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Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Milan, ItalyDepartment of Oncology and Haematology (DIPO), University of Milan, Milan, Italy
Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Milan, ItalyDepartment of Oncology and Haematology (DIPO), University of Milan, Milan, Italy
Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Milan, ItalyDepartment of Oncology and Haematology (DIPO), University of Milan, Milan, Italy
Department of Oncology and Haematology (DIPO), University of Milan, Milan, ItalyApplied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan, Italy
Corresponding author: Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Via Ripamonti 435, 20141 Milan, Italy.
Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Milan, ItalyDepartment of Oncology and Haematology (DIPO), University of Milan, Milan, Italy
COVID-19 has affected more than 96 million people. WHO declared a pandemic in March 2020.
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Cancer patients as a group have been shown to be at a higher risk of severe COVID-19.
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Evidence from ongoing vaccine RCTs is currently lacking for cancer patients.
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Data extrapolation from other vaccines showed a favourable safety and efficacy profile.
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Cancer patients need vaccination prioritisation and tailored administration time-point.
Abstract
Coronavirus disease 2019 (COVID-19) has affected more than 96 million people worldwide, leading the World Health Organization (WHO) to declare a pandemic in March 2020. Although an optimal medical treatment of COVID-19 remains uncertain, an unprecedented global effort to develop an effective vaccine hopes to restore pre-pandemic conditions. Since cancer patients as a group have been shown to be at a higher risk of severe COVID-19, the development of safe and effective vaccines is crucial. However, cancer patients may be underrepresented in ongoing phase 3 randomised clinical trials investigating COVID-19 vaccines. Therefore, we encourage stakeholders to provide real-time data about the characteristics of recruited participants, including clearly identifiable subgroups, like cancer patients, with sample sizes large enough to determine safety and efficacy. Moreover, we envisage a prompt implementation of suitable registries for pharmacovigilance reporting, in order to monitor the effects of COVID-19 vaccines and immunisation rates in patients with cancer. That said, data extrapolation from other vaccine trials (e.g. anti-influenza virus) showed a favourable safety and efficacy profile for cancer patients. On the basis of the evidence discussed, we believe that the benefits of the vaccination outweigh the risks. Consequently, healthcare authorities should prioritise vaccinations for cancer patients, with the time-point of administration agreed on a case-by-case basis. In this regard, the American Society of Clinical Oncology and the European Society of Medical Oncology are advocating for cancer patients a high priority status, in the hope of attenuating the consequences of the pandemic in this particularly vulnerable population.
Since the first reports of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, coronavirus disease 2019 (COVID-19) has affected more than 96 million people worldwide, leading the World Health Organization (WHO) to claim a public health emergency in late January 2020 and a pandemic in March 2020 [
]. At present, an optimal medical treatment of COVID-19 remains uncertain. Besides oxygen therapy and positive pressure ventilation, glucocorticoids, dexamethasone in particular, showed a mortality benefit in patients requiring respiratory support, while this benefit was not clear among patients who did not require respiratory support [
]. Consistently, on 14th January 2021, the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial independent Data Monitoring Committee (DMC) closed recruitment to the convalescent plasma arm of the trial [
The RECOVERY trial chief investigators. "RECOVERY trial closes recruitment to convalescent plasma treatment for patients hospitalised with COVID-19". 14th January 2021. https://bit.ly/3sveWsu.
]. Finally, two monoclonal antibody therapies targeting SARS-CoV-2 (bamlanivimab and the combination casirivimab–imdevimab) have received emergency use authorisation from the Food and Drug Administration (FDA) for non-hospitalised patients who have mild to moderate COVID-19 and certain risk factors for severe disease on the basis of preliminary reports of randomised trials [
Patients living with breast cancer during the coronavirus pandemic: the role of family resilience, coping flexibility, and locus of control on affective responses.
Since the history of cancer seems to be related to higher mortality rates due to COVID-19, the development of safe and effective vaccines may be crucial for this group of patients [
]. Indeed, there are about 32 million cancer survivors worldwide, with almost 1.8 million new cancer cases projected to have occurred in the United States in 2020 [
]. Like other coronaviruses, SARS-CoV-2 has four structural proteins, namely the S (spike), E (envelope), M (membrane) and N (nucleocapsid) proteins (Fig. 1) [
]. The N protein holds the RNA genome, and the S, E and M proteins together form the viral envelope. The spike glycoprotein is responsible for allowing the virus to attach to and fuse with the membrane of a host cell. Specifically, its S1 subunit catalyses attachment and the S2 subunit enables fusion (not shown) [
Symptomatic SARS-CoV-2 infection can range from mild to critical, with mild disease (asymptomatic patient or mild pneumonia) accounting for ~80% of cases [
Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.
Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.
Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.
Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.
]. Pneumonia is the most common serious manifestation of the infection, characterised by cough, fever and dyspnoea, with bilateral infiltrates on chest imaging [
Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.
]. Humoral immune responses to SARS-CoV-2 are mediated by antibodies that are directed to viral surface glycoproteins, such as the spike glycoprotein receptor-binding domain (RBD) and the nucleocapsid protein [
3. Biological and clinical data about SARS-CoV-2 vaccine candidates
Because vaccines to prevent SARS-CoV-2 infection are considered the most promising approach for controlling the pandemic, an unprecedented effort was made since the beginning of 2020 in order to develop an effective vaccine strategy. As of 17th January 2021, 40 vaccine candidates are being tested for prevention of COVID-19 in phase I clinical trials, followed by 24 and 20 vaccine candidates investigated in phase 2 and 3 trials, respectively (Fig. 2) [
Fig. 2Principal mechanisms of action for COVID-19 vaccine candidates in late-phase clinical trials. These include live-attenuated or inactivated vaccines, replication-incompetent or -competent vector vaccines, recombinant protein subunits and nucleic acid-based vaccines [
]. To date, BNT162b2 (Comirnaty – Pfizer/BioNTech) and mRNA-1273 (Moderna) are the only vaccines authorised for Emergency Use by both the FDA and the European Medicines Agency (EMA). They are messenger ribonucleic acid (mRNA) vaccines delivered in a lipid nanoparticle to express a full-length spike protein. BNT162b2 and mRNA-1273 are given intramuscularly in two doses, 21 and 28 days apart, respectively. In phase III randomised controlled trials (RCTs), these vaccines showed 95% (BNT162b2, 95% confidence interval (CI), 90.3–97.6) and 94.1% efficacy (mRNA-1273, 95% CI, 89.3–96.8) in preventing symptomatic COVID-19 after the second dose [
]. On 31st December 2020, the WHO issued its first emergency use validation for Comirnaty, aiming to speed up authorisation in many countries. A summary of COVID-19 vaccine candidates approved or in phase III trials as of January 17, 2021 is provided in Table 1, with temporal milestones (Fig. 3).
Table 1COVID-19 vaccine candidates approved or in phase III trials as of January 17, 2021, with details about cancer patient eligibility.
Developer
Vaccine
Immune Features
Clinical Trial Identifier
Exclusion Criteria for Cancer Patients
Demographic Data (if available)
Moderna/NIAID
mRNA-1273 (lipid nanoparticle-mRNA)
Expressing S protein; two repeated IM doses 4 w apart. 94.1% efficacy for symptomatic COVID-19 at/after 14d following the II dose
NCT04470427 Ph 3 ongoing. Emergency authorisation by FDA and EMA.
People who have received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening.
30,420 volunteers. No cancer patients enumerated.
Pfizer/BioNTech
Comirnaty BNT162b2 (lipid nanoparticle-mRNA)
RBD of S protein; two repeated IM doses 3 w apart. 95% efficacy for symptomatic COVID-19 at/after day 7 following the II dose
NCT04368728 Ph 3 ongoing. Emergency authorisation by FDA and EMA. WHO Emergency Use Listing
People receiving immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g. for cancer.
43,548 volunteers. No cancer patients enumerated.
AstraZeneca/University of Oxford
ChAdOx1 nCov-19 (AZD-1222 or Covishield) (Non-replicating viral vector)
Expressing S protein; two repeated IM doses 4 w apart. 62.1% efficacy for symptomatic COVID-19 at/after 14d following the II dose (SD/SD). 90% efficacy for symptomatic COVID-19 at 14d following the II dose (LD/SD).
NCT04516746 NCT04540393 (COV002 and COV003) ISRCTN89951424 CTRI/2020/08/027170 Ph 3 ongoing.
History of primary malignancy except for malignancy with low potential risk for recurrence after curative treatment or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator.
23,848 volunteers No cancer patients enumerated.
CanSino Biologics
Ad5-nCoV/Convidecia (Non-replicating Adenovirus Type 5 Vector)
Expressing S protein; single IM dose.
NCT04526990 NCT04540419 Ph 3 ongoing. Limited emergency approval in China
People with current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
Malignancy within 1 year before screening, except squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or other malignancies with minimal risk of recurrence. Patients receiving CT, immune-modulating drugs or RT within 6 months before administration of vaccine and/or during the study.
(UK) Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator). (US) Active malignancy on therapy within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
CoVLP (plant-derived VLP adjuvanted with GSK or Dynavax adjs)
Two repeated IM doses, 3 w apart.
NCT04636697 Ph 3 ongoing.
Any confirmed or suspected immunosuppressive conditions, including cancer. Investigator discretion is permitted. People receiving cytotoxic, antineoplastic or immunosuppressants within 36 months prior to vaccination.
Chinese Academy of Medical Sciences/Anhui Zhifei Longcom
COVID-19 vaccine (protein subunit)
Two or three repeated IM doses, 1 month apart
NCT04466085 (ph 2) Ph 3 ongoing.
History of any malignant tumours.
n.a.
Wuhan Institute of Biological Products/Sinopharm
BBIBP-CorV (Vero Cell, Inactivated)
Multiple viral antigens; two repeated IM doses, 3 w apart
NCT04560881 NCT04612972 Ph 3 ongoing. Limited emergency approval in China and U.A.E
History of any malignant tumours.
n.a.
Beijing Institute of Biological Products/Sinopharm
BBIBP-CorV (Vero Cell, Inactivated)
Multiple viral antigens; two repeated IM doses, 3 w apart. 79.34% efficacy for symptomatic COVID-19 following the II dose
NCT04560881 NCT04510207 Ph 3 ongoing. Full approval in U.A.E and Bahrain. Limited emergency approval in China
History of any malignant tumours.
n.a.
Sinovac Biotech
CoronaVac (Inactivated)
Multiple viral antigens; two repeated IM doses, 2 w apart. 50.38% efficacy for symptomatic COVID-19 following the II dose
NCT04456595 (PROFISCOV) 669/UN6.KEP/EC/2020 NCT04582344 NCT04617483 Ph 3 ongoing. Limited emergency approval in China and Turkey
Use of CT or RT within 6 months prior to enrolment or planned use within the two years following enrolment. History of malignancy or antineoplastic CT, RT, immunosuppressants in the past 6 months.
Clover Biopharmaceuticals/The Coalition for Epidemic Preparedness
SCB-2019
AS03-adjuvanted recombinant trimeric S-protein; two repeated IM doses, 3 w apart
NCT04672395 Ph 3 ongoing.
Treatment with immunosuppressive therapy (cytotoxic agents, systemic corticosteroids) or planned receipt during the study period; history of malignancy within 1 year before screening
Research Institute for Biological Safety Problems (Kazakhstan)
QazCovid
Two repeated IM doses, 3 w apart
NCT04691908
History of any malignant tumours.
n.a.
Murdoch Children's Research Institute
BCG
BCG
NCT04327206 (BRACE) Ph 3 ongoing.
History of any malignant tumours.
n.a.
Abbreviations: FDA, Food and Drug Administration; EMA, European Medical Agency; WHO, World Health Organization; d, days; mRNA, messenger ribonucleic acid; IM, intramuscular; SD, standard dose; LD, low dose; RBD, receptor-binding domain; COVID, coronavirus disease; Abs, antibodies; w, weeks; Ad, Adenovirus; n.a., not applicable; S protein, Spike protein; NIAID, National Institute of Allergy and Infectious Diseases; UK, United Kingdom; US, United States; CT, chemotherapy; RT, radiotherapy; VLP, virus-like particles; adjs, adjuvants; GSK, GlaxoSmithKline; DMARDs: disease-modifying antirheumatic drug; ph, phase; BCG, Bacillus Calmette-Guérin, US, United States; EU, European Union; U.A.E, United Arab Emirates.
Fig. 3Temporal milestones in the development and approval of COVID-19 vaccine candidates as of January 17, 2021. Abbreviations: COVID, coronavirus disease; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; NIH, National Institutes of Health; mRNA, messenger ribonucleic acid; NEJM, New England Journal of Medicine; EUA, Emergency Use Authorisation; FDA, Food and Drug Administration; EMA, European Medicines Agency; WHO, World Health Organisation; US, United States; Uni of Oxford, University of Oxford; RCT, randomised controlled trial; UK, United Kingdom; CMA, conditional marketing authorisation; Nov, November; Dec, December; Mar, March; Jul, July; Aug, August; Oct, October; Jan, January.
In 2020, about 1.8 million new cancer cases are projected to have occurred in the United States, with an estimated 32 million cancer survivors worldwide [
]. Overall, active disease confers a significantly increased risk of severe COVID-19; similarly, haematological, lung malignancies and the presence of metastatic disease are associated with a persistently increased risk [
Risk factors for Coronavirus Disease 2019 (COVID-19) severity and mortality among solid cancer patients and impact of the disease on anticancer treatment: a French nationwide cohort study (GCO-002 CACOVID-19).
]. To appropriately assess COVID-19 outcomes in cancer patients, the COVID-19 and Cancer Consortium (CCC19) database collected data of patients from the USA, Canada and Spain with active or previous malignancy and a confirmed SARS-CoV-2 infection [
]. Another international effort, namely the Thoracic Cancers International COVID-19 Collaboration (TERAVOLT) registry, focused on outcomes of patients with thoracic malignancies developing COVID-19 [
]. Among 200 patients with a thoracic tumour and a confirmed or suspected diagnosis of COVID-19, 66 (33%) died, with few people (10%) ultimately admitted to an intensive care unit [
]. The high lethality of thoracic tumours, together with the possible exclusion from intensive care due to triage reasons, might have accounted for the high mortality observed [
Risk factors for Coronavirus Disease 2019 (COVID-19) severity and mortality among solid cancer patients and impact of the disease on anticancer treatment: a French nationwide cohort study (GCO-002 CACOVID-19).
]. A pooled analysis of 52 registries of cancer patients with COVID-19 identified a pooled case mortality rate of 25.6%, supporting the idea that oncological patients may be a particularly vulnerable population to SARS-CoV-2 infection [
]. Finally, a recent meta-analysis including sixteen studies highlighted that administering chemotherapy within the last thirty days before COVID-19 diagnosis may increase the risk of death in cancer patients (odds ratio: 1.85; 95% CI: 1.26–2.71) [
]. However, the higher severity of COVID-19 observed in patients with cancer is based on non-comparative retrospective studies, which may be potentially affected by unmeasured confounding and selection biases [
Garassino MC, Giesen N, Grivas P, Jordan K, Lucibello F, Mir O, et al.: ESMO Statements for Vaccination against COVID-19 in patients with cancer. https://bit.ly/3swNx9G. [Accessed 16 January 2020].
]. It should be noted that the majority of registries did not identify a detrimental effect of most cancer medical therapies, highlighting the importance of continuing treatment amidst a global healthcare emergency [
Risk factors for Coronavirus Disease 2019 (COVID-19) severity and mortality among solid cancer patients and impact of the disease on anticancer treatment: a French nationwide cohort study (GCO-002 CACOVID-19).
]. In fact, due to COVID-19 pandemic, cancer patients are experiencing significant delays in screening, diagnosis, treatment and surveillance, with consequent additional psychological distress [
]. As a consequence, an increased risk of cancer-related morbidity and mortality may occur, as well as major economic burden and a negative impact on clinical trials accrual [
5. Current evidence of SARS-CoV-2 vaccines in cancer patients
Since cancer patients as a group have been shown to be at a higher risk of severe COVID-19, the development of safe and effective COVID-19 vaccines may be crucial in this subpopulation [
], it is unknown whether an effective immunisation will be achieved in this subset of people. In this regard, data about how many individuals with history of cancer have been involved in all phase 3 vaccine RCTs are lacking [
]. Yet, eligibility of cancer patients can be deduced from inclusion and exclusion criteria of the trials, since some manufacturers made their full study protocols publicly available [
]. Most protocols excluded cancer patients on the basis of conditions that can be summarised in three categories (Table 1): (a) any prior history of cancer, (b) recent immunosuppressive therapies (e.g. chemotherapy, radiotherapy, immunomodulating agents and systemic immunosuppressants) and (c) immunodeficiency and lack of stable disease, at the discretion of the investigator [
]. So, people at higher risk, like cancer patients, who should be sensibly prioritised to receive an approved vaccine, may be underrepresented in ongoing phase 3 clinical trials [
]. We therefore encourage manufacturers and investigators to provide real-time data about the characteristics of recruited participants, preferably including clearly identifiable subgroups, like cancer patients, with sample sizes large enough to determine safety and efficacy in these categories [
]. Besides, we envisage a prompt implementation of suitable registries for pharmacovigilance reporting, in order to monitor the effects of COVID-19 vaccines and immunisation rates in patients with cancer.
6. A call to action for the administration of SARS-CoV-2 vaccines in cancer patients
Although evidence from RCTs is lacking, it is plausible that the safety and efficacy of vaccination against SARS-CoV-2 for cancer patients may be similar to those of patients without cancer, considering data extrapolation from other vaccines and the mechanism of action of most COVID-19 vaccines [
]. For example, considering anti-influenza vaccination, seroconversion and seroprotection appear to be lower in patients receiving chemotherapy than in the general population, but not in patients receiving single-agent immune checkpoint inhibitors (ICI) [
]. However, good tolerability and safety of anti-influenza vaccination in patients with cancer receiving ICI as well as in patients on cytotoxic therapy or targeted agents are suggested by retrospective evidence [
Immunogenicity and safety of the influenza A H1N1v 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study.
]. So, although enrolment of cancer patients in COVID-19 vaccination trials is limited, enough evidence supports anti-infective vaccination in general (except live-attenuated vaccines and replication-competent vector vaccines), even in patients under immunosuppressive therapy [
Anti-infective vaccination strategies in patients with hematologic malignancies or solid tumors-guideline of the infectious diseases working party (AGIHO) of the German Society for hematology and medical oncology (DGHO).
]. Therefore, we strongly encourage the healthcare authorities to prioritise vaccinations for cancer patients, even with active disease or receiving anticancer treatment. The time-point for vaccination should be discussed on a case-by-case basis (Table 2) [
]. Alternatively, patients can be immunised about a week after the start of a chemotherapy cycle, according to limited data from patients with solid tumours receiving chemotherapy, in whom immunisation on day 4–5 of a cycle resulted more immunogenic than on day 16 [
]. In the case of allogeneic stem cell transplantation or cellular therapy, the vaccine should be administered around 3–6 months after the procedure, in the absence of graft-versus-host disease (Table 2) [
Garassino MC, Giesen N, Grivas P, Jordan K, Lucibello F, Mir O, et al.: ESMO Statements for Vaccination against COVID-19 in patients with cancer. https://bit.ly/3swNx9G. [Accessed 16 January 2020].
Preliminary Recommendations of the NCCN COVID-19 vaccination advisory committee. Version 1.0 1/22/2021. https://bit.ly/3qN6uTD. [Accessed 22 January 2021].
Preliminary Recommendations of the NCCN COVID-19 vaccination advisory committee. Version 1.0 1/22/2021. https://bit.ly/3qN6uTD. [Accessed 22 January 2021].
COVID-19 vaccines should be prioritised over other vaccines, since data on dual vaccination is not yet available. NCCN recommends at least 14 days between COVID-19 vaccines and other approved vaccines.
Granulocytopenia does not significantly affect immunologic response to vaccination, thus it is not used for timing of vaccination in people with solid tumours, due to its short duration. Conversely, in the setting of profound immunosuppression for patients with haematologic malignancies, neutropenia is a surrogate marker for the recovery of immunocompetence to respond to vaccines.
In order to allow for the correct attribution of perioperative symptoms (surgery versus vaccination). For surgeries inducing immunosuppression (e.g. complex surgeries and splenectomy), a wider window (e.g. 2 weeks) may be recommended.
GvHD and immunosuppressive regimens to treat GvHD can weaken immune responses to vaccination. Delay of vaccination until immunosuppressive therapy is reduced or based on immunophenotyping of T cell and B cell immunity can be considered. Patients on maintenance therapies (e.g. rituximab, Bruton tyrosine kinase inhibitors and Janus kinase inhibitors), may have attenuated response to vaccination.
Autologous transplantation
Cellular therapy (e.g. CAR-T cell)
Haematologic malignancies
Receiving intensive cytotoxic chemotherapy (e.g. cytarabine/anthracycline-based induction regimens for AML)
Granulocytopenia does not significantly affect immunologic response to vaccination, thus it is not used for timing of vaccination in people with solid tumours, due to its short duration. Conversely, in the setting of profound immunosuppression for patients with haematologic malignancies, neutropenia is a surrogate marker for the recovery of immunocompetence to respond to vaccines.
Marrow failure from disease and/or therapy expected to have limited or no recovery
When vaccine available
Long-term maintenance therapy (e.g. targeted agents for chronic lymphocytic leukaemia or myeloproliferative neoplasms)
Granulocytopenia does not significantly affect immunologic response to vaccination, thus it is not used for timing of vaccination in people with solid tumours, due to its short duration. Conversely, in the setting of profound immunosuppression for patients with haematologic malignancies, neutropenia is a surrogate marker for the recovery of immunocompetence to respond to vaccines.
Patients enrolled in clinical trials
Patients receiving experimental cancer drugs or combinations
When vaccine available, after discussing each case with the trial sponsor
a Granulocytopenia does not significantly affect immunologic response to vaccination, thus it is not used for timing of vaccination in people with solid tumours, due to its short duration. Conversely, in the setting of profound immunosuppression for patients with haematologic malignancies, neutropenia is a surrogate marker for the recovery of immunocompetence to respond to vaccines.
b Limited data available and consider the variability of specific chemotherapy regimens and intervals between cycles.
c While there are no solid data on the timing of vaccine administration in this setting, the risk of exacerbated irAEs should be taken into account.
d In order to allow for the correct attribution of perioperative symptoms (surgery versus vaccination). For surgeries inducing immunosuppression (e.g. complex surgeries and splenectomy), a wider window (e.g. 2 weeks) may be recommended.
e GvHD and immunosuppressive regimens to treat GvHD can weaken immune responses to vaccination. Delay of vaccination until immunosuppressive therapy is reduced or based on immunophenotyping of T cell and B cell immunity can be considered. Patients on maintenance therapies (e.g. rituximab, Bruton tyrosine kinase inhibitors and Janus kinase inhibitors), may have attenuated response to vaccination.
f COVID-19 vaccines should be prioritised over other vaccines, since data on dual vaccination is not yet available. NCCN recommends at least 14 days between COVID-19 vaccines and other approved vaccines.
]. Finally, patients enrolled in clinical trials with experimental cancer drugs or combinations should not be arbitrarily deprived of COVID-19 vaccination [
Garassino MC, Giesen N, Grivas P, Jordan K, Lucibello F, Mir O, et al.: ESMO Statements for Vaccination against COVID-19 in patients with cancer. https://bit.ly/3swNx9G. [Accessed 16 January 2020].
]; therefore, we invite clinical trial sponsors and investigators to allow for concurrent COVID-19 vaccines. Concurrently, psychological interventions could be useful to promote vaccinations and overcome possible vaccine hesitancy in the general and oncological populations [
As vaccination plans have been published worldwide in order to prioritise vaccine administration in different populations, the WHO considers the healthcare professionals and the elderly as first priorities, putting cancer patients in phase 2 [
WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination, 14 September 2020. World Health Organization. https://bit.ly/35NPC7m. License: CC BY-NC-SA 3.0 IGO.
]. On the basis of the evidence discussed, we strongly believe that healthcare authorities should prioritise vaccinations for cancer patients in current vaccination priority policies, even for those with active disease or receiving anticancer treatment, with time-point of administration agreed on a case-by-case basis [
Garassino MC, Giesen N, Grivas P, Jordan K, Lucibello F, Mir O, et al.: ESMO Statements for Vaccination against COVID-19 in patients with cancer. https://bit.ly/3swNx9G. [Accessed 16 January 2020].
]. In this regard, the American Society of Clinical Oncology (ASCO) and the European Society of Medical Oncology (ESMO) are advocating for cancer patients a high priority status, in hope of attenuating the consequences of the pandemic in this particularly vulnerable population and in line with the WHO principles of reducing deaths and disease burden worldwide.
Funding
This work did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: CC, EC, PT and GP have no potential conflicts of interest to disclose. AMME served as consultant or advisor for Ellipses Pharma, GlaxoSmithKline, ISA Pharmaceuticals, MSD, Novartis, Pfizer, Sellas Life Sciences, Skyline Diagnostics, BioInvent, IO Biotech, CatalYm and Nektar, served on the speaker's bureau for MSD, BIOCAD, received travel funding from Bristol Myers Squibb and received honoraria from Ellipses Pharma, GlaxoSmithKline, ISA Pharmaceuticals, MSD, Novartis, Pfizer, Sellas Life Sciences, Skyline Diagnostics, BIOCAD, CatalYm, BioInvent, IO Biotech, Nektar, provided expert testimony for Novartis and has stock and other ownership interest with RiverD, Skyline Diagnostics, Theranovir, all outside the submitted work. SD served as consultant or advisor for AstraZeneca, received research funding from AstraZeneca (Inst), Pfizer (Inst), Roche/Genentech (Inst), Puma (Inst), Eli Lilly (Inst), Novartis (Inst), Sanofi (Inst) and received travel funding from Pfizer, AstraZeneca and Roche. GC served as consultant or advisor for Roche, Lilly and Bristol-Myers Squibb, served on the speaker's bureau for Roche, Pfizer and Lilly, received travel funding from Pfizer and Roche and received honoraria from Roche, Pfizer, Lilly, Novartis and SEAGEN, all outside the submitted work.
Acknowledgements
CC contributed to the literature search, conception and design of the article and drafted the first version of the manuscript. EC, PT and GP contributed to the literature search, design of the article and provided critical revisions of the manuscript. AMME and SD provided critical revisions of the manuscript. GC contributed to conception and design of the article and provided critical revisions of the manuscript. All the authors provided final approval to the submitted work.
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Patients living with breast cancer during the coronavirus pandemic: the role of family resilience, coping flexibility, and locus of control on affective responses.
Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.
Risk factors for Coronavirus Disease 2019 (COVID-19) severity and mortality among solid cancer patients and impact of the disease on anticancer treatment: a French nationwide cohort study (GCO-002 CACOVID-19).
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Anti-infective vaccination strategies in patients with hematologic malignancies or solid tumors-guideline of the infectious diseases working party (AGIHO) of the German Society for hematology and medical oncology (DGHO).
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