A woman holds a small bottle labeled “COVID-19 Vaccine” and a medical syringe in this illustration taken on April 10, 2020.
Given Ruvic | Reuters
More than 100 prominent scientists, including 15 Nobel laureates, are calling healthy volunteers to expose themselves to the coronavirus to see if the Covid-19 vaccines really work.
The scientists signed an open letter to Dr. Francis Collins, head of the National Institutes of Health (NIH) in the United States, asking Wednesday for “challenge trials” in humans that they say could “greatly accelerate” the development of a Covid. – 19 vaccine.
Challenge trials see healthy volunteers deliberately exposed to a virus, after receiving a vaccine, to assess whether the vaccine works to prevent infection.
Such trials are not without controversy, but the organization ‘1 Day Sooner’ and other prominent experts insist that the benefit of rapid follow-up challenge trials outweigh the risks, and are calling on the US government to authorize.
“If test trials can safely and effectively speed up the vaccine development process, then there is a formidable presumption in favor of its use, which would require a very compelling ethical justification to overcome it,” wrote the letter published by 1 Day. Sooner, an organization that advocates challenge testing, states.
The scientists who signed the letter, including the director of the University of Oxford’s Covid-19 vaccine program, said that “human challenge trials can provide much faster information than conventional efficacy trials, which take months longer” .
“In such trials, volunteers are still receiving the candidate vaccine 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. Beyond being more faster than conventional trials, a challenge is more likely to end the test with interpretable results, for example, if the presence of viruses around the study site begins to fade over time, “they added.
The signers of the letter come from a range of disciplines including epidemiology, medicine, economics, and philosophy. They argue that “the Covid-19 pandemic must be urgently combated on many fronts, but it is difficult to imagine solid economic and social recoveries in the absence of a vaccine. We are writing to underscore the great importance of human challenge trials as a method of helping to develop vaccines. ”
The letter notes that US lawmakers are already supporting the measure. In April, 35 members of the House of Representatives asked US regulators to consider allowing volunteers to become infected with the coronavirus to speed up vaccine testing.
According to the World Health Organization, more than 100 vaccine candidates are already under development worldwide, and there are 23 candidate vaccines in the clinical evaluation stage.
There appears to be a cautious acceptance that challenge trials could play a role in accelerating the development of a coronavirus vaccine. For his part, NIH Director Dr. Francis Collins said the challenge trials are “on the table for discussion, not on the table to start designing a plan.”
The letter was also signed by more than 2,000 challenge volunteers organized by 1 Day Sooner. Explaining the principles for an “effective” human challenge test, experts said that “crucial protections must be extended to protect the health and autonomy rights of volunteers.”“
The World Health Organization (WHO) guide says that challenge trials in humans are ethical when they meet certain criteria. Experts said the protections should be clearly established, including that the trial participants are relatively young and in good health and have the highest quality medical care with frequent monitoring.
The WHO notes that it is essential that challenge trials be “conducted within an ethical framework in which truly informed consent is given” and that they be conducted with “abundant foresight, caution and oversight.” Consideration should be given to both the potential individual risks and benefits, says WHO, and the potential social benefits and risks, such as the release into the environment of a pathogen that would not otherwise be present.
Experts said Thursday that the ethical and scientific review of any challenge test must be of the highest quality and finally, but most importantly, “the autonomy of volunteers is of paramount importance … This means that the process of Informed consent must be robust. “
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