{"id":26358,"date":"2020-05-19T13:10:50","date_gmt":"2020-05-19T13:10:50","guid":{"rendered":"https:\/\/www.ceo-na.com\/?p=26358"},"modified":"2020-05-18T18:11:01","modified_gmt":"2020-05-18T18:11:01","slug":"weighing-the-risk-and-benefit-of-human-challenge-trials","status":"publish","type":"post","link":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/business\/industry\/weighing-the-risk-and-benefit-of-human-challenge-trials\/","title":{"rendered":"Weighing the risk and benefit of human challenge trials"},"content":{"rendered":"

A range of voices, from medical experts to politicians, are increasingly calling for a controversial voluntary program to test vaccines on people deliberately infected with COVID-19. <\/p>\n

In the U.S., more than\u00a016,000 willing participants\u00a0have joined an advocacy group, and 35 members of Congress have asked regulators to consider the use of human challenge trials to help find a vaccine for the COVID-19. In Europe, London\u2019s hVIVO and the Swiss-based SGS are working to launch similar studies, and the WHO itself has already published\u00a0a working document\u00a0outlining criteria for an ethically acceptable design.<\/p>\n

A \u201chuman challenge trial\u201d is a controversial way\u00a0to test coronavirus vaccines\u00a0that would deliberately infect people with a virus that has killed some 285,000 people worldwide\u00a0and has no cure.<\/p>\n

A vaccine is the only real way people can go back to their daily lives without fear of contracting the virus\u2014back to sports stadiums, birthday parties, family visits, and most importantly, work, with an estimated 33 million jobs lost in the U.S. alone. Until one is found, social distancing could be an almost permanent state of reality and fears will continue of a second major outbreak of the virus this winter.<\/p>\n

The problem is that vaccines take time to test and develop. The final phase of testing often requires tracking up to tens of thousands of people to see who actually becomes infected, sometimes over several years.<\/p>\n

As a result, leading epidemiologists and vaccionologists are arguing in favor of human challenge studies as a way of speeding up the process. They claim that if designed correctly and carried out with consent, such trails could save an untold number of lives.<\/p>\n

There are currently no public plans for such a study in the U.S., but both experts and politicians are pushing for one\u2014and volunteers are quickly coming forward. An advocacy group known as 1DaySooner<\/a> has already signed up 16,213 from 106 different countries.<\/p>\n

Political support is also growing. In April, 35 members of Congress signed a letter written by their colleagues Bill Foster and Donna Shalala to the Commissioner of the Food and Drug Administration and Secretary of Health and Human Services, urging them to speed up the approval and deployment of a vaccine, including the use of the aforementioned trials.<\/p>\n

\u201cWe wanted to let the regulators know that we in Congress understand the justifiable risks involved in human challenge trials,\u201d Foster said in an interview with The FT. \u201c(But) they may be essential if we want to sort through realistic vaccine candidates to find the one that works best \u2014 or as an insurance if something goes wrong and the first vaccines don\u2019t work as well as we hope, or if the virus mutates and we have to identify rapidly the best alternatives.\u201d<\/p>\n

Notable voices within the pharmaceutical industry have also been supportive. Paul Stoffels, chief scientist at Johnson & Johnson, said his company would consider using a human challenge trial for its COVID-19 vaccine to quicken the process, as long as such a study was deemed legally and ethically acceptable.<\/p>\n

The fallout to the COVID-19 crisis will involve analyzing many such ethical questions, not only to protect those especially vulnerable to infection or mortality, but also those who have no option but to return to jobs and professions that put them directly in the firing line of the virus. And of course, there will be no easy answers.<\/p>\n","protected":false},"excerpt":{"rendered":"

A range of voices, from medical experts to politicians, are […]<\/p>\n","protected":false},"author":21,"featured_media":26357,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[45,53],"tags":[99,1385,3357,3692,3693],"class_list":["post-26358","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry","category-opinion","tag-ceo","tag-ceo-northam","tag-covid-19","tag-test-vaccines","tag-trials"],"_links":{"self":[{"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/posts\/26358","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/users\/21"}],"replies":[{"embeddable":true,"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/comments?post=26358"}],"version-history":[{"count":2,"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/posts\/26358\/revisions"}],"predecessor-version":[{"id":26360,"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/posts\/26358\/revisions\/26360"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/media\/26357"}],"wp:attachment":[{"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/media?parent=26358"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/categories?post=26358"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/servidor-mxigen1.com\/ceona-antiguo\/wp-json\/wp\/v2\/tags?post=26358"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}