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Political support is building for regulators in the United States to embrace the controversial strategy of intentionally infecting volunteers with the virus that causes COVID-19 in order to test experimental vaccines. Such human challenge trials could greatly accelerate the development of an effective vaccine, 35 members of the House of Representatives argue in a letter sent yesterday to the heads of the U.S. Food and Drug Administration (FDA) and its parent agency, the Department of Health and Human Services (HHS).
“[A] more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine,” write the group of lawmakers, which includes both Democrats and Republicans. “The enormous human cost of the COVID-19 epidemic alters the optimization of the risk/benefit analysis.”
The lawmakers also back the idea of parallel, simultaneous testing of different doses of a vaccine—as opposed to the traditional practice of sequential testing that, for safety reasons, begins by giving trial participants the lowest dose first and then ratchets up. Parallel testing could more quickly move a candidate vaccine from small studies that look only at safety and immune responses to larger ones that actually assess efficacy, the letter notes.
The letter was spearheaded by Representatives Bill Foster (D–IL), a physicist, and Donna Shalala (D–FL), former HHS secretary. “This is designed as much as anything to give the FDA political cover” needed to approve challenge trials, Foster tells ScienceInsider. “The FDA must be worried that they’re going to have these trials, something bad is going to happen, there’ll be a bad story in the newspaper about a sympathetic person who got unlucky in one of these trials and didn’t survive. And then Congress is going to go and say: ‘Let’s have a hearing on this,’ and start dragging them in. … One of my goals in here was to let them know that Congress understands that there are no risk-free paths here.”
Despite the high morbidity and mortality rates that resulted from the epidemic, the Spanish flu began to fade from public awareness over the decades until the arrival of news about bird flu and other pandemics in the 1990s and 2000s.[129] This has led some historians to label the Spanish flu a "forgotten pandemic".[26]
There are various theories of why the Spanish flu was "forgotten". The rapid pace of the pandemic, which, for example, killed most of its victims in the United States within less than nine months, resulted in limited media coverage. The general population was familiar with patterns of pandemic disease in the late 19th and early 20th centuries: typhoid, yellow fever, diphtheria and cholera all occurred near the same time. These outbreaks probably lessened the significance of the influenza pandemic for the public.[130] In some areas, the flu was not reported on, the only mention being that of advertisements for medicines claiming to cure it.[131]
Additionally, the outbreak coincided with the deaths and media focus on the First World War.[132] Another explanation involves the age group affected by the disease. The majority of fatalities, from both the war and the epidemic, were among young adults. The number of war-related deaths of young adults may have overshadowed the deaths caused by flu.[92]
When people read the obituaries, they saw the war or postwar deaths and the deaths from the influenza side by side. Particularly in Europe, where the war's toll was high, the flu may not have had a tremendous psychological impact or may have seemed an extension of the war's tragedies.[92] The duration of the pandemic and the war could have also played a role. The disease would usually only affect a particular area for a month before leaving[citation needed]. The war, however, had initially been expected to end quickly but lasted for four years by the time the pandemic struck.
originally posted by: alldaylong
a reply to: neoholographic
Isn't the way a vaccine works, is to stop you contracting the virus in the first place ?
Surely if someone is already infected, then you are looking at a cure and not a vaccine.
In 1966, Henry K. Beecher, MD, published a study describing 22 instances of mainstream medical research that he claimed were unethical. In his article in the New England Journal of Medicine, Beecher described medical studies in which
medical treatment was withheld from subjects for research purposes
institutionalized children and adults were involved
surgeons performed experimental techniques with unknown effects
infectious or otherwise harmful substances were deliberately introduced into a subject’s body.
originally posted by: alldaylong
a reply to: neoholographic
Isn't the way a vaccine works, is to stop you contracting the virus in the first place ?
Surely if someone is already infected, then you are looking at a cure and not a vaccine.
originally posted by: neoholographic
No, it's not a joke headline. Lawmakers are actually pushing for this.
Political support is building for regulators in the United States to embrace the controversial strategy of intentionally infecting volunteers with the virus that causes COVID-19 in order to test experimental vaccines. Such human challenge trials could greatly accelerate the development of an effective vaccine, 35 members of the House of Representatives argue in a letter sent yesterday to the heads of the U.S. Food and Drug Administration (FDA) and its parent agency, the Department of Health and Human Services (HHS).
“[A] more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine,” write the group of lawmakers, which includes both Democrats and Republicans. “The enormous human cost of the COVID-19 epidemic alters the optimization of the risk/benefit analysis.”
The lawmakers also back the idea of parallel, simultaneous testing of different doses of a vaccine—as opposed to the traditional practice of sequential testing that, for safety reasons, begins by giving trial participants the lowest dose first and then ratchets up. Parallel testing could more quickly move a candidate vaccine from small studies that look only at safety and immune responses to larger ones that actually assess efficacy, the letter notes.
The letter was spearheaded by Representatives Bill Foster (D–IL), a physicist, and Donna Shalala (D–FL), former HHS secretary. “This is designed as much as anything to give the FDA political cover” needed to approve challenge trials, Foster tells ScienceInsider. “The FDA must be worried that they’re going to have these trials, something bad is going to happen, there’ll be a bad story in the newspaper about a sympathetic person who got unlucky in one of these trials and didn’t survive. And then Congress is going to go and say: ‘Let’s have a hearing on this,’ and start dragging them in. … One of my goals in here was to let them know that Congress understands that there are no risk-free paths here.”
www.sciencemag.org...#
This is kind of crazy and of course them or their young family members will not be the first to volunteer. This is how it would work.
In theory, challenge trials could enroll volunteers who are at low risk of harm from the virus that causes COVID-19—dubbed SARS-CoV-2—such as young adults who rarely develop serious symptoms after becoming infected naturally. “Our situation in this pandemic is analogous to war, in which there is a long tradition of volunteers risking their health and lives on dangerous missions for which they understand the risks and are willing to do so in order to help save the lives of others,” the letter states. “Every week of delay in the deployment of a vaccine to the seven billion humans on Earth will cost thousands of lives.”
This is why this pandemic can be worse than the Spanish flu. Not in terms of deaths but in terms of how things will change. This is because information is practically instant and we're seeing these things unfold around the world in real time.
Thhis also means Governments will react and in some cases overreact to news and they can make changes quickly. In 1918, you lived in one area and really had no idea how things were changing in other areas. So change didn't really occur because many people didn't even realize what was happening until after it happened.
Despite the high morbidity and mortality rates that resulted from the epidemic, the Spanish flu began to fade from public awareness over the decades until the arrival of news about bird flu and other pandemics in the 1990s and 2000s.[129] This has led some historians to label the Spanish flu a "forgotten pandemic".[26]
There are various theories of why the Spanish flu was "forgotten". The rapid pace of the pandemic, which, for example, killed most of its victims in the United States within less than nine months, resulted in limited media coverage. The general population was familiar with patterns of pandemic disease in the late 19th and early 20th centuries: typhoid, yellow fever, diphtheria and cholera all occurred near the same time. These outbreaks probably lessened the significance of the influenza pandemic for the public.[130] In some areas, the flu was not reported on, the only mention being that of advertisements for medicines claiming to cure it.[131]
Additionally, the outbreak coincided with the deaths and media focus on the First World War.[132] Another explanation involves the age group affected by the disease. The majority of fatalities, from both the war and the epidemic, were among young adults. The number of war-related deaths of young adults may have overshadowed the deaths caused by flu.[92]
When people read the obituaries, they saw the war or postwar deaths and the deaths from the influenza side by side. Particularly in Europe, where the war's toll was high, the flu may not have had a tremendous psychological impact or may have seemed an extension of the war's tragedies.[92] The duration of the pandemic and the war could have also played a role. The disease would usually only affect a particular area for a month before leaving[citation needed]. The war, however, had initially been expected to end quickly but lasted for four years by the time the pandemic struck.
en.wikipedia.org...
So because of the flow of information, we see these things unfolding in real time and Politicians can react in real time and change things based on every alarmist news report.
There will not be a return to normal. People will just have to live under a new normal. Governments will not just give up controls tha
t they put in place. Things will only get worse in this regard before it gets better.
originally posted by: neoholographic
No, it's not a joke headline. Lawmakers are actually pushing for this.