Is it feasible to test the effectiveness of the new crown vaccine "by testing the poison"?

To speed up research and development of the new crown vaccine, the British government will fund the world's first "human challenge trial" of the new crown vaccine in the country, in which volunteers will be infected with the new crown virus after being vaccinated against the candidate new crown vaccine to test its effectiveness, the Financial Times reported recently.
despite many precedents, "human challenge testing" is still a controversial method of testing, and volunteers who "test the drug by themself" need to be isolated and subject to certain health risks.
is this unconventional experimental approach feasible under the dual pressure of the global public health and economic crisis caused by the new crown pandemic? The trial is expected to be officially launched in January, sources involved in the project told the Financial Times.
its academic leader is Imperial College, which is run by an institution called hVivo.
site has not yet been finalized and could be carried out at a quarantine clinic in east London or at another nearby facility.
subjects will be given the candidate new crown vaccine first, and the new coronavirus will be given a "challenging" dose under controlled conditions after about a month, with a quarantine period of up to one month.
reported that about 2,000 people have signed up for the trial, which will take place in the UK, "one day early" through the US-based human challenge advocacy group Human Challenge.
the trial will begin with the use of the antiviral drug Redsyvir, which has been approved in several countries to treat new coronavirus infections, to prevent serious diseases after the subjects were infected with the virus.
to conduct such trials in the UK requires approval from the UK Medicines and Healthcare Products Authority and an independent research ethics committee.
the safety of the subjects is our top priority," the Financial Times quoted a statement from the UK's Medicines and Healthcare Products Authority as saying.
Any proposal from (vaccine) developers to make the human infection challenge part of clinical trials for vaccine development will be considered on the basis of (trade-offs) of benefits-risks and will monitor and minimize risks in the proposed trial design".
community has jointly called for a general approach to vaccine development to assess vaccine effectiveness through Phase 3 clinical trials, why should new crown vaccine development consider "human challenge trials" as an unconventional approach to research? Some experts believe that the current increase of thousands of new crown deaths around the world makes vaccine research and development an extremely urgent task, and that "human challenge trials" can significantly speed up the process.
Claire Waddington, clinical lecturer in infectious diseases at the University of Cambridge in the UK, said: "The advantage of a controlled human infection model is that it gives us an accurate picture of when people are exposed to the relevant pathogens, allowing us to directly and accurately study the response and protective effects of any vaccine used in the model to infection.
" in fact, U.S. and British scientists have been discussing or calling for "human challenge trials" in the development of new crown vaccines for months.
Researchers at Rutgers University, Harvard University and others published an article in the American Journal of Infectious Diseases in May entitled "Human Challenge Research Accelerates Coronavirus Vaccine Licensing", saying that controlled "human challenge trials" of the new crown vaccine could shorten the time it takes to evaluate vaccines and allow them to be rolled out earlier.
suggested that most new crown vaccines could be "human challenge trials" before they are ready for effectiveness trials.
In addition to measuring vaccine effectiveness, the Human Challenge Trials help to evaluate drugs used to prevent infection, discontinue infection after exposure, or prevent morbidity in high-risk individuals, and to improve understanding of mechanisms related to the development of infection to disease.
In mid-July, more than 170 U.S. and British scientists, including 15 Nobel laureates in science, sent an open letter to Francis Collins, president of the National Institutes of Health, urging the U.S. government to prepare for "human challenge trials," including supporting safe and reliable new coronavirus culture and providing isolation facilities for subjects.
's history of ethical "human challenge trials" dates back to 1796, when vaccine pioneer Edward Jenner inoculated eight-year-old James Phipps with the live bovine pox virus, an adventurous approach that left the little boy miraculously immune.
, such "test-and-test" research has played an active role in developing vaccines and therapies for infectious diseases such as typhoid, cholera and malaria, as well as in understanding how the human immune system responds to viruses such as influenza.
A number of precedents have been set, "human challenge trials" are still a highly controversial way of studying, especially for the new coronavirus, a virus with a certain lethality, no special effects drugs and therapies, "test-to-poison" is contrary to medical ethics norms? In a May article in the British journal The Lancet Infectious Diseases, researchers at Monash University in Australia said such studies are ethically acceptable when a particular pathogen creates a significant public health threat, especially in the absence of special-effects therapies and vaccines.
can accelerate and improve vaccine development, and trial design can limit and reduce the risk to subjects.
according to the aforementioned article "Accelerated Coronavirus Vaccine Licensing for Human Challenge Research", the "challenge trial" was conducted against the background of the volunteer's informed consent, the minimization of the risk of research and the subject's "baseline infection risk (risk of infection in normal life), and as a need for emergency response, it does not infringe on the individual rights and interests of the subjects, but rather takes into account the individual's rights and interests and global public health emergencies."
In response to discussions in the scientific community, the World Health Organization issued the Key Guidelines on Ethical Acceptability of Research on the Human Challenge of the New Coronavirus in May, stressing the importance of conducting "human challenge trials" of the new coronavirus in accordance with the "highest scientific and ethical" standards, with at least eight ethical guidelines to be observed, including A strong scientific basis for obtaining information through consultations involving the public, relevant experts and decision makers, close coordination among researchers, funders, decision makers and regulators to ensure that subject screening criteria limit and minimize trial risk, subject to review by an independent commission and strict informed consent procedures.
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