Abstract

Patients with cancer experience higher burden of SARS-CoV-2 infection, disease severity, complications, and mortality, compared to the general population. SARS-CoV-2 mRNA vaccines have shown to be highly effective in clinical trials; however, few data are available on the efficacy of SARS-CoV-2 vaccines in patients with cancer. Using a prospective cohort study design, we assessed the seroconversion rates and anti-SARS-CoV-2 S antibody titers following the 1st and 2nd dose of BNT162b2 and mRNA-1273 SARS-CoV-2 vaccines in patients with cancer at centers in U.S. and Europe from January 2021 to April 2021. Among 131 patients included in the immunogenicity analysis, most (94%) developed antibody levels; however, 6% showed no seroconversion after completing the mRNA vaccination series. No differences in seroconversion rates were observed between BNT162b2 and mRNA-1273 vaccine groups. Patients with solid tumors (98%) were much more likely to seroconvert and develop higher antibody titers than those with hematological malignancy (77%). Although seroconversion rates were consistently high in patients receiving different types of anti-cancer therapy except anti-CD-20 antibody; the antibody titers were much lower in patients who received cytotoxic chemotherapy, immunotherapy, or monoclonal antibody compared to those on clinical surveillance or receiving endocrine therapy within six months prior to vaccination. None of the patients on anti-CD-20 antibody therapy developed an antibody response, even after receiving 2 doses of the vaccines. After correlating with cell-mediated immunity in a subset of patients at high-risk for antibody non-response, we propose exploring the addition of a second booster, or convalescent plasma therapy, or postpone vaccination until after completion of their specific anti-cancer treatment. Although encouraging results, we suggest high-risk vaccinated patients with cancer to continue taking safety precautions until their immune response is confirmed at 4 weeks after 2nd dose of mRNA vaccines. We also highly encourage all eligible individuals in the general population to get vaccinated to ensure the protection of the most vulnerable groups, such as those with cancer.Funding: This project has been funded in whole or in part with federal funds from National Cancer Institute grant P30 CA054174 (Mays Cancer Center at University of Texas Health San Antonio MD Anderson); and grant MRSG-16-152-01-CCE the American Cancer Society and Hope Foundation for Cancer Research. A ‘Research & Development Program’ grant from Geneva University Hospitals awarded to Natacha Bordry funded part of this study.Declaration of Interest: Dr. Addeo reported receiving personal fees for attending advisory from Bristol‐Myers Squibb, AstraZeneca, Roche, Pfizer, Merck Sharp and Dohme,Astella, Eli Lilly and Boehringer‐Ingelheim. He has received fees for speaking bureau for Eli Lilly, AstraZeneca, MSD for work performed outside of the current study. Dr. P. Shah reported receiving grant from the Biomedical Advanced Research and Development Authority outside of this work. Dr Labidi-Galy reported receiving personal fees for attending advisory from AstraZeneca. Proferssor Mach is a founder and minority shareholder of MaxiVAX SA, a private biotech company based in Geneva Switzerland, working on personalized cancer immunotherapy and infectious disease vaccines; with no impact on the current manuscript. Dr. Taylor reported funding from NIAID/NIH and the COVID-19 Prevention Network which conducts COVID-19 vaccine trials. Dr. Patel reported receiving grant support from the National Institutes of Health, Cancer Prevention Research Institute of Texas, ThriveWell Foundation and the Bill and Ella Owens Medical Foundation outside of this work Dr. Wang reported receiving grants from 80/20 Foundation, National Institute of Health, and Nancy Smith Hurd Foundation. Dr. Mesa reported receiving research support from Celgene, Incyte, Abbvie, Samus, Genotech, Promedior, and CTI; and consulting fees from Novartis, Sierra Onc, LaJolla, and Pharma. Dr. D. Shah reported receiving grants from American Cancer Society and Hope Foundation for Cancer Research during the conduct of the study. Dr. D. Shah reported receiving grant from the Biomedical Advanced Research and Development Authority outside of this work. No other disclosures were reported. All other coauthors reported no conflict of interests.Ethical Approval: This study was approved by institutional review boards at each institution.

Highlights

  • Among 131 patients included in the immunogenicity analysis, most (94%) developed antibody levels; 6% showed no seroconversion after completing the messenger RNA (mRNA) vaccination series

  • Seroconversion rates were consistently high in patients receiving different types of anti-cancer therapy except anti-CD-20 antibody; the antibody titers were much lower in patients who received cytotoxic chemotherapy, immunotherapy, or monoclonal antibody compared to those on clinical surveillance or receiving endocrine therapy within six months prior to vaccination

  • The novel coronavirus disease 2019 (COVID-19) pandemic has spread throughout the world with over 161 million confirmed cases globally and more than 3 million deaths as of May 2021.1 Unprecedented global effort has been made to develop different SARS-CoV-2 vaccines using technologies based on messenger RNA, synthetic long viral peptides, plasmid DNA, and inactivated, attenuated, or genetically modified viruses including those from Pfizer-BioNTech,[2] Moderna,[3] Oxford–AstraZeneca,[4] and Johnson & Jonhson.[5]

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Summary

Introduction

The novel coronavirus disease 2019 (COVID-19) pandemic has spread throughout the world with over 161 million confirmed cases globally and more than 3 million deaths as of May 2021.1 Unprecedented global effort has been made to develop different SARS-CoV-2 vaccines using technologies based on messenger RNA (mRNA), synthetic long viral peptides, plasmid DNA, and inactivated, attenuated, or genetically modified viruses including those from Pfizer-BioNTech,[2] Moderna,[3] Oxford–AstraZeneca,[4] and Johnson & Jonhson.[5]. Scarce experimental data about safety and efficacy of vaccine have been reported on patients with cancer, as they were excluded from SARS-CoV-2 vaccine clinical trials. Patients with cancer have been heavily affected by the COVID-19 pandemic either by representing a more vulnerable population[6] or by the disruption of their care pathway caused by the pandemic.[7] Most healthcare settings implemented minimal services with programmed activity being canceled or suspended, and patients have delayed routine health procedures or assessment of serious symptoms, due to fear of visiting providers that were handling suspected COVID-19 cases. It has been estimated that about 40% of countries reported partial or complete disruptions of cancer treatment during the different peaks of the pandemic.[8]

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