{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,5]],"date-time":"2026-04-05T08:00:29Z","timestamp":1775376029413,"version":"3.50.1"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T00:00:00Z","timestamp":1598486400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"},{"start":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T00:00:00Z","timestamp":1598486400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["DARU J Pharm Sci"],"published-print":{"date-parts":[[2020,12]]},"DOI":"10.1007\/s40199-020-00371-8","type":"journal-article","created":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T04:09:58Z","timestamp":1598501398000},"page":"807-812","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["COVID-19 vaccines: ethical framework concerning human challenge studies"],"prefix":"10.1007","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1523-9116","authenticated-orcid":false,"given":"Daniela","family":"Calina","sequence":"first","affiliation":[]},{"given":"Thomas","family":"Hartung","sequence":"additional","affiliation":[]},{"given":"Anca Oana","family":"Docea","sequence":"additional","affiliation":[]},{"given":"Demetrios A.","family":"Spandidos","sequence":"additional","affiliation":[]},{"given":"Alex M.","family":"Egorov","sequence":"additional","affiliation":[]},{"given":"Michael I.","family":"Shtilman","sequence":"additional","affiliation":[]},{"given":"Felix","family":"Carvalho","sequence":"additional","affiliation":[]},{"given":"Aristidis","family":"Tsatsakis","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2020,8,27]]},"reference":[{"key":"371_CR1","first-page":"1631","volume":"45","author":"AO Docea","year":"2020","unstructured":"Docea AO, Tsatsakis A, Albulescu D, Cristea O, Zlatian O, Vinceti M, et al. A new threat from an old enemy: re-emergence of coronavirus (review). Int J Mol Med. 2020;45:1631\u201343.","journal-title":"Int J Mol Med"},{"key":"371_CR2","doi-asserted-by":"publisher","first-page":"467","DOI":"10.3892\/ijmm.2020.4608","volume":"46","author":"G Nitulescu","year":"2020","unstructured":"Nitulescu G, Paunescu H, Moschos S, Petrakis D, Nitulescu G, Ion GN, et al. Comprehensive analysis of drugs to treat SARS-CoV-2 infection: mechanistic insights into current COVID-19 therapies (review). Int J Mol Med. 2020;46:467\u201388.","journal-title":"Int J Mol Med"},{"key":"371_CR3","doi-asserted-by":"publisher","first-page":"111418","DOI":"10.1016\/j.fct.2020.111418","volume":"141","author":"A Tsatsakis","year":"2020","unstructured":"Tsatsakis A, Petrakis D, Nikolouzakis TK, Docea AO, Calina D, Vinceti M, et al. COVID-19, an opportunity to reevaluate the correlation between long-term effects of anthropogenic pollutants on viral epidemic\/pandemic events and prevalence. Food Chem Toxicol. 2020;141:111418.","journal-title":"Food Chem Toxicol"},{"key":"371_CR4","doi-asserted-by":"publisher","first-page":"185","DOI":"10.31925\/farmacia.2020.2.1","volume":"68","author":"AL Arsene","year":"2020","unstructured":"Arsene AL, Dumitrescu IB, Dragoi CM, Udeanu DI, Lupuliasa D, Jinga V, et al. A new era for the therapeutic management of the ongoing COVID-19 pandemic. Farmacia. 2020;68:185\u201396.","journal-title":"Farmacia."},{"key":"371_CR5","doi-asserted-by":"publisher","first-page":"622","DOI":"10.1377\/hlthaff.24.3.622","volume":"24","author":"PA Offit","year":"2005","unstructured":"Offit PA. Why are pharmaceutical companies gradually abandoning vaccines? Congress has the power to protect vaccines, a product that is vital to the health of the United States and the rest of the world. Health Aff. 2005;24:622\u201330.","journal-title":"Health Aff"},{"key":"371_CR6","doi-asserted-by":"publisher","first-page":"2263","DOI":"10.1007\/s00204-020-02787-2","volume":"94","author":"F Busquet","year":"2020","unstructured":"Busquet F, Hartung T, Pallocca G, Rovida C, Leist M. Harnessing the power of novel animal-free test methods for the development of COVID-19 drugs and vaccines. Arch Toxicol. 2020;94:2263\u201372.","journal-title":"Arch Toxicol"},{"issue":"8","key":"371_CR7","doi-asserted-by":"publisher","first-page":"e198","DOI":"10.1016\/S1473-3099(20)30438-2","volume":"20","author":"E Jamrozik","year":"2020","unstructured":"Jamrozik E, Selgelid MJ. COVID-19 human challenge studies: ethical issues. Lancet Infect Dis. 2020;20(8):e198\u2013203.","journal-title":"Lancet Infect Dis"},{"issue":"8","key":"371_CR8","doi-asserted-by":"publisher","first-page":"281","DOI":"10.3389\/fpubh.2020.00281","volume":"3","author":"M Torequl Islam","year":"2020","unstructured":"Torequl Islam M, Nasiruddin M, Khan IN, Mishra SK, Kudrat-E-Zahan M, Alam Riaz T, et al. A Perspective on Emerging Therapeutic Interventions for COVID-19. Front Public Health. 2020;3(8):281.","journal-title":"Front Public Health"},{"key":"371_CR9","first-page":"605","volume":"64","author":"AO Docea","year":"2020","unstructured":"Docea AO, Gofita E, Calina D, Zaharie SI, Valcea DI, Mitrut P. Autoimmune disorders due to double antiviral therapy with Peginterferon and ribavirin in patients with hepatitis C virus infection. Farmacia. 2020;64:605\u201311.","journal-title":"Farmacia."},{"key":"371_CR10","doi-asserted-by":"publisher","first-page":"942","DOI":"10.1126\/science.abc6141","volume":"368","author":"SS Lakdawala","year":"2020","unstructured":"Lakdawala SS, Menachery VD. The search for a COVID-19 animal model. Science. 2020;368:942\u20133.","journal-title":"Science."},{"key":"371_CR11","doi-asserted-by":"publisher","first-page":"3","DOI":"10.3892\/ijmm.2020.4596","volume":"46","author":"D Calina","year":"2020","unstructured":"Calina D, Docea AO, Petrakis D, Egorov AM, Ishmukhametov AA, Gabibov AG, et al. Towards effective COVID-19 vaccines: updates, perspectives and challenges (review). Int J Mol Med. 2020;46:3\u201316.","journal-title":"Int J Mol Med"},{"key":"371_CR12","doi-asserted-by":"publisher","first-page":"1","DOI":"10.29252\/ibj.24.1.1","volume":"24","author":"M Rostami-Nejad","year":"2020","unstructured":"Rostami-Nejad M, Yazdi MH, Nikfar S, Rezaie A, Abdollahi M. Potential vaccines for treating Crohn\u2019s disease. Iran Biomed J. 2020;24:1\u201314.","journal-title":"Iran Biomed J"},{"key":"371_CR13","doi-asserted-by":"publisher","first-page":"759","DOI":"10.15585\/mmwr.mm6924e2","volume":"69","author":"EK Stokes","year":"2020","unstructured":"Stokes EK, Zambrano LD, Anderson KN, Marder EP, Raz KM, Suad El Burai F, et al. Coronavirus Disease 2019 Case Surveillance \u2014 United States, January 22\u2013May 30, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:759\u201365.","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"371_CR14","unstructured":"Rapid Risk Assessment: Coronavirus disease 2019 (COVID-19) in the EU\/EEA and the UK \u2013 tenth update. https:\/\/www.ecdc.europa.eu\/en\/publications-data\/rapid-risk-assessment-coronavirus-disease-2019-covid-19-pandemic-tenth-update. Accessed 19 June 2020."},{"key":"371_CR15","unstructured":"World Health Organization: Draft landscape of COVID-19 candidate vaccines - 15 May 2020. Who, 2020. https:\/\/www.chathamhouse.org\/expert\/comment\/hurdles-developing-covid-19-vaccine-why-international-cooperation-needed?gclid=EAIaIQobChMI4dKa-oys6gIVCRd7Ch3ydQv0EAAYASAAEgLi9vD_BwE. Accessed 11 June 2020."},{"key":"371_CR16","unstructured":"CDC Seasonal Flu Vaccine Effectiveness Studies | CDC. https:\/\/www.cdc.gov\/flu\/vaccines-work\/effectiveness-studies.htm. Accessed 15 May 2020."},{"key":"371_CR17","doi-asserted-by":"publisher","first-page":"2025","DOI":"10.1093\/infdis\/jit359","volume":"208","author":"E Movert","year":"2013","unstructured":"Movert E, Wu Y, Lambeau G, Kahn F, Touqui L, Areschoug T. Using patient pathways to accelerate the drive to ending tuberculosis. J Infect Dis. 2013;208:2025\u201335.","journal-title":"J Infect Dis"},{"issue":"3","key":"371_CR18","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0057755","volume":"8","author":"ES Pronker","year":"2013","unstructured":"Pronker ES, Weenen TC, Commandeur H, Claassen EH, Osterhaus AD. Risk in vaccine research and development quantified. PLoS One. 2013;8(3):e57755.","journal-title":"PLoS One"},{"key":"371_CR19","unstructured":"Mortality Risk of COVID-19 - Statistics and Research - Our World in Data. https:\/\/covid19.who.int\/?gclid=EAIaIQobChMI1brnrY2s6gIVxgJ7Ch2iFwLyEAAYASAAEgILofD_BwE. Accessed 12 June 2020."},{"issue":"24","key":"371_CR20","doi-asserted-by":"publisher","first-page":"3987","DOI":"10.1016\/j.vaccine.2020.04.039","volume":"38","author":"SA Plotkin","year":"2020","unstructured":"Plotkin SA, Caplan A. Extraordinary diseases require extraordinary solutions. Vaccine. 2020;38(24):3987\u20138.","journal-title":"Vaccine."},{"key":"371_CR21","doi-asserted-by":"publisher","unstructured":"Bullen CK , Hogberg HT , Bahadirli-Talbott A , Bishai WR , Hartung T, Keuthan C. Infectability of Human BrainSphere Neurons Suggests Neurotropism of SARS-CoV-2. ALTEX - Alternatives to animal experimentation. 2020;https:\/\/doi.org\/10.14573\/altex.2006111.","DOI":"10.14573\/altex.2006111"},{"key":"371_CR22","doi-asserted-by":"publisher","first-page":"708","DOI":"10.1002\/emmm.201403876","volume":"6","author":"I Delany","year":"2014","unstructured":"Delany I, Rappuoli R, De Gregorio E. Vaccines for the 21st century. EMBO Mol Med. 2014;6:708\u201320.","journal-title":"EMBO Mol Med"},{"key":"371_CR23","doi-asserted-by":"crossref","unstructured":"Bompart F. Healthy volunteers for clinical trials in resource-poor settings: National registries can address ethical and safety concerns. In: Cambridge Quarterly of Healthcare Ethics. vol. 28.2019; Cambridge University Press, pp134\u2013143.","DOI":"10.1017\/S0963180118000476"},{"issue":"1","key":"371_CR24","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1093\/phe\/phv026","volume":"9","author":"B Bambery","year":"2016","unstructured":"Bambery B, Selgelid M, Weijer C, Savulescu J, Pollard AJ. Ethical criteria for human challenge studies in infectious diseases. Public Health Ethics. 2016;9(1):92\u2013103.","journal-title":"Public Health Ethics"},{"issue":"11","key":"371_CR25","doi-asserted-by":"publisher","first-page":"1752","DOI":"10.1093\/infdis\/jiaa152","volume":"221","author":"N Eyal","year":"2020","unstructured":"Eyal N, Lipsitch M, Smith PG. Human challenge studies to accelerate coronavirus vaccine licensure. J Infect Dis. 2020;221(11):1752\u20136.","journal-title":"J Infect Dis"},{"issue":"33","key":"371_CR26","doi-asserted-by":"publisher","first-page":"5085","DOI":"10.1016\/j.vaccine.2020.06.007","volume":"38","author":"GO Schaefer","year":"2020","unstructured":"Schaefer GO, Tam CC, Savulescu J, Voo TC. COVID-19 vaccine development: time to consider SARS-CoV-2 challenge studies? Vaccine. 2020;38(33):5085\u20138.","journal-title":"Vaccine."},{"issue":"6","key":"371_CR27","doi-asserted-by":"publisher","first-page":"1119","DOI":"10.1016\/j.mayocp.2020.04.019","volume":"95","author":"KM Meagher","year":"2020","unstructured":"Meagher KM, Cummins NW, Bharucha AE, Badley AD, Chlan LL, Wright RS. COVID-19 ethics and research. Mayo Clin Proc. 2020;95(6):1119\u201323.","journal-title":"Mayo Clin Proc"},{"issue":"6","key":"371_CR28","doi-asserted-by":"publisher","first-page":"669","DOI":"10.1016\/S1473-3099(20)30243-7","volume":"20","author":"R Verity","year":"2020","unstructured":"Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, et al. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020;20(6):669\u201377.","journal-title":"Lancet Infect Dis"},{"issue":"2","key":"371_CR29","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1007\/s11017-011-9201-1","volume":"33","author":"DB Resnik","year":"2012","unstructured":"Resnik DB. Limits on risks for healthy volunteers in biomedical research. Theor Med Bioeth. 2012;33(2):137\u201349.","journal-title":"Theor Med Bioeth"},{"key":"371_CR30","doi-asserted-by":"publisher","first-page":"239","DOI":"10.1186\/1743-422X-10-239","volume":"10","author":"WH Gerlich","year":"2013","unstructured":"Gerlich WH. Medical virology of hepatitis B: how it began and where we are now. Virol J. 2013;10:239.","journal-title":"Virol J"}],"container-title":["DARU Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40199-020-00371-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40199-020-00371-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40199-020-00371-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,26]],"date-time":"2021-08-26T23:12:22Z","timestamp":1630019542000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40199-020-00371-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8,27]]},"references-count":30,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["371"],"URL":"https:\/\/doi.org\/10.1007\/s40199-020-00371-8","relation":{},"ISSN":["2008-2231"],"issn-type":[{"value":"2008-2231","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8,27]]},"assertion":[{"value":"8 July 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 August 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 August 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This content has been made available to all.","name":"free","label":"Free to read"}]}}