More than 100 scientists on Thursday called for healthy volunteers to undergo “challenge trials” in humans to speed up vaccine development.
These scientists include 15 Nobel Prize winners.
In an open letter to NIH Director Francis Collins, they said the Novel Coronavirus challenge trial would dramatically accelerate vaccine development.
Proponents argue that the benefits outweigh the risks
The so-called Challenge test, in which healthy vaccine subjects are artificially infected with the virus, tests the vaccine’s protection against infection.
While this will undoubtedly be hugely controversial, the group, 1DaySooner, and more than 100 experts believe that the benefits of the “Challenge Test” fast track outweigh the risks and have called on the US government to give it a go.
Among the laureates who signed the letter were Michael Rosbach, a biology professor at HHMI; Alvin Roth, an economics professor at Stanford; And William Kaelin, a professor at Harvard Medical School.
Also including vaccines, epidemiologists and law, economics, philosophy and so on, including the jenner institute at Oxford University, head of the vaccine Adrian Hill (Adrian Hill), a professor at the harvard professor of epidemiology at the university of Marc’s curious (Marc Lipsitch), duke university law professor Kim carat wake (Kim Krawiec), etc.
“Ethical regulatory barriers should be removed and support supported as long as’ challenge testing ‘can safely and effectively promote vaccine development,” 1DaySooner said.
Scientists such as Professor Hill, head of vaccines at Oxford’s Jenner Institute, who signed the letter, said: “Traditional efficacy trials tend to take months, whereas’ challenge trials’ in humans can get more information much more quickly.”
In such trials, they added, volunteers who were given a candidate vaccine or a control reagent were not naturally exposed to the virus in their daily lives but were artificially exposed to it under controlled conditions.
“The coVID-19 pandemic must be urgently responded to across multiple disciplines, and it is difficult to imagine how the global economy and society can recover without a vaccine,” the joint letter states.
“Challenging trials in humans will make a huge contribution to vaccine development.”
Already in April, 35 lawmakers called on U.S. regulators to approve human challenge tests and allow volunteers to be infected to speed up vaccine development.
Of the hundreds of COVID-19 vaccines announced by WHO, more than 20 candidate vaccines have entered clinical trials.
Protecting the health and autonomy of volunteers is a principle
But Collins, the NIH director, says: “The ‘challenge trial’ is still in the discussion stage, not at the design stage.
The authors stressed that effective “challenge testing” must be based on the first principle of protecting the health and autonomy of volunteers.
According to WHO guidelines, challenge testing in humans is ethical if certain criteria are met.
Zhu Tongyu, director of the Shanghai Clinical Centre for Public Health, told China Business News: “These protection measures include subjects being relatively young, in good health and being able to provide the best quality medical services and be monitored in real time.”
He believes that “challenging targets” are young people aged 18 to 28 who have high levels of indicators such as CD4 cells in their bodies after medical examinations.
“Of course human ‘challenge testing’ is not the best approach, and vaccine emergency use is best determined by in vitro tests of the immune system.”
Zhu Tongyu told China Business News.
“The most important thing is that ‘challenge testing’ must be carried out within an ethical framework with informed consent, carefully considered and under careful supervision,” who said.
At the same time, the potential personal risk benefits and social risk benefits are considered and evaluated.
But some scientists are staunchly opposed to the idea.
“It is unethical to artificially release the virus into the environment, as there is no guarantee of 100 percent safety for infected people,” an Ebola expert told China Business News.
Novel Coronavirus does not yet have a particularly suitable animal test model, but it is clearly unethical to model a human.”
He added that the world may have lost its mind because coVID-19 is on its doorstep.