COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials

Abstract

Emerging efficacy data have led to the emergency use authorization or approval of COVID-19 vaccines in several countries worldwide. Most trials of COVID-19 vaccines excluded patients with active malignancies, and thus data on the safety, tolerability and efficacy of the vaccines in patients with cancer are currently limited. Given the risk posed by the COVID-19 pandemic, decisions regarding the use of vaccines against COVID-19 in patients participating in trials of investigational anticancer therapies need to be addressed promptly. Patients should not have to choose between enrolling on oncology clinical trials and receiving a COVID-19 vaccine. Clinical trial sponsors, investigators and treating physicians need operational guidance on COVID-19 vaccination for patients with cancer who are currently enrolled or might seek to enrol in clinical trials. Considering the high morbidity and mortality from COVID-19 in patients with cancer, the benefits of vaccination are likely to far outweigh the risks of vaccine-related adverse events. Herein, we provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials. In our perspective, continued quality oncological care requires that patients with cancer, including those involved in trials, be prioritized for COVID-19 vaccination, which should not affect trial eligibility.

COVID-19 vaccines in patients with cancer

“… 7 High-priority groups should include patients with cancer and their close contacts (eg, non-professional carers). 10 The implementation of alternative vaccine schedules is not inconsequential and can often affect the efficacy of vaccines. 6 Similarly, adapting the schedules to account for the risk of severe outcomes from COVID-19, and the capacity of individuals to mount and maintain an immune response, is very important.…”

“… 6 Similarly, adapting the schedules to account for the risk of severe outcomes from COVID-19, and the capacity of individuals to mount and maintain an immune response, is very important. 7 , 10 Customising vaccination schedules could be one way to formulate more efficient health policies that are data driven.…”

Ad5-spike COVID-19 vaccine does not aggravate heart damage after ischemic injury

“…There has been an unprecedented rapid response by vaccine developers with now over 60 COVID-19 vaccine candidates in clinical trials and ten having been approved for at least limited use as of 1 March 2021. Although trials of the approved spike-based COVID-19 vaccines have not detected vaccinerelated serious adverse events, it should be noticed that safety of these vaccines were mostly evaluated in healthy volunteers, and little is known about their effects on patients with or at risk of chronic diseases [3][4][5].…”

Emerging issues related to COVID-19 vaccination in patients with cancer

“… Even though COVID-19 vaccines currently have an emergency use authorization rather than full authorization, the US FDA has clarified that patients on clinical trials may receive COVID-19 vaccines, and this will not be considered a protocol deviation in studies that disallow the concurrent use of investigational agents [ 54 ]. Optimal timing of the vaccination vis-à-vis the administration of anti-cancer therapy is an important clinical consideration; vaccines should ideally be administered at a time when the patient’s immune system is least perturbed by therapy; operational guidance is emerging [ 55 , 56 ]. Transient axillary lymphadenopathy has been reported following COVID-19 vaccination.…”