Who's getting the shot?

[Rival]

These vaccines have ALL gone through EXACTLY the same rigorous testing as any other.

The reason they have been approved so fast is because (i) everybody dropped everything to work on them (normally these organisations have lots on the go at once) and (ii), very significantly, the approval authorities did something they never normally do, which is to monitor the data as it came in. Normally they don't have the resources to do that, so they ask the developers not to bother them until everything is completed and then they go through it, once it reaches the head of the queue for approval.

That is how it has been done so fast, not by taking short cuts in the trials. It is vital to understand that.

If you don't get the vaccine when you can, you risk causes someone, possibly even you, serious long term illness or death that could have been avoided.

How can a vaccine possibly go through a meaningful trial period in under a year? It looks the opposite to me - rushing it through, likely to result in more mistakes.

Before a potential new therapy can reach patients, it goes through several clinical trial phases that test an intervention for both safety and effectiveness. Looking at the big picture, it takes approximately ten years for a new treatment to complete the journey from initial discovery to the marketplace. Clinical trials alone take six to seven years on average to complete.

Before a potential treatment reaches the clinical trial stage, scientists research ideas in what is called the discovery phase. This step can take from three to six years. Typically, researchers will test a potential new treatment in animals before moving on to the first stage of clinical testing in humans.

How long do clinical trial phases take? (antidote.me)

 

[Altfish]

Hmmm... Everything I've heard about this vaccine has been running around the rumor mill from those who've gotten the shot inside the hospital, and I can confirm the rumors that have been circulating here. Maybe things might be different in the future, but for now, it's not a super pleasant shot to get. It's been about 48 hours and I do feel quite a lot better now!

I'm gonna attempt workingo ut a little later on today. I'll know for sure then.

I know of about 6 people who had the jab; no complaints from anyone.

 

[Lyndon]

How can a vaccine possibly go through a meaningful trial period in under a year? It looks the opposite to me - rushing it through, likely to result in more mistakes.

Before a potential new therapy can reach patients, it goes through several clinical trial phases that test an intervention for both safety and effectiveness. Looking at the big picture, it takes approximately ten years for a new treatment to complete the journey from initial discovery to the marketplace. Clinical trials alone take six to seven years on average to complete.

Before a potential treatment reaches the clinical trial stage, scientists research ideas in what is called the discovery phase. This step can take from three to six years. Typically, researchers will test a potential new treatment in animals before moving on to the first stage of clinical testing in humans.

How long do clinical trial phases take? (antidote.me)

complete rubbish, a new flu vaccine is developed every year

 

[exchemist]

How can a vaccine possibly go through a meaningful trial period in under a year? It looks the opposite to me - rushing it through, likely to result in more mistakes.

Before a potential new therapy can reach patients, it goes through several clinical trial phases that test an intervention for both safety and effectiveness. Looking at the big picture, it takes approximately ten years for a new treatment to complete the journey from initial discovery to the marketplace. Clinical trials alone take six to seven years on average to complete.

Before a potential treatment reaches the clinical trial stage, scientists research ideas in what is called the discovery phase. This step can take from three to six years. Typically, researchers will test a potential new treatment in animals before moving on to the first stage of clinical testing in humans.

How long do clinical trial phases take? (antidote.me)

You are quoting from a description of routine timescales. That tells you nothing.

What you need to look at is the extent of the trials and their thoroughness: how many people, what trial protocols, etc. These trials have involved tens of thousands of people, in many different countries across the world. The UK regulatory authorities, who are independent of government, are adamant that no corners have been cut and that the extent of testing is just as extensive as for other vaccines.

All sorts of things can be concertina-ed if money is no object. One example: the manufacturers started making doses while the trials were still in progress, in the hope they would be successful. If they had failed, that would have been a huge waste of money, time and manufacturing capacity. But government underwrote the cost, so they could set that aside and take the gamble. What has been done is to run the various stages as far as possible in parallel, instead of sequentially as you do it if you are a commercial drug company trying to control your costs and maximise your profit.

You can trust these vaccines. Millions of people have already had them with no ill effects. Roll up your sleeve and get jabbed!

 

[SigurdReginson]

I know of about 6 people who had the jab; no complaints from anyone.

Good to know! Hmm...I wonder why there's such a difference? I doubt it's due to all the nurses in my hospital giving bad injections. I wonder if the people you knew got the pfizer injection, and if the moderna one hurts more?

My hospital did offer the pfizer one too, but the default one offered was moderna.

 

[Vinayaka]

STOP PRESS: just got an email from a couple in their 70s who have just had the jab and both have quite badly sore arms 24hrs later.

I often get a sore arm. Boss never does. Sometimes it's only because you tense up at the last moment, or the jab is crooked. That's called a bruise, not a reaction to the vaccine.

 

[exchemist]

I often get a sore arm. Boss never does. Sometimes it's only because you tense up at the last moment, or the jab is crooked. That's called a bruise, not a reaction to the vaccine.

Yeah can be that or can be your immune system sensing the foreign invader and going to war. Which is exactly what you want, if you think about it.

 

[Rival]

You are quoting from a description of routine timescales. That tells you nothing.

What you need to look at is the extent of the trials and their thoroughness: how many people, what trial protocols, etc. These trials have involved tens of thousands of people, in many different countries across the world. The UK regulatory authorities, who are independent of government, are adamant that no corners have been cut and that the extent of testing is just as extensive as for other vaccines.

All sorts of things can be concertina-ed if money is no object. One example: the manufacturers started making doses while the trials were still in progress, in the hope they would be successful. If they had failed, that would have been a huge waste of money, time and manufacturing capacity. But government underwrote the cost, so they could set that aside and take the gamble. What has been done is to run the various stages as far as possible in parallel, instead of sequentially as you do it if you are a commercial drug company trying to control your costs and maximise your profit.

You can trust these vaccines. Millions of people have already had them with no ill effects. Roll up your sleeve and get jabbed!

I don't want to take the gamble, not with my health, thanks!

I'm sorry, I just have no idea why anyone would trust such a rushed out vaccine.

Will covid-19 vaccines save lives? Current trials aren’t designed to tell us | The BMJ

But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.6

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7

Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

[...]

But Tal Zaks, chief medical officer at Moderna, told The BMJ that the company’s trial lacks adequate statistical power to assess those outcomes. “The trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good here,” he said.

Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out.

Zaks said, “Would I like to know that this prevents mortality? Sure, because I believe it does. I just don’t think it’s feasible within the timeframe [of the trial]—too many would die waiting for the results before we ever knew that.”

[...]

“Our trial will not demonstrate prevention of transmission,” Zaks said, “because in order to do that you have to swab people twice a week for very long periods, and that becomes operationally untenable.”

He repeatedly emphasised these “operational realities” of running a vaccine trial. “Every trial design, especially phase III, is always a balancing act between different needs,” he said. “If you wanted to have an answer on an endpoint that happens at a frequency of one 10th or one fifth the frequency of the primary endpoint, you would need a trial that is either 5 or 10 times larger or you’d need a trial that is 5 or 10 times longer to collect those events. Neither of these, I think, are acceptable in the current public need for knowing expeditiously that a vaccine works.”

 

[Vinayaka]

Yeah can be that or can be your immune system sensing the foreign invader and going to war. Which is exactly what you want, if you think about it.

For sure. Thanks for your determination on this thread. I often wish I was more proactive, but then I think ... Meh, if somebody wants to forego a tried and trusted vaccine, let them take that huge risk. Tons of people refused to wear seat belts too. A selfish reason I will get it is to travel. I hope that for a year or two, airlines insist you produce proof of vaccination. Health insurance shouldn't be covering wilful ignorance, because we all end up paying more.

 

[exchemist]

I don't want to take the gamble, not with my health, thanks!

I'm sorry, I just have no idea why anyone would trust such a rushed out vaccine.

Will covid-19 vaccines save lives? Current trials aren’t designed to tell us | The BMJ

But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.6

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7

Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

[...]

But Tal Zaks, chief medical officer at Moderna, told The BMJ that the company’s trial lacks adequate statistical power to assess those outcomes. “The trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good here,” he said.

Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out.

Zaks said, “Would I like to know that this prevents mortality? Sure, because I believe it does. I just don’t think it’s feasible within the timeframe [of the trial]—too many would die waiting for the results before we ever knew that.”

[...]

“Our trial will not demonstrate prevention of transmission,” Zaks said, “because in order to do that you have to swab people twice a week for very long periods, and that becomes operationally untenable.”

He repeatedly emphasised these “operational realities” of running a vaccine trial. “Every trial design, especially phase III, is always a balancing act between different needs,” he said. “If you wanted to have an answer on an endpoint that happens at a frequency of one 10th or one fifth the frequency of the primary endpoint, you would need a trial that is either 5 or 10 times larger or you’d need a trial that is 5 or 10 times longer to collect those events. Neither of these, I think, are acceptable in the current public need for knowing expeditiously that a vaccine works.”

What is this is about is what the trials can show and what they can't.

They can show, first of all, that the vaccine is safe. There is nothing in this article (I have read the whole thing) that raises any questions about safety.

Secondly, they can show that the vaccine reduces dramatically the chance of developing Covid 19 (i.e. the symptoms of infection). There is nothing in this article that calls that into question.

What the article points out that trials cannot show is whether the vaccine prevents the very old from dying, because to do that you have to give it to loads of old people at risk of infection, and watch them die or not - at a time when everyone is moving heaven and earth to shield them from the virus.

Similarly the article points out the trials cannot show that the vaccine prevents transmission of infection. That is because to do that you need to hold a entire population captive and swab them every day for 3 months to see who gets the illness and from whom - quite impossible.

Exactly the same limitations apply to flu vaccines and many others. No trial can tell you these things. You need years of using them in whole populations to get that data. So what you do is make the reasonable inference that if the vaccine stops people developing Covid 19 symptoms (which we know from the trials), it is highly likely to prevent deaths, hospital admissions and, with any luck, transmission.

Just to stress again, the trials do show the vaccine is safe. So not having the vaccine because you think it could be unsafe is irrational.

 

[Rival]

Exactly the same limitations apply to flu vaccines and many others. No trial can tell you these things. You need years of using them in whole populations to get that data.

Exactly.

This vaccine is simply not up to what I'd consider a reasonable standard. Before I let anyone inject anything into me, I want to be pretty much certain of its effects.

My other issue here is that it doesn't show it stops the spread of Corona, which, I thought, was the main point here - that we all have the vaccine and then this lockdown nonsense ends? But that's not what this is saying.

So we have been asked to take a vaccine that has not undergone what I would consider a long enough trial period, nor does it prevent the spread of the Corona, nor does it show that those most vulnerable (the elderly) will be protected from death (another major concern), or that,

"None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus."

Not good enough, imo. Just not good enough.

 

[exchemist]

Exactly.

This vaccine is simply not up to what I'd consider a reasonable standard. Before I let anyone inject anything into me, I want to be pretty much certain of its effects.

My other issue here is that it doesn't show it stops the spread of Corona, which, I thought, was the main point here - that we all have the vaccine and then this lockdown nonsense ends? But that's not what this is saying.

So we have been asked to take a vaccine that has not undergone what I would consider a long enough trial period, nor does it prevent the spread of the Corona, nor does it show that those most vulnerable (the elderly) will be protected from death (another major concern), or that,

"None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus."

Not good enough, imo. Just not good enough.

You are being irrational.

- It is known to be safe.
- It is known to stop people getting ill.

You therefore have nothing to lose by being vaccinated.

Whereas if you don't get vaccinated, you definitely risk death or serious long term health problems, either for yourself or someone you are in contact with. We know that.

 

[Rival]

You are being irrational.

- It is known to be safe.
- It is known to stop people getting ill.

You therefore have nothing to lose by being vaccinated.

Whereas if you don't get vaccinated, you risk death or serious long term health problems, either for yourself or someone you are in contact with.

How am I being irrational? The study said we can't know whether the vaccine actually prevents the spread of the virus, nor that it stops the most vulnerable from dying, so what's the point of it exactly? Sure, I may be safe, good for me, but apparently that doesn't stop me spreading the disease if I get it, and if it's an elderly person I spread it to, even if that person has had the vaccine, they are still not necessarily safe?

I mean I don't even?

 

[Mock Turtle]

I don't want to take the gamble, not with my health, thanks!

I'm sorry, I just have no idea why anyone would trust such a rushed out vaccine.

Will covid-19 vaccines save lives? Current trials aren’t designed to tell us | The BMJ

But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.6

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7

Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

[...]

But Tal Zaks, chief medical officer at Moderna, told The BMJ that the company’s trial lacks adequate statistical power to assess those outcomes. “The trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good here,” he said.

Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out.

Zaks said, “Would I like to know that this prevents mortality? Sure, because I believe it does. I just don’t think it’s feasible within the timeframe [of the trial]—too many would die waiting for the results before we ever knew that.”

[...]

“Our trial will not demonstrate prevention of transmission,” Zaks said, “because in order to do that you have to swab people twice a week for very long periods, and that becomes operationally untenable.”

He repeatedly emphasised these “operational realities” of running a vaccine trial. “Every trial design, especially phase III, is always a balancing act between different needs,” he said. “If you wanted to have an answer on an endpoint that happens at a frequency of one 10th or one fifth the frequency of the primary endpoint, you would need a trial that is either 5 or 10 times larger or you’d need a trial that is 5 or 10 times longer to collect those events. Neither of these, I think, are acceptable in the current public need for knowing expeditiously that a vaccine works.”

You would prefer to take the risk of long-Covid damage? Where it can affect the brain and/or the lungs, and often damaging them quite enough to cause concern - and not just the elderly apparently. I'd trust the various vaccines (some more than others probably - if I knew more) but then I am older. At your age you should be OK though.

 

[Rival]

You would prefer to take the risk of long-Covid damage? Where it can affect the brain and/or the lungs, and often damaging them quite enough to cause concern - and not just the elderly apparently. I'd trust the various vaccines (some more than others probably - if I knew more) but then I am older. At your age you should be OK though.

I think maybe clouding my subconscious view is that I'm pretty dangerously suicidal right now. I don't actually care if I end up with this virus.

 

[Saint Frankenstein]

I'm definitely not getting it. I was tested twice lately, in the ER and the loony bin, and both were negative.

 

[exchemist]

How am I being irrational? The study said we can't know whether the vaccine actually prevents the spread of the virus, nor that it stops the most vulnerable from dying, so what's the point of it exactly? Sure, I may be safe, good for me, but apparently that doesn't stop me spreading the disease if I get it to someone else, and if it's an elderly person, even if that person has had the vaccine, they are still not necessarily safe?

I mean I don't even?

Re-read my post 54. I cannot make it any clearer. At worst you have nothing to lose and and at best you get protected from death or serious illness.

Bear in mind that: "we can't know whether the vaccine actually prevents the spread of the virus" does not mean "the vaccine does not stop the spread of the virus".

It means what it says - we can't know - though we have jolly good grounds for expecting it will at least reduce transmission. So you are drawing an entirely wrong conclusion from what you have read.

Frankly, I am beginning to suspect I am up against a belief system of some kind here. What's wrong with you?

 

[exchemist]

I'm definitely not getting it. I was tested twice lately, in the ER and the loony bin, and both were negative.

Well that takes the prize for the silliest contribution yet. "I'm not locking the door, because I've never been burgled yet". Durrh.

 

[Saint Frankenstein]

Well that takes the prize for the silliest contribution yet. "I'm not locking the door, because I've never been burgled yet". Durrh.

I don't give a damn if I get sick and die and I certainly don't care about the rest of you. It's not like I'm socializing much, so you'll be safe, don't worry.

 

[exchemist]

I don't give a damn if I get sick and die and I certainly don't care about the rest of you. It's not like I'm socializing much, so you'll be safe, don't worry.

Oh well that makes sense then, and I retract what I said.