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      COVID‐19 vaccine research and development: ethical issues

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      Author(s): 1 , 2 ,
      Publication date (Electronic):
      Journal: Tropical Medicine & International Health
      Publisher: John Wiley and Sons Inc.
      Keywords: COVID‐19, vaccine research, ethics

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          Abstract

          The achievements of vaccine research and development bring a hope to our societies that we may cope with the COVID‐19 pandemic. There are two aspects that should be maintained in balance: the immediate necessity for speed of vaccine research and the inherent need for protection of research subjects, which is the foremost concern of research ethics. This narrative review highlights ethical issues in COVID‐19 vaccine research and development that every stakeholder needs to be aware of and to consider.

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          An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

          Lisa A Jackson, Evan J Anderson, Nadine G Rouphael … (2020)
          Abstract Background The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein. Methods We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group. Results After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events. Conclusions The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461).
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            Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections

            Quan-Xin Long, Xiao-Jun Tang, Qiu-Lin Shi … (2020)
            The clinical features and immune responses of asymptomatic individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have not been well described. We studied 37 asymptomatic individuals in the Wanzhou District who were diagnosed with RT-PCR-confirmed SARS-CoV-2 infections but without any relevant clinical symptoms in the preceding 14 d and during hospitalization. Asymptomatic individuals were admitted to the government-designated Wanzhou People's Hospital for centralized isolation in accordance with policy1. The median duration of viral shedding in the asymptomatic group was 19 d (interquartile range (IQR), 15-26 d). The asymptomatic group had a significantly longer duration of viral shedding than the symptomatic group (log-rank P = 0.028). The virus-specific IgG levels in the asymptomatic group (median S/CO, 3.4; IQR, 1.6-10.7) were significantly lower (P = 0.005) relative to the symptomatic group (median S/CO, 20.5; IQR, 5.8-38.2) in the acute phase. Of asymptomatic individuals, 93.3% (28/30) and 81.1% (30/37) had reduction in IgG and neutralizing antibody levels, respectively, during the early convalescent phase, as compared to 96.8% (30/31) and 62.2% (23/37) of symptomatic patients. Forty percent of asymptomatic individuals became seronegative and 12.9% of the symptomatic group became negative for IgG in the early convalescent phase. In addition, asymptomatic individuals exhibited lower levels of 18 pro- and anti-inflammatory cytokines. These data suggest that asymptomatic individuals had a weaker immune response to SARS-CoV-2 infection. The reduction in IgG and neutralizing antibody levels in the early convalescent phase might have implications for immunity strategy and serological surveys.
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              mRNA vaccines — a new era in vaccinology

              Norbert Pardi, Michael Hogan, Frederick W. Porter … (2018)
              mRNA vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration. However, their application has until recently been restricted by the instability and inefficient in vivo delivery of mRNA. Recent technological advances have now largely overcome these issues, and multiple mRNA vaccine platforms against infectious diseases and several types of cancer have demonstrated encouraging results in both animal models and humans. This Review provides a detailed overview of mRNA vaccines and considers future directions and challenges in advancing this promising vaccine platform to widespread therapeutic use.
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                Author and article information

                Contributors
                T. Wibawa: twibawa@ugm.ac.id
                Journal
                Journal ID (nlm-ta): Trop Med Int Health
                Journal ID (iso-abbrev): Trop Med Int Health
                Journal ID (doi): 10.1111/(ISSN)1365-3156
                Journal ID (publisher-id): TMI
                Title: Tropical Medicine & International Health
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 1360-2276
                ISSN (Electronic): 1365-3156
                Publication date (Electronic): 19 October 2020
                Electronic Location Identifier: 10.1111/tmi.13503
                Affiliations
                [ 1 ] Department of Microbiology Faculty of Medicine Public Health and Nursing Universitas Gadjah Mada Yogyakarta Indonesia
                [ 2 ] Medical and Health Research Ethics Committee Faculty of Medicine Public Health and Nursing Universitas Gadjah Mada / Dr. Sardjito General Hospital Yogyakarta Indonesia
                Author notes
                [*] [* ] Corresponding Author: Tri Wibawa, Department of Microbiology, Faculty of Medicine Public Health and Nursing, Universitas Gadjah Mada, Jl. Farmaco, Sekip Utara, Yogyakarta 55281, Indonesia. Phone +62274580297; Fax +62274581876; E‐mail: twibawa@ 123456ugm.ac.id

                Article
                Publisher ID: TMI13503
                DOI: 10.1111/tmi.13503
                PMC ID: 7675299
                PubMed ID: 33012020
                SO-VID: 92d8bc69-9116-461f-806a-af85c6d6a391
                Copyright © © 2020 John Wiley & Sons Ltd
                License:

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                Page count
                Figures: 0, Tables: 1, Pages: 6, Words: 9818
                Categories
                Subject: Narrative Review
                Subject: Narrative Reviews
                Custom metadata
                source-schema-version-number 2.0
                edited-state corrected-proof
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.4 mode:remove_FC converted:19.11.2020

                ScienceOpen disciplines: Medicine
                Keywords: covid‐19,vaccine research,ethics
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: covid‐19, vaccine research, ethics

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