COVID-19 vaccine development: Time to consider SARS-CoV-2 challenge studies? 2020

G Owen Schaefer, and Clarence C Tam, and Julian Savulescu, and Teck Chuan Voo
Centre for Biomedical Ethics, National University of Singapore, Yong Loo Lin School of Medicine, Block MD11, Clinical Research Centre, #02-03, 10 Medical Drive, Singapore 117597, Singapore.

While a human challenge study holds the prospect of accelerating the development of a vaccine for the coronavirus SARS-CoV-2, it may be opposed due to risks of harm to participants and researchers. Given the increasing number of human deaths and severe disruption to lives worldwide, we argue that a SARS-CoV-2 challenge study is ethically justifiable as its social value substantially outweighs the risks. Such a study should therefore be seriously considered as part of the global research response towards the COVID-19 pandemic. In this paper, we contribute to the debate by addressing the misperception that a challenge study for the coronavirus would lower scientific and ethical standards for vaccine research and development, and examine how it could be ethically conducted. We also set out information that needs to be disclosed to prospective participants to obtain their consent.

UI MeSH Term Description Entries
D007258 Informed Consent Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. Consent, Informed
D011024 Pneumonia, Viral Inflammation of the lung parenchyma that is caused by a viral infection. Pneumonias, Viral,Viral Pneumonia,Viral Pneumonias
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000073640 Betacoronavirus A genus of the family CORONAVIRIDAE which causes respiratory or gastrointestinal disease in a variety of mostly mammals. Human betacoronaviruses include HUMAN ENTERIC CORONAVIRUS; HUMAN CORONAVIRUS OC43; MERS VIRUS; and SEVERE ACUTE RESPIRATORY SYNDROME-RELATED CORONAVIRUS. Members have either core transcription regulatory sequences of 5’-CUAAAC-3’ or 5’-CUAAAC-3’ and mostly have no ORF downstream to the N protein gene. HCoV-HKU1,Human coronavirus HKU1,Pipistrellus bat coronavirus HKU5,Rousettus bat coronavirus HKU9,Tylonycteris bat coronavirus HKU4,Betacoronaviruses
D000086382 COVID-19 A viral disorder generally characterized by high FEVER; COUGH; DYSPNEA; CHILLS; PERSISTENT TREMOR; MUSCLE PAIN; HEADACHE; SORE THROAT; a new loss of taste and/or smell (see AGEUSIA and ANOSMIA) and other symptoms of a VIRAL PNEUMONIA. In severe cases, a myriad of coagulopathy associated symptoms often correlating with COVID-19 severity is seen (e.g., BLOOD COAGULATION; THROMBOSIS; ACUTE RESPIRATORY DISTRESS SYNDROME; SEIZURES; HEART ATTACK; STROKE; multiple CEREBRAL INFARCTIONS; KIDNEY FAILURE; catastrophic ANTIPHOSPHOLIPID ANTIBODY SYNDROME and/or DISSEMINATED INTRAVASCULAR COAGULATION). In younger patients, rare inflammatory syndromes are sometimes associated with COVID-19 (e.g., atypical KAWASAKI SYNDROME; TOXIC SHOCK SYNDROME; pediatric multisystem inflammatory disease; and CYTOKINE STORM SYNDROME). A coronavirus, SARS-CoV-2, in the genus BETACORONAVIRUS is the causative agent. 2019 Novel Coronavirus Disease,2019 Novel Coronavirus Infection,2019-nCoV Disease,2019-nCoV Infection,COVID-19 Pandemic,COVID-19 Pandemics,COVID-19 Virus Disease,COVID-19 Virus Infection,Coronavirus Disease 2019,Coronavirus Disease-19,SARS Coronavirus 2 Infection,SARS-CoV-2 Infection,Severe Acute Respiratory Syndrome Coronavirus 2 Infection,COVID19,2019 nCoV Disease,2019 nCoV Infection,2019-nCoV Diseases,2019-nCoV Infections,COVID 19,COVID 19 Pandemic,COVID 19 Virus Disease,COVID 19 Virus Infection,COVID-19 Virus Diseases,COVID-19 Virus Infections,Coronavirus Disease 19,Disease 2019, Coronavirus,Disease, 2019-nCoV,Disease, COVID-19 Virus,Infection, 2019-nCoV,Infection, COVID-19 Virus,Infection, SARS-CoV-2,Pandemic, COVID-19,SARS CoV 2 Infection,SARS-CoV-2 Infections,Virus Disease, COVID-19,Virus Infection, COVID-19
D000086402 SARS-CoV-2 A species of BETACORONAVIRUS causing atypical respiratory disease (COVID-19) in humans. The organism was first identified in 2019 in Wuhan, China. The natural host is the Chinese intermediate horseshoe bat, RHINOLOPHUS affinis. 2019 Novel Coronavirus,COVID-19 Virus,COVID19 Virus,Coronavirus Disease 2019 Virus,SARS Coronavirus 2,SARS-CoV-2 Virus,Severe Acute Respiratory Syndrome Coronavirus 2,Wuhan Coronavirus,Wuhan Seafood Market Pneumonia Virus,2019-nCoV,2019 Novel Coronaviruses,COVID 19 Virus,COVID-19 Viruses,COVID19 Viruses,Coronavirus 2, SARS,Coronavirus, 2019 Novel,Coronavirus, Wuhan,Novel Coronavirus, 2019,SARS CoV 2 Virus,SARS-CoV-2 Viruses,Virus, COVID-19,Virus, COVID19,Virus, SARS-CoV-2,Viruses, COVID19
D000086663 COVID-19 Vaccines Vaccines or candidate vaccines containing SARS-CoV-2 component antigens, genetic materials, or inactivated SARS-CoV-2 virus, and designed to prevent COVID-19. 2019 Novel Coronavirus Vaccine,2019 Novel Coronavirus Vaccines,2019-nCoV Vaccine,2019-nCoV Vaccines,COVID 19 Vaccine,COVID-19 Vaccine,COVID-19 Virus Vaccine,COVID-19 Virus Vaccines,COVID19 Vaccine,COVID19 Vaccines,COVID19 Virus Vaccine,COVID19 Virus Vaccines,Coronavirus Disease 2019 Vaccine,Coronavirus Disease 2019 Vaccines,Coronavirus Disease 2019 Virus Vaccine,Coronavirus Disease 2019 Virus Vaccines,Coronavirus Disease-19 Vaccine,Coronavirus Disease-19 Vaccines,SARS Coronavirus 2 Vaccines,SARS-CoV-2 Vaccine,SARS-CoV-2 Vaccines,SARS2 Vaccine,SARS2 Vaccines,2019 nCoV Vaccine,2019 nCoV Vaccines,COVID 19 Vaccines,COVID 19 Virus Vaccine,COVID 19 Virus Vaccines,Coronavirus Disease 19 Vaccine,Coronavirus Disease 19 Vaccines,SARS CoV 2 Vaccine,SARS CoV 2 Vaccines,Vaccine, 2019-nCoV,Vaccine, COVID 19,Vaccine, COVID-19,Vaccine, COVID-19 Virus,Vaccine, COVID19,Vaccine, COVID19 Virus,Vaccine, Coronavirus Disease-19,Vaccine, SARS-CoV-2,Vaccine, SARS2,Vaccines, 2019-nCoV,Vaccines, COVID-19,Vaccines, COVID-19 Virus,Vaccines, COVID19,Vaccines, COVID19 Virus,Vaccines, Coronavirus Disease-19,Vaccines, SARS-CoV-2,Vaccines, SARS2,Virus Vaccine, COVID-19,Virus Vaccine, COVID19,Virus Vaccines, COVID-19,Virus Vaccines, COVID19
D012306 Risk The probability that an event will occur. It encompasses a variety of measures of the probability of a generally unfavorable outcome. Relative Risk,Relative Risks,Risk, Relative,Risks,Risks, Relative
D014611 Vaccination Administration of vaccines to stimulate the host's immune response. This includes any preparation intended for active immunological prophylaxis. Immunization, Active,Active Immunization,Active Immunizations,Immunizations, Active,Vaccinations
D014765 Viral Vaccines Suspensions of attenuated or killed viruses administered for the prevention or treatment of infectious viral disease. Viral Vaccine,Vaccine, Viral,Vaccines, Viral

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