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ESMO Statements for vaccination against COVID-19 in patients with cancer

COVID-19 vaccination in cancer patients: ESMO statements

ESMO has released ten statements to address issues and concerns on immunising patients with cancer against COVID-19.

By reviewing the current knowledge available, a group of 16 ESMO representatives authored and reviewed answers to key questions on the efficacy and safety of vaccines targeting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The World Health Organization (WHO) currently counts 214 research projects for the development of a vaccine conferring protective immunity against the SARS-CoV-2 virus, among which 52 are in clinical development. New technologies, previous experience with vaccine projects against related viruses and the presence of a pandemic health hazard accelerated the usual development cycle from years to months. Presentation of SARS-CoV-2 antigens to the host, in the context of vaccine development, relied on technologies based on messenger RNA (mRNA), inactivated/attenuated or genetically modified viruses, synthetic long viral peptides and plasmid DNA vaccines. Two vaccines have been approved by some regulators, including one which has been approved by the European Medicines Agency (EMA) on 21 December 2021, and a third is expected to do so soon.  Many more vaccines are being tested in placebo-controlled Phase III studies for efficacy and safety in a total of more than 100,000 participants. 

Specifically, one large trial on a novel mRNA-based vaccine against SARS-CoV-2 infection (BNT162b2) has been published. This is a Phase III trial which included 43,448 participants who received two doses of the vaccine or placebo (1:1 randomisation), 21 days apart. The primary endpoint was the efficacy of the vaccine in reducing the cases with laboratory-confirmed COVID-19 with onset at least 7 days after the second dose. After a median follow-up of 2 months, the number of COVID-19 cases was 8 versus 162 in the vaccine or placebo arm, respectively, with 1 versus 9 severe cases. Adverse events occurred in >50% of vaccinated participants and included local reactions as well as frequent systemic reactogenicity such as fatigue and headache. Fever (temperature >38°C) occurred in approximately 15% of participants who received the vaccine. Altogether, 6 participants died (2 in the vaccine arm and 4 in the placebo arm), all of them from unrelated causes. Approximately 3% of participants suffered from some form of malignant disease. Another Phase III trial investigating another mRNA-vaccine (mRNA-1273) with >30,000 participants will soon be published. Preliminary reports suggest a similar efficacy and safety profile as for BNT162b2.

The safety and efficacy of the ChAdOx1 nCoV-19 adenoviral vector-based vaccine was recently published in a pooled interim analysis of four trials that randomised 23,848 participants to two doses of the vaccine or placebo; a subset of 2741 patients in the UK trial received a half dose as their first dose (low dose, LD) and a standard dose (SD) as their second dose (LD/SD cohort). In participants who received two standard doses, vaccine efficacy was 62.1% (27 COVID-19 events in the ChAdOx1 nCoV-19 group versus 71 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90.0% (three versus 30 disease events). Overall vaccine efficacy across both groups was 70.4%. From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. In total, 175 severe adverse events occurred in 168 participants; 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine.

A large array of other vaccine candidates against SARS-CoV-2 are currently under investigation applying various techniques such as mRNA-, protein subunit-, viral vector- or inactivated vaccines. 

Overall mRNA-based vaccines have shown >90% protection from COVID-19 disease with good tolerance, whereas a non-replicating adenoviral vector-based vaccine has shown protection rates of 62%-90% conferred by different dosing regimens. Storage requirements and number of doses differ between vaccines and operational practicalities related to transport, administration, recording and follow-up of vaccinated people, pharmacovigilance are pivotal for the successful roll-out of vaccination programmes and their optimal impact on public health. Additional questions exist that necessitate generation of data, including long-term safety, duration of immunity, protective immunity against mild as opposed to severe cases of infection as well as immunity in the elderly, vaccine impact on contagious potential of vaccinated people and repeat vaccination intervals. Specifically, for patients with cancer or a history of cancer, such strategies will provide more insights on vaccine activity, optimal dose and frequency, safety, potential for interaction with malignant disease, antineoplastic therapies or other comorbidities. Consequently, prospective observational studies focusing on patients with active cancer receiving chemotherapy, targeted therapy or immunotherapy, as well as in patients in the chronic phase of disease or in the survivorship phase are warranted and may lead to interventional clinical trials, if needed.

Statements:

  • 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. 
  • 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].
Selected references:

Draft landscape of COVID-19 candidate vaccines(19th December 2020, date last accessed).

Dong Y, Dai T, Wei Y et al. A systematic review of SARS-CoV-2 vaccine candidates. Sig Transduct Target Ther 2020; 5:237. doi: 10.1038/s41392-020-00352-y

Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 Covid-19 vaccine. N Engl J Med 2020; Online ahead of print. doi: 10.1056/NEJMoa2034577

Jackson LA, Anderson EJ, Rouphael NJ, et al. An mRNA Vaccine against SARS-CoV-2 — Preliminary Report. N Engl J Med 2020; 383:1920-1931.  doi: 10.1056/NEJMoa2022483

Voysey M, Clemens SAC, Madhi SA, et al; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2020; Online ahead of print. doi: 10.1016/S0140-6736(20)32661-1

Rubin EJ, Longo DL. SARS-CoV-2 Vaccination — An Ounce (Actually, Much Less) of Prevention. N Engl J Med 2020; Online ahead of print. doi: 10.1056/NEJMe2034717 Treatments and vaccines for COVID-19 | European Medicines Agency (19th December 2020, date last accessed).

Patients with cancer as a group have been shown to be at higher risk of severe COVID-19 [1]. Among patients with cancer, it seems that haematological and lung malignancies and the presence of metastatic disease are associated with a persistently increased risk. Patients with solid tumours appear to suffer an increased risk, particularly in the first year after diagnosis which drops to baseline if diagnosis is >5 years ago [2]. For any malignancy, active disease confers a significantly increased risk of severe COVID-19 [IV] [3, 4]. However, the higher incidence and severity of COVID-19 in patients with cancer, as opposed to those without cancer, are observations based on non-comparative retrospective studies. Data on the true incidence and direct comparisons remain elusive. Most studies do not have the full denominator to calculate the true incidence [IV].

Severity and mortality rates from the COVID-19 and Cancer Consortium (CCC19) registry and other cohorts have ranged from 5% to 61% (meta-analysis showed 26%) which is much higher than in the overall population (~2%-3%), but this is with caveats of unadjusted rates, while the cancer population is an older population with more comorbidities, poorer performance status, and many unmeasured confounding and selection biases [IV].

SARS-Cov-2 infection may also result in significant and devastating delays in screening, diagnosis, treatment and monitoring/surveillance strategies in patients with cancer which can ultimately cause an increased risk of cancer-related morbidity and mortality, as well as major economic burden and high patient volumes needing care in the healthcare systems. Moreover, the impact on clinical trials accrual appears to be very significant and detrimental, although it is hard to measure [V].

Although evidence regarding vaccination in patients with cancer is limited, there is enough evidence to support anti-infective vaccination in general (excluding live-attenuated vaccines and replication-competent vector vaccines) even in patients with cancer undergoing immunosuppressive therapy [5-7]. Reduced protective effects may occur in patients treated with B cell-depleting agents (anti-CD19, anti-CD20, anti-CD10 monoclonal antibodies and CD19 CAR-T cells) in view of suboptimal immune response [8-12]. The level of efficacy may be expected to be generally reduced in certain populations of cancer patients with intense immunosuppression, such as recipients of haematopoietic stem cell transplantation [V] [5-7]. However, based on data extrapolation from other vaccines and the mechanism of action of the COVID-19 vaccines (not live), it is conceivable that the efficacy and safety of vaccination against COVID-19 may be estimated to be similar to that of patients without cancer, although data from clinical trials are lacking [V]. Beyond stem cell transplantation, the efficacy of COVID-19 vaccines can also vary in patients with distinct contexts of malignant disease (tumour type, disease extent, intrinsic or therapy-induced immunosuppression); however, the benefits of vaccination seem to significantly and substantially outweigh the risks [V].

The timing of vaccination depends on individual therapy scenarios and may ideally occur before systemic therapy starts; however, if the patient has already started systemic therapy, it is reasonable to vaccinate during therapy [V].

Vaccinating healthcare staff against influenza has been shown to reduce nosocomial transmission of the infection in cancer care [13]. Furthermore, certain immunocompromised cancer patients might not achieve a sufficient immune response to vaccination. This provides a rationale for vaccinating healthcare staff who work in a high-risk setting against COVID-19 as well [Evidence III for influenza]

Statements:

  • 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 made for clinical trial protocols to allow concurrent COGID-19 vaccines.
  • Healthcare workers caring for patients with cancer with increased risk should be prioritised in receiving vaccination to minimise nosocomial transmission [III].
  • 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].
  • 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].
  • 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].
References:
  1. Rüthrich MM, Giessen-Jung C, Borgmann S, et al. COVID-19 in cancer patients: clinical characteristics and outcome-an analysis of the LEOSS registry. Ann Hematol 2020; Online ahead of print. doi: 10.1007/s00277-020-04328-4
  2. Williamson EJ, Walker AJ, Bhaskaran K, et al. Factors associated with COVID-19-related death using OpenSAFELY. Nature 2020; 584:430-436.
  3. Kuderer NM, Choueiri TK, Shah DP, et al. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet 2020; 395:1907-1918.
  4. Martín-Moro F, Marquet J, Piris M, et al. Survival study of hospitalised patients with concurrent COVID-19 and haematological malignancies. Br J Haematol 2020; 190:e16-e20.
  5. Cordonnier C, Einarsdottir S, Cesaro S, et al. Vaccination of haemopoietic stem cell transplant recipients: guidelines of the 2017 European Conference on Infections in Leukaemia (ECIL 7). Lancet Infect Dis 2019; 19:e200-e212.
  6. Mikulska M, Cesaro S, de Lavallade H, et al. Vaccination of patients with haematological malignancies who did not have transplantations: guidelines from the 2017 European Conference on Infections in Leukaemia (ECIL 7). Lancet Infect Dis 2019; 19:e188-e199.
  7. Rieger CT, Liss B, Mellinghoff S, et al. 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). Ann Oncol 2018; 29:1354-1365.
  8. Bedognetti D, Ansaldi F, Zanardi E, et al. Seasonal and pandemic (A/H1N1 2009) MF-59-adjuvanted influenza vaccines in complete remission non-Hodgkin lymphoma patients previously treated with rituximab containing regimens. Blood 2012; 120:1954-1957.
  9. Bedognetti D, Zoppoli G, Massucco C, et al. Impaired response to influenza vaccine associated with persistent memory B cell depletion in non-Hodgkin's lymphoma patients treated with rituximab-containing regimens. J Immunol 2011; 186:6044-6055.
  10. Berglund A, Willén L, Grödeberg L, et al. The response to vaccination against influenza A(H1N1) 2009, seasonal influenza and Streptococcus pneumoniae in adult outpatients with ongoing treatment for cancer with and without rituximab. Acta Oncol 2014; 53:1212-1220.
  11. van Assen S, Holvast A, Benne CA, et al. Humoral responses after influenza vaccination are severely reduced in patients with rheumatoid arthritis treated with rituximab. Arthritis Rheum 2010; 62: 75-81.
  12. Yri OE, Torfoss D, Hungnes O, et al. Rituximab blocks protective serologic response to influenza A (H1N1) 2009 vaccination in lymphoma patients during or within 6 months after treatment. Blood 2011; 118:6769-6771.
  13. Frenzel E, Chemaly RF, Ariza-Heredia E, et al. Association of increased influenza vaccination in health care workers with a reduction in nosocomial influenza infections in cancer patients. Am J Infect Control 2016; 44:1016-1021.

Data on humoral and cellular immune response to antiviral vaccination in cancer patients are scarce, and mostly address the issue of influenza vaccination [1,2]. Observational clinical studies indicate that lower mortality and morbidity rates from influenza are observed in cancer patients receiving influenza vaccination [II] [3], suggesting an efficient immune response.

In lung and breast cancer patients, the humoral immune response to vaccination appears adequate, although not all patients were receiving chemotherapy [IV] [4,5]. In a study of patients with various solid tumours, the response to vaccination was better than in patients with lymphoma [IV] [6].

In patients receiving chemotherapy, seroconversion and seroprotection rates are expected to be lower than in the general population [IV] [7], but not in patients receiving single-agent immune checkpoint inhibitors targeting programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) [IV] [8].

In patients receiving chemotherapy, multiple doses of vaccine might help to reach adequate seroconversion and seroprotective rates. As an illustration, in a non-randomised Phase II study on 65 patients with solid tumours receiving chemotherapy (+/- molecular targeted agents) during the 2009 influenza season, 5% of patients had vaccine strain titres of specific haemagglutination inhibition antibodies that were ≥1:40 at baseline. After one and two doses of AS03A-adjuvanted H1N1v vaccine, seroprotection rates (i.e. the proportion of participants with antibody titres ≥1:40) were 48% and 73%, respectively, and seroconversion rates were 44% and 73%, respectively [III] [9].

Whenever possible, the administration of the vaccine should be performed before initiation of chemotherapy [V] [2]. In patients who have already initiated chemotherapy, the existing data do not support a specific timing of administration with respect to chemotherapy infusions [III] [2, 9].

In order to generate protective immunity following vaccination, intact host immunity is needed, particularly with respect to antigen presentation, B- and T-cell activation. In this context, vaccination may be less effective in patients receiving anti–B-cell antibodies or intensive chemotherapy (e. g. induction or consolidation chemotherapy for acute leukaemia) because the antibody response may be low, due to B-cell depletion, though the role and potential protective effect of T-cell immunity has not been studied extensively [V] [2].

The level of evidence is weak, due to the small number of studies and their methodology; placebo-controlled randomised controlled trials of antiviral vaccination among adults with cancer being often considered ethically questionable [V] [2].

Statement:

  • 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.
References
  1. Ward EM, Flowers CR, Gansler T, et al. The importance of immunization in cancer prevention, treatment, and survivorship. CA Cancer J Clin 2017; 67:398-410.
  2. Rubin LG, Levin MJ, Ljungman P, et al; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014; 58:309-318.
  3. Bitterman R, Eliakim-Raz N, Vinograd I, et al. Influenza vaccines in immunosuppressed adults with cancer. Cochrane Database Syst Rev 2018; 2: CD008983.
  4. Anderson H, Petrie K, Berrisford C, et al. Seroconversion after influenza vaccination in patients with lung cancer. Br J Cancer 1999; 80:219-220.
  5. Brydak LB, Guzy J, Starzyk J, et al. Humoral immune response after vaccination against influenza in patients with breast cancer. Support Care Cancer 2001; 9:65-68.
  6. Nordøy T, Aaberge IS, Husebekk A, et al. Cancer patients undergoing chemotherapy show adequate serological response to vaccinations against influenza virus and Streptococcus pneumoniae. Med Oncol 2002; 19:71-78.
  7. Loulergue P, Alexandre J, Iurisci I, et al. Low immunogenicity of seasonal trivalent influenza vaccine among patients receiving docetaxel for a solid tumour: results of a prospective pilot study. Br J Cancer 2011; 104:1670-1674.
  8. Bayle A, Khettab M, Lucibello F, et al. Immunogenicity and safety of influenza vaccination in cancer patients receiving checkpoint inhibitors targeting PD-1 or PD-L1. Ann Oncol 2020; 31:959-961.
  9. Rousseau B, Loulergue P, Mir O, et al. Immunogenicity and safety of the influenza A H1N1v 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study. Ann Oncol 2012; 23:450-457.

No SARS-CoV-2 vaccine trial is enrolling patients receiving immunosuppressive therapy, though data from some patients with cancer have been accrued. Most trials require patients to be off immunosuppression for a certain period in order to be eligible for vaccination.

Currently developed SARS-CoV-2 vaccines are either live attenuated/non-replicating vaccines (using vectors as adenovirus or measles virus), mRNA-based vaccines or more conventional protein subunit vaccines [1].

Live vaccines are, in general, contraindicated in patients under immunosuppressive therapy [V] [2,3]. Indeed, serious adverse events are possible, as was shown with BCG (Bacillus Calmette–Guérin) [3]. One of the anti-SARS-CoV-2 live virus vaccines developed utilised a replication-deficient simian adenoviral vector (ChAdOx1).

There are no published data on the immunogenicity and interaction of mRNA-based antiviral vaccines with antineoplastic therapies in cancer patients. Some of these vaccines are encapsulated in small liposomes, vectors that are expected to accumulate in tumour tissues. An increased uptake of these liposomes in tumour tissues is theoretically possible and might impact the immunogenicity of such vaccines [V] [4]. Otherwise, mRNA-based vaccines against non-communicable diseases (e.g. melanoma) have been tested in cancer patients for the past 10 years, without raising specific safety concerns [5]. Retrospective datasets suggest good tolerability and safety of influenza vaccination in patients with cancer receiving immune checkpoint inhibitors [6-8], as well as in patients on cytotoxic therapy or targeted agents [9, 10].

Finally, regarding protein subunit vaccines, there is no conclusive evidence regarding the use of adjuvanted versus non-adjuvanted inactivated influenza vaccines in cancer patients [II] [11].

Statement:

  • 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].
References
  1. Brisse M, Vrba SM, Kirk N, et al. Emerging Concepts and Technologies in Vaccine Development. Front Immunol 2020; 11:583077.
  2. Rubin LG, Levin MJ, Ljungman P, et al; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014; 58:309-318.
  3. Lopez A, Mariette X, Bachelez H, et al. Vaccination recommendations for the adult immunosuppressed patient: A systematic review and comprehensive field synopsis. J Autoimmun 2017; 80:10-27.
  4. Fanciullino R, Ciccolini J, Milano G. COVID-19 vaccine race: watch your step for cancer patients. Br J Cancer 2020; Online ahead of print. doi: 10.1038/s41416-020-01219-3
  5. Weide B, Carralot JP, Reese A, et al. Results of the first phase I/II clinical vaccination trial with direct injection of mRNA. J Immunother 2008; 31:180-188.
  6. Failing JJ, Ho TP, Yadav S, et al. Safety of influenza vaccine in patients with cancer receiving pembrolizumab. JCO Oncol Pract 2020; 16:e573-e580. doi: 10.1200/JOP.19.00495
  7. Chong CR, Park VJ, Cohen B, et al. Safety of inactivated influenza vaccine in cancer patients receiving immune checkpoint inhibitors. Clin Infect Dis 2020; 70:193-199. doi: 10.1093/cid/ciz202
  8. Wijn DH, Groeneveld GH, Vollaard AM, et al. Influenza vaccination in patients with lung cancer receiving anti-programmed death receptor 1 immunotherapy does not induce immune-related adverse events. Eur J Cancer 2018; 104:182-187. doi: 10.1016/j.ejca.2018.09.012
  9. Bayle A, Khettab M, Lucibello F, et al. Immunogenicity and safety of influenza vaccination in cancer patients receiving checkpoint inhibitors targeting PD-1 or PD-L1. Ann Oncol 2020; 31:959-961.
  10. Rousseau B, Loulergue P, Mir O, et al. Immunogenicity and safety of the influenza A H1N1v 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study. Ann Oncol 2012; 23:450-457.
  11. Bitterman R, Eliakim-Raz N, Vinograd I, et al. Influenza vaccines in immunosuppressed adults with cancer. Cochrane Database Syst Rev 2018; 2: CD008983.

Vaccination strategies have been published worldwide, in order to prioritise vaccine administration in the different populations [1]. The World Health Organization (WHO) considers the elderly and healthcare professionals as first priorities (respectively phases 1b and 1a), and cancer patients are positioned in phase 2 [2, 3]. In the United States (US), professionals are considered priorities (1a), followed by cancer patients and the elderly ≥65 years old (1b) [4]. In Australia, professionals, those with comorbidities such as cancer and the elderly are the first priority for vaccination against COVID-19 [5]. In Europe, the UK and France base their recommendation priorities on age before comorbidities such as cancer [6, 7]. Belgium, Luxembourg and Sweden will vaccinate in priority cancer patients and healthcare professionals [8-10]. In a German joint position paper “persons (groups of persons) who have a significantly increased risk of serious or fatal disease progression due to their age or underlying medical condition” are prioritised [11]. However, patients with cancer do not represent a homogeneous population.

In general, cancer disease reveals three aspects of pathways: patients with active disease on treatment, those with chronic disease after specific treatment and patients in the survivorship phase. In the “survivorship” phase, previous studies revealed a higher risk of complications related to influenza in cancer patients compared to a cancer-free control cohort, specifically in haematological cancer survivors [12]. Consequently, vaccination seems essential to protect survivors along with patients in the chronic phase of their cancer without active treatment [V]. The question is more uneasy in patients with active disease on anticancer therapy for whom vaccination could have reduced efficacy or adverse events. Additionally, there are no granular data that dissect the vaccine role in protection from COVID-19, protection from SARS-CoV-2 infection (at the mucosal level) and protection from SARS-CoV-2 transmission in patients with cancer.

Acceptability of COVID-19 vaccination has reached 69% among adults in the US, notably if their healthcare provider would recommend vaccination [13]. Informed consent and shared decisions should be the rule to discuss benefits and risks of the anti-COVID-19 vaccination to prevent patients from a double jeopardy: cancer and infection.

Statement:

  • 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.
References:
  1. Kuderer NM, Choueiri TK, Shah DP et al. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet 2020; 395:1907-1918. doi: 10.1016/S0140-6736(20)31187-9
  2. World Health Organization. WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination, 14 September 2020. World Health Organization, 2020. (19th December 2020, date last accessed).
  3. Evidence to recommendations for COVID-19 vaccines: Evidence framework. World Health Organization, 2020. (19th December 2020, date last accessed).
  4. K. Dooling; ACIP COVID-19 Vaccines Work Group. Phase 1 allocation COVID-19 vaccine: Work Group considerations.  ACIP COVID-19 Vaccines Work Group, 2020.  (19th December 2020, date last accessed).
  5. Australian Technical Advisory Group on Immunisation (ATAGI). Preliminary advice on general principles to guide the prioritisation of target populations in a COVID-19 vaccination program in Australia.  (19th December 2020, date last accessed).
  6. Independent report. JCVI: updated interim advice on priority groups for COVID-19 vaccination. JCI, 2020  (19th December 2020, date last accessed).
  7. Stratégie de vaccination contre le Sars-Cov-2 - Recommandations préliminaires sur la stratégie de priorisation des populations à vacciner. HAS, 2020. (19th December 2020, date last accessed).
  8. Conseil supérieur de la santé. Stratégie de vaccination contre le Covid-19 en Belgique. 2020. (19th December 2020, date last accessed).
  9. RECOMMANDATIONS générales du CONSEIL SUPERIEUR des MALADIES INFECTIEUSES, concernant la stratégie vaccinale contre la COVID-19. Conseil Superieur Des Maladies Infectieuses, 2020. (19th December 2020, date last accessed).
  10. Nationell plan för vaccination mot covid-19.  (19th December 2020, date last accessed).
  11. How should access to a COVID-19 vaccine be regulated? POSITION PAPER OF THE JOINT WORKING GROUP OF MEMBERS OF THE STANDING COMMITTEE ON VACCINATION, THE GERMAN ETHICS COUNCIL AND THE NATIONAL ACADEMY OF SCIENCES LEOPOLDINA. (19th December 2020, date last accessed).
  12. Carreira H, Strongman H, Peppa M, et al. Prevalence of COVID-19-related risk factors and risk of severe influenza outcomes in cancer survivors: A matched cohort study using linked English electronic health records data. Lancet 2020; 29:100656. doi: 10.1016/j.eclinm.2020.100656
  13. Reiter PL, Pennell ML, Katz ML. Acceptability of a COVID-19 vaccine among adults in the United States: How many people would get vaccinated? Vaccine 2020; 38:6500–6507.

I - Evidence from at least one large randomised, controlled trial of good methodological quality (low potential for bias) or meta-analyses of well-conducted randomised trials without heterogeneity

II - Small randomised trials or large randomised trials with a suspicion of bias (lower methodological quality) or meta-analyses of such trials or of trials with demonstrated heterogeneity

III - Prospective cohort studies

IV - Retrospective cohort studies or case–control studies

V - Studies without control group, case reports, expert opinions

Vaccine 

Company 

Clinical Trial Identifier 

Exclusion Criteria for cancer patients  

mRNA-1273 (Lipid nanoparticle-mRNA) 

Moderna / NIAID 

NCT04470427 

People who have received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening. 

BNT162b2 (Lipid nanoparticle-mRNA) 

BioNTech, Pfizer, 
Fosun Pharma 

NCT04368728 

People receiving 

Immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g. for cancer. 

Ad5-nCoV (Non-replicating Adenovirus Type 5 Vector) 

CanSino 
Biologics 

NCT04526990 

NCT04540419 

People with current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ

Gam-Covid-Vac  

(Sputnik V) 

Adeno-based (rAd26-S+rAd5-S) 

Gamaleya 
Research Institute 

NCT04530396 

(RESIST) 

NCT04564716 

History of any malignant tumours. 

Ad26.COV2.S / JNJ-78436735 

(Adenovirus Type 26 vector) 

Beth Israel Deaconess Medical Center 
and Johnson & Johnson (Janssen) 

NCT04505722 

(ENSEMBLE) 

NCT04614948 

(ENSEMBLE 2) 

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 chemotherapy, immune-modulating drugs or radiotherapy within 6 months before administration of vaccine and/or during the study. 

ChAdOx1 

nCov-19 (AZD-1222) 

(Non-Replicating 

Viral Vector)

University of Oxford/ 

AstraZeneca 

NCT04516746 

NCT04540393 

(COV002 and  COV003) 

ISRCTN89951424 

CTRI/2020/08/027170 

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. 

NVX-CoV2373 

(Protein Subunit)

Novavax 

(UK) 2020-004123-16 / 2019nCoV-301  

(US) NCT04611802 / 2019nCoV-301 

(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)

Medicago 

/GSK 

NCT04636697 

Any confirmed or suspected immunosuppressive condition, including cancer. Investigator discretion is permitted. 

People receiving cytotoxic, antineoplastic, or immunosuppressants within 36 months prior to vaccination. 

COVID-19 Vaccine 

(Protein Subunit) 

Chinese Academy of Medical Sciences/ 

Anhui Zhifei 
Longcom 

NCT04466085 (ph 2) 

Phase III announced on November 20, 2020. 

History of any malignant tumours. 

BBIBP-CorV 

(Inactivated)

Wuhan Institute of Biological Products / Sinopharm 

ChiCTR2000034780 

ChiCTR2000039000 

NCT04612972 

History of any malignant tumours. 

CoronaVac 
(Inactivated) 

Sinovac Biotech 

NCT04456595 (PROFISCOV) 

669/UN6.KEP/EC/2020 

NCT04582344 

NCT04617483 

Use of chemotherapy or radiotherapy within 6 months prior to enrolment or planned use within the 2 years following enrolment.  

 

History of malignancy or antineoplastic chemotherapy, radiotherapy, immunosuppressants in the past 6 months. 

Covaxin 
(Inactivated)

Indian Council of Medical Research / Bharat Biotech 

CTRI/2020/11/028976 

Treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or radiotherapy within the preceding 36 months. 

BCG

Murdoch Children’s Research Institute 

NCT04327206 

(BRACE) 

History of any malignant tumours. 

Published on 22 December 2020

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