The Vaccine Thread

[Spy Car]

8 minutes ago, Bootsie said:

The committee specifically asked if they could consider the Israeli data.  The question posed to them was only stated results from the cilincial trial (which was extremely small).  If the committee had been told that the Israeli data could not be considered, I think they might have not voted affirmative for anything. 

They did discuss what age they woud be comfortable with and were looking for an age at which they could get an affirmative vote for their new question.  In addition to 65 they included those who are at risk for severe COVID and later added health care workers    Doesn't that leave room for a patient and doctor to discuss the individual risk assessment for someone under 65 to receive a booster?

Why 65? Many doctors mentioned earlier ages, including one who I believe said he was going to go out and get his own shot despite being "under age?"

All we can hope for at this point is that the full FDA decision broadens the discretion of doctors and patients who wish to avoid becoming infected (and infectious). This panel did a very poor job in protecting people who don't wish to become ill in the first place.

They seem "uncomfortable" with 16 year olds getting boosters, but comfortable letting adults become infected. 

And I heard no discussion of Long Covid, which generally manifests--as best as I understand the facts--in those with mild or moderate illness, not servere illness. Was this even considered? 

Bill

Edited September 21, 2021 by Spy Car

[whitestavern]

1 hour ago, BronzeTurtle said:

YOu're assuming I haven't looked at the things you've mentioned. I think any epidemiology or why covid comes and goes the way it does is a mystery to a lot of people. There are whole names of disease curves and laws that people name and still don't totally understand. I gave you several reasons why I think there are too many confounders to ascibe a covid wave's decline to one specific intervention. Yes I think there are things that humans do not know and are not likely to pin down even if we think we have, espeically on a population scale. History is full of stuff like that in science. Even in this pandemic, people have confidently asserted things that have turned out 6 months later to be wrong. Even in this thread there are people lamenting that the vaccine brand of choice they loved when they got because of all the data on it would now be their second choice because of new data. Who knows what will show up in 5 years, right? And studying entire populations dealing with infectious disease as they are experiencing it? I think we're very unlikely to know anything definitive in that instance, yes. That doesn't mean I think "we can know nothing" and I find that highly dismissive of all I've said and asked here.

I think went on to say that I think vaccines are very helpful in mitigating severe disease and death and gave even more lengthy explanation of my stances. It's not like I'm throwing up my hands and saying, "well, we just can't know anything" It's not like I don't think it's worth studying. But I do not think,, especially since as far as I know none of us here are especially learned in epidemiology, public health, immunology, vaccines, infectious disease, etc., etc, that we are able to say booster shots in Isreal stamped out their latest wave. I know you disagree that one has to be an expert on those things to make proclamations, but there are those in those fields admiting they need further study to figure this thing out, so I don't think it's out of bounds to say that we, having spun up our disease knowledge in 18 months during the pandemic, might not know things we feel certain about. And yes, I do feel certain about that. 😛

We can't say the booster shot has stamped out the latest wave because they are having an increase right now. I watched the meeting as well and even the rep from Israel said she didn't know why there has been a recent uptick in cases (one of the panelists asked the question). The guess is it is due to the recent holidays, but we will have to wait for confirmation on that. 

[Spy Car]

1 minute ago, whitestavern said:

We can't say the booster shot has stamped out the latest wave because they are having an increase right now. I watched the meeting as well and even the rep from Israel said she didn't know why there has been a recent uptick in cases (one of the panelists asked the question). The guess is it is due to the recent holidays, but we will have to wait for confirmation on that. 

Uh yeah. Israel has a huge population of people who refuse to vax, who refuse to mask, refuse to distance, and on the High Holy Days they packed indoors with many thousands of others who are also unvaxxed. There will be a spike and there will be unnecessary death and illness.

Like here, sane Israelis are getting boosters as much against the crazy behaviors of fellow citizens as against the Delta virus itself.

Bill

 

[Bootsie]

16 minutes ago, Spy Car said:

Why 65? Many doctors mentioned earlier ages, including one who I believe said he was going to go out and get his own shot despite being "under age?"

All we can hope for at this point is that the full FDA decision broadens the discretion of doctors and patients who wish to avoid becoming infected (and infectious). This panel did a very poor job in protecting people who don't wish to become ill in the first place.

They seem "uncomfortable" with 16 year olds getting boosters, but comfortable letting adults become infected. 

And I heard no discussion of Long Covid, which generally manifests--as best as I understand the facts--in those with mild or moderate illness, not servere illness. Was this even considered? 

Bill

My impression was there were enough on the committee that thought the data for those of 65 was compelling to get an affirmative vote.  There were definitely some who said they would be comfortable with a younger age and there was some discussion of what data did they really have to use to be able to make a break point.  Overall, I got the sense that they were really frustrated that they did not have good data because of such a small sample size and were having to do the best they could do with the data they did have. 

 

[whitestavern]

33 minutes ago, Spy Car said:

So? Doctor after doctor on the panel said the Israeli data was compelling. And doctor after doctor said that those who were most vulnerable would likely benefit from a booster. And more than a few mentioned ages younger than 65.

It seems like their "discomfort" about 16 year olds led them to a different extreme.

Why so restrictive? Why not let (adult) individuals and their doctors do risk assessments based on odds of exposure, odds of passing the virus to those at risk, and odds of negative ramifications if infected?

There was an acknowledgement that risk of infection and contagion is much higher if people do not have high antibody levels. They seem willing to let many people get sick (and become contagious) on the odds that an immune response will eventually kick in that reduces the odds of hospitalization and death. OK.

But what about those who'd prefer not to become sick (and contagious) in the first place? And why no mention (at lest in the significant parts I watched) of Long Covid, which appears to be a devastating illness?

Bill

 

Once approved for 65+, doctors can still do this off label, no?

[Spy Car]

20 minutes ago, Bootsie said:

My impression was there were enough on the committee that thought the data for those of 65 was compelling to get an affirmative vote.  There were definitely some who said they would be comfortable with a younger age and there was some discussion of what data did they really have to use to be able to make a break point.  Overall, I got the sense that they were really frustrated that they did not have good data because of such a small sample size and were having to do the best they could do with the data they did have. 

 

Seems like a very high "breakpoint" to me when so many doctors mentioned younger ages. Quite a few mentioned 60.

Seems to me like "being uncomfortable" with the data for 16 year olds led them to rather age drastic limits from my perspective. 

I'm guessing that you heard no mention of Long Covid risks. I did not (but mainly listened to the latter hours). Seems like a huge omission when assessing risks of breakthrough infections. Heck, they didn't even want the term "breakthrough infections" to be used, as they seem to think people getting infected is to be expected and not something they are really trying to stop. That's concerning.

It was acknowledged that w/o adequate antibodies that infection (and infectiousness) is a distinct probability and they also acknowledged that antibodies wane w/o boosters. They seem OK with that. 

So I guess it comes down to what is the goal of public health and the vaccine regimen. Are they fine with people getting Covid (and becoming contagious with Delta), but lowering their odds of severe illness and death, or are they going to act to try to stop infection and spread.

Seem like they chose the former, rather than the latter. I find that deeply disappointing.

Bill

 

 

 

Edited September 21, 2021 by Spy Car

[Spy Car]

18 minutes ago, whitestavern said:

Once approved for 65+, doctors can still do this off label, no?

I suppose if one is in the privileged position of having a physician who is willing to write a script off label, it will be possible for them. Might leave many people out, including some "rule followers" who may be unwilling to ask.

We will see what the final wording is. I pray that more rational heads at the FDA and CDC will chime in and broaden the categories, by making sure those at high risk due to exposure (due to jobs, etc), and those who have vulnerable people in their care, or those with underlying conditions have broader access.

Otherwise, this will be a tragedy in the making in my estimation. 

I do have some optimism that the cohort definitions will expand from the ones approved by the advisory group. I hope so.

Bill 

Edited September 21, 2021 by Spy Car

[Laura Corin]

@BronzeTurtle I  think you can see decoupling of case rates from hospitalisation and death in the UK. Our double vaccination rate in over 16yos is in the 80 percents. Scroll down to see the graphs. In previous waves, the three graphs were roughly the same shape,  just shifted by a few weeks. This time not.

https://www.theguardian.com/world/2021/aug/20/covid-uk-coronavirus-cases-deaths-and-vaccinations-today?CMP=Share_AndroidApp_Other

Edited September 21, 2021 by Laura Corin

[Bootsie]

1 hour ago, Spy Car said:

Seems like a very high "breakpoint" to me when so many doctors mentioned younger ages. Quite a few mentioned 60.

Seems to me like "being uncomfortable" with the data for 16 year olds led them to rather age drastic limits from my perspective. 

I'm guessing that you heard no mention of Long Covid risks. I did not (but mainly listened to the latter hours). Seems like a huge omission when assessing risks of breakthrough infections. Heck, they didn't even want the term "breakthrough infections" to be used, as they seem to think people getting infected is to be expected and not something they are really trying to stop. That's concerning.

It was acknowledged that w/o adequate antibodies that infection (and infectiousness) is a distinct probability and they also acknowledged that antibodies wane w/o boosters. They seem OK with that. 

So I guess it comes down to what is the goal of public health and the vaccine regimen. Are they fine with people getting Covid (and becoming contagious with Delta), but lowering their odds of severe illness and death, or are they going to act to try to stop infection and spread.

Seem like they chose the former, rather than the latter. I find that deeply disappointing.

Bill

 

 

 

I did hear some mention of long covid--I was not specifically listening for that so I can't really qauntify how much discussion there was.  I think part of the difficulty in analyzing the discussion is that the committee was not asked to decide whether they thought boosters were a good idea or not or should be up to an individual person or not.  They were asked to evaluate the risks and benefits as presented in the clinical trial.  I think they were very disappointed that the clinical trial was not very large and much of the data they would like to have was not provided.  I was surprised by Pfizer's presentation of their data; I expected it to be much better.  But, the committee can only make a decision based upon the data that is supplied.  

[Spy Car]

4 minutes ago, Bootsie said:

I did hear some mention of long covid--I was not specifically listening for that so I can't really qauntify how much discussion there was.  I think part of the difficulty in analyzing the discussion is that the committee was not asked to decide whether they thought boosters were a good idea or not or should be up to an individual person or not.  They were asked to evaluate the risks and benefits as presented in the clinical trial.  I think they were very disappointed that the clinical trial was not very large and much of the data they would like to have was not provided.  I was surprised by Pfizer's presentation of their data; I expected it to be much better.  But, the committee can only make a decision based upon the data that is supplied.  

They seemingly had enough evidence that the boosters are safe enough to approve them for older people, right?

They also had enough evidence to see that the boosters are effective in reducing infections, right?

To my ears they seem not to care that their actions will lead to more people getting sick and becoming contagious, against what? 

After watching a considerable amount of the video meeting I'm more confounded than ever in their decision making. They seem to acknowledge that not getting boosters will eliminate advantages of people not getting infected, and many seem OK with that.

Quite strange.

Bill

 

[Bootsie]

13 minutes ago, Spy Car said:

They seemingly had enough evidence that the boosters are safe enough to approve them for older people, right?

They also had enough evidence to see that the boosters are effective in reducing infections, right?

To my ears they seem not to care that their actions will lead to more people getting sick and becoming contagious, against what? 

After watching a considerable amount of the video meeting I'm more confounded than ever in their decision making. They seem to acknowledge that not getting boosters will eliminate advantages of people not getting infected, and many seem OK with that.

Quite strange.

Bill

 

They acknowledged that the safety may be different for different age groups.  They had little evidence of what the safety level was in a younger population.  I am not sure what the feeling of the committee was regarding the effectiveness in reducing infections--especially over a longer time period and whether this effectiveness level met the FDA definitions of effectiveness; there seemed to be some differing opinions and uncertainty in that area and I did not get a strong sense of where they stood.

I think to understand the committee's think one much watch (1) what questions they raised throughout the day and (2) their discussion during the last hour.  Much of what occurs earlier in the day are non-decision makers discussing their opinions.  The committee heard those arguments and positions, but those arguments and positions can't be viewed as the committee member's positions.  Unless the committee members specifically say what they thought about particular claims during the day and how that factored into their vote, one does not know how much they were influenced by any of those arguments.   

[Spy Car]

8 minutes ago, Bootsie said:

They acknowledged that the safety may be different for different age groups.  They had little evidence of what the safety level was in a younger population.  I am not sure what the feeling of the committee was regarding the effectiveness in reducing infections--especially over a longer time period and whether this effectiveness level met the FDA definitions of effectiveness; there seemed to be some differing opinions and uncertainty in that area and I did not get a strong sense of where they stood.

I think to understand the committee's think one much watch (1) what questions they raised throughout the day and (2) their discussion during the last hour.  Much of what occurs earlier in the day are non-decision makers discussing their opinions.  The committee heard those arguments and positions, but those arguments and positions can't be viewed as the committee member's positions.  Unless the committee members specifically say what they thought about particular claims during the day and how that factored into their vote, one does not know how much they were influenced by any of those arguments.   

By younger population they mentioned 16 year olds. Fine. They then set the bar at 65. Doesn't strike me as logical.

I watched a considerable amount of the video. Approximately the last third.

I don't know how they go from "not comfortable with 16 year olds" to 65+.

And they acknowledged that under their plan people who are not boosted will get sick and will become infectictious, and they seem fine with that.

I am of another mind on that.

Bill

[whitestavern]

3 hours ago, Bootsie said:

I did hear some mention of long covid--I was not specifically listening for that so I can't really qauntify how much discussion there was.  I think part of the difficulty in analyzing the discussion is that the committee was not asked to decide whether they thought boosters were a good idea or not or should be up to an individual person or not.  They were asked to evaluate the risks and benefits as presented in the clinical trial.  I think they were very disappointed that the clinical trial was not very large and much of the data they would like to have was not provided.  I was surprised by Pfizer's presentation of their data; I expected it to be much better.  But, the committee can only make a decision based upon the data that is supplied.  

It didn't help that due to their technical difficulties, they (Pfizer) really didn't answer any of the questions they were asked. Disappointing. 

Edited September 22, 2021 by whitestavern

[whitestavern]

2 hours ago, Spy Car said:

By younger population they mentioned 16 year olds. Fine. They then set the bar at 65. Doesn't strike me as logical.

I watched a considerable amount of the video. Approximately the last third.

I don't know how they go from "not comfortable with 16 year olds" to 65+.

And they acknowledged that under their plan people who are not boosted will get sick and will become infectictious, and they seem fine with that.

I am of another mind on that.

Bill

There was a question asked (IIRC - have been watching many videos) about age range for concern on cardio issues, and the answer was up to 40. So yes, they could've recommended perhaps 50+.

[Spy Car]

8 minutes ago, whitestavern said:

There was a question asked (IIRC - have been watching many videos) about age range for concern on cardio issues, and the answer was up to 40. So yes, they could've recommended perhaps 50+.

Assuming their concerns are valid, a 50+ recommendation would have opened the doors to a great number of people who are over 50 but under 65. I'm sure many of our bodies are in that boat. I am.

As to heart concerns, is that mainly (or exclusively) myocarditis? I was under the impression that cases of myocarditis post vaccination were very rare and that they were in the main self-resolving. But I don't have comprehensive knowledge here. Anyone?  

Bill

Edited September 22, 2021 by Spy Car

[whitestavern]

15 minutes ago, Spy Car said:

Assuming their concerns are valid, a 50+ recommendation would have opened the doors to a great number of people who are over 50 but under 65. I'm sure many of our bodies are in that boat. I am.

As to heart concerns, is that mainly (or exclusively) myocarditis? I was under the impression that cases of myocarditis post vaccination were very rare and that they were in the main self-resolving. But I don't have comprehensive knowledge here. Anyone?  

Bill

They did not go into detail on severity. Someone asked why Israel's numbers for myocarditis were much higher than ours and someone else answered that ours are actually similar to Israel's. I don't remember why that isn't reported correctly, but in actuality it is about 1 in 5000 to 1 in 6000 cases. 

[Bootsie]

57 minutes ago, Spy Car said:

Assuming their concerns are valid, a 50+ recommendation would have opened the doors to a great number of people who are over 50 but under 65. I'm sure many of our bodies are in that boat. I am.

As to heart concerns, is that mainly (or exclusively) myocarditis? I was under the impression that cases of myocarditis post vaccination were very rare and that they were in the main self-resolving. But I don't have comprehensive knowledge here. Anyone?  

Bill

My impression is that it is primarily, but perhaps not only, myocarditis, They can base a rate off of first and second injections but do not have data on third injections--which was a big concern to them.  If you have only 300 people in a study, you are unlikely to pick up incidence of events that occur in one in 500 people.  

[Spy Car]

1 minute ago, Bootsie said:

My impression is that it is primarily, but perhaps not only, myocarditis, They can base a rate off of first and second injections but do not have data on third injections--which was a big concern to them.  If you have only 300 people in a study, you are unlikely to pick up incidence of events that occur in one in 500 people.  

True enough. But wasn't the incidence of myocarditis after the two regular vaccines extremely rare and generally self-resolving? With no causation established?

And isn't the rate of myocarditis higher after getting Covid than it is after vaccines? I'm fairly certain I read that's the case.

It is good to be highly cautious, but the risks on the other side (denying boosters to many) seems pretty risky in its own right. The is a balancing act here.

Bill

[KSera]

31 minutes ago, whitestavern said:

There was a question asked (IIRC - have been watching many videos) about age range for concern on cardio issues, and the answer was up to 40. So yes, they could've recommended perhaps 50+.

By 40 years old, it seems the risk of myocarditis, which has been mostly mild and resolving without incidence, would be a less concerning risk than cardiac issues that could actually be caused by getting a breakthrough case of the virus. I guess that’s something I haven’t actually seen data for. What is the incidence of people with breakthrough infections who end up with myocarditis? Do we have any data on that yet?

[Bootsie]

1 hour ago, whitestavern said:

It didn't help that due to their technical difficulties, they (Pfizer) really didn't answer any of the questions they were asked. Disappointing. 

I was surprised at the quality of the presentation by Pfizer and as well as their technical difficulties during questions and answers.  I was also surprised that in their clinical trial they could not use 2% of the participants because they had been injected in error with a wrong booster; if you mess up on what you are injecting 2% of your participants with, how careful are you being?

[Bootsie]

20 minutes ago, Spy Car said:

True enough. But wasn't the incidence of myocarditis after the two regular vaccines extremely rare and generally self-resolving? With no causation established?

And isn't the rate of myocarditis higher after getting Covid than it is after vaccines? I'm fairly certain I read that's the case.

It is good to be highly cautious, but the risks on the other side (denying boosters to many) seems pretty risky in its own right. The is a balancing act here.

Bill

I am not sure what the rates are, but at this point, it would not be appropriate to compare the rate between the vaccine and the rate if one has COVID.  The rate of incidence for those who have COVID would have to adjusted for how much the vaccine decreases the risk of having COVID.  

[KSera]

2 minutes ago, Bootsie said:

I am not sure what the rates are, but at this point, it would not be appropriate to compare the rate between the vaccine and the rate if one has COVID.  The rate of incidence for those who have COVID would have to adjusted for how much the vaccine decreases the risk of having COVID.  

Very true. That seems doable, though. 

[KSera]

Also, is anywhere using different vaccine recommendations for men vs women? There clearly seems to be some basis to do so, but I can see that not being well received. 

[mommyoffive]

Pediatric Vaccines: FAQ from parents - by Katelyn Jetelina - Your Local Epidemiologist (substack.com)

[Bootsie]

1 minute ago, KSera said:

Very true. That seems doable, though. 

One of the things the committee members commented on was that they didn't have any data on how much a booster reduced the risk of contracting COVID,

[Spy Car]

4 minutes ago, Bootsie said:

I am not sure what the rates are, but at this point, it would not be appropriate to compare the rate between the vaccine and the rate if one has COVID.  The rate of incidence for those who have COVID would have to adjusted for how much the vaccine decreases the risk of having COVID.  

I'm not sure I'm following. If the incidence of myocarditis for the unvaccinated who get Covid  is higher than the incidence of myocarditis following vaccination, what needs to be adjusted?

Bill

[Corraleno]

6 hours ago, whitestavern said:

Once approved for 65+, doctors can still do this off label, no?

Doctors can already prescribe Pfizer off label — they can vaccinate underage kids and do boosters for anyone of any age  — because of the full biologics license that was granted last month. The "approval" of boosters for over 65s will be an EUA, though, and medications or vaccines under EUA technically can only be used for the limited purposes described in the EUA. So there's a bit of a conflict there between what's authorized by the EUA and what's allowed by the biologics license. From what I've read, though, I don't think the EUA on boosters overrides a doctor's right to prescribe the vaccine however they see fit based on their own professional judgement. Maybe it will make a difference to insurance companies, who might decide to cover it for over 65s but not under-65s since it's not FDA authorized? I don't know.

I think people with the time, money, and connections to find a sympathetic doctor will likely be able to get a booster regardless of age, but it may be more difficult for under-65s to just walk in and get it from a pharmacy or vaccine clinic. I think a lot will depend on how loosely the EUA defines "higher risk," and how strict various pharmacies and clinics are. As we've seen with the EUA for a 3rd shot in the immunocompromised, some pharmacies are giving third shots to whoever wants them without asking for proof, and others are being extremely strict and refusing anyone whose illnesses and medications are not on a very short list. 

[Spy Car]

4 minutes ago, Bootsie said:

One of the things the committee members commented on was that they didn't have any data on how much a booster reduced the risk of contracting COVID,

What I heard was that the only way to prevent infection was having high antibodies and that the only way to have high antibodies when there was antibody waning, was by giving boosters.

Bill

 

[Syllieann]

2 minutes ago, Spy Car said:

I'm not sure I'm following. If the incidence of myocarditis for the unvaccinated who get Covid  is higher than the incidence of myocarditis following vaccination, what needs to be adjusted?

Bill

We don't know if the people who get breakthrough cases after a 2-dose series develop myocarditis at a rate higher than vaccination.  Also, if kids are vaccinated and older people are boosted, overall rates should decline, so it's not a straight up comparison of covid vs vax.  Instead it becomes the x% chance of covid vs the vax.

[Spy Car]

4 minutes ago, Corraleno said:

Doctors can already prescribe Pfizer off label — they can vaccinate underage kids and do boosters for anyone of any age  — because of the full biologics license that was granted last month. The "approval" of boosters for over 65s will be an EUA, though, and medications or vaccines under EUA technically can only be used for the limited purposes described in the EUA. So there's a bit of a conflict there between what's authorized by the EUA and what's allowed by the biologics license. From what I've read, though, I don't think the EUA on boosters overrides a doctor's right to prescribe the vaccine however they see fit based on their own professional judgement. Maybe it will make a difference to insurance companies, who might decide to cover it for over 65s but not under-65s since it's not FDA authorized? I don't know.

I think people with the time, money, and connections to find a sympathetic doctor will likely be able to get a booster regardless of age, but it may be more difficult for under-65s to just walk in and get it from a pharmacy or vaccine clinic. I think a lot will depend on how loosely the EUA defines "higher risk," and how strict various pharmacies and clinics are. As we've seen with the EUA for a 3rd shot in the immunocompromised, some pharmacies are giving third shots to whoever wants them without asking for proof, and others are being extremely strict and refusing anyone whose illnesses and medications are not on a very short list. 

Yes that seems correct, and of course this widens an already great inequality gap.

One of the panel mentioned he was going out and getting his third shot. The well connected and wealthy will get what they need and the rest are left to their own devices.

This stuff makes people cynical. Rightly so.

Bill

[Spy Car]

2 minutes ago, Syllieann said:

We don't know if the people who get breakthrough cases after a 2-dose series develop myocarditis at a rate higher than vaccination.  Also, if kids are vaccinated and older people are boosted, overall rates should decline, so it's not a straight up comparison of covid vs vax.  Instead it becomes the x% chance of covid vs the vax.

Ah. Thanks for that explanation. 

Bill

[Bootsie]

3 minutes ago, Spy Car said:

I'm not sure I'm following. If the incidence of myocarditis for the unvaccinated who get Covid  is higher than the incidence of myocarditis following vaccination, what needs to be adjusted?

Bill

I am totally making up numbers here--but if the incidence with vaccination is 1 in 500, you have a 1 in 500 chance of the adverse event if you receive the vaccination.

If the incidence with COVID is 1 in 600, you have a 1 in 600 chance of the adverse event IF you have COVID.  If your chances of getting COVID are 1 in 2, then you have a 50% chance of a 1 in 600 chance.  

[Bootsie]

8 minutes ago, Spy Car said:

What I heard was that the only way to prevent infection was having high antibodies and that the only way to have high antibodies when there was antibody waning, was by giving boosters.

Bill

 

But you would need to know how high "high" is.  If even after waning antibodies the level is high enough to prevent infection, there is no benefit to a booster (and there are risks).  There is also little evidence regarding how long antibodies increase after the booster, so you don't know what the benefit to infection reduction is to compare the benefits and the risk.  

[Spy Car]

1 minute ago, Bootsie said:

I am totally making up numbers here--but if the incidence with vaccination is 1 in 500, you have a 1 in 500 chance of the adverse event if you receive the vaccination.

If the incidence with COVID is 1 in 600, you have a 1 in 600 chance of the adverse event IF you have COVID.  If your chances of getting COVID are 1 in 2, then you have a 50% chance of a 1 in 600 chance.  

Thank you for the patient explanation. I get what you are saying now.

I will need to check the numbers later, but my recollections (which may be wrong) are that myocarditis following vaccinations was very rare. Where post-Covid it is not that uncommon. With Delta the odds of evading Covid for the unvaccinated seem vanishingly small to me.

Tomorrow perhaps Not a Number can crunch the numbers?

Bill

[Spy Car]

1 minute ago, Bootsie said:

But you would need to know how high "high" is.  If even after waning antibodies the level is high enough to prevent infection, there is no benefit to a booster (and there are risks).  There is also little evidence regarding how long antibodies increase after the booster, so you don't know what the benefit to infection reduction is to compare the benefits and the risk.  

What I heard was that the panel was counting on "memory" to kick in with an immune response after days of being infected that would reduce serious illness and death, but that they were resigned to the fact that people would become infected if antibodies waned.

In the real world, in Israel, we saw this was the case. One doctor, Portnoy IMS, made the case that the only way to prevent infection was to keep antibodies up, which is what boosters are demonstrated to do.

Bill

 

[Not_a_Number]

6 minutes ago, Spy Car said:

Thank you for the patient explanation. I get what you are saying now.

I will need to check the numbers later, but my recollections (which may be wrong) are that myocarditis following vaccinations was very rare. Where post-Covid it is not that uncommon. With Delta the odds of evading Covid for the unvaccinated seem vanishingly small to me.

Tomorrow perhaps Not a Number can crunch the numbers?

Bill

I tend to assume that most people will get COVID without boosters, so I don’t even think incidence of COVID and vaccination is all that different. But yes, I’ll come back to this. Poke me if I don’t!

[Syllieann]

8 minutes ago, Not_a_Number said:

I tend to assume that most people will get COVID without boosters, so I don’t even think incidence of COVID and vaccination is all that different. But yes, I’ll come back to this. Poke me if I don’t!

Even if we say that everyone who isn't boosted will become infected, it's not appropriate to assume that someone who completed a two-dose series and gets a breakthrough case is just as likely to develop myocarditis as someone who is unvaccinated.  It actually seems extremely unlikely, and I'd say that is what the UK is banking on with the single dose rec for the adolescents.  The data you need don't yet exist.

[Not_a_Number]

2 minutes ago, Syllieann said:

Even if we say that everyone who isn't boosted will become infected, it's not appropriate to assume that someone who completed a two-dose series and gets a breakthrough case is just as likely to develop myocarditis as someone who is unvaccinated.  It actually seems extremely unlikely, and I'd say that is what the UK is banking on with the single dose rec for the adolescents.  The data you need don't yet exist.

That’s fair. But Pfizer was down to 86% for severe cases in Israel, right? So you’d kind of expect myocarditis risk to be off by one order of magnitude from unvaccinated people, not more.

Edited September 22, 2021 by Not_a_Number

[Bootsie]

Does anyone have any idea of how many people in the US have been vaccinated with 2 Pfizer shots long enough ago for this to apply?  I haven't seen a breakdown (especially by age) of the shots in the US by manufacturer.

[Syllieann]

3 minutes ago, Not_a_Number said:

That’s fair. But Pfizer was down to 86% for severe cases in Israel, right? So you’d kind of expect myocarditis risk to be off by one order of magnitude from unvaccinated people, not more.

That sounds like a reasonable guess.

[KSera]

26 minutes ago, Spy Car said:

I will need to check the numbers later, but my recollections (which may be wrong) are that myocarditis following vaccinations was very rare. Where post-Covid it is not that uncommon. With Delta the odds of evading Covid for the unvaccinated seem vanishingly small to me.

 

Right, but we're not talking about evading Covid for the unvaccinated, we're talking about evading Covid for the twice vaccinated. So, we would have to see what the rate of Catching Covid was for those with two shots, combined with the rate of myocarditis for a breakthrough case after 2 shots in order to see the overall probability of myocarditis for someone double vaccinated to compare it with the chance of myocarditis as a vaccine side effect. I still feel like the age is going to be significantly lower than 65 for the point at which the disease poses more of a risk of serious side effect vs a booster. Like, decades younger, )and quite possibly could end up being true across all age groups, except we really don't have data on kid breakthroughs enough to have even the slightest idea of that yet). But, I don't have any data to show that's the case, I'm just saying based on everything we know, my hunch is that's the way it's going to end up.

[Spy Car]

So I'm looking at a paper published Aug 4, 2021 in the JAMA network.

I'll link below.

2,000,287 vaccinated individuals monitored. Median age 57.

Only 11 cases of myocarditis with Pfizer (55% of cohort) and 9 with Moderna (45%). More details at link.

19 patients (out of the 2 million) were hospitalized with myocarditis, which isn't great, but none died and none was readmitted.

This study does not address lingering effects of myocarditis, but other writings I've seen suggest patients return to normal with no lingering issues.

An earlier study, cited by the linked one, has an incidence of myocarditis post-vaccination at 4.8 cases per million.

If this is the case, there seems to me to be very great concern about a relatively rare issue that is not causing long-term harm, while underplaying the risks of contracting Covid and Long Covid.

Bill

https://jamanetwork.com/journals/jama/fullarticle/2782900

 

 

 

[Bootsie]

22 minutes ago, Spy Car said:

So I'm looking at a paper published Aug 4, 2021 in the JAMA network.

I'll link below.

2,000,287 vaccinated individuals monitored. Median age 57.

Only 11 cases of myocarditis with Pfizer (55% of cohort) and 9 with Moderna (45%). More details at link.

19 patients (out of the 2 million) were hospitalized with myocarditis, which isn't great, but none died and none was readmitted.

This study does not address lingering effects of myocarditis, but other writings I've seen suggest patients return to normal with no lingering issues.

An earlier study, cited by the linked one, has an incidence of myocarditis post-vaccination at 4.8 cases per million.

If this is the case, there seems to me to be very great concern about a relatively rare issue that is not causing long-term harm, while underplaying the risks of contracting Covid and Long Covid.

Bill

https://jamanetwork.com/journals/jama/fullarticle/2782900

 

 

 

The overall incidence was 4.8 per million (which these authors say they think is under-reporting), but the incidence in males under the age of 25 is over 50 per million--so over 10 times higher.  In fact over half of the cases of myocarditis in this study are in males under the age of 25.  (The incidence is only about 0.6 per million in the over 65 male population).  

[Spy Car]

6 minutes ago, Bootsie said:

The overall incidence was 4.8 per million (which these authors say they think is under-reporting), but the incidence in males under the age of 25 is over 50 per million--so over 10 times higher.  In fact over half of the cases of myocarditis in this study are in males under the age of 25.  (The incidence is only about 0.6 per million in the over 65 male population).  

And if that is the case it would seem reasonable to recommend withholding boosters to males under 25 (or in that ballpark), where 65+ is hard to fathom.

Bill

[Bootsie]

6 minutes ago, Spy Car said:

And if that is the case it would seem reasonable to recommend withholding boosters to males under 25 (or in that ballpark), where 65+ is hard to fathom.

Bill

These numbers were from June and there is a note that more potential cases were under review (but they give no clue of how many that might be); in the meeting some of the committee members mentioned that there were different studies that had different results.  These results are after a second shot, so there is still a question about what happens after a third.  These results show the incidence increasing as age decreases, with even the 40-49 year old males have a rate over 6 times greater than those over 65.  

My perception is the committee sees evidence that the risk is higher in younger people and that the outcomes from a covid case are better in younger people, so as you move down the age spectrum the risk of vaccine increases and the benefit decreases--they do not know how stable those results are for a third dose.  I think a major issue is that it was Pfizer's job to provide evidence of benefit of a booster (and the committee found that some of the information that would generally be used to evaluate benefits was not provided) and it was Pfizer's job to provide evidence of low risk--and again the committee found that data lacking.

 

[KSera]

23 minutes ago, Bootsie said:

I think a major issue is that it was Pfizer's job to provide evidence of benefit of a booster (and the committee found that some of the information that would generally be used to evaluate benefits was not provided) and it was Pfizer's job to provide evidence of low risk--and again the committee found that data lacking.

 

I wonder if Pfizer was overconfident in approval, so didn’t bring as much data as they could or should have.

[Laura Corin]

4 hours ago, whitestavern said:

There was a question asked (IIRC - have been watching many videos) about age range for concern on cardio issues, and the answer was up to 40. So yes, they could've recommended perhaps 50+.

The UK is planning on giving boosters to over-fifties, the medically fragile, and staff working in health and social care. As our initial vaccination spacing was mostly 12 or 8 weeks, six months later will not come up for many for some time.  I was vaccinated as soon as my cohort became eligible, but my six months won't be up until late November. 

I would expect my 97 year old mother to get hers very soon though, as she had her second - on the four-week schedule - in January. 

[Not_a_Number]

6 hours ago, Spy Car said:

And if that is the case it would seem reasonable to recommend withholding boosters to males under 25 (or in that ballpark), where 65+ is hard to fathom.

Bill

Well, depends on rates when catching COVID while vaccinated, though.

[Lucy the Valiant]

I found Dr. Steve Kirsh's testimony quite concerning. He is not on the FDA panel but was invited to testify. According to his data, one in 317 boys (16-17) will get myocarditis from the Pfizer vaccine. This rate could increase to 1 in 25 after those patients have received the booster. He also discussed concerning heart attack incidence in adult trial participants.

And Dr. Joseph Fraiman spoke after him, frustrated that Pfizer did not have clinical evidence to disprove the claim that covid vaccines are harming more people than they save. (He is not claiming the vaccines do injure people, just lamenting that science can't prove that.)

That testimony comes around the 4:20 mark of the 8 hr long video.

 

 

ETA: Maybe these are untrustworthy doctors or statistics; I have no idea how to evaluate. The FDA invited them to the meeting. I'm just a concerned parent trying like the rest of us to read and understand. 

Edited September 22, 2021 by Lucy the Valiant

[Syllieann]

2 hours ago, Not_a_Number said:

Well, depends on rates when catching COVID while vaccinated, though.

Yes!  But it also makes sense to consider males and females separately.  If we don't boost males under a certain age, we could still provide them additional protection by boosting females.  I'm guessing this would make a big difference in household transmission with high inoculum.

Edited September 22, 2021 by Syllieann