In a race to find a vaccine for COVID-19, some medical professionals and politicians are advocating the use of a controversial method called human challenge studies (HCS), where healthy volunteers are injected with a candidate vaccine or a placebo followed by an attenuated CCP virus.
Proponents of the HCS argue that more lives will be lost the longer it takes for an efficacious vaccine to be developed. Thirty-five lawmakers headed by Reps. Bill Foster (D-Ill.) and Donna Shalala (D-Fla.) sent a letter (pdf) to the Department of Health and Human Services and the Food and Drug Administration last month urging for all options to be considered in accelerating the development and deployment of a vaccine as “the enormous human cost of the COVID-19 epidemic alters the optimization of the risk/benefit analysis in favor of more rapid approval and deployment.”
“We write to assure you that Congress understands that a more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine,” Foster and Shalala wrote in the letter.
“In the case of accelerated human trials, justifiable risks may be taken by parallel testing of multiple dose levels, advancing more rapidly from phase to phase and potentially by challenge trials that involve deliberately infecting volunteers who have received candidate vaccines or placebos to confirm the efficacy of those vaccines and are at very low risk of serious disease from the infection.”
Dr. Rajeev Fernando, infectious disease specialist and rapid responder at three New York hospitals, supports HCS if it can speed up the process of finding a vaccine. “I really support these kinds of trials right now,” he told The Epoch Times. “As a matter of fact, if I had an option, Id be more than happy to be a part of these trials.”
Fernando, who is also the founder of Chiraj Charities, said “everything is a risk versus benefit situation,” so people should be allowed to assess for themselves and make “an intelligent decision” regarding participation in the CCP (Chinese Communist Party) virus challenge studies.
“The virtue of a human challenge trial is that it cuts to the chase, so to speak, with 100 percent of those in the study exposed,” Kirk Allison, a faculty member in Health Humanities at Saint Scholastica College and Adjunct Professor of Theology at the University of Saint Thomas teaching bioethics-related courses, told The Epoch Times in an email.
According to Allison, the number of participants needed in a challenge study in both the vaccination and placebo group are “lower to obtain a statistically significant result.” This is an advantage since “an adverse result following exposure would become apparent with far fewer individuals exposed to the vaccine than in a traditional phase 3 efficacy study.”
Opponents of the HCS, however, say that there are ethical concerns to consider since there is still much that is unknown about the novel CCP virus. “Where youre going to give somebody a virus on purpose, you really want to understand the disease so that you know what youre doing is a reasonable risk,” Mathew Memoli, who has conducted many challenge studies and is an immunologist at the National Institute of Allergy and Infectious Diseases, said in Science Magazine.
Fox News medical contributor Dr. Janette Nesheiwat stated it more bluntly on Fox News, “We are knowingly asking volunteers to inject themselves with a deadly pathogen that could potentially kill them.”
Nesheiwat questions the need for challenge studies as the vaccine trials are already moving at “an extraordinarily fast pace” to get a vaccine out in 18 months. Traditionally, it takes about “10-15 years to get a vaccine on the market and it costs millions of dollars” as the vaccines have to go through three different trial phases.
In the standard trial phases, Fernando says that in phase one, “probably less than 100 people” are clinically assessed for adverse effects and to confirm the safety of the candidate vaccine before moving on to the second phase involving several hundred test subjects. “The last one, thats the real one, which you have to watch these people very closely,” Fernando said. Thousands of people are monitored over a long period to study the efficacy of the vaccine.
To address the concern of the length it normally takes a vaccine to be developed and how to make it available for the public quicker, Dr. Deborah Birx, senior coordinator for the White House Coronavirus Task Force, said on Fox News Sunday, that several different candidate vaccines were being studied simultaneously, while “doing compressed phase one, phase two, phase three trRead More From Source