SARS-CoV-2 vaccines for cancer patients: a call to action

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.

Keywords: Advocacy; COVID-19; Cancer; Pandemics; Public health; Sars-CoV-2; Trial; Vaccine.

Fig. 1

Structure of SARS-CoV-2 virus and its replication kinetics [15]. 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) [15]. Abbreviations: S, spike; E, envelope; M, membrane; N, nucleocapsid; ACE, angiotensin-converting enzyme; mRNA, messenger ribonucleic acid; APC, antigen-presenting cell; Abs, antibodies.

Fig. 2

Principal 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 [20]. Abbreviations: mRNA, messenger ribonucleic acid; S, spike, GSK, GlaxoSmithKline; UniOxford, University of Oxford; RBD, receptor-binding domain.

Fig. 3

Temporal 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.