Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Jan 25, 2023
Open Peer Review Period: Jan 25, 2023 - Feb 8, 2023
Date Accepted: Oct 31, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Safety of COVID-19 vaccination in patients with breast cancer
ABSTRACT
Background:
`The widespread vaccination of the novel coronavirus vaccine (COVID-19 vaccine) has become one of the most likely effective means to end the COVID-19 pandemic. Tumor patients with high risk of infection, high incidence of serious events and high mortality should be the focus of epidemic prevention and treatment in the setting of COVID-19. But real-world data on the safety of vaccination for breast cancer patients are still unknown.
Objective:
This study aims to further analyze the safety of COVID-19 vaccine in vaccinated breast cancer patients.
Methods:
In the CSCO BC NCP-02 study, breast cancer patients who seek medical advice from October 2021 to December 2021were screened, from whom the vaccinated patients were enrolled in order to analysis the safety of vaccination.
Results:
The CSCO BC NCP-02 study screened 5766 patients who received COVID-19 vaccine, 45.1% (2599/5766) of the population were vaccinated before diagnosis of breast cancer, 41.3% (2379/5766) of the population were vaccinated after diagnosis of breast cancer, and the time of vaccination or diagnosis in 13.6% (784/5766) of the patients was unknown. Among breast cancer patients, 85.4% (2032/2379) were vaccinated one year after breast cancer diagnosis, and 95.4% (2270/2379) were vaccinated in the early breast cancer stage. Of all patients, 93.9% (5415/5766) received inactivated vaccine, 3.7% received recombinant subunit vaccine, 2.4% received other vaccines, including adenovirus and mRNA vaccine. In the first dose, the highest incidence of AE was 24.4% (95%CI, 11.2-37.5) for these received adenovirus vaccine. The lowest was 12.5% (95%CI: 11.6-13.4) for these received inactivated vaccines. In the second dose, both inactivated vaccines (8.7%, 95%CI:8.0-9.5) and recombinant vaccine (8.7%, 95%CI:5.5-12.0) showed the same incidence of AEs. Patients with metastatic breast cancer had the highest incidence of AEs (16.5%, 95%CI:9.5-23.5) at the first dose. The total incidence of AE vaccinated before and after diagnosis of breast cancer was 16.4% and 16.9%, respectively. The most common AEs were local pain (11.1% vs 9.1%), fatigue (5.5% vs 6.3%) and muscle soreness (2.3% vs 3.6%). The type of vaccines (OR=0.937,95% CI：0.689-1.273) and time window of vaccination (OR=0.919,95% CI：0.785-1.077) did not affect the incidence of AEs.
Conclusions:
Compared with the patients vaccinated before diagnosis of breast cancer, the incidence of AEs of COVID-19 vaccine in breast cancer patients was not significantly increased. It is safe for these breast cancer patients to receive COVID-19 vaccines. Clinical Trial: ChiCTR2200055509
Citation
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