AstraZeneca vaccine clinical trial "pause"

[outside shooter]

good scientific overview here: https://blogs.sciencemag.org/pipeline/archives/2020/09/09/serious-adverse-event-time

Transverse myelitis (TM), a rare neurological condition in which the spinal cord is inflamed, was observed in a patient.

The spinal cord inflammation seen in TM has been associated with various infections, immune system disorders, or damage to nerve fibers, by loss of myelin.

"...since vaccines are designed to be given exclusively to people who are not sick (a very unusual situation in drug development work!), the safety standards have to be very high. But the adverse events themselves (especially the serious ones) can be extremely rare, and the only way to get a statistical foothold on them is to have a very large controlled patient population under study. The Oxford/AstraZeneca trial is enrolling nearly 30,000 people, and the problem is that that may still not be enough for a definite answer on something like this.

bottom line: looking for such stuff is WHY we have clinical trials and why we take the time to look over all of the data with a fine tooth comb, rather than rushing to deliver a miracle late October surprise.

 

[CO. Hoosier]

good scientific overview here: https://blogs.sciencemag.org/pipeline/archives/2020/09/09/serious-adverse-event-time

Transverse myelitis (TM), a rare neurological condition in which the spinal cord is inflamed, was observed in a patient.

The spinal cord inflammation seen in TM has been associated with various infections, immune system disorders, or damage to nerve fibers, by loss of myelin.

"...since vaccines are designed to be given exclusively to people who are not sick (a very unusual situation in drug development work!), the safety standards have to be very high. But the adverse events themselves (especially the serious ones) can be extremely rare, and the only way to get a statistical foothold on them is to have a very large controlled patient population under study. The Oxford/AstraZeneca trial is enrolling nearly 30,000 people, and the problem is that that may still not be enough for a definite answer on something like this.

bottom line: looking for such stuff is WHY we have clinical trials and why we take the time to look over all of the data with a fine tooth comb, rather than rushing to deliver a miracle late October surprise.

Is there an acceptable level of risk for a vaccine? It seems to me that zero risk is an unreasonable expectation so how should we determine acceptable risk? With covid, millions of lives are being ruined when those people are not sick at all. Kids are being deprived of good educations, or at least educations are delayed. This will have an ongoing effect for years.

On a governance front, important decisions are being made by those whose lives and careers are in a safe harbor, while others are tossed around on stormy seas. I think even a risky vaccine will be better long term than no or a vaccine that is delayed even by six months.

 

[mcmurtry66]

1. that's not the vaccine targeted for US distribution
2. the article i read indicated pausing for occurrences like this is pretty common
3. was TM a pre-existing condition for this person or was TM caused by the vaccine or is that what they're trying to determine
4. you could put my understanding of how vaccines work and the study of same on a finger nail and still have room left

 

[Sope Creek]

Is there an acceptable level of risk for a vaccine? It seems to me that zero risk is an unreasonable expectation so how should we determine acceptable risk? With covid, millions of lives are being ruined when those people are not sick at all. Kids are being deprived of good educations, or at least educations are delayed. This will have an ongoing effect for years.

On a governance front, important decisions are being made by those whose lives and careers are in a safe harbor, while others are tossed around on stormy seas. I think even a risky vaccine will be better long term than no or a vaccine that is delayed even by six months.

I might be persuaded by that approach if we were to institute a safety net for those adversely affected by the vaccine, both in the trial phase and in the general population. If the risk of the vaccine is less than the risk of other loss to the general population, then the general population could be persuaded that taking on the costs of medical and living support for those adversely affected by the vaccine is worth the benefits received from making a risky vaccine available.

Otherwise, you're imposing the costs of a socialized risk on individuals . . . you might do that, but I ain't going to. And other perfectly reasonable and rational individuals will choose not to as well.

 

[outside shooter]

TM is rare, but not so rare to think that it might have nothing to do with the vaccine, so that is indeed what they're trying to determine.

A mild but somewhat polio-like condition is a rare, accepted side effect of the polio vaccine. So adverse events do not have to be ZERO to gain/maintain approval for a vaccine. But the bar is pretty darn high, in something given to totally healthy people.

 

[JamieDimonsBalls]

good scientific overview here: https://blogs.sciencemag.org/pipeline/archives/2020/09/09/serious-adverse-event-time

Transverse myelitis (TM), a rare neurological condition in which the spinal cord is inflamed, was observed in a patient.

The spinal cord inflammation seen in TM has been associated with various infections, immune system disorders, or damage to nerve fibers, by loss of myelin.

"...since vaccines are designed to be given exclusively to people who are not sick (a very unusual situation in drug development work!), the safety standards have to be very high. But the adverse events themselves (especially the serious ones) can be extremely rare, and the only way to get a statistical foothold on them is to have a very large controlled patient population under study. The Oxford/AstraZeneca trial is enrolling nearly 30,000 people, and the problem is that that may still not be enough for a definite answer on something like this.

bottom line: looking for such stuff is WHY we have clinical trials and why we take the time to look over all of the data with a fine tooth comb, rather than rushing to deliver a miracle late October surprise.

This reeks of conflicting points. On one hand, this is a serious condition that may have been triggered/caused by the vaccine. On the other, we are pausing something that is being conducted to benefit an attack on humanity.

 

[NPT]

On a side note: Do you think the vaccine should be required? Do you think the government will require a person to get the vaccine?

I have a feeling that it will almost be a requirement to get the vaccine but it won't be a requirement by the government. I think companies will require it before you can come back to work. May be a requirement to get into a sporting event.

How dose everyone think this will play out?

 

[Sope Creek]

This reeks of conflicting points. On one hand, this is a serious condition that may have been triggered/caused by the vaccine. On the other, we are pausing something that is being conducted to benefit an attack on humanity.

Yeah. That's what risk management is all about.

 

[Sope Creek]

On a side note: Do you think the vaccine should be required? Do you think the government will require a person to get the vaccine?

I have a feeling that it will almost be a requirement to get the vaccine but it won't be a requirement by the government. I think companies will require it before you can come back to work. May be a requirement to get into a sporting event.

How dose everyone think this will play out?

Or it might be a requirement to participate in other normal behaviors, like go to a grocery store or restaurant. You can opt not to get a vaccine if you want to, but . . . .

 

[HillzHoozier]

Or it might be a requirement to participate in other normal behaviors, like go to a grocery store or restaurant. You can opt not to get a vaccine if you want to, but . . . .

Maybe a small numerical tattoo on the wrist to identify the vaccinated?

 

[NPT]

Or it might be a requirement to participate in other normal behaviors, like go to a grocery store or restaurant. You can opt not to get a vaccine if you want to, but . . . .

I see a big demand for fake vaccination cards in the future.

 

[Courtsensetwo]

Or it might be a requirement to participate in other normal behaviors, like go to a grocery store or restaurant. You can opt not to get a vaccine if you want to, but . . . .

That is the road i would like to see us go down. Your kids are not getting in school, you have to show ID to get in certain spaces.

And yes, fake IDs will be a thing but given the mentality of the anti-logic crowd, the misspellings on the card will give away the fakes.

 

[JamieDimonsBalls]

Or it might be a requirement to participate in other normal behaviors, like go to a grocery store or restaurant. You can opt not to get a vaccine if you want to, but . . . .

We could up the ante and say... no healthcare for those that decline or refuse to get vaccinated. Might be more impactful.

 

[Marvin the Martian]

We could up the ante and say... no healthcare for those that decline or refuse to get vaccinated. Might be more impactful.

Maybe create a tax break if one is vaccinated (for those that pay) or addition to Earned Income Credit for those that don't.

 

[mcmurtry66]

Maybe create a tax break if one is vaccinated (for those that pay) or addition to Earned Income Credit for those that don't.

Or penalties. Didn’t Obamacare have a penalty if you were uninsured.

 

[mcmurtry66]

That is the road i would like to see us go down. Your kids are not getting in school, you have to show ID to get in certain spaces.

And yes, fake IDs will be a thing but given the mentality of the anti-logic crowd, the misspellings on the card will give away the fakes.

Ha for sure. The ahole I bought my fake Id from when I was a kid gave me the name John Paul Jones

 

[Courtsensetwo]

We could up the ante and say... no healthcare for those that decline or refuse to get vaccinated. Might be more impactful.

Self cleaning oven

 

[Bulk VanderHuge]

Ha for sure. The ahole I bought my fake Id from when I was a kid gave me the name John Paul Jones

Did you live on Bonhomme Richard Avenue?
"I have not yet begun to drink!"

 

[outside shooter]

This reeks of conflicting points. On one hand, this is a serious condition that may have been triggered/caused by the vaccine. On the other, we are pausing something that is being conducted to benefit an attack on humanity.

Yes. I imagine that they are trying to find out if there are presymptomatic biomarkers that indicate a tendency to develop TM, then looking to see if those biomarkers are commonly elevated in the vaccinated vs. placebo people.

 

[mcmurtry66]

Did you live on Bonhomme Richard Avenue?
"I have not yet begun to drink!"

Ha yes! but no. i got it in high school from a buddy's older bro who was a bully. he had a board in the basement and all that. it was after the guy in led zeppelin. i bought beer at a seven eleven on spring break in daytona and the clerk read the name bust out laughing and said he loved led zeppelin. he gave me the beer but not the id back

 

[hoosboot]

1. that's not the vaccine targeted for US distribution
2. the article i read indicated pausing for occurrences like this is pretty common
3. was TM a pre-existing condition for this person or was TM caused by the vaccine or is that what they're trying to determine
4. you could put my understanding of how vaccines work and the study of same on a finger nail and still have room left

I think that pausing for occurrences like this being pretty common is an indicator of why vaccine development isn't something that can be rushed. This isn't something that says the AZ vaccine candidate is a bust. Rather, it's something that says it is being seriously vetted. That's a good thing.

And I can't believe that a fine, upstanding man of the court such as yourself would besmirch his reputation with felonious behavior like obtaining fraudulent identification. That's why I'm certain you are merely speaking of your time in the CIA when obtaining such identification was a necessary part of your work duties.

 

[mcmurtry66]

I think that pausing for occurrences like this being pretty common is an indicator of why vaccine development isn't something that can be rushed. This isn't something that says the AZ vaccine candidate is a bust. Rather, it's something that says it is being seriously vetted. That's a good thing.

And I can't believe that a fine, upstanding man of the court such as yourself would besmirch his reputation with felonious behavior like obtaining fraudulent identification. That's why I'm certain you are merely speaking of your time in the CIA when obtaining such identification was a necessary part of your work duties.

LOL. and now the guy who was making fake ids owns a chain of bars. destiny i guess

 

[HillzHoozier]

We could up the ante and say... no healthcare for those that decline or refuse to get vaccinated. Might be more impactful.

Canada Forcefully Imprisons ‘Uncooperative’ Citizens At Secret COVID-19 Facility, Report Says

Authorities in Quebec City, Canada, will isolate “uncooperative” citizens in a COVID-19 facility, the location of which is unknown, according to a new report. Dr. Jacques Girard, who heads the Quebec City public health authority, said in a press conference that patrons of a bar were recently...

www.dailywire.com

If you won't quarantine in Canada, they'll do it for you.

 

[NPT]

I think that pausing for occurrences like this being pretty common is an indicator of why vaccine development isn't something that can be rushed. This isn't something that says the AZ vaccine candidate is a bust. Rather, it's something that says it is being seriously vetted. That's a good thing.

And I can't believe that a fine, upstanding man of the court such as yourself would besmirch his reputation with felonious behavior like obtaining fraudulent identification. That's why I'm certain you are merely speaking of your time in the CIA when obtaining such identification was a necessary part of your work duties.

There's someone around where I live that has their Wireless label as CIA Surveillance Van. Your CIA reference reminded me of that.

 

[JamieDimonsBalls]

Maybe create a tax break if one is vaccinated (for those that pay) or addition to Earned Income Credit for those that don't.

While appealing, is that as bad as saying... if you refuse to get vaccinated without an agreed exception, you aren't allowed in a healthcare setting? Why endanger others and create risks for those that refuse to accept science?

 

[Sope Creek]

We could up the ante and say... no healthcare for those that decline or refuse to get vaccinated. Might be more impactful.

I still wouldn't get vaccinated until it was pretty damned well proven safe and effective with no significant side effects.

 

[NPT]

According to this article a lot of people won't get vaccinated if it's left up to them. I've argued with one person I know that refuses to get the flu shot. Her argument is that the virus builds up immunity to it like bacteria do to antibiotics. I told her time after time that comparing antibiotics and a vaccine is like comparing a car to a tractor.... they are two completely different things but she won't buy it.

 

[NPT]

I still wouldn't get vaccinated until it was pretty damned well proven safe and effective with no significant side effects.

They'll probably make a special one for lawyers.

 

[Sope Creek]

They'll probably make a special one for lawyers.

Do you know why they bury lawyers 20 feet underground?

Because deep down they're really good people.

 

[NPT]

Do you know why they bury lawyers 20 underground?

Because deep down they're really good people.

I'll have to remember that one..... hadn't heard that one before.

 

[i'vegotwinners]

Is there an acceptable level of risk for a vaccine? It seems to me that zero risk is an unreasonable expectation so how should we determine acceptable risk? With covid, millions of lives are being ruined when those people are not sick at all. Kids are being deprived of good educations, or at least educations are delayed. This will have an ongoing effect for years.

On a governance front, important decisions are being made by those whose lives and careers are in a safe harbor, while others are tossed around on stormy seas. I think even a risky vaccine will be better long term than no or a vaccine that is delayed even by six months.

once we learned youngers were of little risk and olders of much more risk, had we used the trillion$ thrown at the problem to logistically and financially enable the olders who didn't want to play Chinese roulette to lock down, half our population or more would have acquired herd immunity a month ago.

and send your hate mail to Mr Obvious everybody.

i don't make the rules for covid..

i just don't totally ignore them, or pretend they don't exist.

 

[outside shooter]

...half our population or more would have acquired herd immunity a month ago.

You don't seem to undertstand the concept of herd immunity, and you seem to think that getting halfway there means anything.

Let's say 70% need to be immune. Usual estimates are between 60-80%. 70% of 330,000,000 is 231,000,000

So you are aiming for 231 M people infected. We are at 6.6 M now. We're <3% of the way there.

If herd immunity is the goal line, we are on our own 3 yard line, with 97 yards to travel.

190,000 dead. We need to pump it up 33-fold, to 6.3 M dead, to get to where you want to be, it seems.

 

[TheOriginalHappyGoat]

Canada Forcefully Imprisons ‘Uncooperative’ Citizens At Secret COVID-19 Facility, Report Says

Authorities in Quebec City, Canada, will isolate “uncooperative” citizens in a COVID-19 facility, the location of which is unknown, according to a new report. Dr. Jacques Girard, who heads the Quebec City public health authority, said in a press conference that patrons of a bar were recently...

www.dailywire.com

If you won't quarantine in Canada, they'll do it for you.

I don't think that's real.

 

[i'vegotwinners]

You don't seem to undertstand the concept of herd immunity, and you seem to think that getting halfway there means anything.

Let's say 70% need to be immune. Usual estimates are between 60-80%. 70% of 330,000,000 is 231,000,000

So you are aiming for 231 M people infected. We are at 6.6 M now. We're <3% of the way there.

If herd immunity is the goal line, we are on our own 3 yard line, with 97 yards to travel.

190,000 dead. We need to pump it up 33-fold, to 6.3 M dead, to get to where you want to be, it seems.

1st off, i don't buy for 2 seconds that only 6.6 mil have been bitten to date in the US, and no way to know for sure without a ton of random reliable antibodies tests.

and the percent who are testing positive on any given week, multiplied by the number of weeks since March, indicates to me a lot more than less than 3% have been bitten to date.

regardless,

you might work on both your reading comprehension, and your understanding of the spread.

i said "half the population would have acquired herd immunity", not all of it..

which it would have, as it spreads exponentially.

only reason the youngers haven't achieved herd immunity already, is because society is stopping it. (take sorority X that had a lot of positives in a very short time.. likely most everyone in the sorority would have been bitten within a wk or two had outside forces not intervened).

as to whether that's a good thing or not is a whole different debate, but a debate we none the less should be having and aren't.

again, i don't make the rules for covid.

but once i'm aware of the rules i'm not anti using them to our best advantage, which many seem to be no matter what.

everyone has dug in deeper and deeper on their original opinion on the matter, which they formed prior to our having extensive statistics on the massive disparities of vulnerability by age, and aren't budging one inch off those original stances now, despite our learning of game changing information on the subject since.

that's never a good way to attack a problem, and definitely isn't now.

facts matter.

 

[TheOriginalHappyGoat]

good scientific overview here: https://blogs.sciencemag.org/pipeline/archives/2020/09/09/serious-adverse-event-time

Transverse myelitis (TM), a rare neurological condition in which the spinal cord is inflamed, was observed in a patient.

The spinal cord inflammation seen in TM has been associated with various infections, immune system disorders, or damage to nerve fibers, by loss of myelin.

"...since vaccines are designed to be given exclusively to people who are not sick (a very unusual situation in drug development work!), the safety standards have to be very high. But the adverse events themselves (especially the serious ones) can be extremely rare, and the only way to get a statistical foothold on them is to have a very large controlled patient population under study. The Oxford/AstraZeneca trial is enrolling nearly 30,000 people, and the problem is that that may still not be enough for a definite answer on something like this.

bottom line: looking for such stuff is WHY we have clinical trials and why we take the time to look over all of the data with a fine tooth comb, rather than rushing to deliver a miracle late October surprise.

What exactly does "pause" mean in this context?

 

[outside shooter]

What exactly does "pause" mean in this context?

stop enrolling new patients, I guess...

But continue to follow up with all persons already treated, and commit to investigate the adverse event, looking for evidence of causation

 

[UncleMark]

Maybe a small numerical tattoo on the wrist to identify the vaccinated?

Mark of the Beast.

 

[sglowrider]

Personally I appreciate the Oxford/AZ's openness in view of the rush to getting out the vaccine -- and despite the temptation of the financial riches at the end of the Covid rainbow. (Maybe it helps that its a University-driven project.)
Hopefully, it will set the standards for the other pharmas.

 

[Standard Issue]

Mark of the Beast.

Wouldn't that be a MAGA tattoo?

 

[sglowrider]

Mark of the Beast.

QR code. Very apt.