Nobel laureates call for 'challenge trials' to speed up vaccine process

Dr Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, joins Christiane with an update on the urgent search for a Covid-19 vaccine

Posted: Jul 18, 2020 1:50 PM
Updated: Jul 18, 2020 1:51 PM

More than 100 top scientists including 15 Nobel laureates have written an open letter calling for volunteers to be exposed to the coronavirus to assist with vaccine development.

They said so-called "human challenge trials" or "controlled infection trials" were of "vast importance" in speeding up the testing of the vaccines in development around the world.

"If challenge trials can safely and effectively speed the vaccine development process, there is a formidable presumption in favor of their use, which would require a very compelling ethical justification to overcome," the scientists wrote in the letter to Dr. Francis Collins, director of the US National Institutes of Health (NIH).

It urged the US government to undertake immediate preparations for human challenge trials, "including supporting safe and reliable production of the virus and any biocontainment facilities necessary to house participants."

The letter said human challenge trials -- in which volunteers are deliberately exposed to the pathogen under controlled conditions -- can provide information months before conventional efficacy trials, in which candidates receive a vaccine or control and resume their normal life, with the assumption that they may be eventually exposed to the virus.

More than 2,000 challenge trial volunteers also signed the letter published by 1Day Sooner, an organization advocating on their behalf.

Adrian Hill, director of the Jenner Institute at the University of Oxford in England, and signatory of the open letter, wrote in a statement that "collaborative human challenge studies should be feasible and informative in the coming months."

Oxford's Jenner Institute is working with 1Day Sooner to produce a Covid-19 human challenge virus and Hill said it had "considerable potential" for helping to accelerate vaccine development and optimize vaccination approaches.

The World Health Organization (WHO) issued guidance in May saying challenge studies can be "substantially faster" and more effective than other methods, in part because fewer participants need to be exposed to experimental vaccines and because they can be used to compare potential vaccines.

Challenge trials were used in early research with smallpox, yellow fever and malaria, which changed the course of global public health, according to WHO.

Over the past 50 years, tens of thousands of consenting adult volunteers have safely undergone such trials under the oversight of research ethics committees, WHO reported.

It said controlled infection trials could be ethically acceptable if they met certain criteria. These include choosing young and healthy adults as participants, starting with low doses, ensuring public engagement, and providing high-quality care and close monitoring.

The notion of a human challenge trial for Covid-19 was jump-started by a March 31 article in the Journal of Infectious Diseases, which made the case that the nature of the global emergency warranted consideration of unconventional approaches.

Co-authored by Nir Eyal of Rutgers, Marc Lipsitch of Harvard, and Peter Smith of the London School of Hygiene & Tropical Medicine, the piece concluded that while a human challenge study would not be without risks, "every week that vaccine rollout is delayed will be accompanied by many thousands of deaths globally."

But members of the NIH's Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) Vaccines Working Group said earlier this month that challenge trials would not speed up vaccine development.

In a commentary published in the New England Journal of Medicine, ACTIV members wrote that using controlled human infection models to support vaccine development requires "essential criteria" to limit the risk for participants and could take "one to two years."

"A single death or severe illness in an otherwise healthy volunteer would be unconscionable and would halt progress," they wrote.

They said it would be unethical to organize an experiment in which people were deliberately infected unless there were a rescue therapy -- a treatment that can save lives -- which does not exist for coronavirus.

"Large, randomized, controlled trials of SARS-CoV-2 vaccines are currently the most efficient, generalizable, and scientifically robust path to establishing vaccine efficacy," the authors concluded.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 727764

Reported Deaths: 13397
CountyCasesDeaths
Marion995211738
Lake53461965
Allen40457675
St. Joseph35506550
Hamilton35489408
Elkhart28433441
Tippecanoe22359218
Vanderburgh22284396
Porter18668307
Johnson17905377
Hendricks17180315
Clark12930191
Madison12592339
Vigo12431246
Monroe11858170
LaPorte11821210
Delaware10648185
Howard9865216
Kosciusko9378117
Hancock8251140
Bartholomew8052155
Warrick7771155
Floyd7649177
Grant7027174
Wayne7026199
Boone6679101
Morgan6555139
Dubois6150117
Marshall6005111
Dearborn579277
Cass5788105
Henry5688103
Noble558883
Jackson500872
Shelby490296
Lawrence4505120
Harrison434772
Gibson434692
Clinton427053
DeKalb426484
Montgomery423588
Whitley394739
Huntington389080
Steuben383857
Miami380666
Knox371890
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Fayette279262
Greene277385
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Scott265453
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Clay259146
Washington240032
Randolph239781
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Jennings229549
Starke215453
Fountain212046
Sullivan211142
Owen198156
Fulton194740
Jay192530
Carroll188320
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Perry182637
Rush172925
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Parke145916
Blackford134632
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Newton107234
Brown101641
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Benton98414
Martin88315
Warren81715
Switzerland7848
Union70810
Ohio56411
Unassigned0414

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1081518

Reported Deaths: 19428
CountyCasesDeaths
Franklin1256551400
Cuyahoga1117782115
Hamilton798901205
Montgomery513291014
Summit47080945
Lucas42049788
Butler38301584
Stark32242906
Lorain24958481
Warren24262298
Mahoning21511588
Lake20618369
Clermont19747238
Delaware18503133
Licking16410212
Fairfield16160199
Trumbull16019468
Medina15247264
Greene15043244
Clark13970299
Wood13065189
Portage12825203
Allen11626232
Richland11323199
Miami10661217
Muskingum8799133
Wayne8784211
Columbiana8766229
Pickaway8551121
Marion8514135
Tuscarawas8470244
Erie7871154
Hancock6906127
Ross6842155
Ashtabula6792170
Geauga6677148
Scioto6405101
Belmont5873167
Union570348
Lawrence5546102
Jefferson5521151
Huron5427119
Darke5347123
Sandusky5337120
Seneca5275121
Athens518858
Washington5153109
Auglaize489584
Mercer480385
Shelby468893
Knox4483110
Madison435561
Putnam4278100
Fulton421669
Ashland421489
Defiance419297
Crawford3970107
Brown393857
Logan381576
Preble379398
Clinton371263
Ottawa366679
Highland354662
Williams338575
Champaign331458
Guernsey315653
Jackson312151
Perry294850
Morrow284639
Fayette281550
Hardin270664
Henry268466
Coshocton264557
Holmes2593101
Van Wert243363
Adams237752
Pike237534
Gallia235349
Wyandot230855
Hocking215262
Carroll191247
Paulding172540
Meigs144740
Noble133337
Monroe132042
Morgan108323
Harrison107637
Vinton82815
Unassigned02
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