Monitoring vaccines

[sesquiterpene]

Frequently at the end of a clinical trial, those who received the placebo are the first to receive the "real thing" if they wish to.

Most of the trials seem to be scheduled to last a year - will these actually be halted after an EAU is issued? You might miss some critical data on both efficacy and safety. I suspect the answer will depend on exactly which trial you're enrolled in.

 

[JohnDB]

Frequently at the end of a clinical trial, those who received the placebo are the first to receive the "real thing" if they wish to.

Correct...
But this is Emergency Use Approval.
Safety is stage 2 trials (actually all)
Where they give huge dosages to the point of toxicity of a drug.
Stage three is widespread distribution across many genetic heritages and ages to determine effective rates. It's double blind to see if the vaccine is truly effective or not. When they get to a ¼ of the people in the trials getting infected with coronavirus they stop and remove the double blindedness and see who is sick. If any of the vaccinated people got sick they usually call that a failure and note the age group...they might do some more studies of those who have gotten the vaccine successful or otherwise.

But usually years and not months are used for vaccine studies.

 

[hedrick]

Most of the trials seem to be scheduled to last a year - will these actually be halted after an EAU is issued? You might miss some critical data on both efficacy and safety. I suspect the answer will depend on exactly which trial you're enrolled in.

If you actually got the vaccine, and it looks reasonably effective, I don't see why you would drop out. That would allow the trial to find rare side effects. It would, however, compromise statistics.

Issuing an EUA for certain high-risk populations sounds like a good compromise. We can't do 300 million people at once, so it's going to be prioritized anyway.

 

[sesquiterpene]

Correct...

Stage three is widespread distribution across many genetic heritages and ages to determine effective rates. It's double blind to see if the vaccine is truly effective or not.

Also, very much for safety testing

When they get to a ¼ of the people in the trials getting infected with coronavirus they stop and remove the double blindedness and see who is sick..

Some of the pharma companies have published detailed plans for Phase III testing. They will look at efficacy long before 1/4 of the people get sick - the first look may be as little as 60 people getting ill out of 30-40,000 participants. [edit: add link https://blogs.sciencemag.org/pipeline/archives/2020/09/21/the-vaccine-protocols

 

[sesquiterpene]

Also, very much for safety testing
Some of the pharma companies have published detailed plans for Phase III testing. They will look at efficacy long before 1/4 of the people get sick - the first look may be as little as 60 people getting ill out of 30-40,000 participants.

Sorry - duplicate post

 

[JohnDB]

If you actually got the vaccine, and it looks reasonably effective, I don't see why you would drop out. That would allow the trial to find rare side effects. It would, however, compromise statistics.

Issuing an EUA for certain high-risk populations sounds like a good compromise. We can't do 300 million people at once, so it's going to be prioritized anyway.

Ok...
But who takes priority?
We are skipping stage 4 trials... mostly because of demand. Widespread use will be our stage 4.

Because the reward/risk of a vaccine and quarantine fatigue...it's not going to be a peaceful release. People who get the vaccine will be free to not need to quarantine any longer. Travel, concerts, and movies once again...

 

[Kenny'sID]

We can always find something wrong with what any president is doing, even if there really is nothing there, as in this case.

 

[paul1149]

We can always find something wrong with what any president is doing, even if there really is nothing there, as in this case.

And be very careful of the NY Times.

 

[dqhall]

Also, very much for safety testing
Some of the pharma companies have published detailed plans for Phase III testing. They will look at efficacy long before 1/4 of the people get sick - the first look may be as little as 60 people getting ill out of 30-40,000 participants. [edit: add link The Vaccine Protocols

A vaccine need not be 100% effective to be of use.

 

[JohnDB]

A vaccine need not be 100% effective to be of use.

Yeah...

And I'm somewhat concerned about those re-infected with the same strains of this virus. As in not having immunity once infected.

Not a lot of testing or research has been done about this phenomenon.
But I'm thinking that we will find out with the use of these vaccines.

It might be that these vaccines (or anything) will work for certain people because of the nature of the virus.
There might be a segment of the population that there isn't much scientists' can do anything for.
That's what usually comes out in a 2yr stage three trial or a stage 4 trial. (We aren't getting one)

I wish there was more study of those cases of re-infection and ineffectual vaccine people. So that they could know beforehand.

 

[sesquiterpene]

We can always find something wrong with what any president is doing, even if there really is nothing there, as in this case.

It must be nice to be so blase about public health measures in the middle of a pandemic. Me, I'm worried about the lack of leadership, and the fact that they cut one part of our safety monitoring of vaccines. We may be weeks away from a rollout of a critical bunch of new vaccines.

 

[sesquiterpene]

A vaccine need not be 100% effective to be of use.

Sure. If there are 60 cases of illness in the placebo and none in the treatment group, that might be enough to trigger an emergency approval (EAU). But the less effective the vaccine is, the longer it might take to get good statistics. The effect size matters quite a bit.

 

[Kenny'sID]

It must be nice to be so blase about public health measures in the middle of a pandemic. Me, I'm worried about the lack of leadership, and the fact that they cut one part of our safety monitoring of vaccines. We may be weeks away from a rollout of a critical bunch of new vaccines.

I've seen enough to easily recognise fear mongering from the left on this, so yes, I'm generally blase over nothing. l personally think they have the experts to rely on, meaning theyll do the best they possibly can.

As far as I'm concerned, they have this well in hand.

 

[dqhall]

Sure. If there are 60 cases of illness in the placebo and none in the treatment group, that might be enough to trigger an emergency approval (EAU). But the less effective the vaccine is, the longer it might take to get good statistics. The effect size matters quite a bit.

According to the WSJ, the US is looking to approve a vaccine that is at least 50% effective.
European Union Would Apply Lower Threshold in Assessing Covid-19 Vaccine

 

[JohnDB]

I've seen enough to easily recognise fear mongering from the left on this, so yes, I'm generally blase over nothing. l personally think they have the experts to rely on, meaning theyll do the best they possibly can.

As far as I'm concerned, they have this well in hand.

The experts actually do.

I can see that someone I'm ignoring is replying but can't tell who...
It's either my gloss of facts or that they think there is no virus that has them in a tizzy. Whatever...

That being said...

These vaccines are not going to be perfect.
There's a lot that we don't know about them yet. They will provide a certain measure of protection and be safe for the vast majority of people. This will get us back to begin to becoming a more normalized society.

The menangitis vaccine is one that's been around for a very long time and effective. Not much in the way of side effects. This vaccine is brand new. Lots we don't know yet. I suspect that in a few years we will know. But then we can't afford to wait for years.

 

[Kenny'sID]

These vaccines are not going to be perfect.

Thats the whole thing, vaccines, nor people will ever be perfect, and the left will aparently be using that fact till the end, even though they know, they themselves nor their candidate are perfect either.

 

[sesquiterpene]

According to the WSJ, the US is looking to approve a vaccine that is at least 50% effective.
European Union Would Apply Lower Threshold in Assessing Covid-19 Vaccine

Sure. In the example above - 60 vs. 0 people - you could probably say that the vaccine statistically is at least 50% effective (I'd guess that's how they designed their protocols). But what about 40 vs. 20 - exactly 50% - it might give you a range of 30-70% statistically, not enough to get approval. You'd have to continue on until you get large enough sample to tighten up the statistics.

 

[sesquiterpene]

Thats the whole thing, vaccines, nor people will ever be perfect, and the left will aparently be using that fact till the end, even though they know, they themselves nor their candidate are perfect either.

Pretty much no one, right or left is counting on anything being perfect. The issue here is whether the government is going to bother collecting or analyzing the data on exactly how safe the vaccines might be - they've already stopped using one of their best tools for monitoring vaccine safety, and it's not clear whether they even have a plan at this late date.

 

[dqhall]

Sure. In the example above - 60 vs. 0 people - you could probably say that the vaccine statistically is at least 50% effective (I'd guess that's how they designed their protocols). But what about 40 vs. 20 - exactly 50% - it might give you a range of 30-70% statistically, but not enough to get approval. You'd have to continue on until you get large enough sample to tighten up the statistics.

I don’t understand your logic as I am not a statistician, only a newsreader.

If a vaccine prevents infections in 50% of the population, it is 50% effective. The U.K. has a study planned for early next year using 20 - 30 yr old volunteers. They want to inject them with vaccine, wait awhile, then expose them to COVID viruses applied to their nostrils in a safe sanitary ward. Next they will wait to measure the responses. It should be a double blinded placebo test. This is supposed to speed up the time needed to reach a conclusion.

 

[JohnDB]

Thats the whole thing, vaccines, nor people will ever be perfect, and the left will aparently be using that fact till the end, even though they know, they themselves nor their candidate are perfect either.

Yeah...one of the things about the "left" is their definition of "prudent" and "reasonable".

If you are someone who has hayfever... probably a good idea to take the vaccine.

However if you have very violent and severe allergies to some things...might not want to be first in line for the vaccine.

All a matter of prudence and being reasonable.

If I was a medical professional and got the vaccine...I still wouldn't want to walk into a Covid ward at the hospital without some PPE.