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‘Reassuring Safety Signal’ For COVID-19 Vaccine During ICI Therapy

The BNT162b2 mRNA vaccine has a similar profile of short-term side effects for cancer patients undergoing immune checkpoint inhibitor therapy and healthy individuals
09 Apr 2021
COVID-19 and Cancer;  Immunotherapy

Author: By Lynda Williams, Senior medwireNews Reporter 


medwireNews: Initial research from Israel indicates that the BNT162b2 messenger (m)RNA vaccine against SARS-CoV-2 is feasible for patients with cancer undergoing immune checkpoint inhibitor (ICI) therapy.  

Overall, 170 cancer patients undergoing ICI therapy at the Tel Aviv Sourasky Medical Center or the Bnei-Zion Medical Center were offered the vaccination between 11 January and 25 February 2021, of whom 137 received a first dose.  

A second dose was given to 134 of these patients, as one patient died from COVID-19 and two patients died from disease progression after the first dose, say Ido Wolf, from Tel Aviv Sourasky Medical Center, and co-workers in a comment published in The Lancet Oncology

Telephone questionnaire responses 17–21 days after the first dose revealed that localised side effects were more common after the first vaccination than systemic effects, with pain at the injection site occurring in 21%. Less common symptoms included fatigue (4%), headache (2%), muscle pain (2%) and chills (1%). 

A median of 19 days after the second vaccination, the majority (63%) of patients reported pain at the injection site, 9% localised swelling and 2% localised rash, with muscle pain and fatigue both occurring in 34% of patients and headache in 16%. Fever, chills and gastrointestinal adverse events (AEs) each occurred in 10% of patients and flu-like symptoms in 2%. 

None of the patients required hospital care for AEs after the second vaccination; three patients were admitted to hospital for cancer-related complications and one patient for fever, all of whom were later discharged.  

Ido Wolf and co-workers remark that there was a similar rate of systemic AEs after vaccination in patients using ICIs alone and in those also given chemotherapy (32 vs 44%) and emphasize that patients did not develop “new immune-related side effects or exacerbation of existing immune-related side effects”. 

Moreover, there was no difference in the rate of systemic side effects among patients who had previously developed immune-related AEs to ICI therapy and those who had not (33 vs 34%). Vaccine-related AEs in patients with prior immune-related AEs were “mild and did not lead to admission to hospital or cessation of cancer treatment”, the researchers observe. 

Furthermore, the vaccine AE profile among the ICI therapy patients was generally comparable to that reported by a control group of age- and sex-matched healthy individuals given the BNT162b2 vaccine, except for the higher rate of muscle pain reported by the cancer patients. 

“This observation further supports the safety of the BNT162b2 mRNA vaccine in patients with cancer being treated with immune checkpoint inhibitors”, Ido Wolf et al write. 

While acknowledging the need for longer follow-up, the authors believe that their findings point to “a reassuring safety signal regarding the BNT162b2 mRNA COVID-19 vaccine in patients with cancer treated with immune checkpoint inhibitors.” 

They conclude: “Considering the high mortality due to COVID-19 in patients with cancer who are being treated, our data support current guidelines and call for vaccination of patients being treated with immune checkpoint inhibitors, especially during pandemic surges.” 


Waissengrin B, Agbarya A, Safadi E, Padova H, Wolf I. Short-term safety of the BNT162b2 mRNA COVID-19 vaccine in patients with cancer treated with immune checkpoint inhibitorsLancet Oncol; Advance online publication 1 April 2021. DOI: 10.1016/S1470-2045(21)00155-8

medwireNews (www.medwireNews.com) is an independent medical news service provided by Springer Healthcare. © 2021 Springer Healthcare part of the Springer Nature group

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