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, I’d 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 you’re going to give somebody a virus on purpose, you really want to understand the disease so that you know what you’re 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, that’s 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 trials in an overlapping way, moving forward when you have a good safety and immunogenicity data, but not with the level of pauses that are often present in vaccine development.”
Whether a vaccine will be available by next January, Birx says that depends on “whether we can execute and execute around the globe, because you also, for phase three, have to have active viral transmission in the community in order to study its efficacy.”
Opponents Say Too Much Is Unknown About COVID-19
Human challenge studies have been conducted for a long time since they were first experimented on in 1796 when Edward Jenner inoculated a young, healthy boy with the pus of a smallpox sore, only after he was first given the supposed “vaccine” that consisted of pus from a cowpox sore on cuts of the boy’s arm. The boy did not fall ill to the disease.
HCS has evolved since then to help scientists learn about certain diseases and their treatments. They are particularly used to test vaccines for a disease that has therapeutic treatments or can be cured.
It is deeply concerning for opponents of the CCP virus challenge studies when there is still much that is unknown about the virus as physicians continue to learn new things about it. In addition, there currently is no treatment or a cure for the disease if a consenting volunteer develops a serious illness.
Allison says to address the adverse effects that may arise from the vaccine study in a standard trial or an HCS, participants in the studies should be “covered for any expenses and costs proceeding from participation (including for any adverse medical outcomes).”
He furthers states that compensation “could be covered by the federal government similar to the National Vaccine Injury Compensation Program administered by the Health Resources and Services Administration.”
The program was set up in 1988 to compensate children injured by a vaccine listed on the vaccine injury table (pdf). The program has extended to compensate adults injured by the flu vaccine since the same vaccine is given to children and is listed on the vaccine injury table.