Covid-19 #17: Covid Is For Ever

[Altherion]

52 minutes ago, Old Zog said:

What do you suggest they should do instead?

It depends on the type of vaccine. If this is like the measles vaccine, dispense with the control group and simply try to infect the people who have been given the vaccine. If the vaccine works, they should be fine and if not, we'll know it does not work. There is no need for a double-blind study in this case as the vaccinated should simply be immune.

If this is more like a flu vaccine (i.e. it only works of order 50% of the time), then they should strongly consider coming up with a better vaccine rather than spending time testing this one. If it is clear that it's difficult to do better on a reasonable time scale, they do need the double-blind test which makes it ethically dubious, but I think the quick way is still better (see below).

31 minutes ago, Mudguard said:

It sounds like you are suggesting that they should be deliberately infecting clinical trial subjects with SARS-CoV-2, when we don't have any really effective treatments yet.  That's crazy, and was never seriously considered anywhere in the world, as far as I can tell.  Such a clinical trial where subjects are challenged with a potentially deadly virus with no cure would violate numerous ethical rules and guidelines, and I can't imagine such a trial actually getting approved.  Old people and other types of susceptible people would need to be tested too to see if the vaccine protects these types of people.  You are OK with deliberately infecting all these people?  Maybe the vaccine doesn't work.  A large portion are also getting a placebo.  Bunch of people would die during such a trial.

Their number of test subjects who actually contribute is of order 100 for each group. If you actually need the double-blind test (you don't need it for the full immunity type of vaccine), then yes, around 100 people who don't have the vaccine but do have the virus are necessary and if you want it to it properly (i.e. trick them into thinking that they might be vaccinated rather than simply taking existing patients), then yes, a few of them will die. But again, this is the action vs. inaction dilemma (or, if you like, a real life analogue of the trolley problem): if you wait until they become infected naturally, some of them will die anyway and in the meantime, thousands of people are dying of the virus every day.

[HoodedCrow]

Covid would be a test run, except that many thousands of people have already died and the transmission happens while people are unaware they are sick. If it were the plague the variations were known. They couldn’t know that the vectors were fleas, likely from rodents. What they did do was mark households and used quarantines , or leave town for a place of relative safety, if they had the resources. 
People do die or get sick from medications. Actually, I almost did, because, in retrospect, they got the dosage wrong. The worst thing that could happen is the vaccinated may get covid or covid damage. Also people can be vaccinated can infect others, when they think they are good to go. That might happen even if it is marginally effective. If you don’t believe me than you can ponder taking whatever Trump and the boys are pushing. A robot would probably say that there were insufficient data for prescribing medication other that steroids or proven medication ( that have already passed safety trials) , lay people on there stomachs if they are in hospital, wash your hands and wear a mask.  The data points are in progress.

[Zorral]

1 hour ago, The Anti-Targ said:

My interpretation of the attempted point is that to speed things along with vaccines it would be scientifically robust to actively infect people as part of the process.

You and Mengele. Thanks for revealing yet again we're yet again in nazi times, Your  posts underscore this fact about you every time. See, along with your smart ideas, the Tuskegee syphillis studies using only black soldiers.  You attitude is racist and evil.

[The Anti-Targ]

Just now, Zorral said:

You and Mengele. Nazi, but then we know we're in nazi times and your posts underscore this fact about you every time.

LOL!!!!!!

[Zorral]

He thinks this is funny.

 

[The Anti-Targ]

1 minute ago, Zorral said:

He thinks this is funny.

 

If you don't know which bit of your post I am laughing at I can't help you.

[Fragile Bird]

22 minutes ago, The Anti-Targ said:

If you don't know which bit of your post I am laughing at I can't help you.

Are there 30,000 New Zealanders willing?

[Old Zog]

1 hour ago, Altherion said:

It depends on the type of vaccine. [...] If this is more like a flu vaccine (i.e. it only works of order 50% of the time), then they should strongly consider coming up with a better vaccine rather than spending time testing this one. [...]

At what point in the process do they find out whether the vaccine works (almost) all the time, about half of the time, or none of the time?

[Zorral]

Is Anti-targ gonna volunteer, or be just chosen, to be one of them?

Who gets to be the infected? Who gets to choose? Who tells the truth?  Who doesn't tell the truth?

[The Anti-Targ]

1 hour ago, Fragile Bird said:

Are there 30,000 New Zealanders willing?

I don't understand why you are asking me this, so I don't know how to respond.

[Fragile Bird]

7 minutes ago, The Anti-Targ said:

I don't understand why you are asking me this, so I don't know how to respond.

 

3 hours ago, The Anti-Targ said:

It seems pretty trivial in the grand scheme of the pandemic, but this week we had our first death in someone under the age of 60. It was almost someone in their 40s (the person was 50). The age distribution of cases here is, I guess, normal in that the vast majority of confirmed cases is in the under 60s. Only 7% of confirmed cases are in the 60+ age group, and until this week 100% of deaths.

My interpretation of the attempted point is that to speed things along with vaccines it would be scientifically robust to actively infect people as part of the process. The quality of data you can get from actively infecting people is as good, arguably better, than the quality of data you can get by just sending people out into the world and relying on probability to get you the data you need. But you are going to deliberately make some people in the placebo group sick and potentially die, and some people in the vaccine group also, since it is not expected that the vaccine will be 100% effective. So it would be ethically, and probably legally proscribed to do this.

 

Clear enough? It's why Zorral calls you Mengele. Do you have 30,000 New Zealanders to volunteer up?

[The Anti-Targ]

1 minute ago, Fragile Bird said:

 

Clear enough? It's why Zorral calls you Mengele. Do you have 30,000 New Zealanders to volunteer up?

So you fail to understand my post too then. Nothing more to say, really.

[The Anti-Targ]

1 minute ago, Chataya de Fleury said:

Oh, FFS *eye-roll*
What reliable news sources can you cite?

https://www.stuff.co.nz/national/politics/300092612/90day-trials-would-return-but-lunchtime-gone-by-lunchtime-under-national-small-business-policy

Quote

90-day trials would return, but lunchtime gone by lunchtime under National small business policy

Though on closer reading it appears we may not have had mandatory meal breaks for most of our history, which is pretty sad.

[Altherion]

1 hour ago, Old Zog said:

At what point in the process do they find out whether the vaccine works (almost) all the time, about half of the time, or none of the time?

Presumably they have some knowledge from the underlying biology (otherwise there's a nearly infinite combination of chemicals to test). The test with only vaccinated people would give them a pretty good idea of this if they don't already have it (at the price of some risk to the test subject if the vaccine is mostly useless).

[rotting sea cow]

@Zorral @The Anti-Targ @Mudguard @Clueless Northman, etc.

The WHO allows human challenging studies under strict ethical guidance

https://www.who.int/ethics/publications/key-criteria-ethical-acceptability-of-covid-19-human-challenge/en/

It is rumoured that the Russians conducted such challengings with their Sputnik V vaccine although results haven't been published. Probably they are showing them only to interested partners. 

 

 

 

[rotting sea cow]

On 8/27/2020 at 3:30 AM, The Anti-Targ said:

Edit: and pretty much on queue with my post-COVID social and economic pessimism we have one party campaigning to implement permanent erosion of employment conditions in the guise of "post-COVID" economic recovery by eliminating mandatory work breaks. Such a shitty mean-spirited policy. Help business recover by making workers suffer. Mandatory lunch / dinner breaks have been sacrosanct for maybe a century now. All it takes is the worst health crisis in living memory to have some politicians decide now is a good time to get rid of it.

The world is full of idiotic policy makers proposing all sort of stupid stuff. They aren't helping and they are contributing to the feeling that this crisis is BS. This feeling is increasing in the population and will bring further troubles. For example

- Some member of some ethical committee in Spain proposed to take out the parental rights to vaccinate the kids against the parental consent. Exactly what we need now.

- A politician in Germany proposed to isolate kids in special facilities if there are suspect cases in their home.

- ETA; Do not forget the Australian police raiding homes of people for expressing some opinions in facebook.

I can post links later.

[DaveSumm]

7 hours ago, Altherion said:

It depends on the type of vaccine. If this is like the measles vaccine, dispense with the control group and simply try to infect the people who have been given the vaccine. If the vaccine works, they should be fine and if not, we'll know it does not work. There is no need for a double-blind study in this case as the vaccinated should simply be immune.

Putting the ethics aside for a minute, there are many other reasons why you should simulate the actual means of infection rather than just shooting them up with some covid. We don’t really know how the virus might manifest if contracted through air particles, or touching surfaces, or how these means affect the viral load, or how a vaccine might be efficacious against these different methods, if at all. People are contracting this virus naturally in their every day lives, and that is the environment it should be tested in. It’s also not black and white, it might work in some circumstances and some not, it might work 75% of the time (in which case we most definitely need data on the circumstances of the 25%). We’ll need a robust understanding of how it works to compare it to other candidates, when you might administer one or the other, what time scales they remain effective for.

And double blind tests are the gold standard for scientific experiments, you don’t just stop bothering cos we’re in a hurry. It’s more important in this instance, not less.

[Mudguard]

10 hours ago, Altherion said:

It depends on the type of vaccine. If this is like the measles vaccine, dispense with the control group and simply try to infect the people who have been given the vaccine. If the vaccine works, they should be fine and if not, we'll know it does not work. There is no need for a double-blind study in this case as the vaccinated should simply be immune.

If this is more like a flu vaccine (i.e. it only works of order 50% of the time), then they should strongly consider coming up with a better vaccine rather than spending time testing this one. If it is clear that it's difficult to do better on a reasonable time scale, they do need the double-blind test which makes it ethically dubious, but I think the quick way is still better (see below).

Their number of test subjects who actually contribute is of order 100 for each group. If you actually need the double-blind test (you don't need it for the full immunity type of vaccine), then yes, around 100 people who don't have the vaccine but do have the virus are necessary and if you want it to it properly (i.e. trick them into thinking that they might be vaccinated rather than simply taking existing patients), then yes, a few of them will die. But again, this is the action vs. inaction dilemma (or, if you like, a real life analogue of the trolley problem): if you wait until they become infected naturally, some of them will die anyway and in the meantime, thousands of people are dying of the virus every day.

I don't know what you mean by "type of vaccine."  If you mean whether the vaccine is a live attenuated vaccine (i.e., measles vaccine, nasal spray influenza vaccine) or an inactivated virus based influenza vaccine, then none of the three vaccines under consideration in the US (Moderna, Pfizer, Oxford) or the Russian or Chinese vaccines are based on either of these technologies.  Even if they were based on one of these technologies, you cannot assume that the performance of an live attenuated vaccine is always as good as the measles vaccine.  For example, FluMist sometimes performs worse than the traditional inactivated influenza vaccine, which already is a mediocre performing vaccine at best.  

All the early vaccine candidates are based on unproven technologies that have yet to result in a commercially sold vaccine.  Consequently, there is even more uncertainty around these vaccines than usual.  We have no idea how well any of these vaccines will work.  It could range anywhere from actually increasing your chance of getting infected to 80+% effective.

Your comment that they should just come up with a better vaccine rather than do the testing if the effectiveness is around 50% or less is nonsensical.  Again, the effectiveness of the vaccine is unknown until it's tested in clinical trials.  I don't get why you think this is something that is known beforehand.  Normally your posts are logical, even if they may be controversial, but there appears to be a big disconnect here.  There are over 150 vaccine candidates under development, and we have no idea about the efficacy of any of them.  

3 hours ago, rotting sea cow said:

@Zorral @The Anti-Targ @Mudguard @Clueless Northman, etc.

The WHO allows human challenging studies under strict ethical guidance

https://www.who.int/ethics/publications/key-criteria-ethical-acceptability-of-covid-19-human-challenge/en/

It is rumoured that the Russians conducted such challengings with their Sputnik V vaccine although results haven't been published. Probably they are showing them only to interested partners. 

I read the challenge guidance paper, and the WHO is not saying outright that coronavirus challenge studies are OK.  They are merely recommending that anyone considering doing a challenge study needs to consider 8 criteria before making a decision whether to proceed.  Also, since the WHO doesn't really have any actual authority over any country, they cannot allow or prevent countries from going forward with challenge studies, at least to the best of my knowledge.

Anyway, criteria 2 is about assessing the risks and benefits of conducting a challenge study and trying to weigh the two against each other.  Currently, I don't think potential benefit of possibly speeding up the approval time exceeds all the risks of deliberately infecting subjects with a potentially deadly disease, for many reasons. 

For example, the WHO paper recommends only recruiting young healthy subjects that are at low risk for suffering serious symptoms.  However, young healthy subjects are the group that needs the vaccine the least.  We really want to know how well the vaccine protects the most at risk people, like the elderly and people with underlying conditions.  It is risky to assume that if the vaccine performs well in the young and healthy, it will also perform well in the elderly and/or sick.  

It's also not clear to me how much faster the challenge study would be.  Potentially, it could be quite a bit faster, say around at least 4 months faster if the standard trial takes 6 months to complete, but there are many unknowns around this.  It's not clear to me how many subjects would be needed, and how quickly they'll be able to recruit willing subjects.  Will they require a certain number of minorities to be recruited?  The US already has a shameful history of medical experimentation on Black people so there is a higher level of distrust regarding medical testing, which is already making recruitment difficult in the current vaccine studies.  I think it'll be even harder to recruit black people for a challenge study, at least in the US.  Also, how long will it take to figure out the right dosing?  And how easy will it be to find willing guinea pigs for the dosing studies?  Will the artificial dosing result in an laboratory determined efficacy that matches real world efficacy?

To improve recruitment, especially when there is a significant risk involved, money is often handled out as compensation.  Also, it's probably difficult for many people that work to just take off a month or so to participate in a clinical study.  I think it's very likely that a disproportionate number of subjects will be recruited from the poor.  Ethically and morally, this is problematic as well.

I think it's telling that the US has not seriously considered doing a challenge study.  No one wants a vaccine sooner than Trump, and it's clear he is doing everything possible to speed up the timeline.  I assume that his administration considered it, but ruled it out.  I can't imagine that a challenge study will be conducted in the US.  A challenge study should only be a last resort type thing to do here, and when we won't even mandate enforceable mask usage across the country and/or uniform social distancing measures, it's impossible to justify the necessity of a challenge study.  We're going to deliberately infect the poorest and most desperate of our country so that a bunch of morons can continue to refuse to wear masks or socially distance?  We haven't fallen quite that low ... yet.

[rotting sea cow]

On 9/6/2020 at 1:33 PM, The Anti-Targ said:

Interesting to now see the companies developing vaccines saying they will make a collective pledge not to apply for any vaccine approval until they are sure it is safe and effective. It's a sad day when multinational corporations appear to have a greater social conscience than the most powerful governments in the world.

Quote

Biopharma Leaders Unite to Stand with Science

All nine CEOs signed the following pledge:  

We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

• Always make the safety and well-being of vaccinated individuals our top priority.
• Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
• Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
• Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

https://investors.modernatx.com/news-releases/news-release-details/biopharma-leaders-unite-stand-science/

Signatories: AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, Sanofi

 

 

[Knight Of Winter]

Here's one interesting case.

When pandemic started, Brazilian city of Manaus failed to react in any way: they had no distancing, no masks and no obligatory disinfection in stores. Naturally, they were hit hard - and I mean really hard - by the virus. Hospitals ran out of beds very quickly, death toll skyrocketed to such a degree that impromptu mass graves were dug to accommodate all the bodies. It'd not be far-fetched to say that Manaus was one on the worst places to be during the corona-crisis.

But recently, something changed. Not the population - who still don't wear masks and don't practice distancing - but the disease itself. Number of fatalities suddenly plummeted - having gone from 120 daily in May to almost zero recently. So scientists speculate that maybe enough people survived the virus to develop the herd immunity. Far from anything definite, but certainly interesting food for thought.