The Vaccine Thread

[kbutton]

Just now, Not_a_Number said:

I'd honestly guess these are going to have to be like the flu shot -- we'll have to keep getting them 😕 . I am hoping they manage to reduce side effects in the meantime. 

I do too, but even flu shots get boosted in children when they get them for the first time. It might be something where people have to get 2-3 initial shots for Covid and then yearly shots. 

I suspect we'll start mixing different shots over time and/or have multiple strains in a yearly shot like we do with flu. 

[Corraleno]

Just now, kbutton said:

I do too, but even flu shots get boosted in children when they get them for the first time. It might be something where people have to get 2-3 initial shots for Covid and then yearly shots. 

I suspect we'll start mixing different shots over time and/or have multiple strains in a yearly shot like we do with flu. 

I think by next fall we will have several combined covid/flu shots. I really hope Novavax's combo shot is approved by then.

[kbutton]

Just now, Corraleno said:

I think by next fall we will have several combined covid/flu shots. I really hope Novavax's combo shot is approved by then.

That would be cool, though I wonder if flu plus Covid will have really nasty side effects. I don't usually have any side effects from the flu except for an itchy arm (likely from sensitivity to gelatin). Covid is another story, lol! But if it's not worse than Covid alone, sign me up. Sounds great!

[Corraleno]

So I decided to look up the credentials of the members of the advisory committee — the vast majority are professors of pediatrics, not vaccine experts. Maybe that makes sense when the vaccines under review are designed for young children, but this committee was voting on boosters for adults (16+). Here are the credentials of the committee that just voted to restrict boosters to over 65s:

Professor of Pediatrics, Stanford Medical School
Professor of Pediatrics, Tufts Medical Center
Professor of Pediatrics, University of Cincinnati Medical School
Professor of Pediatrics, Children’s Hospital of Philadelphia
Professor of Pediatrics, Emory University School of Medicine
Dean, Chicago Medical School, (Specialty: Pediatrics)
Associate Professor of Obstetrics and Gynecology, Duke University
Medical Director, Seattle Cancer Care Alliance
Professor, Vaccine & Infectious Diseases Division, Fred Hutchinson Cancer Research Center
Professor, Baylor College of Medicine (Specialty: Vaccines)
Associate Dean for Global Health, University of Maryland School of Medicine

Government Agency Representatives:
Director of Scientific Advisors, FDA
Designated Federal Officer, FDA
Committee Management Specialist, FDA
Chief Medical Officer, CDC
Director of Clinical Innovation, NIH

Industry Representatives:
VP for Medical Affairs, Seqirus
VP of Vaccine Research, Merck

[RootAnn]

2 hours ago, BronzeTurtle said:

They did just have 2 people resign, right? Maybe because they knew it wouldn't get approved?

My understanding is they resigned because of the Biden Asministration's announcimg there should be boosters before waiting for the FDA Advisory committee opinion. I think they disagreed with offering boosters to everyone but I don't know that for sure. https://www.businessinsider.com/2-top-fda-officials-resigned-biden-booster-plan-reports-2021-9%3famp

1 hour ago, Not_a_Number said:

Obviously it's OK! Everyone makes their own decisions, and I understand why you feel hesitant. Frankly, I do, too. 

I used to think that everyone in the US was allowed to make their own decisions and would have to live with the consequences, but this country has started to turn topsy-turvy on me. I don't know if that is going to be the case much longer. 

I would frankly not be surprised if the out of the box thinkers in the White House would try to use the Houlahan amendment to the National Defense Authorization Act for 2022 to draft any citizen (within the limited ages) to help with the Covid (national) emergency response (medical training, teachers, even truck drivers). And that would require them to be vaccinated, too, since that will soon be required of most government employees & service members.  

Yes, my tin foil hat was definitely on for that last paragraph.

[Corraleno]

Also, for anyone who doesn't think political pressure from the WHO had anything to do with yesterday's decision, the anti-booster opinion piece that was published in the Lancet by the two FDA employees who resigned was coauthored by five members of the WHO as well as other coauthors from India, South Africa, Mexico, Jamaica, France, and the UK. 

Edited September 20, 2021 by Corraleno

[Spy Car]

23 minutes ago, Corraleno said:

So I decided to look up the credentials of the members of the advisory committee — the vast majority are professors of pediatrics, not vaccine experts. Maybe that makes sense when the vaccines under review are designed for young children, but this committee was voting on boosters for adults (16+). Here are the credentials of the committee that just voted to restrict boosters to over 65s:

Professor of Pediatrics, Stanford Medical School
Professor of Pediatrics, Tufts Medical Center
Professor of Pediatrics, University of Cincinnati Medical School
Professor of Pediatrics, Children’s Hospital of Philadelphia
Professor of Pediatrics, Emory University School of Medicine
Dean, Chicago Medical School, (Specialty: Pediatrics)
Associate Professor of Obstetrics and Gynecology, Duke University
Medical Director, Seattle Cancer Care Alliance
Professor, Vaccine & Infectious Diseases Division, Fred Hutchinson Cancer Research Center
Professor, Baylor College of Medicine (Specialty: Vaccines)
Associate Dean for Global Health, University of Maryland School of Medicine

Government Agency Representatives:
Director of Scientific Advisors, FDA
Designated Federal Officer, FDA
Committee Management Specialist, FDA
Chief Medical Officer, CDC
Director of Clinical Innovation, NIH

Industry Representatives:
VP for Medical Affairs, Seqirus
VP of Vaccine Research, Merck

Do you know which specialists voted for the boosters?

Bill

[Corraleno]

2 hours ago, Spy Car said:

Do you know which specialists voted for the boosters?

Bill

No I've been looking for that information but haven't found it. I think it's ridiculous that so many are pediatric MDs though. And the VP of Merck* gets a vote??? Maybe they should have had some pulmonologists, cardiologists, and critical care specialists on the committee instead.

*(Merck is currently developing anti-covid drugs, btw, and would benefit from fewer Americans getting boosters)

Edited September 20, 2021 by Corraleno

[BronzeTurtle]

1 hour ago, Corraleno said:

There IS political pressure on the FDA — to NOT approve boosters. There is political pressure from the WHO, which has nothing to do with the efficacy of boosters. There is the perception of pressure from antivaxxers, in the sense that some committee members fear that approving a 3rd dose will further discourage anti-vaxxers. That also has nothing to do with the efficacy of boosters. 

There is a reason the committee is called an ADVISORY committee — they provide advice, they do not approve vaccines. The FDA staff then take that advice into account when deciding whether to approve something, but they are free to take other factors into account as well.

Wouldn't it have been weird though if the advisory committe advised against the eua, for example, and the executive branch (or whomever) authorized it for the general public anyway? 

There's also political pressure the other way, it seems to me, if the sentiment here is any indication. Their decision can't be entirely based on the WHO and anti-vaxxers can it? They did have to look at other stuff right?  We're saying 14 out of 16 people were somehow cowed by the WHO and a minority who don't/won't take the vaccine? I guess if that is true then the advisory committee is pretty useless. I wonder if approving the vaccine and before that the eua was also politically motivated. This is making me question a lot of assumptions I had about how vaccines are approved at all. I absolutely would not have taken the vaccine without the eua even if I could get one under the radar. I assumed, maybe wrongly, that they were taking all sorts of things into account like what a given does to us medically, what the risks and benefits are, etc. I assumed the same would be true for the 3rd dose. Now I don't know what to believe about the whole process if it's all just based on perception and international pressure.

[BronzeTurtle]

16 minutes ago, Corraleno said:

Also, for anyone who doesn't think political pressure from the WHO had anything to do with yesterday's decision, the anti-booster opinion piece that was published in the Lancet by the two FDA employees who resigned was coauthored by five members of the WHO as well as other coauthors from India, South Africa, Mexico, Jamaica, France, and the UK. 

Now I'm totally confused. These scientists agree with each other and some are from different countries so they are not credible? Or because some are members of the WHO? It seems like that would disqualify quite a few public health/vaccine/etc researchers from authoring anything or recommending anything at all.

I think the WHO did a pretty good job of discrediting itself right from the beginning but I don't know that means every researcher or scientist they have must be politically pressuring the fda or the cdc?
 

[BronzeTurtle]

1 hour ago, regentrude said:

the two situations have absolutely nothing to do with each other. The advisory committee is not making a statement about the safety of a medication or approving a substance. 

I'm discussing going against fda/cdc recommendations and using a medication/getting a shot without it being fda approved.

So the advisory committee does not take safety into account when making their recommendations? I feel so dumb that I did not know all this. I thought it was like committee meets, fda takes their advice, issues approvals or disapprovals, but the committee was looking at all the things, safety, efficacy, necessity, etc. I didn't realize it was mostly a political thing for show.

[RootAnn]

In trying to find who votes yes, I found this stated about the discussion surrounding whether to approve the boosters.

"They [committee members] were worried about the safety of the vaccine in younger people, and many said that the situation in Israel did not map to the one in the U.S."

Also, did anyone else read there was a non-committee member (speaker at the meeting) who tried to vote yes in the original question? That was interesting.

[Bootsie]

55 minutes ago, Corraleno said:

So I decided to look up the credentials of the members of the advisory committee — the vast majority are professors of pediatrics, not vaccine experts. Maybe that makes sense when the vaccines under review are designed for young children, but this committee was voting on boosters for adults (16+). Here are the credentials of the committee that just voted to restrict boosters to over 65s:

Professor of Pediatrics, Stanford Medical School
Professor of Pediatrics, Tufts Medical Center
Professor of Pediatrics, University of Cincinnati Medical School
Professor of Pediatrics, Children’s Hospital of Philadelphia
Professor of Pediatrics, Emory University School of Medicine
Dean, Chicago Medical School, (Specialty: Pediatrics)
Associate Professor of Obstetrics and Gynecology, Duke University
Medical Director, Seattle Cancer Care Alliance
Professor, Vaccine & Infectious Diseases Division, Fred Hutchinson Cancer Research Center
Professor, Baylor College of Medicine (Specialty: Vaccines)
Associate Dean for Global Health, University of Maryland School of Medicine

Government Agency Representatives:
Director of Scientific Advisors, FDA
Designated Federal Officer, FDA
Committee Management Specialist, FDA
Chief Medical Officer, CDC
Director of Clinical Innovation, NIH

Industry Representatives:
VP for Medical Affairs, Seqirus
VP of Vaccine Research, Merck

I see this more as a list of titles of these individuals and not their credentials.  The titles seem to vary from med school to med school, but someone can be a professor of X (title) at a medical school without have the credential of being a medical doctor.  At some schools many people are listed as "professor of pediatrics" but that could range from a highly specialized MD working in cardiology to a PhD in nutritionist studying sugar in diets of children to someone with a degree in public health

[Not_a_Number]

7 minutes ago, RootAnn said:

"They [committee members] were worried about the safety of the vaccine in younger people, and many said that the situation in Israel did not map to the one in the U.S."

What does that even mean??? 

[BronzeTurtle]

1 hour ago, Corraleno said:

I believe that boosters are warranted and intend to get one. If the recommendation is broad enough, or I can find a doctor who is flexible enough, I will also try to get boosters for my kids. Other people are free to make their own choices based on their own assessment of risks and benefits as well as their ability to access a provider who can accommodate their wishes.

It seems like you believe there must be a single black/white, right/wrong answer to this question, and you want someone to tell you what to do — or at least tell you which authority you should trust or whose advice you should take. But that's something you're just going to have to work out for yourself.

Well I usually go to my doctor and they have a vaccine schedule. They usually go by what the fda and cdc recommend. I'm not a medical expert or researcher. As a lay person I go to these people because they have years of training that I'm not ever likely going to get. Work out a good vaccine schedule for myself? That doesn't make any sense to me as a liberal arts major who has a lot of trouble with math, especially statistics. That's WHY I go to the doctor. Who in the world thinks it's a good idea to work out a vaccine schedule for themselves?? This is going to give so much ammo to people who think the cdc vax schedule is bunk and already don't want to give their kids their shots on schedule. Work it out for myself? You really think average people should be working out their own vax schedules for themselves and their kids?

[Not_a_Number]

28 minutes ago, BronzeTurtle said:

I assumed, maybe wrongly, that they were taking all sorts of things into account like what a given does to us medically, what the risks and benefits are, etc. I assumed the same would be true for the 3rd dose.

They are certainly taking all that into account. Except that there's really no safety concern at the moment at all, so that's not the issue, and no one has said that it's the issue. 

[Corraleno]

6 minutes ago, Bootsie said:

I see this more as a list of titles of these individuals and not their credentials.  The titles seem to vary from med school to med school, but someone can be a professor of X (title) at a medical school without have the credential of being a medical doctor.  At some schools many people are listed as "professor of pediatrics" but that could range from a highly specialized MD working in cardiology to a PhD in nutritionist studying sugar in diets of children to someone with a degree in public health

All but one of the professors is an MD; the other is a PhD biostatistician. A few also have public health degrees.

[Not_a_Number]

1 minute ago, BronzeTurtle said:

Who in the world thinks it's a good idea to work out a vaccine schedule for themselves?? This is going to give so much ammo to people who think the cdc vax schedule is bunk and already don't want to give their kids their shots on schedule. Work it out for myself? You really think average people should be working out their own vax schedules for themselves and their kids?

Again, anti-vaxxers literally do NOT care what I think. I can't possibly give them ammo, because they don't need any. 

Look, if you don't have faith in your own ability to deal with the statistics, then I'm sure the FDA is a fine body to listen to. When I say it's politically motivated, I don't mean they are being corrupt or anything like that -- just that the data is dubious, all this requires some forward thinking, and I think they made the wrong call. But it's not, like, a call I don't understand. I just happen to think they are incorrect, and you're right that you have less reason to believe me than you do the FDA 🤷‍♀️

[Corraleno]

2 minutes ago, BronzeTurtle said:

Who in the world thinks it's a good idea to work out a vaccine schedule for themselves?? This is going to give so much ammo to people who think the cdc vax schedule is bunk and already don't want to give their kids their shots on schedule. Work it out for myself? You really think average people should be working out their own vax schedules for themselves and their kids?

NO ONE is suggesting that you or anyone else "should" work out your own vaccine schedule. I feel like I'm banging my head against a brick wall. If you trust your doctor and want to follow the CDC vaccine schedule, then you should do that! 

I did not follow the CDC recommended vaccine schedule because I have a child who was adopted from an orphanage and did not get any of the normal vaccines in the first 6 months, so after she came home I worked out a schedule to spread them out. My other child was born in the UK, which has a different vaccine schedule — because their scientists and their regulatory board made different decisions  — so I also spread out his vaccines when we moved to the US rather than catching him up all at once. I was comfortable doing that.

YOU should do what YOU are comfortable with, and follow the advice of people YOU trust.

[Not_a_Number]

9 minutes ago, Corraleno said:

I feel like I'm banging my head against a brick wall.

I'm also feeling this a bit. 

 

9 minutes ago, Corraleno said:

If you trust your doctor and want to follow the CDC vaccine schedule, then you should do that! 

Right. It's a perfectly fine schedule and I basically respect the CDC! It's just that it's been kind of lumbering and bureaucratic in this pandemic instead of being nimble and flexible, and same for the FDA. 

[Corraleno]

12 hours ago, Not_a_Number said:

They are certainly taking all that into account. Except that there's really no safety concern at the moment at all, so that's not the issue, and no one has said that it's the issue. 

Exactly. There is ZERO evidence that the 3rd shot causes more adverse events than the first two. In fact the stats were almost identical for the booster and the 2nd shot — it was something like 60% experienced fatigue, 50% headaches, and 40% muscle aches. The one difference was fever — there was a significantly lower incidence of fever with the booster. There is also no evidence of increased risk of myocarditis vs the original shots. There was a single case in Israel out of nearly 3 million booster doses, but the committee said they weren't sure than was enough data to know for certain. So how many people are going to develop myocarditis when they catch covid due to waning immunity?

I feel like they're failing to see the forest for the trees. They are hyper focused on hospitalizations and deaths while ignoring the risks of increased transmission, ignoring the risks of increased long covid and other long-term issues (including myocarditis), and ignoring the impact that even moderate illness (sick enough to miss a lot of work but not sick enough to be hospitalized) will have on working Americans who often live paycheck to paycheck. I'm sure taking a couple of weeks off is NBD if you're a med school professor at Stanford or U Chicago or Duke, but there are a lot of Americans for whom that would be catastrophic.

Edited September 20, 2021 by Corraleno

[Corraleno]

6 minutes ago, Not_a_Number said:

It's a perfectly fine schedule and I basically respect the CDC! It's just that it's been kind of lumbering and bureaucratic in this pandemic instead of being nimble and flexible, and same for the FDA. 

This. There are times when being super slow and deliberate and over-the-top cautious is a fine approach. The middle of a pandemic that has killed 670,000 Americans so far, and is currently killing another 1600 every day, is not that time.

Edited September 20, 2021 by Corraleno

[BronzeTurtle]

 

 

1 minute ago, Not_a_Number said:

Again, anti-vaxxers literally do NOT care what I think. I can't possibly give them ammo, because they don't need any. 

Look, if you don't have faith in your own ability to deal with the statistics, then I'm sure the FDA is a fine body to listen to. When I say it's politically motivated, I don't mean they are being corrupt or anything like that -- just that the data is dubious, all this requires some forward thinking, and I think they made the wrong call. But it's not, like, a call I don't understand. I just happen to think they are incorrect, and you're right that you have less reason to believe me than you do the FDA 🤷‍♀️

I don't have faith in my own ability to deal with statistics, that is my whole point! That's why I get my shots on a schedule from the cdc with fda approved vaccines. I guess I am under some kind of rock because if someone I know is differing from the cdc schedule, if I know about it at all, it's because they're reading Dr. Sears non-science based vax schedule, not because they've evaluated the myriad studies themselves about each vax.

Anti-vaxxers very much care what is happening with all this. They are gaining credibility in corners where they had none before. They are going to make their choices regardless, but they are very much looking at what's happening here with the cdc, the fda, what people are doing. They see people making individual choices, working it out for themselves as it were, and that's exactly what they advocate for.

You can persuade some people who are reluctant to vax but aren't anti-vax, I know this to be true in my own life (not for myself, just in case that needed to be said). But the more illogical and convoluted things seem, the less likely that is. I can think of at least one example of this off the top of my head, and there are likely others.  It's on the news that the fda advisory panel has not recommended boosters for under 65s. If it gets approved anyway and then people try to enforce 3 shots as fully vaxxed, there is definitely credibility lost.

I honestly feel like, after reading a lot of this discussion, that I don't know what to think about a lot of this anymore. I read a lot of news. I have never gotten the idea until now that the fda advisory process would be influenced primarily by the WHO or anti-vax sentiment.

[Not_a_Number]

Just now, BronzeTurtle said:

Anti-vaxxers very much care what is happening with all this. They are gaining credibility in corners where they had none before. They are going to make their choices regardless, but they are very much looking at what's happening here with the cdc, the fda, what people are doing. They see people making individual choices, working it out for themselves as it were, and that's exactly what they advocate for.

I know they are gaining credibility, but trust me, it’s not because of the vanishingly small subset of people who are reading the studies.

 

1 minute ago, BronzeTurtle said:

If it gets approved anyway and then people try to enforce 3 shots as fully vaxxed, there is definitely credibility lost.

Who’s gonna enforce this??

[BronzeTurtle]

20 minutes ago, Corraleno said:

NO ONE is suggesting that you or anyone else "should" work out your own vaccine schedule. I feel like I'm banging my head against a brick wall. If you trust your doctor and want to follow the CDC vaccine schedule, then you should do that! 

I did not follow the CDC recommended vaccine schedule because I have a child who was adopted from an orphanage and did not get any of the normal vaccines in the first 6 months, so after she came home I worked out a schedule to spread them out. My other child was born in the UK, which has a different vaccine schedule — because their scientists and their regulatory board made different decisions  — so I also spread out his vaccines when we moved to the US rather than catching him up all at once. I was comfortable doing that.

YOU should do what YOU are comfortable with, and follow the advice of people YOU trust.

No need to shout. I simply misinterpreted what you meant in the previous post. I quoted the relevant bit below just because I also feel a bit like I'm finding circles in all of this discussion as well. I thought that's what you meant when you said I'm going to have to work it out for myself, given that many people here are working out a covid vaccine schedule for themselves. I am very obviously not an expert here and you clearly have years of training given your ability to decide for your kids their best spacing and schedules. I'm not similarly equipped or knowledgable. I would have no idea how to create a vaccine schedule for a child who is behind absent a doctor telling me the best way to do it. I feel like it would take me years to acquire that training.

I'm so sorry to frustrate you all. I have a lot of things that I'm reading that seem to conflict. You all seem so sure of yourselves that getting a 3rd shot is the right thing to do no matter what any approval body might say. This is only one corner of the internet I'm on, so I have to say it's not something I've found commonly but I suppose it depends on where one lives and who one talks to. I wish you all well, sincerely.

 

It seems like you believe there must be a single black/white, right/wrong answer to this question, and you want someone to tell you what to do — or at least tell you which authority you should trust or whose advice you should take. But that's something you're just going to have to work out for yourself.

[BronzeTurtle]

6 minutes ago, Not_a_Number said:

I know they are gaining credibility, but trust me, it’s not because of the vanishingly small subset of people who are reading the studies.

 

Who’s gonna enforce this??

I don't know. Don't they enforce vaccine cards in some places now? Who enforces that?

[Mom_to3]

I read that they meant that a much more sizable fraction in the US (than in Israel) is unvaccinated, and so we have no hope of stopping major transmission by allowing boosters. 

[BronzeTurtle]

10 minutes ago, Not_a_Number said:

I know they are gaining credibility, but trust me, it’s not because of the vanishingly small subset of people who are reading the studies.

 

Who’s gonna enforce this??

It's not that subset specifically. It's about people not trusting the cdc, or at least that is what I was trying to speak to.

Okay, really, I'll go now. I appreciate all the feedback and attempts to set me straight on some of this. I don't claim to understand a lot of the opinions, but I appreciate the conversation.

[Corraleno]

56 minutes ago, BronzeTurtle said:

Now I'm totally confused. These scientists agree with each other and some are from different countries so they are not credible? Or because some are members of the WHO? It seems like that would disqualify quite a few public health/vaccine/etc researchers from authoring anything or recommending anything at all.

They agree that the US should not do boosters because they want the US to donate all those doses to the WHO's COVAX program.

If you were debating whether to have a medical procedure, and a bunch of your relatives say you shouldn't have it — because they think you should give the money to them instead — does the fact that they agree you should give the money to them mean the medical procedure is ineffective or unnecessary?

[BronzeTurtle]

9 minutes ago, Corraleno said:

They agree that the US should not do boosters because they want the US to donate all those doses to the WHO's COVAX program.

If you were debating whether to have a medical procedure, and a bunch of your relatives say you shouldn't have it — because they think you should give the money to them instead — does the fact that they agree you should give the money to them mean the medical procedure is ineffective or unnecessary?

I didn't leave, not a surprise, because I forgot to turn off notifications.

But it's a bit different right? Than what you're saying? Because stopping or slowing global transmission is beneficial to me long term, whereas if someone else gets my donated knee surgery, I just don't get any benefit from someone else having a knee surgery that I can't have. Also, if I'm in a wealthy enough situation (as the US is) I can just buy another surgery, right, maybe a bit later? 

Isn't this exactly what equity is about? Are we only concerned about US deaths? That's an interesting proposition actually. Are other countries donating? Is global transmission in developming nations not a concern? What about variants? I'll have to think on this.

Edited September 20, 2021 by BronzeTurtle

[Corraleno]

19 minutes ago, BronzeTurtle said:

Anti-vaxxers very much care what is happening with all this. They are gaining credibility in corners where they had none before. They are going to make their choices regardless, but they are very much looking at what's happening here with the cdc, the fda, what people are doing. They see people making individual choices, working it out for themselves as it were, and that's exactly what they advocate for.

Antivaxxers think vaccines contain microchips and dead babies, make you magnetic and sterile, and are the Mark of the Beast. A handful of people on a homeschooling board opining that the FDA made a mistake will not embolden a single antivaxxer. 

 

19 minutes ago, BronzeTurtle said:

It's on the news that the fda advisory panel has not recommended boosters for under 65s. If it gets approved anyway and then people try to enforce 3 shots as fully vaxxed, there is definitely credibility lost.

There's no way the FDA will totally ignore the committee and approve boosters for everyone. I'm hoping they will include some vague language like "people over 65 and others at increased risk," which will leave room for interpretation that people who are obese or have high blood pressure or are essential workers with a lot of public contact, etc., could technically qualify. I don't think there's much chance they would go any further than that.

 

19 minutes ago, BronzeTurtle said:

I honestly feel like, after reading a lot of this discussion, that I don't know what to think about a lot of this anymore. I read a lot of news. I have never gotten the idea until now that the fda advisory process would be influenced primarily by the WHO or anti-vax sentiment.

Well members of the committee have literally said out loud that they think approving boosters for everyone will discourage antivaxxers from getting the shot and that they think we shouldn't do boosters when other countries haven't had first shots. I mean, those aren't things we're just guessing at or trying to read between the lines; they've come right out and said it.

[Corraleno]

4 minutes ago, BronzeTurtle said:

Isn't this exactly what equity is about? Are we only concerned about US deaths? That's an interesting proposition actually. Are other countries donating? Is global transmission in developming nations not a concern?

The US has pledged to donate more than half a billion doses — more than the entire EU combined. And those are Pfizer doses, not crap like Sinovax or Sputnik. For the WHO to insist that the US should stop protecting their own citizens and donate an additional 200 million doses to COVAX, on top of what we've already pledged, is unreasonable IMO.

The main bottleneck with getting vaccines to poor countries is that most of the vaccine manufacturers that the WHO contracted with to supply vaccines for COVAX are in India, and India banned exports and decided to keep all the vaccines for themselves. And there have been many cases where tens of thousands of vaccines that were donated to poor countries ended up being wasted because they simply didn't have the infrastructure and staff necessary to carry out an intensive nationwide vaccine campaign. It's not the rich greedy US that's keeping the rest of the world from getting vaxxed.

[Faith-manor]

7 hours ago, Corraleno said:

The US has pledged to donate more than half a billion doses — more than the entire EU combined. And those are Pfizer doses, not crap like Sinovax or Sputnik. For the WHO to insist that the US should stop protecting their own citizens and donate an additional 200 million doses to COVAX, on top of what we've already pledged, is unreasonable IMO.

The main bottleneck with getting vaccines to poor countries is that most of the vaccine manufacturers that the WHO contracted with to supply vaccines for COVAX are in India, and India banned exports and decided to keep all the vaccines for themselves. And there have been many cases where tens of thousands of vaccines that were donated to poor countries ended up being wasted because they simply didn't have the infrastructure and staff necessary to carry out an intensive nationwide vaccine campaign. It's not the rich greedy US that's keeping the rest of the world from getting vaxxed.

Infrastructure is a huge deal. We have friends in D.O.B., and that is the issue where they are serving. They do the best they can to get folks vaccinated, but imagine the logistics when there are hundreds and thousands of square miles without ANY medical infrastructure at all, and you and your underfunded, tiny staffed NGO are trying to reach folks. It is a staggering task and far more vaccine goes to waste than gets distributed. 

[ktgrok]

9 hours ago, BronzeTurtle said:

I'm discussing going against fda/cdc recommendations and using a medication/getting a shot without it being fda approved.

So the advisory committee does not take safety into account when making their recommendations? I feel so dumb that I did not know all this. I thought it was like committee meets, fda takes their advice, issues approvals or disapprovals, but the committee was looking at all the things, safety, efficacy, necessity, etc. I didn't realize it was mostly a political thing for show.

There is a HUGE difference between hypothetically approving something that isn't safe vs saying something is safe, but they don't think it is necessary (yet).  They are being uber cautious, which does not mean they would approve things without thinking it was safe - in fact it means the opposite. 

And none of us are second guessing what they are saying about the safety or efficacy of the vaccines. The FDA has accepted that they are safe and do increase immunity - so we really are NOT arguing with them about that, or doubting them. We who are pro booster are in agreement with them as to the safety and efficacy of it. We just disagree on if it that increased immunity is worth the financial and political cost of having everyone get boosters. 

That is VERY different than if they had said that these boosters were not helpful, didn't improve immunity, were probably dangerous, etc and then we all said, "nope, you lie they are fantastic". 

[Not_a_Number]

24 minutes ago, ktgrok said:

That is VERY different than if they had said that these boosters were not helpful, didn't improve immunity, were probably dangerous, etc and then we all said, "nope, you lie they are fantastic". 

Right. Whereas the data suggests that they are effective and safe. 

DH said he read the meeting minutes and they basically discounted the Israeli data because it's not peer-reviewed yet 😕 . I don't see why they couldn't have done some kind of review process themselves... that seems so arrogant. 

[BeachGal]

India’s DNA vaccine is going to be rolled out soon if not already. It’s 67% effective but it’s a first for DNA.

https://www.nature.com/articles/d41586-021-02385-x
 

@Corraleno My understanding is that there is some slight concern about myocarditis, that it’s occurring in 1 out of 1,000 (data gathered from an academic setting), which is higher than what VAERS showed. The myocarditis is manageable and clears up, though, and is far better than damage from a Covid infection. Have you read about this? Thoughts?

Btw, regarding mild to moderate infections, damage has been observed in brain tissue with no virus present in the tissue. So it appears Covid is capable of doing significant damage without actually entering the brain. This was a study done on brains of deceased individuals aged 5 to 70s.

[mommyoffive]

State of Affairs: Sept 19, 2021 - by Katelyn Jetelina - Your Local Epidemiologist (substack.com)

Right before I hit send, my phone buzzed with some amazing breaking news!! Pfizer just announced promising results for the pediatric (5-11 years) vaccine and will submit their EUA application soon. A pediatric vaccine should come by Halloween!!! Haven’t had time to process the data yet…will of course fill you in with a post. But I’m just so excited. This pandemic will, in fact, end.

 

Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years | Pfizer

 

 

Pfizer, BioNTech Say Vaccine Is Safe for Young Children (msn.com)

 

Pfizer said a review of data for 2,268 children in the trial showed that those who received two 10 microgram doses had antibody levels one month after the second dose similar to those found in people aged 16 to 25 years who received 30 microgram doses in a separate Pfizer study.

There appeared to be fewer side effects such as fever and chills among younger children who got the vaccine compared with 16-25 year olds, according to Pfizer. There also were no cases of myocarditis, an inflammatory heart condition that has so far been found to be a rare side effect primarily in young men.

Edited September 20, 2021 by mommyoffive

[Not_a_Number]

14 minutes ago, mommyoffive said:

State of Affairs: Sept 19, 2021 - by Katelyn Jetelina - Your Local Epidemiologist (substack.com)

Right before I hit send, my phone buzzed with some amazing breaking news!! Pfizer just announced promising results for the pediatric (5-11 years) vaccine and will submit their EUA application soon. A pediatric vaccine should come by Halloween!!! Haven’t had time to process the data yet…will of course fill you in with a post. But I’m just so excited. This pandemic will, in fact, end.

 

Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years | Pfizer

 

 

Pfizer, BioNTech Say Vaccine Is Safe for Young Children (msn.com)

 

Pfizer said a review of data for 2,268 children in the trial showed that those who received two 10 microgram doses had antibody levels one month after the second dose similar to those found in people aged 16 to 25 years who received 30 microgram doses in a separate Pfizer study.

There appeared to be fewer side effects such as fever and chills among younger children who got the vaccine compared with 16-25 year olds, according to Pfizer. There also were no cases of myocarditis, an inflammatory heart condition that has so far been found to be a rare side effect primarily in young men.

Ooooh, that's great!! I'm so glad about the fact there are fewer side effects... it was looking like the side effects got worse and worse as the recipients got younger, so I'm delighted that doesn't hold for the little ones. 

 

[Syllieann]

25 minutes ago, Not_a_Number said:

Ooooh, that's great!! I'm so glad about the fact there are fewer side effects... it was looking like the side effects got worse and worse as the recipients got younger, so I'm delighted that doesn't hold for the little ones. 

 

Probably fewer side effects because of the much lower dosage. Maybe they will revise dosing for 12-24 year old males.  I could see 20 micrograms being the sweet spot.

[Not_a_Number]

46 minutes ago, Syllieann said:

Probably fewer side effects because of the much lower dosage. Maybe they will revise dosing for 12-24 year old males.  I could see 20 micrograms being the sweet spot.

Yes, this is where it's kind of nice not to be the guinea pig for a new vaccine, lol. I mean, I think the evidence is overwhelmingly in favor of getting the vaccine, don't get me wrong... but kinks do get ironed out in time. 

[SKL]

12 hours ago, BronzeTurtle said:

Wouldn't it have been weird though if the advisory committe advised against the eua, for example, and the executive branch (or whomever) authorized it for the general public anyway? 

There's also political pressure the other way, it seems to me, if the sentiment here is any indication. Their decision can't be entirely based on the WHO and anti-vaxxers can it? They did have to look at other stuff right?  We're saying 14 out of 16 people were somehow cowed by the WHO and a minority who don't/won't take the vaccine? I guess if that is true then the advisory committee is pretty useless. I wonder if approving the vaccine and before that the eua was also politically motivated. This is making me question a lot of assumptions I had about how vaccines are approved at all. I absolutely would not have taken the vaccine without the eua even if I could get one under the radar. I assumed, maybe wrongly, that they were taking all sorts of things into account like what a given does to us medically, what the risks and benefits are, etc. I assumed the same would be true for the 3rd dose. Now I don't know what to believe about the whole process if it's all just based on perception and international pressure.

Actually many people believe(d) there was political motivation behind holding off the mRNA EUA until shortly after the 2020 election.

There is zero question that there is tons of political pressure on the FDA to approve a booster.  I mean the prez is pushing for it, just for starters.

[Corraleno]

2 hours ago, BeachGal said:

 

@Corraleno My understanding is that there is some slight concern about myocarditis, that it’s occurring in 1 out of 1,000 (data gathered from an academic setting), which is higher than what VAERS showed. The myocarditis is manageable and clears up, though, and is far better than damage from a Covid infection. Have you read about this? Thoughts?

Btw, regarding mild to moderate infections, damage has been observed in brain tissue with no virus present in the tissue. So it appears Covid is capable of doing significant damage without actually entering the brain. This was a study done on brains of deceased individuals aged 5 to 70s.

I saw that study, it involved 32 cases in Canada, all of whom fully recovered within a few days with no complications. On the other hand, estimates of post-covid myocarditis range from 2% to 20%, depending on the severity of the illness.

The Big 10 conference requires that any varsity athlete who has had covid must undergo comprehensive cardiac testing before they can return to practice. Using the same diagnostic technique (CMR) that they used in the Canadian study, they found myocarditis in 2.3% of athletes who had covid. That's 1 in 43 —  in super fit young people — vs 1 in 1000 in the general population. And in Israel it was 1 in 18,000, and only 1 in 2.8 million for booster doses. There is no question that the risk of myocarditis is vastly higher in people who get covid vs people who get the vaccine.

Edited September 20, 2021 by Corraleno

[SKL]

12 hours ago, Not_a_Number said:

They are certainly taking all that into account. Except that there's really no safety concern at the moment at all, so that's not the issue, and no one has said that it's the issue. 

This is not factual.

[SKL]

11 hours ago, Not_a_Number said:

Who’s gonna enforce this??

Potentially the same people who currently think they are going to enforce "fully vaccinated" status.

[SKL]

2 hours ago, Not_a_Number said:

Right. Whereas the data suggests that they are effective and safe. 

DH said he read the meeting minutes and they basically discounted the Israeli data because it's not peer-reviewed yet 😕 . I don't see why they couldn't have done some kind of review process themselves... that seems so arrogant. 

That is definitely not how research works.  And I don't get calling them names.  I get the feeling you are not as fully informed on this topic as you claim to be.

[wathe]

12 minutes ago, Corraleno said:

I saw that study, it involved 32 cases in Canada, all of whom fully recovered within a few days with no complications. On the other hand, estimates of post-covid myocarditis range from 2% to 20%, depending on the severity of the illness.

The Big 10 conference requires that any varsity athlete who has had covid must undergo comprehensive cardiac testing before they can return to practice. Using the same diagnostic technique (CMR) that they used in the Canadian study, they found myocarditis in 2.3% of athletes who had covid. That's 1 in 43 —  in super fit young people — vs 1 in 1000 in the general population. And in Israel it was 1 in 18,000, and only 1 in 2.8 million for booster doses. There is no question that the risk of myocarditis is vastly higher in people who get covid vs people who get the vaccine.

Definitely true.

But the calculus here is risk of myocarditis from third dose vs risk of myocarditis from covid in a fully (double) vaccinated person combined with the risk of catching covid as a fully vaccinated person in the first place.  I don't know how those numbers work out.  It will depend on the local covid prevalence and what other public health measures are in place.

[wathe]

I know that here, and in a lot of other countries, third doses for the general population aren't being considered at this time.  Here, third doses here are for vulnerable elderly in high risk congregate living environments (AKA nursing homes) and the very  immune-compromised (very narrowly defined, includes active chemo for solid organ or heme malignancy and organ transplants).  That's it.

 I'm in a publicly funded health care system. We have decent public health precautions in place: mandatory masking in indoor public spaces, with vaccine passport/restricted access to certain non-essential businesses and services starts Wednesday.  We also have relatively good numbers.  TPTB have decided that, at this time,  the probable modest population benefit from a third dose doesn't justify the costs.

ETA: I'd totally take a third dose if I could get one.  I'd be first in line.  But I understand why they aren't being offered here.

Edited September 20, 2021 by wathe

[BronzeTurtle]

2 hours ago, Not_a_Number said:

Right. Whereas the data suggests that they are effective and safe. 

DH said he read the meeting minutes and they basically discounted the Israeli data because it's not peer-reviewed yet 😕 . I don't see why they couldn't have done some kind of review process themselves... that seems so arrogant. 

Wait, I somehow missed this. This explains so much to me. The stuff you're citing out of Israel hasn't been peer reviewed yet? Doesn't that make a huge difference? Why would it be arrogant to not use data that hasn't been fully vetted? It would seem more arrogant to me for them to assume that they could just do their own review process, peer review be damned. What is the reason we have peer review if not for exactly this type of thing? This clears up a lot of the confusion I had last night.

[Not_a_Number]

3 minutes ago, BronzeTurtle said:

Wait, I somehow missed this. This explains so much to me. The stuff you're citing out of Israel hasn't been peer reviewed yet? Doesn't that make a huge difference? Why would it be arrogant to not use data that hasn't been fully vetted? It would seem more arrogant to me for them to assume that they could just do their own review process, peer review be damned. What is the reason we have peer review if not for exactly this type of thing? This clears up a lot of the confusion I had last night.

You probably don't have a husband who spends a significant chunk of his life doing peer review/chasing down other people to do peer reviews, lol. Peer reviews are great. But it's not like people doing them are never sloppy or always take a lot of care or otherwise don't make mistakes. 

I'm not against peer review, obviously. I think it's a really, really, really valuable step. But is it sensible to wait on that during a pandemic in which many people may die?? Why wouldn't you examine the damn data yourself? What, are they not supposed to be "peers" in this case? Do they somehow not have the expertise that would have allowed them to review this?? 

Edited September 20, 2021 by Not_a_Number

[BronzeTurtle]

11 hours ago, Corraleno said:

The US has pledged to donate more than half a billion doses — more than the entire EU combined. And those are Pfizer doses, not crap like Sinovax or Sputnik. For the WHO to insist that the US should stop protecting their own citizens and donate an additional 200 million doses to COVAX, on top of what we've already pledged, is unreasonable IMO.

The main bottleneck with getting vaccines to poor countries is that most of the vaccine manufacturers that the WHO contracted with to supply vaccines for COVAX are in India, and India banned exports and decided to keep all the vaccines for themselves. And there have been many cases where tens of thousands of vaccines that were donated to poor countries ended up being wasted because they simply didn't have the infrastructure and staff necessary to carry out an intensive nationwide vaccine campaign. It's not the rich greedy US that's keeping the rest of the world from getting vaxxed.

You don't think so? The rich, greedy US keeps a lot of developing nations from getting ahead in various ways. I can't imagine vaccines would be an exception. Maybe principles of equity should apply here.

I still think if someone who had no doses was standing in front of me wanting one dose and I was offered a 3rd, I'd give mine to the person with 0. That's to answer your earlier hypothetical about giving away a medical procedure meant for myself. I actually thought about it as I was falling asleep last night. I would rather more people get at least one dose than me getting a 3rd, if that is the choice you were offering, especially since I'm likely to be spared severe disease, hospitalization, and death with my 2 doses even with waning of antibodies over time.