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Corona / Covid-19 Virus - General Discussion (politics go to the Off Topic / Politics thread)

MedEwok wrote:

The data is from an international meta-analysis of 27 different studies and thus not country-specific

Just one Caveat: It’s meta analysis on papers published before Mid. September so that the data source of these papers is most likely before August. Therefore the age distribution is quite limited to first wave and does not take the second wave changes into account.

Germany

Why this surprises anyone, I don’t know.

Tell the BBC, etc

The aspect which perhaps not many knew is that the trial of these “drugs” has to be “clean” so they intentionally exclude people with certain conditions. The two people in question are NHS workers so this wasn’t a surprise.

Administrator
Shoreham EGKA, United Kingdom

Malibuflyer wrote:

Just one Caveat: It’s meta analysis on papers published before Mid. September so that the data source of these papers is most likely before August. Therefore the age distribution is quite limited to first wave and does not take the second wave changes into account.

Yes, indeed. Even though Covid-19 has massively accelerated the publishing process in medical journals, you never get peer-reviewed live data. It is alway a look into the past. Though from my understanding, there are so far no indications that the virus has mutated to become more (or less) deadly. The efficacy of Covid-19 treatment has improved somewhat from since the first wave, so lethality might now be lower than published here.

Last Edited by MedEwok at 09 Dec 13:47
Low-hours pilot
EDVM Hildesheim, Germany

Peter wrote:

The aspect which perhaps not many knew is that the trial of these “drugs” has to be “clean” so they intentionally exclude people with certain conditions.

Indeed, people are learning a lot about clinical trials that they didn’t know before!

One part that has passed the media by is the concept of an analysis dataset. It is widely reported that the vaccines are being tested on tens of thousands of people, but not why. The public is left with the impression that this is the number necessary to prove something.

In fact, most proof-of-concept (phase II) trials have an analysis dataset of around 100 subjects. Evidence of effect across that many subjects is generally enough for regulators to approve a phase III trial (200-1,500 subjects) and for companies to spend the money ($10-50m) on one. Good data from a phase III trial is generally enough to get approval.

Because a vaccine trial is a reverse logical deduction (you’re not allowed to deliberately expose people to the virus, so you have to vaccinate healthy people and then test them repeatedly as they run the risk of normal exposure in the population) you need a much larger number of people in the trial than the eventual analysis dataset.

Say the rate of infection in the population is 1 in 1,000 in some high-prevalence area (why do you think they went to Brazil?) – you jab say 10,000 trial subjects (half with the vaccine, half with a control) and then test them repeatedly. Eventually 100 of your subjects (the analysis dataset) will have tested positive, and you break the blind and see how many had the vaccine. Turns out 90 had control and 10 had vaccine (or whatever) and that is statistically significant – it could not reasonably have occurred by chance – and demonstrates that the choice of vaccine or control has an effect on how likely someone is to be infected. The other 9,900 in the trial provide useful safety data, but tell you nothing on efficacy – you don’t know if they were protected or if they just were never exposed.

You might also learn something about efficacy based on how long it takes you to reach 100 positive tests (what we call the trial endpoint, or in this case an interim endpoint) because if your vaccine is very effective then you are effectively halving the incidence rate in your trial population – but to draw any firm conclusions on that you would need to be very confident of your infection rate data.

Last Edited by Graham at 09 Dec 14:59
EGLM & EGTN

Surely vaccine intake and willingness has to do with risk-benefit? if one has 10% CFR they will take it

For main population, I think politicians willingness to take the vaccine helps as well, in France, I am assuming lot of people put a lot of trust in their politicians but not as one may think: lot of high profile government heads want people to take vaccines but they are skeptical to take it themselves, this did not send the right message !

I am waiting for Putin to get his jab before buying a 6-pack of sputnik for my family
I imagine no point for Boris Johnson to get vaccinated in front public TV

Last Edited by Ibra at 09 Dec 15:23
Paris/Essex, France/UK, United Kingdom

Peter wrote:

The aspect which perhaps not many knew is that the trial of these “drugs” has to be “clean” so they intentionally exclude people with certain conditions.

That is a little bit too condensed in my opinion:
- Generally you do not want people to die or to suffer significant harm during a trial. Therefore you obviously exclude patients where the likelihood of such result is high even without any kind of trial.
- There are some phases of clinical trials, (esp.1 and 3a) where you look specifically on safety and side effects. In those phases you obviously do not want any medical event to happen as it is quite impossible if a test patient has a heart attack during the trial to determine if it was actually caused by the drug or has nothing to do with it.
- Generally, however, you test with a population which is as diverse (from medical point of view) as the population you later on want to administer the drug to. But yes, there is a whole industry around identifying patients that fulfill these diversity criteria but are as “clean” as possible…

Germany

MedEwok wrote:

Though from my understanding, there are so far no indications that the virus has mutated to become more (or less) deadly. The efficacy of Covid-19 treatment has improved somewhat from since the first wave, so lethality might now be lower than published here.

I would expect that esp. in higher age groups lethality has gone down significantly both for better treatment but also (frankly speaking) because the parts of the population with the worst immune system also died in the first wave so that the remaining parts of the elderly that are still alive (which is a prerequisite for being infected now ;-)) on average has a better health status when the average cohort in January…

Survivor effect!

Germany

Malibuflyer wrote:

But yes, there is a whole industry around identifying patients that fulfill these diversity criteria but are as “clean” as possible…

It is why each protocol has a comprehensive set of inclusion/exclusion criteria. It is nothing nefarious – companies are not trying to hide safety issues. They’re just trying to ensure that the analysis is as robust as possible, which is difficult when the analysis dataset is full of people who had heart attacks because they’re in poor shape, or even people who got hit by a bus ;-)

Of course some trials, in very sick patients with very serious diseases, have inherently messy analysis datasets.

You have find a balance between keeping the dataset clean and being so strict that you struggle to find enough patients.

Last Edited by Graham at 09 Dec 15:38
EGLM & EGTN

No one in their right mind (normal persons) will take vaccines unless they have to, or think they are better off with a vaccine than without. When I went to Africa a few years ago, I took vaccines because I had to, or I wouldn’t be allowed to enter specific countries. A flu vaccine is more in the pragmatic category. I don’t have time (due to work) to get the flu within the next couple of months, so I take the vaccine, for instance. The covid vaccine is more in the latter category, unless you are 60+, then it could be a real life saver. A 20 year old saying he won’t take the vaccine is a completely different story than a 90 year old saying he won’t take the vaccine.

The elephant is the circulation
ENVA ENOP ENMO, Norway

A 20 year old saying he won’t take the vaccine is a completely different story than a 90 year old saying he won’t take the vaccine.

That’s a line taken by many on social media, but it assumes that someone who has been vaccinated remains equally likely to

  • catch the disease and
  • pass it on to others

and none of the above are likely to be true once one has been vaccinated. To become infectious you need to catch it properly first, which you won’t if vaccinated. And asymptomatic spreading has been a key issue with CV19, enabling young people to catch it, spread it to older people, while not getting ill themselves.

The proposition also ignores the long-term or permanent organ damage which people get, and this is over all ages, not just the “old ones”.

Administrator
Shoreham EGKA, United Kingdom
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