among older adults with cancer

Contact Info

Product

Resources

About