Would you accept to participate in a vaccine clinical trial against Covid-19 before animal tests were complete? ?

@JtC (are their ways to embed a yes/no counter in an essay page?)

This is an automated translation of the German article of "Der Spiegel - Science"
here. (I did not edit it)

The risky race of the pharmaceutical companies

Research into a new vaccine against Covid-19 is under high pressure. Common rules are now being softened in drug development. That poses dangers.
Martin Schlak reports from Boston
14.03.2020, 2:08 p.m.

Up to half a milligram should be injected into the test subjects, divided into two doses. There is $ 1100 compensation for participation. It is in the guidelines for the world's first study in which people are given a possible vaccine against Covid-19. A research institute in Seattle, USA has recently started looking for 45 volunteers. The US vaccine manufacturer Moderna announced that the first doses could be injected later this month.

Vaccines have never been developed as quickly as in the case of Covid-19. In addition to Moderna, other pharmaceutical companies say they are about to carry out human tests. In the race against the deadly pathogen, experimental substances should now be administered to people before their efficacy has been extensively researched on experimental animals - a break with a noble principle of pharmaceutical research. While some scientists find this haste appropriate, others warn of incalculable risks.

Testing a new vaccine is a highly complex, multi-stage process. As a rule, national regulatory authorities only give the green light for clinical studies, i.e. tests on humans, if both the safety and the effectiveness of a substance has been demonstrated on laboratory animals. This applies, for example, to the powerful American Food and Drug Administration (FDA). The WHO is said to have given the green light for accelerated procedures

The authorities often want to see not only the results of experiments on mice, but also on more highly developed animals, guinea pigs, rabbits or primates. Such studies can take months, sometimes years. Time that is not available in the event of a pandemic.

At a meeting of the World Health Organization (WHO) in mid-February, representatives of public research institutions and pharmaceutical companies discussed how the process could be accelerated. According to media reports, they agreed that because of the acute threat from the virus, vaccine developers should begin testing on humans before all animal studies are complete.

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mimi's picture

How much would you ask to be compensated for taking the risk and volunteer as a human guinea pig, before the real guinea pigs had been tested successfully?

If you get paid for it, were you bribed? At what price do you break and offer yourself? What is the ethical dilemma here. I can't think clearly now.

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mimi

@JtC (are their ways to embed a yes/no counter in an essay page?)

But folks can weigh in yes or no in their comments.

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mimi's picture

@JtC

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mimi

Lily O Lady's picture

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"The object of persecution is persecution. The object of torture is torture. The object of power is power. Now do you begin to understand me?" ~Orwell, "1984"

Granma's picture

@Lily O Lady

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Deja's picture

@Lily O Lady
I don't know what they would say. I will ask them. Have a feeling my son would decline and my daughter would say, "absolutely".

I believe my brother committed covid19 suicide, or at least attempted to; we shall see.

He abhorrently despises pretty much any large social gathering (people in grocery stores seriously piss him off, though I can relate), but went to the Houston Livestock Show and Rodeo on Sunday. He also planted flowers instead of food, this year.

His financial situation is grim, and has declined in the last year, substantially.

He had an organic urban garden, in what used to be called, "The Montrose" . I've eaten the most glorious (and persistent) collard greens I've ever had from it for years, as well as herbs and other veggies.

Time for a text, and maybe a call if he's up. I just realized what he did. I will not rag on him and will try not to cry.

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for a vaccine to stimulate antibody production before I am likely to be exposed. In the much less likely event that I avoid becoming infected, there’s a very real possibility that the vaccine might result in an active infection or even kill me oughtright.

No speedy vaccine for me. I’m content to roll the dice and wait like everyone else for a properly vetted vaccine a year or two down the road.

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"I fear that monstrous russian dictatorship going to attack the free world with bioweapons it seized in unexisting Pentagon funded humanitarian Ukrainian biolabs."
Greg Galloway 3/14/22

@ovals49
Now if the vaccine were to be made available at cost or at no cost and without patent protection, then I might reconsider my position.

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"I fear that monstrous russian dictatorship going to attack the free world with bioweapons it seized in unexisting Pentagon funded humanitarian Ukrainian biolabs."
Greg Galloway 3/14/22

I am something of an anti vaxxer for myself. I rarely get sick and when I do it is a mild version of whatever it is that is going around. I have worked in public or the equivalent of a giant airplane with recycled air for 35 years. I believe I have been exposed to just about everything out there plus I seem to have great genetics. My mother went 96 years without taking an antibiotic. When asked if she was allergic to penicillin she didn't know. The doctor glared at her with a raised eyebrow like she was an alien life form. At 58 I have never needed an antibiotic either. I think I will continue to trust that, it got me this far.

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CB's picture

EDIT: Maybe I shouldn't have posted this in this diary. Should I delete it?
EDIT 2: I published a diary with this info.

National Security Adviser Robert O'Brien spouts lies and misconceptions about how China has handled the COVID-19 outbreak.

I'm so pissed at this asshole I'd like to give him a hard kick in the ass to dislodge his head.

Read the following timeline on Wiki. All the events occurring in China were publicly available. The WHO was involved almost from the very beginning.

If you watch O'Brien's talk from the beginning of that video, he speaks about the necessity of expanding and increasing the Defense Budget to counter new threats to American hegemonic world power. The US is the greatest threat to human health and existence on the face of the earth.

The following is the gist of O'Brien's talk. But you should really watch the video because he praises Trump, Pence and Pompeo for getting a firm handle on the problem.

National security adviser says China "covered up" coronavirus, delaying global response
By Melissa Quinn
March 11, 2020

Washington — National Security Adviser Robert O'Brien suggested Wednesday that China "covered up" the initial outbreak of the coronavirus, delaying an effective global response by two months.
...
"Unfortunately, rather than using best practices, this outbreak in Wuhan was covered up," O'Brien said. "There's lots of open-source reporting from China, from Chinese nationals, that the doctors involved were either silenced or put in isolation or that sort of thing, so that the word of this virus could not get out."

As a result of those actions by the Chinese government, "it probably cost the world community two months to respond," as health officials from the World Health Organization and the Centers for Disease Control and Prevention could have been on the ground sooner, he said.

"I think we could have dramatically curtailed what happened, both in China and what's now happening across the world," O'Brien added.
...

I'm looking forward to the US version of China's response to COVID-19

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snoopydawg's picture

@CB

The massive war games in Europe on still on

Now, the drills' plan is cracking at the seams and it is increasingly unclear if the large-scale war games will take place at all. The US European Command already said earlier this week it would scale down America's participation in the exercise and modify it accordingly. The news comes on the heels of another drill cancellation, with Norway calling off another NATO exercise, all because of the fears of the pandemic.

Let's be clear: NATO has not yet canceled Defender Europe 2020. Nor has the US pulled back from the event, for now at least. Yet this might well happen, analysts and former military officials told RT. "I would not be surprised if those exercises are postponed for several months," former Pentagon official Michael Maloof said, while a retired US Air Force Lieutenant Colonel Karen Kwiatkowski believed the drills could be either delayed or even canceled altogether.

And the Western nations might have good reasons for such a move, since, according to Kwiatkowski, soldiers might be needed at home, where they could help with cordoning off large quarantine areas or implementing martial law and controlling domestic population movements as part of the state of emergency.

Governments have fallen and collapsed on far less than what this pandemic has already delivered. And that fear is very likely the primary fear of governments, including the US government, and why no one wants their national troops in an overseas exercise at this time."

Apart from that, soldiers returning from overseas drills could themselves be a health risk, particularly if they come back from epidemic-stricken areas. "What we are trying to do is to keep everybody frozen to a place so we will try to keep rotations to a minimum. That is another reason why you are going to see minimal exercises, because all this moving people around will have a potential of spreading the virus," Maloof explains, adding that if any US personnel were sent to Europe for an exercise, they would have to "go through a mandatory two weeks" of quarantine.

Image problems

Sending troops to supposedly disease-plagued areas for no real reason could also very well turn out a PR disaster for the Western leaders. "In our modern, peaceful times, an idea of deliberately putting soldiers' health and even lives at risk would hardly be welcomed," Mikhail Khodarenok, a retired colonel in the Russian Air Defense Forces and former General Staff officer, told RT. "The public both in the West and in the East would hardly understand and accept it," he warned

20,000 US troops will play with their guns along with 10,000 defenders from other countries. One article I read on this said that no one had been given masks.

But then the military has already failed big time for when they took the quarantined folks off the cruise ship after they had been separated in their rooms there they loaded them all on buses and then they sat on them for hours. And people took off their masks to eat and drink. Well done.

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It is not until the tide goes out that you discover who has been swimming naked.

mimi's picture

@CB @CB
to exactly understand the clinical trial procedures.... and other things, I don't understand fully. Thank You upfront for your comment.

PS. In Berlin, Germany all gatherings with more than 50 people are not 'verboten', starting tonight.

My brother in a small town near the lake Lago Maggiore in Switzerland, is not allowed to leave the town's geographical borders anymore. Too close to the Italians ... Wink

One good idea in Switzerland is a new service for anyone, who is too old or weak to do their food supply shopping. You can call them (on land lines too), order items you need, they get out and buy them for you and deliver them to your home, which includes bringing the boxes to your kitchen. I am not sure if it costs extra for delivery. It's a group community effort. (With the mountains and the houses often on steep hills, that is a good idea)

Meanwhile the virus infection hit some media folks and TV talk shows with political talking heads on their round table. They have no studio audience anymore. Looks and sounds quite strange.

Ironically in areas where tourism is a main source of income, hotels themselves send the tourists home and arrange for them to do it ... asap. They don't want the customers anymore. Apparently they prefer an empty hotel It's weirdo, but somewhat thought provoking.

PS. Trump has been tested? You think the results will be published, if he tested positive? Well, in case he is postivie, he at least has the safest quarantine quarters in the world. /s And if he tested negative, who would believe those media who try to make us believe it's true" /s

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mimi

@mimi reported to be negative.

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mimi's picture

@jean

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mimi

earthling1's picture

if I understand this right.
I'm to take the vaccine and then expose myself to the virus to see if it works?
Hmmm.
Uh, no.

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After six years, still getting robo-calls from Marriot Hotels.
They're like herpes.

CB's picture

@earthling1 @earthling1 @earthling1 you will not be infected with anything. The test will just determine how well the body tolerates the vaccine.

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@earthling1 They would test to see the level of antibodies against the coronavirus that you produce after getting the vaccination. They wouldn't expose you to the virus.

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Roy Blakeley's picture

I would have to have a good look at the nature of the vaccine (attenuated virus, dead virus, viral proteins) and ascertain the risk. The best we can do now is to try to minimize infections until a vaccine is ready and do the best we can under what is laughably called the US health care system to deliver the best supportive care for people that are seriously ill from COVID-19. We don't have enough hospital beds or respirators. People will die because we have a breathtakingly stupid health care system. Looking at you Barak Obama, Joe Biden, and all the arrogant neoliberal assheads in both parties. If you had consciences and enough intelligence to realize how pitifully stupid you are, you would apologize to the people of the US and world for the harm you have done and STFU for the rest of your lives.

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mimi's picture

@Roy Blakeley
if that makes you feel better. It's the virologists who have some influence on the politicians. That is new.

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mimi

Moderna's vaccine is an mRNA based vaccine that, when injected, will make a small fragment of coronavirus protein that hopefully will be recognized by the immune system and start the production of antibodies to prevent an infection. There would be no chance to get the COVID-19 disease from the vaccination as it wouldn't contain all of the components necessary to generate an live virus. I think that historically, vaccine making has been one of the most safe and effective methods of combating infectious diseases. We are now living through a time with this pandemic that used to be much more common in human history. Vaccines have made it so we don't often think about polio, measles, whooping cough and many other common illnesses that used to worry all parents raising young kids. Vaccines have even eliminated smallpox, the most deadly viral pathogen known to mankind. Relative to any other medical intervention, vaccine development has been incredibly safe, even in the early days when live virus was commonly used. This coronavirus is going to stick around until a good vaccine is developed and I would be happy to be a guinea pig since this testing will save lives in the very near future

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@innatimm @innatimm I'm a molecular biologist and did not know of Moderna's technology. My initial thought was: injecting mRNA? Yeah, no. that won't work. How do you get it to move inside the cells? How do you keep it from being degraded in a few seconds by enzymes inside and outside the cell? How do you make sure that it is robustly translated? i.e. Proper Kozak sequences etc.
So that's pretty cool that their approach could work.

I wonder as well though what the failure/success rate is on their vaccine trials. I would imagine that any vaccine candidate would have already gone through a lot of testing, along with hundreds of others, to make sure that cells in tissue culture exposed to the "mRNA" take up and express the protein fragment they are meant to at high levels, that the bit of viral protein they "express" is found in an exposed part of the virus and that antibodies targeted to that region of a protein will result in virus infected cells being dutifully killed.

But, trust me, there is a bit of an art to protein sequence "gazing" such that regions of a protein are chosen that work well for a vaccine. There are no algorithms that work well to find regions that are both highly expressed in the cell *and* make a protein that will prove to be antigenic *and* protective. It is, in my experience, a best guess scenario and some folks seem to have a serendipitous knack and others don't.

Either way, yeah I'd probably be OK with testing the vaccine. I would like to know what else is in the sample being injected (adjuvant etc?). But, I think bad outcomes from this type of test would be really rare.

As an aside, a few folks near the top commented that they would not risk the injection because they are in a "high risk" group. I think the assumption is that there is the possibility they might get the disease itself from the vaccine. This is not the case. We are talking about injecting a tiny part of the virus. We are past the days that attenuated (e.g. heat "killed") or any other such formulation that might contain some "live" virus would be a formulation that would be used for vaccines.

Edit: deleted a "not" that changed the meaning of a sentence...

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mimi's picture

I read this one regularly. It's updated all the time. I then put each new update in something like the google translate page to get and English version. May be you want to do that too?
Corona Virus News

This bit of information I found 'telling':
In German:

Bericht: Streit zwischen Deutschland und USA wegen Impfstoff-Firma

7.55 Uhr: Die USA und Deutschland streiten laut einem Bericht der "Welt am Sonntag" über die Tübinger Firma CureVac, die einen Impfstoff gegen das Coronavirus entwickeln will. US-Präsident Donald Trump versuche, deutsche Wissenschaftler, die an einem Corona-Impfstoff arbeiten, mit hohen finanziellen Zuwendungen nach Amerika zu locken beziehungsweise das Medikament exklusiv für sein Land zu sichern, berichtete die Zeitung unter Berufung auf deutsche Regierungskreise.

Demnach soll der US-Präsident der Firma einen hohen Betrag angeboten haben, um sich deren Arbeit exklusiv zu sichern. Trump tue alles, um einen Impfstoff für die USA zu bekommen. "Aber eben nur für die USA", zitiert das Blatt eine anonyme Quelle in der Bundesregierung.

English translation via google translation:

.55 clock: According to a report by "Welt am Sonntag", the US and Germany are arguing about the Tübingen company CureVac, which wants to develop a vaccine against the coronavirus.
US President Donald Trump tries to lure German scientists working on a corona vaccine to America with high financial donations to secure the drug exclusivelyfor his country, the newspaper reported, citing German government circles.

The US President is said to have offered the company a large amount in order to secure its work exclusively. Trump is doing everything possible to get a vaccine for the United States. "But only for the United States," the paper quotes an anonymous source in the federal government.

Me sez: Under 'Virus Law' you are all equal, according to the Viral Law Supreme Court. Get that, Mr. Crap.

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mimi