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Serologic Status and Toxic Effects of the SARS-CoV-2 BNT162b2 Vaccine in Patients Undergoing Treatment for Cancer

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME
Key Points

Question  What is the serologic status and incidence of adverse effects in patients with cancer who are receiving therapy after administration of the SARS-CoV-2 BNT162b2 vaccine?

Findings  This cohort study evaluated serologic status and safety of the BNT162b2 vaccine in 232 patients receiving active treatment for cancer and 261 health care workers who served as controls. After the first dose of the vaccine, 29% of the patients were seropositive compared with 84% of the controls; after the second dose, the seropositive rate of the patients reached 86%, and reported adverse events resembled those of healthy individuals.

Meaning  The SARS-CoV-2 BNT162b2 vaccine appears to be safe with satisfactory levels of seropositivity in patients undergoing treatment for cancer, although protection may occur later compared with the healthy population.

Abstract

Importance  The efficacy and safety profile of SARS-CoV-2 vaccines have been acquired from phase 3 studies; however, patients with cancer were not represented in these trials. Owing to the recommendation to prioritize high-risk populations for vaccination, further data are warranted.

Objective  To evaluate the use and safety of the BNT162b2 vaccine in patients undergoing treatment for cancer.

Design, Setting, and Participants  In January 2021, mass SARS-CoV-2 vaccination of high-risk populations, including patients with cancer, was initiated in Israel. This cohort study prospectively enrolled and followed up patients with cancer and healthy participants between January 15 and March 14, 2021. The study was conducted at the Division of Oncology of Rambam Health Care Campus, the major tertiary (referral) medical center of northern Israel. Participants included 232 patients with cancer who were receiving active treatment after the first and second doses of the BNT162b2 vaccine and 261 healthy, age-matched health care workers who served as controls.

Exposures  Serum samples were collected after each vaccine dose and in cases of seronegativity. Questionnaires regarding sociodemographic characteristics and adverse reactions were administered at serum collection. A regulatory agencies–approved assay was used to assess IgG at all time points. Patients’ electronic medical records were reviewed for documentation of COVID-19 infection and results of blood cell counts, liver enzyme levels, and imaging studies.

Main Outcomes and Measures  Seroconversion rate after the first and second doses of the BNT162b2 vaccine and documented COVID-19 infection.

Results  Of the 232 patients undergoing treatment for cancer, 132 were men (57%); mean (SD) age was 66 (12.09) years. After the first dose of BNT162b2 vaccine, 29% (n = 25) patients were seropositive compared with 84% (n = 220) of the controls (P < .001). After the second dose, the seropositive rate reached 86% (n = 187) in the patients. Testing rate ratios per 1000 person-days after the first dose were 12.5 (95% CI, 3.4-45.7) for the patients and 48.5 (95% CI, 37.2-63.2) for the controls. Patients undergoing chemotherapy showed reduced immunogenicity (odds ratio, 0.41; 95% CI, 0.17-0.98). In seronegative patients, the rate of documented absolute leukopenia reached 39%. No COVID-19 cases were documented throughout the study period; however, 2 cases in the patient cohort were noted immediately after the first dose. Reported adverse events were similar to data in former trials comprising mostly healthy individuals.

Conclusions and Relevance  In this cohort study, the SARS-CoV-2 BNT162b2 vaccine appeared to be safe and achieve satisfactory serologic status in patients with cancer. There was a pronounced lag in antibody production compared with the rate in noncancer controls; however, seroconversion occurred in most patients after the second dose. Future real-world data are warranted to determine the long-term efficacy of the vaccine with regard to type of anticancer treatment.

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Article Information

Accepted for Publication: May 10, 2021.

Published Online: July 8, 2021. doi:10.1001/jamaoncol.2021.2675

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Goshen-Lago T et al. JAMA Oncology.

Corresponding Author: Irit Ben-Aharon, MD, PhD, Division of Oncology, Rambam Health Care Campus, HaAliya HaShniya 8, Haifa 31096, Israel (i_benaharon@rambam.health.gov.il).

Author Contributions: Drs Goshen-Lago and Ben-Aharon had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Goshen-Lago, Szwarcwort-Cohen, Almog, Halberthal, Ben-Aharon.

Acquisition, analysis, or interpretation of data: Goshen-Lago, Waldhorn, Holland, Reiner-Benaim, Shachor-Meyouhas, Hussein, Fahoum, Baruch, Peer, Reiter, Almog, Ben-Aharon.

Drafting of the manuscript: Goshen-Lago, Waldhorn, Szwarcwort-Cohen, Reiner-Benaim, Fahoum, Baruch, Ben-Aharon.

Critical revision of the manuscript for important intellectual content: Holland, Reiner-Benaim, Shachor-Meyouhas, Hussein, Peer, Reiter, Almog, Halberthal, Ben-Aharon.

Statistical analysis: Reiner-Benaim, Fahoum, Ben-Aharon.

Obtained funding: Ben-Aharon.

Administrative, technical, or material support: Goshen-Lago, Waldhorn, Holland, Szwarcwort-Cohen, Shachor-Meyouhas, Fahoum, Baruch, Peer, Almog, Halberthal.

Supervision: Hussein, Halberthal, Ben-Aharon.

Conflict of Interest Disclosures: Dr Peer reported receiving Pfizer Lecture fees outside the submitted work. No other disclosures were reported.

Funding/Support: This study was partially supported by Israel Cancer Research Fund grant 16-1276-CRCDA.

Role of the Funder/Sponsor: The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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