A woman holds a small bottle labeled “Vaccine COVID-19” and a medical syringe in this illustration from April 10, 2020.
Dado Ruvic | Reuters
Over 100 prominent scientists, including 15 Nobel Prize winners, have called for healthy volunteers to be exposed to the coronavirus to determine if Covid-19 vaccines actually work.
The scientists signed an open letter to Dr. Francis Collins, head of the National Institutes of Health (NIH) in the United States, calling for human “challenge attempts”
Challenge studies intentionally expose healthy volunteers to a virus after vaccination to test whether the vaccine is effective against infection.
Such trials are not without controversy, but the organization 1 Day Sooner and other prominent experts insist that the benefits of quick-tracking attempts outweigh the risks and urge the US government to approve them.
“If challenge studies can safely and effectively speed up the vaccine development process, there is a huge presumption in favor of their use that, if overcome, would require a very compelling ethical justification,” says the letter published by 1 Day Sooner, an organization committed to this uses to challenge attempts, it is said.
Scientists who signed the letter, including the director of Oxford University’s Covid-19 vaccination program, said: “Trials with human challenges can provide information much faster than traditional efficacy studies, which take months longer.”
“In such studies, volunteers are still given the vaccine candidate or a control. Instead of resuming life as usual and waiting to” catch “a virus, volunteers are deliberately exposed to the pathogen under controlled conditions. They are not only faster than conventional ones Studies, but also a challenge It is more likely that the test will end with interpretable results, for example, the presence of viruses at the site of investigation should begin to fade over time, “they added.
The signers of the letter come from various disciplines, including epidemiology, medicine, economics and philosophy. They argue that “the Covid-19 pandemic is an urgent need to be tackled on many fronts, but it is difficult to imagine robust economic and social recovery without a vaccine. We are writing to underline the enormous importance of human challenge trials as a method to help develop vaccines. ”
The letter points out that US lawmakers are already supporting the move. In April, 35 House members urged U.S. regulators to consider volunteering coronavirus infection to speed up vaccine testing.
Worldwide, there are already over a hundred vaccine candidates under development, and according to the World Health Organization, 23 vaccine candidates are in the clinical evaluation phase.
There appears to be a cautious assumption that challenge studies could play a role in rapidly monitoring the development of a coronavirus vaccine. The director of the NIH, Dr. Francis Collins said attempts to challenge were “on the table for discussion – not on the table to start working on a plan.”
The letter was also signed by more than 2,000 volunteers organized by 1 Day Sooner. The experts laid the foundations for an “effective” attempt to challenge human challenges, saying that “critical protection needs to be expanded to protect volunteers’ health and autonomy rights.“”
The guidelines of the World Health Organization (WHO) state that experiments with human challenges are ethical if they meet certain criteria. Experts said that protective measures should be clearly in place, including the fact that the study participants are relatively young and in good health and receive top quality medical care with frequent monitoring.
The WHO notes that it is a major challenge to conduct trials “in an ethical setting, with really informed consent” and that they should be carried out with “prudent, careful and control”. According to the WHO, both potential individual risks and benefits as well as potential social benefits and risks must be taken into account, for example the release into the environment of a pathogen that might otherwise not be present.
The experts said on Thursday that the ethical and scientific review of all challenge attempts must be of the highest quality and ultimately, but most importantly, “the autonomy of the volunteer is paramount … This means that the informed consent process is robust got to.”