COVID-19 vaccines : ethical framework concerning human challenge studies

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2020
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Calina, Daniela
Docea, Anca Oana
Spandidos, Demetrios A.
Egorov, Alex M.
Shtilman, Michael I.
Carvalho, Felix
Tsatsakis, Aristidis
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DARU Journal of Pharmaceutical Sciences. Springer. 2020, 28(2), pp. 807-812. ISSN 1560-8115. eISSN 2008-2231. Available under: doi: 10.1007/s40199-020-00371-8
Zusammenfassung

Background
The pandemic associated with the new SARS-CoV-2 coronavirus continues to spread worldwide. The most favorable epidemic control scenario, which provides long-term protection against COVID-19 outbreak, is the development and distribution of an effective and safe vaccine. The need to develop a new COVID-19 vaccine is pressing; however, it is likely to take a long time, possibly several years. This is due to the time required to demonstrate the safety and efficacy of the proposed vaccine. and the time required to manufacture and distribute millions of doses.

Objectives
To accelerate this development and associated safety testing, the deliberate infection of healthy volunteers has been suggested. The purpose of this short communication is to describe the ethical aspects of this type of testing,

Results
Deliberate infection of volunteers with a dangerous virus such as SARS-CoV-2 was initially considered unethical by researchers; but the current pandemic is so different from previous ones that these studies are considered ethical if certain criteria are met. Participants in human challenge studies must be relatively young, in good health and must receive the highest quality medical care, with frequent monitoring. Tests should also be performed with great caution and specialized medical supervision. Besides, the fact that obtaining vaccines faster through deliberate infection studies of healthy people has greater benefits than risks, has been demonstrated by obtaining other vaccines in other historical pandemics such as: smallpox, influenza, malaria, typhoid fever, Dengue fever and Zika.

Conclusions
One possibility to shorten the time required for the development of COVID-19 vaccines is to reduce clinical phases II and III by using human challenge studies through eliberate infection of healthy volunteers with SARS-CoV-2 after administration of the candidate vaccine. Accelerating the development of a COVID-19 vaccine even for a few weeks or months would have a great beneficial impact on public health by saving many lives.

Zusammenfassung in einer weiteren Sprache
Fachgebiet (DDC)
570 Biowissenschaften, Biologie
Schlagwörter
COVID-19 vaccines, Risk taking, Human challenge studies, Randomized clinical trials
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ISO 690CALINA, Daniela, Thomas HARTUNG, Anca Oana DOCEA, Demetrios A. SPANDIDOS, Alex M. EGOROV, Michael I. SHTILMAN, Felix CARVALHO, Aristidis TSATSAKIS, 2020. COVID-19 vaccines : ethical framework concerning human challenge studies. In: DARU Journal of Pharmaceutical Sciences. Springer. 2020, 28(2), pp. 807-812. ISSN 1560-8115. eISSN 2008-2231. Available under: doi: 10.1007/s40199-020-00371-8
BibTex
@article{Calina2020-12COVID-51106,
  year={2020},
  doi={10.1007/s40199-020-00371-8},
  title={COVID-19 vaccines : ethical framework concerning human challenge studies},
  number={2},
  volume={28},
  issn={1560-8115},
  journal={DARU Journal of Pharmaceutical Sciences},
  pages={807--812},
  author={Calina, Daniela and Hartung, Thomas and Docea, Anca Oana and Spandidos, Demetrios A. and Egorov, Alex M. and Shtilman, Michael I. and Carvalho, Felix and Tsatsakis, Aristidis}
}
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    <dcterms:abstract xml:lang="eng">Background&lt;br /&gt;The pandemic associated with the new SARS-CoV-2 coronavirus continues to spread worldwide. The most favorable epidemic control scenario, which provides long-term protection against COVID-19 outbreak, is the development and distribution of an effective and safe vaccine. The need to develop a new COVID-19 vaccine is pressing; however, it is likely to take a long time, possibly several years. This is due to the time required to demonstrate the safety and efficacy of the proposed vaccine. and the time required to manufacture and distribute millions of doses.&lt;br /&gt;&lt;br /&gt;Objectives&lt;br /&gt;To accelerate this development and associated safety testing, the deliberate infection of healthy volunteers has been suggested. The purpose of this short communication is to describe the ethical aspects of this type of testing,&lt;br /&gt;&lt;br /&gt;Results&lt;br /&gt;Deliberate infection of volunteers with a dangerous virus such as SARS-CoV-2 was initially considered unethical by researchers; but the current pandemic is so different from previous ones that these studies are considered ethical if certain criteria are met. Participants in human challenge studies must be relatively young, in good health and must receive the highest quality medical care, with frequent monitoring. Tests should also be performed with great caution and specialized medical supervision. Besides, the fact that obtaining vaccines faster through deliberate infection studies of healthy people has greater benefits than risks, has been demonstrated by obtaining other vaccines in other historical pandemics such as: smallpox, influenza, malaria, typhoid fever, Dengue fever and Zika.&lt;br /&gt;&lt;br /&gt;Conclusions&lt;br /&gt;One possibility to shorten the time required for the development of COVID-19 vaccines is to reduce clinical phases II and III by using human challenge studies through eliberate infection of healthy volunteers with SARS-CoV-2 after administration of the candidate vaccine. Accelerating the development of a COVID-19 vaccine even for a few weeks or months would have a great beneficial impact on public health by saving many lives.</dcterms:abstract>
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