Cancer patients and survivors should be included in COVID-19 vaccine trials unless there is a safety justification for excluding them, according to a statement from the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research.1
The statement acknowledges the “great progress” that has been made with COVID-19 vaccines but notes that patients with cancer were “drastically” underrepresented in the clinical trials of these vaccines. Therefore, outcomes for cancer patients “are not optimally characterized.”
ASCO and other professional organizations currently recommend COVID-19 vaccination for patients with cancer, unless vaccination is specifically contraindicated.2
However, in the joint statement, ASCO and Friends of Cancer Research acknowledge that the recommendation to vaccinate is based on consensus expert opinion, and there is a “lack of understanding of the degree of immunity and clinical protection that COVID-19 vaccines provide in individuals with compromised immune systems.”
The joint statement includes 4 recommendations on the inclusion of individuals with cancer in COVID-19 vaccine trials.
First, existing and future trials should only exclude cancer patients and survivors or those who are immunocompromised if there is “specific and credible risk of harm” from participation.
Second, vaccine manufacturers and trial sponsors should partner with oncology practices, cancer centers, and academic medical centers to recruit patients with cancer and ensure that “sufficient numbers” of cancer patients from “diverse populations and age groups” are being enrolled.
Third, government agencies should “encourage and incentivize vaccine manufacturers to include patients with cancer in existing and future COVID-19 vaccine trials.”
Lastly, public health agencies and research organizations should compile and analyze real-world data on vaccine effectiveness in cancer patients. This could help make up for underrepresentation of cancer patients in prior vaccine trials.
“We continue to emphasize that broadening eligibility criteria to clinical trials will help inform the optimal use of new medicines for more people, and the same principles apply to COVID-19 vaccines,” Jeff Allen, PhD, president and chief executive officer of Friends of Cancer Research, said in a press release.3
“Because people with cancer are at greater risk for severe outcomes from COVID-19, we urge manufacturers and trial sponsors to enroll patients with cancer and develop studies specifically geared towards patients with cancer to fully characterize the level of protection these important vaccines provide.”
Considerations When Deciding on Vaccination
The call to include cancer patients in COVID-19 vaccine trials is a reflection of the amazing job the United States has done in its vaccination efforts, according to Robert Ferris, MD, PhD, director of UPMC Hillman Cancer Center in Pittsburg, Pennsylvania.
“It is impressive that, 6 months after starting [to vaccinate], we are trying to go that last mile and get to populations that are vulnerable, like patients with cancer,” Dr Ferris said. “It is a testament to our public health efforts.”
Dr Ferris noted that UPMC has begun efforts to collect real-world data on the effectiveness of COVID-19 vaccines in patients with cancer. In fact, UPMC released an interim analysis of a study designed to evaluate immunocompromised response to COVID-19 vaccination.4
For this study, researchers tested blood samples from 107 healthy volunteers and 489 immunocompromised patients who had completed COVID-19 vaccination.
The majority (98.1%) of healthy participants produced antibodies after vaccination, but responses varied among those who were immunocompromised. About 54% of patients with hematologic malignancies, 82.4% of those with solid tumors, and 83.8% of those with autoimmune disorders produced antibodies.
“Ultimately, the decision to vaccinate is going to be left up to the oncologist and the patient,” Dr Ferris said.
He noted that the oncologist has to consider if it is a good time in a patient’s treatment cycle, possible comorbidities, whether a patient is on therapies that may decrease the likelihood of generating antibodies, and if a patient is participating in a clinical trial of a novel treatment.
- Inclusion of Individuals with Cancer on COVID-19 Vaccine Trials: A Joint Position Statement from the American Society of Clinical Oncology and Friends of Cancer Research. Published June 22, 2021. Accessed July 2, 2021. https://www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/pdf/2021-ASCO-Friends-Vaccine-Trials-Position-Statement.pdf
- COVID-19 Vaccines & Patients with Cancer. Updated May 21, 2021. Accessed July 2, 2021. https://www.asco.org/asco-coronavirus-resources/covid-19-vaccines-patients-cancer
- Individuals with Cancer Must Be Included in COVID-19 Vaccine Trials. News Release. ASCO. Published June 22, 2021. Accessed July 2, 2021. https://www.asco.org/about-asco/press-center/news-releases/individuals-cancer-must-be-included-covid-19-vaccine-trials/
- Haider G, Agha M, Lukanski A, et al. Immunogenicity of COVID-19 vaccination in immunocompromised patients: An observational, prospective, cohort study interim analysis. medRxiv. 2021; doi: 10.1101/2021.06.28.21259576