While the European Union (EU) is getting ready to start the COVID-19 vaccination campaign by the end of the year after the European Medical Agency (EMA)’s approval of a number of vaccines targeting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), ESMO has released today ten statements to address issues and concerns on immunising patients with cancer.
By reviewing the current knowledge, a group of 16 ESMO representatives authored and reviewed answers to key questions on the efficacy and safety of COVID-19 vaccines, their interaction with antineoplastic therapies, the immune response to vaccination in cancer patients and the prioritisation for the vaccine distribution planning.
ESMO states as follows:
1. Effective and safe vaccines against COVID-19, authorised after thorough, independent and robust scientific review by regulatory authorities, should be administered in the context of operationally sound vaccination programmes [V]. A pharmacovigilance plan is mandatory in the context of the vaccination programme.
2. Continued research in the context of clinical trials and registries as well as in-trial and post-trial follow-up is advised in order to generate more data on vaccine efficacy and safety in the general population as well as in special populations, including patients with active cancer or history of cancer [V].
3. Patients with cancer have an increased risk of severe COVID-19 (i.e. haematological malignancy requiring chemotherapy or active, advanced solid tumour or history of solid tumour <5 years ago) and should be vaccinated against SARS-CoV-2 regardless of any other indications (i.e. age) and positioned at high prioritisation [V]. Patients who have received B cell depletion in the past 6 months may derive reduced protection. The time-point for vaccination after allogeneic stem cell transplantation should follow general recommendations – usually, in the absence of graft-versus-host disease (GvHD), the vaccine can be applied 6 months post stem cell transplantation [V]. Patients in clinical trials, e.g. immunotherapy, should not be deprived of COVID-19 vaccination, therefore, efforts should be placed for clinical trial protocols to allow concurrent COVID-19 vaccines.
4. Healthcare workers caring for patients with cancer with increased risk should be prioritised in receiving vaccination to minimise nosocomial transmission [III].
5. The efficacy and duration of immunity in patients with cancer are still unknown and unexplored. Given the often-immune compromised status and the frailty of these patients, we suggest monitoring in the context of registries and dedicated clinical trials [V].
6. Close surveillance and monitoring of patients with cancer is required after COVID-19 vaccination to assess potential adverse events and measure clinical outcomes, e.g. infection, severity and mortality from COVID-19, complications from cancer, etc. [V].
7. Physical distancing measures, masks, face shields, sanitizers and other hygiene measures are still required during the pandemic, including for patients with cancer, and should certainly accompany the vaccination strategies [V].
8. Accumulated evidence from influenza vaccinations suggests that patients with cancer are able to mount a protective immune response from anti-SARS-CoV-2 vaccines, though the level of immunity may be modulated by a range of factors (type of malignancy, antineoplastic therapies and timing of administration, pre-existing immune dysfunction, fitness) [V]. Data on the interaction of such factors with vaccine-induced immunity in patients with cancer are needed.
9. Although no obvious safety concerns are evident, there is a clear need to generate data on preference of vaccine technology and interaction of SARS-CoV-2 vaccines with antineoplastic therapies in patients with cancer, potentially impacting on efficacy, dosing or toxicity, via in-trial, post-trial and registry monitoring [V].
10. While acknowledging the need to generate data in the context of trials or registries, in order to refine the risk/benefit profile and prioritise subgroups of patients with cancer for anti-SARS-CoV-2 vaccination, we propose a four-step process [V]:
- Step 1: Consider the phase of malignant disease and therapy: active cancer on treatment, chronic disease after treatment or survivorship.
- Step 2: Consider age, fitness/performance status and medical comorbidities as general risk factors; specifically, obesity, diabetes mellitus, hypertension, respiratory, cardiac and renal disorders.
- Step 3: Consider vaccine-related interactions on the tumour and on the treatment efficacy.
- Step 4: Secure informed consent and improve shared decision making.
All statements are accompanied by proper evidence level (I to V).
The statements are the first of a series of resources ESMO is producing on COVID-19 vaccination for cancer patients to help medical oncologists to stay up to date with this rapidly changing scenario.