Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 6, 2022; 10(31): 11411-11418
Published online Nov 6, 2022. doi: 10.12998/wjcc.v10.i31.11411
Efficacy and safety profile of two-dose SARS-CoV-2 vaccines in cancer patients: An observational study in China
Sheng-Wei Cai, Jin-Yan Chen, Rong Wan, De-Jian Pan, Wei-Lin Yang, Ren-Gui Zhou
Sheng-Wei Cai, De-Jian Pan, Wei-Lin Yang, Ren-Gui Zhou, Department of Oncology, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Jin-Yan Chen, Department of Disinfection and Supply, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Rong Wan, Department of Quality Control, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Author contributions: Cai SW and Chen JY contributed equally to this work; Cai SW, Wan R, Pan DJ, and Chen JY designed the research study; Cai SW, Wan R, and Chen JY performed the research; Pan DJ, Yang WL, Zhou RG, and Chen JY contributed new reagents and analytic tools; Cai SW, Zhou RG, and Chen JY analyzed the data and wrote the manuscript; and all authors have read and approved the final manuscript.
Institutional review board statement: The study was approved by the Clinical Research Ethics Committees of Anhui Medical University Affiliated with Wuxi Clinical College (Approval number: YXLL-2020-003).
Informed consent statement: Before anyone was allowed to take part in the research project, we made sure that they (or their legal counsel) have provided informed consent to conduct the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: On reasonable request, the corresponding author can provide access to the utilized and processed datasets for this study.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Rong Wan, BHMS, Chief Nurse, Department of Quality Control, The 904th Hospital of Joint Logistic Support Force, No. 101 Xingyuan North Road, Wuxi 214044, Jiangsu Province, China. yings2007@21cn.com
Received: July 21, 2022
Peer-review started: July 21, 2022
First decision: August 4, 2022
Revised: August 16, 2022
Accepted: September 21, 2022
Article in press: September 21, 2022
Published online: November 6, 2022
ARTICLE HIGHLIGHTS
Research background

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine has evolved as the most effective and secure way for protecting healthy individuals against coronavirus disease 2019 (COVID-19). Patients with cancer have been recognized as a highly vulnerable group, and it is of important significance to clarify the risk and efficacy of vaccination. We aimed to clarify and compare the efficacy and safety of SARS-CoV-2 vaccines between cancer patients and non-cancer individuals.

Research motivation

The new coronavirus SARS-CoV-2 has produced a global pandemic of COVID-19, and SARS-CoV-2 vaccine was considered to be a preventive way of accomplishing sufficient herd immunity against SARS-CoV-2 infection to eventually stop the COVID-19 pandemic. Current recommendations suggest cancer patients to undergo SARS-CoV-2 vaccination against COVID-19, but safety and effectiveness evidence is insufficient for SARS-CoV-2 vaccination in cancer patients.

Research objectives

The present observational study was conducted to assess the efficacy and safety of two-dose SARS-CoV-2 vaccines in cancer patients.

Research methods

This multi-center observational study enrolled 132 eligible patients with cancer. Two weeks following the second vaccination dose, subjects underwent an analogous questionnaire survey. Utilizing a magnetic particle-based chemiluminescence immunoassay, serum levels of anti-SARS-CoV-2 immunoglobulin G (IgG) antibodies were measured to determine the effectiveness of vaccination. IgG levels ≥ 10 AU/mL were considered seropositive.

Research results

Local pain at the injection site was the most common side effect, and its incidence was higher in cancer patients than the healthy people (17.2% vs 9.1%; P = 0.035). No significant difference in headache, urticaria, or other adverse reactions was noted between patients with cancer and healthy people. The seropositivity incidence and antibody levels were significantly lower in cancer patients (P < 0.001). This analysis showed a relatively poorer response rate in patients on active immunosuppressive treatment and elderly cancer patients.

Research conclusions

It is effective and safe to accept two-dose Chinese vaccines in cancer patients. Future studies are needed to focus on the efficacy of these vaccines in elderly cancer patients and those on active immunosuppressive treatment.

Research perspectives

Further studies with larger populations of cancer patients undergoing two-dose SARS-CoV-2 vaccination should be performed. Longer follow-up is needed to clarify the long-term efficacy and safety profile of two-dose SARS-CoV-2 vaccines in cancer patients.