tetano
Editor, Senior Moderator
JMIR Public Health Surveill
. 2023 Dec 7:9:e46009.
doi: 10.2196/46009. Safety of COVID-19 Vaccination in Patients With Breast Cancer: Cross-Sectional Study in China
Shaohua Zhang[SUP] #[/SUP][SUP] 1 [/SUP], Jianbin Li[SUP] #[/SUP][SUP] 1 2 [/SUP], Ruonan Xu[SUP] 1 [/SUP], Qianjun Chen[SUP] 3 [/SUP], Gang Sun[SUP] 4 [/SUP], Ying Lin[SUP] 5 [/SUP], Yali Cao[SUP] 6 [/SUP], Yiding Chen[SUP] 7 [/SUP], Cuizhi Geng[SUP] 8 [/SUP], Yuee Teng[SUP] 9 [/SUP], Jianyun Nie[SUP] 10 [/SUP], Xinzheng Li[SUP] 11 [/SUP], Guiying Xu[SUP] 12 [/SUP], Xinlan Liu[SUP] 13 [/SUP], Feng Jin[SUP] 9 [/SUP], Zhimin Fan[SUP] 14 [/SUP], Ting Luo[SUP] 15 [/SUP], Hong Liu[SUP] 16 [/SUP], Fu-Sheng Wang[SUP] 1 [/SUP], Zefei Jiang[SUP] 1 [/SUP]
Affiliations
Background: The widespread use of vaccines against the novel coronavirus disease (COVID-19) has become one of the most effective means to establish a population immune barrier. Patients with cancer are vulnerable to COVID-19 infection, adverse events, and high mortality, and should be the focus of epidemic prevention and treatment. However, real-world data on the safety of vaccines for patients with breast cancer are still scarce.
Objective: This study aims to compare the safety of COVID-19 vaccines between patients vaccinated before or after being diagnosed with breast cancer.
Methods: Patients with breast cancer who sought medical advice from October 2021 to December 2021 were screened. Those who received COVID-19 vaccines were enrolled in this study to analyze the safety of the vaccines. The primary outcome was patient-reported adverse events (AEs). All events after vaccine injection were retrospectively documented from the patients.
Results: A total of 15,455 patients with breast cancer from 41 hospitals in 20 provinces in China were screened, and 5766 patients who received COVID-19 vaccines were enrolled. Of those enrolled, 45.1% (n=2599) of patients received vaccines before breast cancer diagnosis, 41.3% (n=2379) were vaccinated after diagnosis, and 13.6% (n=784) did not known the accurate date of vaccination or cancer diagnosis. Among the patients vaccinated after diagnosis, 85.4% (n=2032) were vaccinated 1 year after cancer diagnosis and 95.4% (n=2270) were vaccinated during early-stage cancer. Of all 5766 vaccinated patients, 93.9% (n=5415) received an inactivated vaccine, 3.7% (n=213) received a recombinant subunit vaccine, and 2.4% (n=138) received other vaccines, including adenovirus and mRNA vaccines. In the first injection of vaccines, 24.4% (n=10, 95% CI 11.2-37.5) of patients who received an adenovirus vaccine reported AEs, compared to only 12.5% (n=677, 95% CI 11.6-13.4) of those who received an inactivated vaccine. Patients with metastatic breast cancer reported the highest incidence of AEs (n=18, 16.5%, 95% CI 9.5-23.5). Following the second injection, patients who received an inactivated vaccine (n=464, 8.7%, 95% CI 8.0-9.5) and those who received a recombinant vaccine (n=25, 8.7%, 95% CI 5.5-12.0) reported the same incidence of AEs. No significant differences in patient-reported AEs were found between the healthy population and patients with breast cancer (16.4% vs 16.9%, respectively); the most common AEs were local pain (11.1% vs 9.1%, respectively), fatigue (5.5% vs 6.3%, respectively), and muscle soreness (2.3% vs 3.6%, respectively). The type of vaccine and time window of vaccination had little impact on patient-reported AEs.
Conclusions: Compared with patients vaccinated before breast cancer diagnosis, there were no significant differences in patient-reported AEs in the patients vaccinated after diagnosis. Thus, it is safe for patients with breast cancer, especially for those in the early stage, to receive COVID-19 vaccines.
Trial registration: Chinese Clinical Trial Registry ChiCTR2200055509; https://tinyurl.com/33zzj882.
Keywords: COVID-19 vaccines; breast cancer; healthy population; patients reported adverse events; vaccine safety.
. 2023 Dec 7:9:e46009.
doi: 10.2196/46009. Safety of COVID-19 Vaccination in Patients With Breast Cancer: Cross-Sectional Study in China
Shaohua Zhang[SUP] #[/SUP][SUP] 1 [/SUP], Jianbin Li[SUP] #[/SUP][SUP] 1 2 [/SUP], Ruonan Xu[SUP] 1 [/SUP], Qianjun Chen[SUP] 3 [/SUP], Gang Sun[SUP] 4 [/SUP], Ying Lin[SUP] 5 [/SUP], Yali Cao[SUP] 6 [/SUP], Yiding Chen[SUP] 7 [/SUP], Cuizhi Geng[SUP] 8 [/SUP], Yuee Teng[SUP] 9 [/SUP], Jianyun Nie[SUP] 10 [/SUP], Xinzheng Li[SUP] 11 [/SUP], Guiying Xu[SUP] 12 [/SUP], Xinlan Liu[SUP] 13 [/SUP], Feng Jin[SUP] 9 [/SUP], Zhimin Fan[SUP] 14 [/SUP], Ting Luo[SUP] 15 [/SUP], Hong Liu[SUP] 16 [/SUP], Fu-Sheng Wang[SUP] 1 [/SUP], Zefei Jiang[SUP] 1 [/SUP]
Affiliations
- PMID: 38060302
- DOI: 10.2196/46009
Background: The widespread use of vaccines against the novel coronavirus disease (COVID-19) has become one of the most effective means to establish a population immune barrier. Patients with cancer are vulnerable to COVID-19 infection, adverse events, and high mortality, and should be the focus of epidemic prevention and treatment. However, real-world data on the safety of vaccines for patients with breast cancer are still scarce.
Objective: This study aims to compare the safety of COVID-19 vaccines between patients vaccinated before or after being diagnosed with breast cancer.
Methods: Patients with breast cancer who sought medical advice from October 2021 to December 2021 were screened. Those who received COVID-19 vaccines were enrolled in this study to analyze the safety of the vaccines. The primary outcome was patient-reported adverse events (AEs). All events after vaccine injection were retrospectively documented from the patients.
Results: A total of 15,455 patients with breast cancer from 41 hospitals in 20 provinces in China were screened, and 5766 patients who received COVID-19 vaccines were enrolled. Of those enrolled, 45.1% (n=2599) of patients received vaccines before breast cancer diagnosis, 41.3% (n=2379) were vaccinated after diagnosis, and 13.6% (n=784) did not known the accurate date of vaccination or cancer diagnosis. Among the patients vaccinated after diagnosis, 85.4% (n=2032) were vaccinated 1 year after cancer diagnosis and 95.4% (n=2270) were vaccinated during early-stage cancer. Of all 5766 vaccinated patients, 93.9% (n=5415) received an inactivated vaccine, 3.7% (n=213) received a recombinant subunit vaccine, and 2.4% (n=138) received other vaccines, including adenovirus and mRNA vaccines. In the first injection of vaccines, 24.4% (n=10, 95% CI 11.2-37.5) of patients who received an adenovirus vaccine reported AEs, compared to only 12.5% (n=677, 95% CI 11.6-13.4) of those who received an inactivated vaccine. Patients with metastatic breast cancer reported the highest incidence of AEs (n=18, 16.5%, 95% CI 9.5-23.5). Following the second injection, patients who received an inactivated vaccine (n=464, 8.7%, 95% CI 8.0-9.5) and those who received a recombinant vaccine (n=25, 8.7%, 95% CI 5.5-12.0) reported the same incidence of AEs. No significant differences in patient-reported AEs were found between the healthy population and patients with breast cancer (16.4% vs 16.9%, respectively); the most common AEs were local pain (11.1% vs 9.1%, respectively), fatigue (5.5% vs 6.3%, respectively), and muscle soreness (2.3% vs 3.6%, respectively). The type of vaccine and time window of vaccination had little impact on patient-reported AEs.
Conclusions: Compared with patients vaccinated before breast cancer diagnosis, there were no significant differences in patient-reported AEs in the patients vaccinated after diagnosis. Thus, it is safe for patients with breast cancer, especially for those in the early stage, to receive COVID-19 vaccines.
Trial registration: Chinese Clinical Trial Registry ChiCTR2200055509; https://tinyurl.com/33zzj882.
Keywords: COVID-19 vaccines; breast cancer; healthy population; patients reported adverse events; vaccine safety.