key: cord-0966428-demc2xao
authors: Garassino, Marina Chiara; Vyas, Malvika; de Vries, Elisabeth; Kanesvaran, Ravindran; Giuliani, Rosa; Peters, Solange
title: The ESMO Call to Action on COVID-19 vaccinations and patients with cancer: Vaccinate. Monitor. Educate
date: 2021-02-12
journal: Ann Oncol
DOI: 10.1016/j.annonc.2021.01.068
sha: e72dbbf819a78d4a088818e7ad48dfdd0ab524d2
doc_id: 966428
cord_uid: demc2xao

nan

March 11, 2021 marks the first anniversary of a pandemic that has pushed the world into shutdown. Of a global population of almost 8 billion, COVID-19 has affected more than a hundred million people, with over 2 million deaths. 1 However, the magnitude of its impact has been heterogeneous, with some groups, including patients with cancer, being more severely affected than others. With initially limited understanding of this infectious disease transmitted by a coronavirus strain, SARS-CoV-2, the World Health Organization (WHO) emerged as the global leader, despite the challenges. For specific disease groups, including cancer, scientific and professional societies such as the European Society for Medical Oncology (ESMO), rose to the challenge of providing recommendations to optimise multi-professional cancer treatment strategies during these unprecedented circumstances. From the perspective of minimising societal impact and subsequently finding a solution to the COVID-19 pandemic, transmission and protective measures were rapidly implemented. At the same time, manufacturers and regulators started the remarkably successful development of safe and effective vaccines.

Globally, solidarity became the number one priority, along with the race towards achieving 'normality', herd immunity, through vaccinations. The combination of the disproportionate impact on vulnerable populations, including patients with cancer affected by an elevated risk of serious morbidity and mortality, and a scarce resource (i.e., vaccines), required the creation of global and national vaccination strategies. However, as patients with cancer, especially when immunocompromised, were excluded from the pivotal trials of the vaccines being tested, the protection level towards COVID-19 after administering the vaccines remains unclear. 2 With 19.3 million new cancer cases in 2020 alone and an inevitable increase in new (including preventable) cancer cases post-pandemic, ESMO launched a Call to Action on COVID-19 Vaccinations and Patients with Cancer to resolve this uncertainty and protect patients with cancer. [3] [4] 

Cancer's complexity as a disease affects individuals in multiple ways including patients with active disease, on anticancer treatment, individuals with chronic disease post-treatment or cancer survivors. 5 Of these categories, immunocompromised patients are most susceptible to complications if they contract a new disease, e.g., COVID-19. Healthcare professionals have been subject to unimaginably difficult conditions: treating those affected by COVID-19 and ensuring that those with diseases requiring treatment continue to receive high-quality care, despite the challenging circumstances.

In patients with cancer, COVID-19's impact has been vast, ranging from: high-risk of developing a severe form of COVID-19, and death; pausing, stopping, or never starting anticancer treatment due to the SARS-CoV-2 infection; fear of contracting the virus; and halting or limiting regular check-ups and monitoring. 4 The impact on the disease itself on these outcomes is yet to be seen. Through the lack of routine screening to detect new cancer cases early and the difficulties in patient adherence to treatment due to COVID-19 will most likely lead to a delayed influx of cases and hampered treatment in the coming years. 6

A year after the declaration of this pandemic, the European Medicines Agency has already conditionally approved two COVID-19 vaccines (Comirnaty and COVID-19 Vaccine Moderna) and evaluates a third vaccine application (ChAdOx1-SARS-CoV-2). 7 Furthermore, numerous countries have started their vaccination programmes, inoculating millions of people so far. 8 To assist countries with a fair and equitable distribution of the limited quantities of vaccines, the scarce resource, the WHO's Strategic Advisory Group of Experts on Immunization (SAGE) developed a values framework for allocation and prioritisation of COVID-19 vaccination. A few of the WHO framework principles and corresponding objectives aim to: 1) reduce deaths and disease burden; 2) protect the continuing function of essential services; 3) protect those who bear significant additional risks and burdens for the welfare of others. 9 The European Commission created a similar strategy, based on the work of Member States and expert organisations, including the WHO. 10

On January 08, 2021, ESMO launched a Call to Action directed towards the EU Member States to underscore the importance of vaccinating early all patients with cancer, especially those on active anticancer treatment. Supported by over 40 healthcare professional and patient organisations, the Call reflects the European oncology community's unified voice towards early vaccinations. The EMA J o u r n a l P r e -p r o o f approved messenger RNA (mRNA) vaccines to date present no contraindications or safety concerns towards patients on active anticancer treatment and the immunocompromised. 11-13 Thus, representing more than 25,000 oncology professionals treating cancer patients daily, it is ESMO's responsibility to reiterate the importance of vaccinating those who are most at risk as soon as possible. Acknowledging the lack of data surrounding immunocompromised patients in the pivotal trials regarding their capacity to develop and maintain an immune response, ESMO emphasises the importance of monitoring the vaccine effects via suitable studies and registries. Lastly, instilling confidence regarding safety of the vaccines and vaccinations and providing information to the population in lay language is key to protect those who are most at risk of developing severe forms of COVID-19. Moreover, as they may not develop a sufficient immune response themselves, it becomes crucial that at least those in their vicinity, including their caregivers, are also vaccinated.

The intricacies of cancer as a disease are still unknown. However, we know that adherence to treatment and regular check-ups are two crucial ways to tackle the disease. As COVID-19 has affected the lives of patients with cancer in several ways, Member States can try to get their treatment schedules back on track through early vaccination and allow them the luxury to be near their loved ones.

Thus, as healthcare professionals and patient advocacy organisations representing patients with cancer and their families, we aim to ensure that WHO's principles and objectives are adhered to, namely, to reduce deaths and disease burden and protect those who most need protection. 4 PANEL: ESMO's Call to Action: Vaccinate. Monitor. Educate. 4 In the context of the Member States developing their vaccination strategies, the European Society for Medical Oncology (ESMO), a scientific society representing over 25,000 oncology professionals, would like to request the Member States to consider the following: 

Ravindran Kanesvaran reports advisory Board / speaker / received honoraria from the following companies

Rosa Giuliani reports no financial interests to disclose; being a core member of the European Medicines Agency Scientific Advisory Group-Oncology, an expert evaluator for the EU Commission on the topic: Global Alliance for Chronic Diseases (GACD) 2 -Prevention and/or early diagnosis of cancer

attended advisory boards and/or provided lectures for the following organizations, from whom I have received honoraria: Consultation / Advisory role: AbbVie

COVID-19 Studies from the World Health Organization Database

International Agency for Research on Cancer

COVID-19 Vaccinations and Patients with Cancer: Vaccinate. Monitor. Educate. An ESMO Call to Action

COVID-19 vaccination in cancer patients: ESMO Statements

Cancer screening tests and cancer diagnoses during the COVID-19 pandemic

COVID-19: latest updates

Our World in Data. Coronavirus Pandemic Data Explorer

WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination

Preparedness for COVID-19 vaccination strategies and vaccine deployment

CHMP opinion: COVID-19 Vaccine Moderna

Interim recommendations for use of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing

The authors would like to thank the ESMO Executive Board, Dr Keith H. McGregor (Chief Executive Officer, ESMO), Dr George Pentheroudakis (Chief Medical Officer, ESMO) for their support. The authors would also like to thank the following organisations who have endorsed* the ESMO Call to Action on COVID-19 Vaccinations and Patients with Cancer: