Tolerability of COVID-19 vaccines in patients with cancer

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SARS-CoV-2 virus is the causative agent of Coronavirus Disease 2019 (COVID-19) and has infected many over the past two-and-a-half years, including healthy people and those with underlying co-morbidities such as the immunocompromised. Following the administration of COVID-19 vaccines from late 2020 onwards,¹ severe and critical COVID-19 outcomes decreased by over 60%.²

While the SARS-COV-2 vaccine-efficacy is reassuring, many still have concerns about their safety profile.³ Vaccine tolerability consists of two components: (1) the occurrence of adverse events (AEs) after vaccination; and (2) AE tolerability by subjects. Adverse events can be vaccine-related (VRAE) or unrelated.⁴ The severity of events is determined by the need for treatment and/or hospitalisation for AE resolution, effect on subjects’ activities of daily life, and presence of sequelae after AE resolution.^4,5 Experts have recommended to use validated patient-reported outcome tools, including the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) to guide severity classification for each event.^6,7 Tolerability (systemic AEs) should be distinguished from reactogenicity (local AEs), which concerns only the appearance of common, “expected” AEs like local injection site pain, redness and swelling.⁸

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Of Note

Cancer is a malignant process marked by uncontrolled proliferation of cancer cells, rendering patients immunocompromised and thus more susceptible to severe COVID-19 outcomes.⁹Of note, in this article, patients with cancer mainly include adults who were diagnosed with both haematological malignancies and solid tumours. Clinical trials for COVID-19 vaccination in paediatric cancer patients are still ongoing.¹⁰Differences in vaccine tolerability between cancer patients with and without active treatment will also be discussed below.

Hong Kong authorities have approved the CZ02 and BNT162b2 COVID-19 vaccines for emergency use, with BNT162b2 being available in more countries than the CZ02 vaccine.³ Conversely, more data on the BNT162b2 vaccine tolerability is available compared to the CZ02 vaccine.

For both CZ02 and BNT162b2 vaccines, local AEs were more frequently reported than systemic AEs for cancer patients in general.^11,12 The most common local AE is injection site pain,¹³ while the most common systemic AEs are fatigue and myalgia. In a study involving 373 cancer patients, 2.1% of the subjects developed CTCAE (“prevents normal activity and requires treatment”) — fatigue, myalgia, diarrhoea, flu-like symptoms, nausea/ vomiting, urosepsis and febrile neutropaenia within the first 7 days of first dose; venous thromboembolism, transaminitis and fatigue after the 7^th day.¹⁴ In a survey evaluating COVID-19 vaccine tolerability (BNT162b2 and mRNA-1273 vaccines) specifically in thymic epithelial tumour (TET) patients,¹⁵ autoimmune disease (AD) flares were noticed. Most reported AD flares were mild and self-limiting, apart from one subject who presented with intermittent hand and feet burning, swallowing difficulty, muscle fasciculation and skin rash. Only that patient had markedly reduced vaccine tolerability. Among TET patients with previously diagnosed AD, not all experienced AD flare after vaccination. In general, COVID-19 vaccination is safe for cancer patients.

Systemic AEs such as fever can be due to many causes, for instance as a post-operative complication, a manifestation of febrile neutropaenia, or a side effect of COVID-19 vaccination. In order to distinguish between the causes more clearly, the National Comprehensive Cancer Network (NCCN) implemented a guideline regarding recommendations on COVID-19 vaccination timing. Patients with solid tumour who have just undergone major surgeries are recommended to receive COVID-19 vaccination at least a few days after surgery; in procedures likely to cause immunosuppression, including splenectomies, patients are advised to wait for two weeks post-operation. Leukemia or myeloma patients currently undergoing intensive cytotoxic chemotherapy are recommended to be vaccinated after their absolute neutrophil counts (ANC) recover to normal range. However, if these patients’ ANCs are not expected to recover soon, patients are advised to receive vaccination as soon as possible.¹⁶ Additionally, specific anti-cancer treatment such as granulocyte-colony stimulating factor (G-CSF) may increase risk of fever as a systemic adverse event (OR=3.37, 95% CI: 1.19-9.56), contributing to reduced vaccine tolerability.^13,17 Since G-CSF is commonly used in cancer patients for raising leukocyte count during chemotherapy and before haematopoietic stem cell transplant,¹⁸ patients should consult physicians regarding their individualised treatment plans.

In summary, the percentages of local and systemic AEs reported among patients with cancer are comparable to those in the general population. COVID-19 vaccination is recommended, but should discuss with physicians-in-charge prior to vaccination. Future research directions concerning COVID-19 vaccination and oncology include more investigation into the safety profiles of CZ02 vaccine, as well as COVID-19 vaccine studies for paediatric cancer patients.

Reference

American Journal of Managed Care. A Timeline of COVID-19 Developments in 2020. Available at: https://www.ajmc.com/view/a-timeline-of-covid19-developments-in-2020 (Accessed 12 May 2022).

Moghadas SM et al. Clinical Infectious Diseases. 2021;73(12): 2257–2264.

Chan WL et al. Vaccines (Basel). 2021;9(7):792.

Centers for Disease Control and Prevention. Vaccine Safety: Side Effects and Adverse Events. Available at: https://www.cdc.gov/vaccinesafety/ensuringsafety/sideeffects/index.html (Accessed 12 May 2022).

Benest J et al. Vaccines. 2021;9(2):78.

Aiyegbusi OL & Calvert MJ. Lancet. 2020;22(396):531.

National Cancer Institute – Division of Cancer Treatment & Diagnosis. Cancer Therapy Evaluation Program. Available at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_60 (Accessed 12 May 2022).

Hervé C et al. npj Vaccines. 2019;4.

Giannakoulis VG et al. JCO Global Oncology. 2020. doi: 10.1200/GO.20.00225

Charla Y et al. Pediatric Blood & Cancer. 2021. doi: 10.1002/pbc.299397

Loew B et al. Journal of Clinical Oncology. 2021. doi: 10.1200/JCO.2021.39.15_suppl.2621

Aznab M et al. Asian Pacific Journal of Cancer Prevention. 2022;23(4):1263–1270.

Nelli F et al. Annals of Oncology. 2022;33(1): 107–108.

So ACP et al. Cancers. 2021;13(14):3573.

Ballman M et al. JTO Clinical and Research Reports. 2021;2(10):100229.

National Comprehensive Cancer Network. COVID-19 Resources. Available at: https://www.nccn.org/covid-19 (Accessed 16 May 2022).

Takada K et al. JTO Clinical and Research Reports. 2021;2(11):100238.

Cancer Research UK. Granulocyte colony stimulating factor (G-CSF). Available at: https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/g-csf (Accessed 12 May 2022).

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).