Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 May;18(5):313-319.
doi: 10.1038/s41571-021-00487-z. Epub 2021 Mar 15.

COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials

Aakash Desai  1 , Justin F Gainor  2 , Aparna Hegde  3 , Alison M Schram  4 , Giuseppe Curigliano  5 , Sumanta Pal  6 , Stephen V Liu  7 , Balazs Halmos  8 , Roman Groisberg  9 , Enrique Grande  10 , Tomislav Dragovich  11 , Marc Matrana  12 , Neeraj Agarwal  13 , Sant Chawla  14 , Shumei Kato  15 , Gilberto Morgan  16 , Pashtoon M Kasi  17 , Benjamin Solomon  18 , Herbert H Loong  19 , Haeseong Park  20 , Toni K Choueiri  21 , Ishwaria M Subbiah  22 , Naveen Pemmaraju  23 , Vivek Subbiah  24   25   26 ; COVID19 and Cancer Clinical Trials Working Group
Affiliations
Review

COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials

Aakash Desai et al. Nat Rev Clin Oncol. 2021 May.

Erratum in

  • Author Correction: COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials.
    Desai A, Gainor JF, Hegde A, Schram AM, Curigliano G, Pal S, Liu SV, Halmos B, Groisberg R, Grande E, Dragovich T, Matrana M, Agarwal N, Chawla S, Kato S, Morgan G, Kasi PM, Solomon B, Loong HH, Park H, Choueiri TK, Subbiah IM, Pemmaraju N, Subbiah V; COVID19 and Cancer Clinical Trials Working Group. Desai A, et al. Nat Rev Clin Oncol. 2021 May;18(5):320. doi: 10.1038/s41571-021-00503-2. Nat Rev Clin Oncol. 2021. PMID: 33758378 Free PMC article. No abstract available.

Abstract

Emerging efficacy data have led to the emergency use authorization or approval of COVID-19 vaccines in several countries worldwide. Most trials of COVID-19 vaccines excluded patients with active malignancies, and thus data on the safety, tolerability and efficacy of the vaccines in patients with cancer are currently limited. Given the risk posed by the COVID-19 pandemic, decisions regarding the use of vaccines against COVID-19 in patients participating in trials of investigational anticancer therapies need to be addressed promptly. Patients should not have to choose between enrolling on oncology clinical trials and receiving a COVID-19 vaccine. Clinical trial sponsors, investigators and treating physicians need operational guidance on COVID-19 vaccination for patients with cancer who are currently enrolled or might seek to enrol in clinical trials. Considering the high morbidity and mortality from COVID-19 in patients with cancer, the benefits of vaccination are likely to far outweigh the risks of vaccine-related adverse events. Herein, we provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials. In our perspective, continued quality oncological care requires that patients with cancer, including those involved in trials, be prioritized for COVID-19 vaccination, which should not affect trial eligibility.

PubMed Disclaimer

Conflict of interest statement

J.F.G. has served as a compensated consultant or received honoraria from Agios, Amgen, Ariad/Takeda, Array Biopharma, AstraZeneca, Blueprint, Bristol-Myers Squibb (BMS), EMD Serono, Genentech/Roche, Gilead, GlydeBio, Incyte, Loxo Oncology/Lilly, Merck, Mirati, Novartis, Oncorus, Pfizer and Regeneron; has received research support from Ariad/Takeda, Genentech/Roche and Novartis; institutional research support from Adaptimmune, Alexo, Array Biopharma, Blueprint, BMS, Jounce, Merck, Moderna, Novartis and Tesaro; and has an immediate family member who is an employee of Ironwood Pharmaceuticals. G.C. has served on advisory boards for AstraZeneca, Daiichi Sankyo, Ellipsis, Genomic Health, Lilly, Novartis, Roche and Veracyte. S.V.L. has served on advisory boards and/or consulted for Amgen, AstraZeneca, Beigene, Blueprint, BMS, Daiichi Sankyo, G1 Therapeutics, Genentech, Guardant Health, Inivata, Janssen, Jazz, Lilly, Merck, PharmaMar, Pfizer, Regeneron and Takeda; and declares research grants (to his institution) from Alkermes, AstraZeneca, Bayer, Blueprint, BMS, Corvus, Genentech, Lilly, Lycera, Merck, Merus, Pfizer, Rain, RAPT, Spectrum and Turning Point Therapeutics. B.H. reports research funding (to his institution) from AbbVie, Advaxis, Amgen, AstraZeneca, Blueprint, BMS, Boehringer Ingelheim, Elevation, GlaxoSmithKline, Lilly, Merck, Mirati, Novartis, and Pfizer; and advisory boards consulting roles for Amgen, Apollomics, AstraZeneca, BMS, Boehringer Ingelheim, Guardant Health, Merck, Novartis, Pfizer and TPT. R.G. has received honoraria from Regeneron. E.G. has received honoraria for advisory boards, meetings and/or lectures from Adacap, BMS, Celgene, Eisai, Eusa Pharma, Ipsen, Lexicon, MSD, Novartis, Pfizer, Pierre Fabre, Roche and Sanofi-Genzyme; and unrestricted research grants from AstraZeneca, Ipsen, Lexicon, MTEM/Threshold, Pfizer and Roche. T.D. declares clinical research support/grants (to his institution) from BMS, Lilly, Exelixis, Holystone, Mirati, Novacure, Pharmacyclics and RAPT Pharma. M.M. has been a consultant for AstraZeneca, Dispersol and Strata Oncology; and has received speaker’s bureau fee from Astellas, AstraZeneca, BMS, Eisai, Janssen, Merck and Seagen N.A. has served as a consultant to Astellas, AstraZeneca, Aveo, Bayer, BMS, Calithera, Clovis, Eisai, Lilly, EMD Serono, Exelixis, Foundation Medicine, Genentech, Janssen, Merck, MEI Pharma, Nektar, Novartis, Pfizer, Pharmacyclics and Seattle Genetics. S.K. has served as a consultant for Foundation Medicine; has received a speaker’s fee from Roche; has served on advisory boards for Pfizer; and has received research funding from ACT Genomics, Konica Minolta, OmniSeq and Sysmex. P.M.K. has served as a consultant and/or advisory board member for Foundation Medicine, Ipsen, Natera, QED and Taiho Oncology; and declares clinical trials involvement and/or funding from AstraZeneca, Boston Scientific and TerSera. H.P. declares research funding/grant support for clinical trials (to her institution) from Ambrx, Amgen, Aprea Therapeutics, Array BioPharma, Bayer, BeiGene, BJ Bioscience, BMS, Daiichi Sankyo, Elicio Therapeutics, Lilly, EMD Serono, Genentech, Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Hoffman-LaRoche, Hutchison MediPharma, ImmuneOncia Therapeutics, Incyte, Jounce, Mabspace Biosciences, MacroGenics, MedImmune, Medivation, Merck, Millennium, Mirati Therapeutics, Novartis Pharmaceuticals, Oncologie, Pfizer, PsiOxus Therapeutics, Puma Biotechnology, Regeneron Pharmaceuticals, Seattle Genetics, Synermore Biologics, Taiho Pharmaceutical, TopAlliance Biosciences, Turning Point Therapeutics, Vedanta Biosciences, Vertex Pharmaceuticals and Xencor. T.K.C. reports institutional and personal research support from Alexion, Analysis Group, AstraZeneca, Bayer, BMS/ER Squibb and Sons, Calithera, Cerulean, Corvus, Eisai, Exelixis, F. Hoffmann-La Roche, Foundation Medicine, Genentech, GlaxoSmithKline, Ipsen, Lilly, Merck, Novartis, Peloton, Pfizer, Prometheus Labs, Roche, Roche Products, Sanofi/Aventis, Takeda and Tracon; honoraria from Alexion, American Society of Medical Oncology, Analysis Group, AstraZeneca, Bayer, BMS/ER Squibb and Sons, Cerulean, Clinical Care Options, Corvus, Eisai, EMD Serono, Exelixis, F. Hoffmann-La Roche, Foundation Medicine, Genentech, GlaxoSmithKline, Harborside Press, Heron Therapeutics, Ipsen, Kidney Cancer Journal, Lancet Oncology, Lilly Oncology, L-path, Merck, Michael J. Hennessy (MJH) Associates (Healthcare Communications Company with several brands such as OnClive, PeerView and PER), Navinata Healthcare, NCCN, New England Journal of Medicine, Novartis, Peloton, Pfizer, Platform Q, Prometheus Labs, Research to Practice, Roche, Roche Products, Sanofi/Aventis and Up-to-Date; consulting or advisory roles with Alexion, Analysis Group, AstraZeneca, Bayer, BMS/ER Squibb and Sons, Cerulean, Corvus, Eisai, EMD Serono, Exelixis, Foundation Medicine, Genentech, GlaxoSmithKline, Heron Therapeutics, Ipsen, Lilly, Lilly Ventures, Merck, NCCN, Novartis, Peloton, Pfizer, Pionyr, Prometheus Labs, Roche, Sanofi/Aventis, Tempest and Up-to-Date; stock/option ownership in Pionyr and Tempest; present or past leadership roles as Director of GU Oncology Division at the Dana-Farber Cancer Institute (DFCI) and past President of Medical Staff at DFCI, a member of NCCN Kidney panel and the GU Steering Committee, past chairman of the Kidney Cancer Association Medical and Scientific Steering Committee, a member of the KidneyCan Advisory board, Kidney Cancer Research Summit co-chair (2019–present); patents, royalties or other intellectual properties related to biomarkers of immune checkpoint blockers and circulating free methylated DNA; and travel, accommodation, expenses, in relation to consulting, advisory roles or honoraria. N.P. serves on the ASH Communications and ASCO Leukemia advisory panels; has received consultant fees from Blueprint, BMS, ImmunoGen, Pacylex Pharmaceuticals; grants from Affymetrix and the Sagerstrong Foundation; honoraria from AbbVie, Blueprint, Celgene, DAVA Oncology, Incyte, LFB Biotechnologies, MustangBio, Novartis, Roche Diagnostics, Springer Science & Business Media and Stemline Therapeutics; research support from AbbVie, Affymetrix, Celgene, Cellectis, Daiichi Sankyo, Novartis, Plexxikon, Samus Therapeutics and Stemline Therapeutics; and travel support from AbbVie, Celgene, DAVA Oncology, MustangBio and Stemline Therapeutics. V.S. declares research funding/grant support for clinical trials (to his institution) from AbbVie, Agensys, Alfa-Sigma, Altum, Amgen, Bayer, Berghealth, Blueprint, Boston Biomedical, Boston Pharmaceuticals, D3, Dragonfly Therapeutics, Exelixis, Fujifilm, Idera Pharma, Incyte, Inhibrx, Loxo oncology, MedImmune, Multivir, NCCN, Novartis, Pharmamar, Pfizer, Takeda and Turning Point Therapeutics; has received travel funding from ASCO, ESMO, Helsinn, Incyte, Novartis and Pharmamar; and has served on advisory boards for AstraZeneca/MedImmune, Helsinn, Incyte, Loxo Oncology/Lilly, Novartis, QED Pharma, R-Pharma US and Signant Health. The other authors declare no competing interests.

References

    1. Baden LR, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N. Engl. J. Med. 2020;384:403–416. doi: 10.1056/NEJMoa2035389. - DOI - PMC - PubMed
    1. Polack FP, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N. Engl. J. Med. 2020;383:2603–2615. doi: 10.1056/NEJMoa2034577. - DOI - PMC - PubMed
    1. Zhang Y, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect. Dis. 2020;21:181–192. doi: 10.1016/S1473-3099(20)30843-4. - DOI - PMC - PubMed
    1. Logunov DY, et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020;396:887–897. doi: 10.1016/S0140-6736(20)31866-3. - DOI - PMC - PubMed
    1. Voysey M, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397:99–111. doi: 10.1016/S0140-6736(20)32661-1. - DOI - PMC - PubMed

Substances