Safety and immunogenicity of the COVID-19 vaccine BNT162b2 in patients undergoing chemotherapy for solid cancer

Funakoshi, Yohei; Yakushijin, Kimikazu; Ohji, Goh; Hojo, Wataru; Sakai, Hironori; Takai, Ryo; Nose, Taku; Ohata, Shinya; Nagatani, Yoshiaki; Koyama, Taiji; Kitao, Akihito; Nishimura, Meiko; Imamura, Yoshiaki; Kiyota, Naomi; Harada, Kiyoshi; Tanaka, Yugo; Mori, Yasuko; Minami, Hironobu

doi:10.1016/j.jiac.2021.12.021

Cited by 19 publications

(17 citation statements)

References 17 publications

(22 reference statements)

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“…Similar results were reported by a group in Israel, without severe adverse events, either life threatening or requiring hospitalization, after the full vaccination course [18]. Funakoshi et al [20] confirmed the acceptable toxicity profile of the Comirnaty vaccine in a small sample of Japanese population with cancer; their data also indicate that serum antibody titer against Spike protein-S1 were significantly lower in patients treated with chemotherapy and ICIs compared to healthy volunteers, underlining the state of chronic immunosuppression of cancer patients due to malignancy itself regardless of the treatment administered.…”

Section: Discussionsupporting

confidence: 85%

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

et al. 2022

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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.

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Section: Discussionsupporting

confidence: 85%

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

et al. 2022

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“…Many controversies might be remain uncertain until today. Whether we give the vaccine directly after definitive surgery or after the adjuvant treatment, it might have its consequences, the side effect of this vaccine should be predicted and informed to the patient before [3], [6]. Clinical symptoms which could be reported during the COVID-19 vaccine are pain at the injection site, fever of various duration, and malaise.…”

Section: Discussionmentioning

confidence: 99%

Gastrointestinal Cancer and Vaccination Safety during COVID-19 Pandemic

Bagus

2022

Open Access Maced J Med Sci

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BACKGROUND: During our past 18 months, we must be faced with the current COVID-19 pandemic era with much uncertainty in the continuation of multimodality treatment of the gastrointestinal cancer patients. Especially in this immunocompromised group with the history of previous chemotherapy treatment, these patients have an increased risk of COVID-19 transmission. Many studies have been reported about the current recommendation for gastrointestinal cancer patients during this pandemic, but there might be a lack of evidence about the safety of vaccination for the gastrointestinal cancer patients. AIM: Since the vaccination has been approved by our government medical support, we would evaluate the safety of the COVID-19 vaccination program in gastrointestinal cancer patients. METHODS: All gastrointestinal cancer patients who have been already diagnosed with cancer will be included in this study. The vaccine-related sign symptoms will be recorded and evaluated. The chemotherapy schedule was not been interrupted following the vaccination. The patient who refused to receive the second vaccination dose will be excluded from this study. RESULTS: Thirty-two patients were included in this study (our past 6-month evaluation from February till August 2021), colorectal adenocarcinoma was the most common gastrointestinal cancer according to organ-specific (25 patients), the others were gastric adenocarcinoma, pancreatic adenocarcinoma, and small bowel gastrointestinal stromal tumor. Both of them already received two doses of COVID-19 vaccine during this period, we reported there was no side effect related to these and the chemotherapy cycle has not been interrupted during vaccination. All of the patients could be tolerated it well and did not refuse to continue the treatment. CONCLUSION: There were no significant signs and symptoms of vaccine-related side effects on gastrointestinal cancer patients. COVID-19 vaccination during this pandemic and following the chemotherapy schedule on any kind of gastrointestinal cancer patients was safe and could be suggested as a routine protocol.

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“…Although high, this proportion is considerably lower than the 99% to 100% found in control groups. 1 , 2 , 3 Indeed, the post‐vaccination seropositivity in UC and RCC patients altogether was 91.8% (78 of 85), which was significantly lower than that in the control groups ( P = 0.0415, Fisher's exact test).…”

mentioning

confidence: 82%

Editorial Comment from Dr Kobayashi to Effect of active anticancer therapy on serologic response to SARS‐CoV‐2 BNT162b2 vaccine in patients with urothelial and renal cell carcinoma

Kobayashi

2022

Int J of Urology

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Safety and immunogenicity of the COVID-19 vaccine BNT162b2 in patients undergoing chemotherapy for solid cancer

Cited by 19 publications

References 17 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

Gastrointestinal Cancer and Vaccination Safety during COVID-19 Pandemic

Editorial Comment from Dr Kobayashi to Effect of active anticancer therapy on serologic response to SARS‐CoV‐2 BNT162b2 vaccine in patients with urothelial and renal cell carcinoma

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