Challenges and Recommendations for COVID-19 Vaccines in patients with cancer

At the start of 2020, the U.S. identified the first case of COVID-19 near Seattle, in Washington State. Shortly after that, we were amid a pandemic. One year after the first case, nearly 140 million confirmed cases of SARS-CoV-2 and nearly 3 million deaths had been reported globally. Within the U.S. alone, we have exceeded 32 million confirmed cases and nearly 600,000 deaths. Although vaccines are being distributed throughout the U.S. population, because of new variants, the number of new cases is expected to increase. Throughout the pandemic, with great clarity, patients with cancer have been at a higher risk for severe complications and mortality than non-cancer patients. This higher risk could be due to the malignancy of the cancer type, immune dysfunction, cancer treatments, comorbidities or a combination of factors. 

Because of the immediate concerns surrounding cancer patient care during the pandemic, oncologists in the U.S. developed the COVID-19 and Cancer Consortium (CCC19) to collect data on patients with cancer and a diagnosis of COVID-19.  From the Division of Public Health Sciences, Dr. Gary Lyman describes CCC19, “The Consortium was launched in mid-March 2020 and represents a collaborative effort of the Hutch/UW/SCCA and nearly 120 other cancer centers throughout the U.S. and now globally. Within 30 days, CCC19 had captured information on over 1,000 patients with cancer and confirmed COVID-19 noting that patients with patients are at exceptionally high risk for severe COVID-19 and early mortality.” Other consortiums, such as the UK Coronavirus Cancer Monitoring Project (UKCCMP), have also reported that patients with cancer are at a higher risk of mortality when diagnosed with COVID-19 than non-cancer patients.

The Lyman Group reviewed recent studies on patients with cancer and COVID-19 and commented on its current impact, “Additional publications have documented the continued growth in cases and detailed information about the impact of COVID-19 on patients with cancer with now nearly 10,000 patients in the registry. Combined with several other cohort studies on the impact of COVID-19 in patients with cancer, we found that, early in the pandemic, the risk of early mortality from COVID-19 in hospitalized patients with cancer averaged 26% among studies with primarily patients with solid tumors and 40% among studies only including hematologic malignancies with greater risk among older patients receiving active cancer therapy. The need for active, supportive care in patients requiring cancer therapy has been highlighted by us and professional oncology organizations.” The COVID-19 pandemic continues and is extremely dangerous and challenging for patients with cancer as we await the widespread distribution of vaccines. The current publication on the opportunities and challenges of COVID-19 vaccination in patients with cancer was an important extension of the Lyman’s Group yearlong effort to better understand the impact of COVID-19 on patients with cancer. The study is published in the journal Cancer Investigation.

The current Pfizer and BioNTech vaccine (BNT-162b2) has overall efficacy of 95% (95% CI:90-98%) in the prevention of COVID-19. However, those receiving immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, were excluded from the study. As a result, there were insufficient subjects to establish whether the vaccine can reduce the risk of COVID-19 in patients with cancer. The Moderna vaccine (mRNA-1273) has an overall efficacy rate of 94.1% (95% CI: 89-97%) in preventing COVID-19 14 days after the second dose. Again, participants who received immunosuppressive therapy for greater than 14 days in total in the 6 months prior to screening were excluded from the study. This trial did not report or present the number of participants with a history of cancer. The Lyman Group concluded that “there is very limited information on the efficacy of the currently authorized COVID-19 vaccines in patients with cancer.” Previous vaccination studies and as yet unpublished data on COVID-19 vaccinations suggest that patients with cancer may develop a less robust serologic response but can achieve substantial protection when fully vaccinated on schedule. “Of continuing concern are patients with hematologic malignancies and recipients of stem cell transplantation (HCT) or CAR-T therapy whom we also feel should be prioritized for vaccination at the appropriate time”, said Dr. Lyman. 

The Lyman Group strongly encourages the prioritization of patients with cancer for COVID-19 vaccination. Despite the limited data currently available, the benefit of COVID-19 vaccination in patients with most cancers far exceeds any risk. The risk of severe illness and early mortality from COVID-19 is exceptionally high in patients with cancer, and there is no evidence for an increase in serious adverse events from the vaccine. Dr. Lyman advises, “We strongly recommend, as have several professional organizations, that while dedicated clinical trials are needed, patients with cancer should be prioritized for COVID-19 vaccination with one of the authorized vaccines at the earliest opportunity. Following vaccination, patients with cancer should still adhere to public health measures of social distancing, hand washing, and masks given uncertainty of the level and duration of protection.”

The Lyman Group discussed future directions for CCC19, “The CCC19 program at the Hutch/UW/SCCA continues to identify patients with cancer and confirmed COVID-19 generating additional pilot data for larger, more definitive trials. With an outstanding group of faculty, fellows, and residents continuing to volunteer time and effort to identifying and record cases, the CCC19 entire registry has now grown to nearly 10,000 patients with cancer and COVID-19 with several additional publications under review or in development. This effort has provided an outstanding opportunity for trainees and junior faculty to conduct pilot studies and participate in major projects and publications related to COVID-19 and cancer, including studies through CCC19 of the impact of COVID-19 in patients with cancer the risk of thrombosis presented orally at ASH 2020 as well as a better understanding of racial and ethnic disparities among patients with breast cancer and COVID-19 to be presented orally at ASCO 2021.”

The Lyman Group has recently applied for NCI funding [OTA-21-015B: SARS-COV-2 Recovery Cohort Studies] for participation in the Post-Acute Sequelae of COVID-19 (PASC) Initiative along with other CCC19 institutions. If funded, this study will identify patients with cancer with distinct and measurable long-term symptoms and complications following acute SARS-CoV-2 infection. It is anticipated that SARS-CoV-2 infection will have a measurable effect on the long-term outcomes of patients with cancer. These changes are likely to result in delays in treatment, dose modifications, and alterations in cancer treatment after SARS-CoV-2 infection, with measurable changes on effectiveness and/or toxicity and potentially measurable changes in cancer recurrence and progression. In collaboration with the Center of International Blood and Marrow Transplantation Research and the BMT CTN, Hutch co-author Dr Joshua Hill is serving as local PI and national protocol co-chair of a collaborative prospective, observational study that aims to assess the safety and efficacy of the available SARS-CoV-2 vaccines in recipients of HCT or CAR-T therapy in the first year after therapy.

This research was supported by Fred Hutchinson Cancer Center

Fred Hutch/UW Cancer Consortium member Gary H. Lyman contributed to this work.

Kuderer NM, Hill JA, Carpenter PA, Lyman GH. Challenges and Opportunities for COVID-19 Vaccines in Patients with Cancer. Cancer Investigation. 2021 Mar 16;39(3):205-13 https://doi.org/10.1080/07357907.2021.1885596