Study: COVID-19 Vaccine Does Not Raise Immune Toxicity Risk for Those Treated With ICI


Findings are encouraging for individuals with cancer who are receiving immune checkpoint inhibition treatment and want to get a third vaccine dose, investigators said.

There is no increased risk of immune toxicity among individuals treated with immune checkpoint inhibition (ICI) who received a COVID-19 vaccine, including those who just started therapy, according to the results of a study published in the Journal of the National Comprehensive Cancer Network.

The findings are encouraging for individuals with cancer who are receiving ICI treatment and want to get a third dose of a COVID-19 vaccine, investigators said.

Investigators from the Memorial Sloan Kettering Cancer Center used electronic pharmacy records to identify individuals who were vaccinated with a first dose between January 16, 2021, and March 27, 2021. The individuals who were included also received FDA-approved ipilimumab, nivolumab, or pembrolizumab within 90 days before or after their first vaccinations.

Investigators recorded age at vaccination, any-grade new-onset immune-related adverse events (AEs) after the first vaccine, dates and type of ICI administration, data on vaccine manufacturer, , death during the follow-up period, sex, and tumor type, and.

A total of 408 individuals were included in the study. Approximately 30% were treated for thoracic cancer, 21% for genitourinary cancer, 12% for upper gastrointestinal (GI) cancer, 12% for melanoma, 10% for gynecologic cancer, 5% for head and neck cancer, 3% for lower gastrointestinal cancer, 5% for sarcoma, 1% for breast cancer, 1% for glioblastoma, and 1% for lymphoma.

Additionally, approximately 65% were on pembrolizumab, 24% on nivolumab, 10% on a combination of ipilimumab and nivolumab, 0.7% were on ipilimumab, and 0.3% on all 3 agents. Ninety-five percent of individuals had received the Pfizer-BioNTech vaccine.

Investigators reported that 7% of individuals experienced a new immune-related AE during the follow-up period. Among those who had a history of immune-related AEs before vaccination, just 6% experienced an immune-related AE postvaccination.

All 4 of the individuals who experienced a grade-3 immune-related AR had GI events, with 3 treated with combination ipilimumab and nivolumab and 1 treated with pembrolizumab.

No one experienced a flare of a prior immune-related AE after vaccination, and there were no significant differences in baseline characteristics or treatment between both groups, with the exception of individuals who began a new immunotherapy agent during the follow-up period.

None of the 28 individuals who received the first dose and ICI therapy on the same day developed an immune-related AE during the follow-up period.

Among those who began new immunotherapy courses after vaccination, 17% developed an immune-related AE. The median follow-up after initiation of a new immunotherapy was 78.5 days.

A limitation of the study was the absence of a temporally aligned comparison group of individuals who did not receive a COVID-19 vaccine but were receiving ICI therapy, according to investigators.

Additionally, the sample size of the study was not large enough to determine the risk of rare postvaccination events, including Guillain-Barré syndrome, investigators said.


Widman AJ, Cohen B, Park V, McClure T, Wolchok J, Kamboj M. Immune-related adverse events among COVID-19–vaccinated patients with cancer receiving immune checkpoint blockade. J Natl Compr Canc Netw. 2022;20(10):1134-1138. doi:10.6004/jnccn.2022.7048

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