Advertisement

Sex-Based Vaccine Response in the Context of COVID-19

Published:August 05, 2020DOI:https://doi.org/10.1016/j.jogn.2020.08.001
      We are in the midst of a global public health emergency with the spread of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19). A safe, effective, accessible, and acceptable vaccine is critically needed to prevent the spread of COVID-19. Reports indicate that the number of COVID-19 cases between men and women is similar, but men experience more severe outcomes, including hospitalization, admission to the intensive care unit, and death (
      • Bischof E.
      • Wolfe J.
      • Klein S.L.
      Clinical trials for COVID-19 should include sex as a variable.
      ;
      Global Health 5050
      COVID-19 sex-disaggregated data tracker.
      ;
      • Klein S.L.
      • Dhakal S.
      • Ursin R.L.
      • Deshpande S.
      • Sandberg K.
      • Mauvais-Jarvis F.
      Biological sex impacts COVID-19 outcomes.
      ;
      • Scully E.P.
      • Haverfield J.
      • Ursin R.L.
      • Tannenbaum C.
      • Klein S.L.
      Considering how biological sex impacts immune responses and COVID-19 outcomes.
      ). Although sex clearly plays a role in this disease, many states in the United States do not report or analyze differences in outcomes between men and women. In some cases, when differences in outcomes are reported by sex, findings are inconsistent (
      • Klein S.L.
      • Dhakal S.
      • Ursin R.L.
      • Deshpande S.
      • Sandberg K.
      • Mauvais-Jarvis F.
      Biological sex impacts COVID-19 outcomes.
      ). Data that are disaggregated for sex are necessary to compare outcomes, inform clinicians, and enable appropriate risk assessment and care, including the development and distribution of a vaccine. In this editorial, I offer a brief overview of what is known about sex-based responses to vaccines, development of a SARS-CoV-2 vaccine, and considerations for research and practice. While sex (biological characteristics of genetics, reproductive organs, and sex hormones) and gender (social and cultural characteristics) have been shown to influence vaccine uptake and related outcomes (
      • Flanagan K.L.
      • Fink A.L.
      • Plebanski M.
      • Klein S.L.
      Sex and gender differences in the outcomes of vaccination over the life course.
      ), I will limit my discussion to biological sex as a variable.
      To read this article in full you will need to make a payment
      AWHONN Member Login
      AWHONN Members, full access to the journal is a member benefit. Use your society credentials to access all journal content and features

      Purchase one-time access:

      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Bar-Zeev N.
        • Moss W.
        Encouraging results from phase 1/2 COVID-19 vaccine trials.
        The Lancet. 2020; 396 (https://doi.org/10.1016/S0140-6736(20)31611-1): 448-449
        • Bischof E.
        • Wolfe J.
        • Klein S.L.
        Clinical trials for COVID-19 should include sex as a variable.
        Journal of Clinical Investigation. 2020; 130: 3350-3352https://doi.org/10.1172/JCI139306
        • Cook I.F.
        Sex differences in injection site reactions with human vaccines.
        Human Vaccines. 2009; 5: 441-449https://doi.org/10.4161/hv.8476
        • Corey L.
        • Mascola J.R.
        • Fauci A.S.
        • Collins F.S.
        A strategic approach to COVID-19 vaccine R&D.
        Science. 2020; 368: 948-950https://doi.org/10.1126/science.abc5312
        • Fink A.L.
        • Klein S.L.
        Sex and gender impact immune responses to vaccines among the elderly.
        Physiology. 2015; 30: 408-416https://doi.org/10.1152/physiol.00035.2015
        • Fink A.L.
        • Klein S.L.
        The evolution of greater humoral immunity in females than males: Implications for vaccine efficacy.
        Current Opinion in Physiology. 2018; 6: 16-20https://doi.org/10.1016/j.cophys.2018.03.010
        • Fischinger S.
        • Boudreau C.M.
        • Butler A.L.
        • Streeck H.
        • Alter G.
        Sex differences in vaccine-induced humoral immunity.
        Seminars in Immunopathology. 2019; 41: 239-249https://doi.org/10.1007/s00281-018-0726-5
        • Flanagan K.L.
        • Fink A.L.
        • Plebanski M.
        • Klein S.L.
        Sex and gender differences in the outcomes of vaccination over the life course.
        Annual Review of Cell & Developmental Biology. 2017; 33: 577-599https://doi.org/10.1146/annurev-cellbio-100616-060718
        • Folegatti P.M.
        • Ewer K.J.
        • Aley P.K.
        • Angus B.
        • Becker S.
        • Belij-Rammerstorfer S.
        • Oxford COVID Vaccine Trial Group
        Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: A preliminary report of a phase 1/2, single-blind, randomised controlled trial.
        The Lancet. 2020; 396: 467-478
        • Global Health 5050
        COVID-19 sex-disaggregated data tracker.
        • Griffioen M.
        • Halsey N.
        Gender differences in immediate hypersensitivity reactions to vaccines: A review of the literature.
        Public Health Nursing. 2014; 31: 206-214https://doi.org/10.1111/phn.12073
        • Jackson L.A.
        • Anderson E.J.
        • Rouphael N.G.
        • Roberts P.C.
        • Makhene M.
        • Coler R.N.
        • mRNA-1273 Study Group
        An mRNA vaccine against SARS-CoV-2—Preliminary report. New England Journal of Medicine. Advance online publication.
        • Klein S.L.
        • Dhakal S.
        • Ursin R.L.
        • Deshpande S.
        • Sandberg K.
        • Mauvais-Jarvis F.
        Biological sex impacts COVID-19 outcomes.
        PLOS Pathogens. 2020; 16e1008570https://doi.org/10.1371/journal.ppat.1008570
        • Klein S.L.
        • Flanagan K.L.
        Sex differences in immune responses. Nature Reviews.
        Immunology. 2016; 16: 626-638https://doi.org/10.1038/nri.2016.90
        • National Institutes of Health
        Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV).
        • Office of Research on Women’s Health. (n.d.)
        NIH policy on sex as a biological variable.
        • Ogburn E.L.
        • Bierer B.E.
        • Brookmeyer R.
        • Choirat C.
        • Dean N.E.
        • De Gruttola V.
        • Scharfstein D.O.
        Aggregating data from COVID-19 trials.
        Science. 2020; 368: 1198-1199https://doi.org/10.1126/science.abc8993
        • Ratzan S.C.
        • Bloom B.R.
        • El-Mohandes A.
        • Fielding J.
        • Gostin L.O.
        • Hodge J.G.
        • Rabin K.
        The Salzburg statement on vaccination acceptance.
        Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2019; 48: 591-592https://doi.org/10.1016/j.jogn.2019.10.001
        • Scully E.P.
        • Haverfield J.
        • Ursin R.L.
        • Tannenbaum C.
        • Klein S.L.
        Considering how biological sex impacts immune responses and COVID-19 outcomes.
        Nature Reviews: Immunology. 2020; 20: 442-447https://doi.org/10.1038/s41577-020-0348-8
        • U.S. Food and Drug Administration
        Guidance for industry toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials.
        • U.S. Food and Drug Administration
        Regulations, guidance, and reports related to women’s health.
        • U.S. House of Representatives, Committee on Energy and Commerce
        Pathway to a vaccine: Efforts to develop a safe, effective, and accessible COVID-19 vaccine. [Hearing].
        • World Health Organization
        Draft landscape of COVID-19 candidate vaccines.