medwireNews: Israeli researchers report promising data regarding the short-term safety of the Pfizer–BioNTech (BNT162b2) COVID-19 vaccine in cancer patients receiving immune checkpoint inhibitor (ICI) therapy.
They did not observe any severe events related either to the vaccine or ICIs, and there were also “no new immune-related side-effects or exacerbation of existing immune-related side-effects.”
The team therefore writes in a comment published in The Lancet Oncology: “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.”
The study included 134 ICI-treated individuals, aged a median of 72 years, who received two doses – given 3 weeks apart – of the BNT162b2 mRNA vaccine between January 11 and February 25, 2021. Participants were monitored using a telephone questionnaire administered 17–21 days after the first dose and at a median of 19 days after the second one.
Just under half (49.2%) of the patients had a diagnosis of lung cancer, with melanoma and genitourinary cancers the next most common diagnoses, at 11.9% and 11.2%, respectively. The majority (72.4%) received ICI therapy alone, while the remaining 27.6% of patients additionally received chemotherapy. Pembrolizumab was the most commonly used ICI, in 55.2% of participants, followed by nivolumab and durvalumab, in a respective 18.6% and 11.2%.
The most common side effect after the first dose was local, namely pain at the injection site, reported by 21%, while systemic side effects including fatigue, headache, muscle pain, and chills were reported by 4%, 2%, 2%, and 1% of patients, respectively.
The rates of local and systemic adverse events were higher after the second dose, which, the researchers note, is in line with the vaccine clinical trial data. Pain at the injection site was once again the most frequent side effect, observed at a rate of 63%, but 9% of patients reported local swelling and 2% had a local rash.
Thirty-four percent of the participants each reported muscle pain and fatigue, while the rates of headache, fever, chills, gastrointestinal complications, and flu-like symptoms were 16%, 10%, 10%, 10%, and 2%, respectively.
Ido Wolf, from Tel Aviv Sourasky Medical Center, and colleagues note, however, that there were no significant differences in the incidence of systemic side effects between the immunotherapy alone and combination subgroups, nor between patients who did versus did not previously experience immune-related adverse events.
“Importantly, even in patients with previous immune-related side-effects, the vaccine-related side-effects were mild and did not lead to admission to hospital or cessation of cancer treatment,” they say.
Furthermore, the vaccine side-effect profile was generally comparable between the 134 cancer patients and an equal number of healthy individuals, matched by age and sex, who also received two doses of the vaccine. The only exception was muscle pain, which was significantly more common among patients with cancer than the controls.
“Our data support the short-term safety of the BNT162b2 mRNA COVID-19 vaccine” in this patient population, summarize Wolf et al.
And they conclude: “Although further studies are needed to determine if these data are also applicable to the other COVID-19 vaccines, our findings might provide some reassurance for their use in patients being treated with immune checkpoint inhibitors.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group
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