PMID- 38060302
OWN - NLM
STAT- MEDLINE
DCOM- 20231211
LR  - 20231224
IS  - 2369-2960 (Electronic)
IS  - 2369-2960 (Linking)
VI  - 9
DP  - 2023 Dec 7
TI  - Safety of COVID-19 Vaccination in Patients With Breast Cancer: Cross-Sectional 
      Study in China.
PG  - e46009
LID - 10.2196/46009 [doi]
LID - e46009
AB  - 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.
CI  - (c)Shaohua Zhang, Jianbin Li, Ruonan Xu, Qianjun Chen, Gang Sun, Ying Lin, Yali 
      Cao, Yiding Chen, Cuizhi Geng, Yuee Teng, Jianyun Nie, Xinzheng Li, Guiying Xu, 
      Xinlan Liu, Feng Jin, Zhimin Fan, Ting Luo, Hong Liu, Fu-sheng Wang, Zefei Jiang. 
      Originally published in JMIR Public Health and Surveillance 
      (https://publichealth.jmir.org), 07.12.2023.
FAU - Zhang, Shaohua
AU  - Zhang S
AUID- ORCID: 0000-0002-3911-2398
AD  - Fifth Medical Center of Chinese People's Liberation Army General Hospital, 
      Beijing, China.
FAU - Li, Jianbin
AU  - Li J
AUID- ORCID: 0000-0001-7813-0452
AD  - Fifth Medical Center of Chinese People's Liberation Army General Hospital, 
      Beijing, China.
AD  - Beijing Institute of Biotechnology, Academy of Military Medical Sciences, 
      Beijing, China.
FAU - Xu, Ruonan
AU  - Xu R
AUID- ORCID: 0000-0002-4180-7754
AD  - Fifth Medical Center of Chinese People's Liberation Army General Hospital, 
      Beijing, China.
FAU - Chen, Qianjun
AU  - Chen Q
AUID- ORCID: 0000-0001-6761-7740
AD  - Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong, China.
FAU - Sun, Gang
AU  - Sun G
AUID- ORCID: 0000-0002-7804-1967
AD  - Cancer Hospital Affiliated to Xinjiang Medical University, Xinjiang, China.
FAU - Lin, Ying
AU  - Lin Y
AUID- ORCID: 0000-0002-5923-3306
AD  - The First Affiliated Hospital of Sun Yat-sen University, Guangdong, China.
FAU - Cao, Yali
AU  - Cao Y
AUID- ORCID: 0009-0008-6465-2880
AD  - Nanchang Third Hospital, Jiangxi, China.
FAU - Chen, Yiding
AU  - Chen Y
AUID- ORCID: 0000-0002-2263-6275
AD  - The Second Affiliated Hospital of Medical College of Zhejiang University, 
      Zhejiang, China.
FAU - Geng, Cuizhi
AU  - Geng C
AUID- ORCID: 0000-0001-5541-5412
AD  - Fourth Hospital of Hebei Medical University, Hebei, China.
FAU - Teng, Yuee
AU  - Teng Y
AUID- ORCID: 0000-0002-9198-9795
AD  - The First Hospital of China Medical University, Liaoning, China.
FAU - Nie, Jianyun
AU  - Nie J
AUID- ORCID: 0000-0003-3691-8940
AD  - Yunnan Cancer Hospital, Yunnan, China.
FAU - Li, Xinzheng
AU  - Li X
AUID- ORCID: 0000-0002-5409-0860
AD  - Shanxi Cancer Hospital, Shanxi, China.
FAU - Xu, Guiying
AU  - Xu G
AUID- ORCID: 0000-0003-0526-7401
AD  - Jilin Cancer Hospital, Jilin, China.
FAU - Liu, Xinlan
AU  - Liu X
AUID- ORCID: 0009-0004-6798-7628
AD  - General Hospital of Ningxia Medical University, Ningxia, China.
FAU - Jin, Feng
AU  - Jin F
AUID- ORCID: 0000-0002-0325-5362
AD  - The First Hospital of China Medical University, Liaoning, China.
FAU - Fan, Zhimin
AU  - Fan Z
AUID- ORCID: 0000-0001-5236-7814
AD  - The First Hospital of Jilin University, Jilin, China.
FAU - Luo, Ting
AU  - Luo T
AUID- ORCID: 0000-0002-9670-4031
AD  - Sichuan Uniersity Huaxi Campus, Sichuan, China.
FAU - Liu, Hong
AU  - Liu H
AUID- ORCID: 0000-0002-3985-9504
AD  - Tumor Hospital of Tianjin Medical University, Tianjin, China.
FAU - Wang, Fu-Sheng
AU  - Wang FS
AUID- ORCID: 0000-0002-8043-6685
AD  - Fifth Medical Center of Chinese People's Liberation Army General Hospital, 
      Beijing, China.
FAU - Jiang, Zefei
AU  - Jiang Z
AUID- ORCID: 0000-0002-4295-0173
AD  - Fifth Medical Center of Chinese People's Liberation Army General Hospital, 
      Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20231207
PL  - Canada
TA  - JMIR Public Health Surveill
JT  - JMIR public health and surveillance
JID - 101669345
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Breast Neoplasms/epidemiology
MH  - COVID-19 Vaccines/adverse effects
MH  - Cross-Sectional Studies
MH  - Retrospective Studies
MH  - *COVID-19/epidemiology/prevention & control
MH  - Vaccination/adverse effects
MH  - China/epidemiology
MH  - Vaccines, Inactivated
PMC - PMC10739232
OTO - NOTNLM
OT  - COVID-19 vaccines
OT  - breast cancer
OT  - healthy population
OT  - patients reported adverse events
OT  - vaccine safety
COIS- Conflicts of Interest: None declared.
EDAT- 2023/12/07 12:42
MHDA- 2023/12/11 12:43
PMCR- 2023/12/07
CRDT- 2023/12/07 11:55
PHST- 2023/01/25 00:00 [received]
PHST- 2023/10/31 00:00 [accepted]
PHST- 2023/07/26 00:00 [revised]
PHST- 2023/12/11 12:43 [medline]
PHST- 2023/12/07 12:42 [pubmed]
PHST- 2023/12/07 11:55 [entrez]
PHST- 2023/12/07 00:00 [pmc-release]
AID - v9i1e46009 [pii]
AID - 10.2196/46009 [doi]
PST - epublish
SO  - JMIR Public Health Surveill. 2023 Dec 7;9:e46009. doi: 10.2196/46009.