United States should allow volunteers to be infected with coronavirus to test vaccines

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 that they put in place. Things will only get worse in this regard before it gets better.

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.

a reply to: alldaylong

US military is all volunteers. People only got outraged about the draft.

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.

If you think it's a good idea, then call them up to volunteer.

No, this isn't how it works. It would be a waste of time and dangerous. You would inject these young people with vaccines and then give them Covid 19. You would have a control group that gets the placebo and a group that gets the vaccine. This wouldn't work for a couple of reasons. First, there's a lot of different candidates.

According to the latest tally by the World Health Organization (WHO), 76 vaccine candidates are already under development around the world. Five have moved into clinical trials. But public health officials have cautioned that, from start to finish, it takes at least 1 year—and more likely 18 months—to prove whether a candidate is safe and effective. And that’s if no problems surface.

First, we need to continue to winnow this number down like we're currently doing. We don't need panicked Politicians to jump the gun and start killing a bunch of young healthy people. Listen to the Politicians:

“[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.”

Again, their just panicked. Like I said, there's a danger of Politicians overreacting to alarmist news stories and making knee jerk changes that cost lives.

Secondly, you're talking about testing young people who have a healthy immune system who don't have Covid 19 vs the people who are most vulnerable. People with underlying conditions and a weaker immune system.

So you can test this vaccinne on healthy young people, kill some of them and then when you give it to older people it accelerates their problems because they have a weak immune system.

My point is, you have to let it play out and you can't bend to every whim of panicked Politicians.

It will not speed things up. We're still a year to 18 months away and we can do this without needlesly killing young people that don't have the virus by injecting them with it.

Finally, this was looked at awhile ago and looked down upon because these "volunteer" studies will always be conducted on those who are most vulnerable either physically or economically. How many rich kids do you think will be volunteers?

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.

It ends like this:

Beecher’s landmark article remains an important milestone in the continuing discussion about the nature of informed consent and the participation of vulnerable populations in vaccine and general medical research.

www.historyofvaccines.org...

Again, you will not see the Obama's or Bush children volunteering. It will be people who have no choice because they need the money.

Maybe your willing just to kill people because of kneejerk reactions from Politicians but I think this type of talk is extremeley premature. Like I said you and some young healthy people in your family can be the first ones in line to get injected and please alarmist Politicians.

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 the UK vaccine trials people receive the vaccine then a couple of days later are being exposed to two less virulent strain of coronavirus to test how effective the vaccine is. The initial trials are only for those young and healthy and with the isolated strains used so the worst symptoms they should experience is a bit of a cold.

Can't say I follow why the US needs to change the law, I thought it was the standard procedure of vaccine trials (apart from the simultaneous studies part).


EDIT: Agree with Neoholographic - one of the biggest problems in testing new drugs and vaccines is that the volunteers are generally vulnerable groups, mainly addicts and ex convicts, which generates bad data as well as being ethically/morally bad as the test subject is unlikely to understand the full potential risks, or know what to look for/what to avoid when volunteering for trials despite all the info pharma companies make available to them.

There are exactly zero effective vaccines for Corona Viruses. Anyone volunteering is an absolute fool.

Not to mention how quickly they mutate.

Do you know 'why' people vaccinate against the flu? It's for the herd immunity. The vaccine you take wouldn't actually become effective for ten years (or more). That's why it's called a vaccination program. And ... as well as the flu vaccination program works (and it does) ... look how many people die from it (the flu) still.

People volunteer for this type of thing all the time. Clinical trials are the way to get vaccines and medical treatments developed. What's the problem?

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.

And that's why Covid-19....is the 19th morphing of this virus...and continues

a reply to: neoholographic

I saw all the volunteers in Pennsylvania on the news the other day, bleating something about the constitution and how they can breathe it when their lungs can't take in enough oxygen or something like that.

Oh and they had guns too, to shoot the pesky virus if it showed up apparently.

originally posted by: neoholographic
No, it's not a joke headline. Lawmakers are actually pushing for this.

I hereby formally volunteer to be infected with this and/or any number of other viruses, but only to prove the safety and efficacy of high-dose Vitamin C.

The only condition is, I get to choose the doctors who select, isolate and deliver the viruses to me, as well as provide the treatment protocols.

I would do it. I’d prefer being the control group though no vaccine just the sickness to test against a similar peer with the vaccine. I’d want paid for it though cause I’d have to be away from my job awhile and the people I love.