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Expert opinions for COVID-19 vaccination in patients with hematologic cancer

Ronja Brockhoff, Hamdi Akan, Rafael Duarte, Martin Hönigl, Nikolay Klimko, Sibylle C. Mellinghoff, Livio Pagano, Antonio Pagliuca, Paul Verweij, Oliver A. Cornely, for the EHA Scientific Working Group Infections in Hematology

Worldwide, the number of people infected by the new coronavirus SARS-CoV-2 continues to increase. After the first outbreak in March 2020, incidence has temporarily decreased, but increase again since the end of July reaching its peak in December 2020 [1].

Rapidly developed vaccines are promising [2-4], whilst their availability is limited for now. In order to prioritize access to licensed vaccines, regulations are made at national levels. Increasingly, registration data for vaccines is becoming available.

In the BNT162b2 study [2], volunteers >16 years of age were included. Patients with a history of COVID-19, immunosuppressive disease or immunosuppressive treatment were excluded. A small number of participants (3%) had a patient history of malignant disease and study results can only be extrapolated to hematology patients. A local reaction at the injection site emerged as the most common side effect. Pain was reported by 83% of patients <55 years after first injection and by 78% after second injection. In older patients the rate of injection site pain was lower (71 and 66%, respectively). Most common systemic reactions were fatigue (59%) and headache (51%). Fever >38°C occurred in 16% of younger patients and in 11% of older patients. Serious adverse events of CTCAE grade 3 were fatigue (3.8%) and headache (2.0%). During routine application of BNT162b2, severe anaphylactic reactions were reported. Both patients had a corresponding history and were equipped with an epinephrine pen.

These data show that the mRNA-based vaccines have high efficacy. Serious adverse events are rare. Long-term results are not yet available. However, mRNA-based vaccines have been tested in cancer patients for almost 10 years without raising concerns in terms of safety [5].

Our recommendations for the COVID-19 vaccination must equally take patients and health care workers (HCW) into consideration. Based on current knowledge we propose:

Vaccination is intended for those with an increased risk of infection, those with an increased risk of a severe course of COVID-19, those with an increased risk of mortality, and their close contacts. These include: Patients with malignant hematologic diseases, particularly acute and chronic leukemia, malignant lymphoma and multiple myeloma; HCW in direct contact with hematology patients. Principles of shared decision making between treating hematologist and patient apply in the individual decisions on COVID-19 vaccination. In immunosuppressed patients, protection prevailed by the COVID-19 vaccination may be lower. In patients after B-cell depletion or HSCT we encourage to keep an interval of 3-6 months in analogy to other vaccinations. In patients with a history of anaphylactic reactions, the risk of a severe side effect should be weighed carefully against the expected benefit. The database on tolerance and efficacy of COVID-19 vaccination in hematologic cancer patients is growing rapidly. This continuous production of knowledge may lead to short-term modifications of current recommendations.

References

1. Von Lilienfeld-Toal, M., et al., Coronavirus-Infektion (COVID-19) bei Patienten mit Blut- und Krebserkrankungen. ONKOPEDIA Leitlinien von DGHO, OeGHO, SGMO und SGH+SSH, Status Dezember 2020.
2. Polack, F.P., et al., Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med, 2020. 383(27): p. 2603-2615.
3. Baden, L.R., et al., Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med, 2020.
4. Voysey, M., et al., 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.
5. Weide, B., et al., Results of the first phase I/II clinical vaccination trial with direct injection of mRNA. J Immunother, 2008. 31(2): p. 180-8.