Coronavirus and Walt Disney World general discussion

[Heppenheimer]

The vote is in for the pediatric vaccination... 17 votes in favor of EAU and one abstention.

The FDA committee notes, however, that they expect that the proposed dosing schedule will likely change with more experience with the vaccine.

The committee also stated that although the overall benefit greatly outweighs the risk, we will need to monitor the incidence of myocarditis very closely, since the trial wasn't sufficiently powered to detect this possible complication.

 

[Tom P.]

The committee also stated that although the overall benefit greatly outweighs the risk, we will need to monitor the incidence of myocarditis very closely, since the trial wasn't sufficiently powered to detect this possible complication.

That's an interesting approach. "The trial wasn't sufficient to measure this particular serious complication, but we assume it's safe anyway." Okey-doke.

 

[JoeCamel]

That's an interesting approach. "The trial wasn't sufficient to measure this particular serious complication, but we assume it's safe anyway." Okey-doke.

No, they decided that the benefits outweigh the risks of vaccinating the children
Myocarditis is a very small risk, many times mild and less fatal than Covid

 

[Tom P.]

No, they decided that the benefits outweigh the risks of vaccinating the children

How do they know that the benefits outweigh the risks when they know that there is a potential risk that the trial was not able to effectively monitor?

 

[correcaminos]

How do they know that the benefits outweigh the risks when they know that there is a potential risk that the trial was not able to effectively monitor?

No.... it's about numbers. The numbers may not be enough to see since it is uber rare. Like the adult trials were huge but missed it.

 

[JoeCamel]

How do they know that the benefits outweigh the risks when they know that there is a potential risk that the trial was not able to effectively monitor?

Why do you push this?

 

[Andrew C]

That's an interesting approach. "The trial wasn't sufficient to measure this particular serious complication, but we assume it's safe anyway." Okey-doke.

Ehh. It’s not even that serious.

 

[lazyboy97o]

How do they know that the benefits outweigh the risks when they know that there is a potential risk that the trial was not able to effectively monitor?

Because it is known how often it is caused by COVID-19.

 

[MisterPenguin]

How do they know that the benefits outweigh the risks when they know that there is a potential risk that the trial was not able to effectively monitor?

Because COVID causes the same symptom, but at a much higher rate.

Also, COVID can cause long term tissue and organ damage and hospitalize you or kill you.

Things which the vaccine doesn't except for these few cases that are easily treatable.

The vaccine can inflame some tissue.

COVID can enflame some tissue.

It's more dangerous to not get vaccinated and thus, catch COVID, than to be vaccinated and get a few mild and treatable symptoms.

This is exactly the same discussion we all had with vaccinating adults.

 

[JoeCamel]

This is exactly the same discussion we all had with vaccinating adults.

At least eight times

 

[Tom P.]

Why do you push this?

The FDA themselves today said that this was a concern that the trial was not able to effectively address due to its small sample size. They said it is a concern that warrants further monitoring. These are their caveats to the emergency use authorization, not mine.

I am not saying that the vaccine is unsafe. I personally have had two doses of Moderna myself and I believe in it. However, I have concerns specifically around the clinical trial for this age group, how relatively small it was, and how even the FDA is saying there still needs to be more monitoring and more data collected. I don't think that is unreasonable, nor is it fringe anti-vax propaganda, given what the FDA itself has said. I think the trial should have been conducted with a larger group of children.

 

[correcaminos]

The FDA themselves today said that this was a concern that the trial was not able to effectively address due to its small sample size. They said it is a concern that warrants further monitoring. These are their caveats to the emergency use authorization, not mine.

I am not saying that the vaccine is unsafe. I personally have had two doses of Moderna myself and I believe in it. However, I have concerns specifically around the clinical trial for this age group, how relatively small it was, and how even the FDA is saying there still needs to be more monitoring and more data collected. I don't think that is unreasonable, nor is it fringe anti-vax propaganda, given what the FDA itself has said. I think the trial should have been conducted with a larger group of children.

The concerns are NOT just for this age. That's what you are missing. When I was called to be unblinded for the Pfizer-BioNTech 3rd dose they brought it up. In short they cannot tell if it will be like older people or not so they will monitor. Perspective matters. If my kid were under 11 I still would be first in line to get it.

They actually added more kids to the trials too. If 45k wasn't enough for the adults, how many kids would you need?

 

[Heppenheimer]

How do they know that the benefits outweigh the risks when they know that there is a potential risk that the trial was not able to effectively monitor?

Because the side effect is rare enough in other age groups that it didn't show up in this trial. That's actually rather encouraging.

Myocarditis isn't something anyone should want, but it is a very treatable condition from which almost every child will completely recover. Its the worst potential complication of hand, foot and mouth disease (caused by coxsackie virus), an illness that nearly every child will catch, but the long-term morbidity is so low that it hasn't been worth the effort to develop a vaccine for it, for example.

 

[BrianLo]

How do they know that the benefits outweigh the risks when they know that there is a potential risk that the trial was not able to effectively monitor?

Children get Myocarditis from COVID as well. At a rate more frequent than the total number of kids enrolled in the trial.

So they already know it's rarer and for all we know may not actually occur in this age group at all.

 

[DisneyCane]

Myocarditis isn't something anyone should want, but it is a very treatable condition from which almost every child will completely recover.

Can't you kind of make the same statement about children 5-11 by substituting "COVID-19" for "Myocarditis" in that sentence?

I get that they are trying to cut off spread vectors by vaccinating this age group but it seems a little odd to me for the FDA to rush an EUA when they, themselves, say that the trial wasn't big enough to find the incidence of a particular side effect.

I've been told that IV Tylenol isn't approved yet for children because it normally takes so long for the FDA to approve things for that age group to err on the side of caution. If I was a parent of a child in that age range, I definitely wouldn't be rushing to get them the shot after the FDA makes a statement like that.

 

[MaryJaneP]

It would seem to be very unfortunate if there was a myocarditis vaccine that sometimes also caused a child to be infected with COVID-19 as a rare, unexpected side effect. Especially if there was a deadly worldwide pandemic outbreak of airborne-transmissible myocarditis that prompted the rapid development of a myocarditis vaccine, deluged ICUs, put ventilators on short supply, killed over 700,000 people in this country alone, etc.

 

[DisneyFan32]

What we know so far about the delta sub-variant AY.4.2

 

[DisneyCane]

It would seem to be very unfortunate if there was a myocarditis vaccine that sometimes also caused a child to be infected with COVID-19 as a rare, unexpected side effect. Especially if there was a deadly worldwide pandemic outbreak of airborne-transmissible myocarditis that prompted the rapid development of a myocarditis vaccine, deluged ICUs, put ventilators on short supply, killed over 700,000 people in this country alone, etc.

Very clever except you left out the stats for children 5-11. Children in that age range are at a miniscule risk from COVID. The only reason to vaccinate them at all is to to reduce the number of potential spreaders. Given the facts, the bar should be extremely high with respect to side effects of the vaccine for children under 12.

 

[Heppenheimer]

Can't you kind of make the same statement about children 5-11 by substituting "COVID-19" for "Myocarditis" in that sentence?

I get that they are trying to cut off spread vectors by vaccinating this age group but it seems a little odd to me for the FDA to rush an EUA when they, themselves, say that the trial wasn't big enough to find the incidence of a particular side effect.

I've been told that IV Tylenol isn't approved yet for children because it normally takes so long for the FDA to approve things for that age group to err on the side of caution. If I was a parent of a child in that age range, I definitely wouldn't be rushing to get them the shot after the FDA makes a statement like that.

No, you can't make that statement, because myocarditis almost never kills kids or even requires hospitalization. Both outcomes are also uncommon in COVID, but about 3 orders of magnitude more rare in myocarditis. And a kid with myocarditis can't spread it to someone else. You're also forgetting or deliberately omitting MIS-C.

I watched some of the meeting, and the committee members were very clear that the morbidity from pediatric COVID cases is significant enough to far outweigh a potential myocarditis risk.

A lot of people seem to be suddenly very concerned about a condition they likely never heard of before. If myocarditis really scares you, then you'd better lock your kids up forever, because hand, foot and mouth disease is the most common cause by far in kids and there's no vaccine against it.

 

[correcaminos]

Very clever except you left out the stats for children 5-11. Children in that age range are at a miniscule risk from COVID. The only reason to vaccinate them at all is to to reduce the number of potential spreaders. Given the facts, the bar should be extremely high with respect to side effects of the vaccine for children under 12.

Or we will listen to medical people who know more than most of us here who suggested we give it to the kids. Kids are not at zero risk from covid at all. But go ahead and keep trying to diminish the vaccine. Why you do baffles me still.