Safety of the BNT162b2 mRNA COVID-19 vaccine in oncologic patients undergoing numerous cancer treatment options

Abstract

The COVID-19 pandemic, caused by the SARS-CoV2 virus, has infected millions worldwide with cancer patients demonstrating a higher prevalence for severe disease and poorer outcomes. Recently, the BNT162b2 mRNA COVID-19 vaccine was released as the primary means to combat COVID-19. The currently reported incidence of local and systemic side effects was 27% in the general public. The safety of the BNT162b2 mRNA COVID-19 vaccine has not been studied in patients with an active cancer diagnosis who are either ongoing or plan to undergo oncologic therapy. This single center study reviewed the charts of 210 patients with active cancer diagnoses that received both doses of the BNT162b2 mRNA COVID-19 vaccine. The development of side effects from the vaccine, hospitalizations or exacerbations from various oncologic treatment were documented. Type of oncologic treatment (immunotherapy, chemotherapy, hormonal, biologic, radiation or mixed) was documented to identify if side effects were related to treatment type. The time at which the vaccine was administered in relation to treatment onset (on long term therapy, within 1 month of therapy or prior to therapy) was also documented to identify any relationships. Sixty five (31%) participants experienced side effects from the BNT162b2 mRNA COVID-19 vaccine, however most were mild to moderate. Treatment protocol was not linked to the development of vaccine related side effects ( P = .202), nor was immunotherapy ( P = .942). The timing of vaccine administered in relation to treatment onset was also not related to vaccine related side effects ( P = .653). Six (2.9%) participants were hospitalized and 4 (2%) died. The incidence of side effects in cancer patients is similar to what has been reported for the general public (31% vs 27%). Therefore, we believe that the BNT162b2 mRNA COVID-19 vaccine is safe in oncologic patients undergoing numerous cancer treatments.

Cancer Patients and the COVID-19 Vaccines: Considerations and Challenges

“…Another study conducted by Kian et al, revealed no significant difference between treatment protocol and development on the side effects of the Pfizer vaccine on cancer patients who received different types of anti-cancer treatments including chemotherapy, radiotherapy, immunotherapy, biological therapy, hormonal therapy, or who had a combination of two therapies. The overall incidence of side effects following either dose was 31%, similar to that reported in the safety data from the phase III trial (27%) [ 58 ].…”

Impact of chemotherapy and/or immunotherapy on neutralizing antibody response to SARS‐CoV‐2 mRNA‐1237 vaccine in patients with solid tumors

“…For comparative purposes, a group of 26 healthy individuals having received two doses of the mRNA-1273 vaccine (from the KING cohort extension of the Hospital Germans Trias i Pujol, PI-20-217) was selected. Samples from this control group were obtained 15 [IQR: [14][15][16] days after the second dose of the vaccine.…”

“…Some adverse events (AE) after vaccination have been reported, mostly graded as mild, however rare, but life‐threatening AE such as myocarditis were also noted in patients with cancer [ 13 , 14 ]. In general, the concomitant administration of chemotherapy (ChT) or immunotherapy (IT) has not demonstrated an increase in toxicity [ 15 , 16 ]. In this prospective study, we analyzed the neutralizing activity and safety of the mRNA‐1273 vaccine in a cohort of patients with solid tumors undergoing different active anticancer treatments (ChT, IT, or chemoimmunotherapy [ChTIT]) during vaccination compared to a non‐cancer control group.…”

Adverse drug reactions to the three doses of the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) mRNA-1273 vaccine in a cohort of cancer patients under active treatment of a tertiary hospital in Madrid, Spain

“…The published literature regarding ADRs in cancer patients after COVID-19 vaccine administration mostly shows an increasing trend of systemic ADRs after the second dose. 13,[20][21][22][23][24][25][26][27] We could only find one study conducted in Thailand in which ADRs after the first and second of AZD1222 vaccine doses were evaluated observing the opposite trend. 28 Some articles have also showed an association between gender and the incidence of ADRs after the SARS-CoV-2 vaccines.…”