Covid-19 News/Discussion

[ramssuperbowl99]

Just now, AFlaccoSeagulls said:

all while the people who peddle these drugs publicly (DeSantis) get kickbacks from these companies.

My understanding is that it's not a kickback, but that DeSantis and a hedge fund CEO invested in Regeneron and used DeSantis' platform to advocate for it. Regeneron is publicly traded, so I'm not sure what their responsibility would be in a case like that. But it certainly warrants investigation.

Not disagreeing with the intent of your post at all. Just trying to be super clear since we want to be giving their drug to as many immunosuppressed COVID-19 patients as possible. 

[DontTazeMeBro]

9 minutes ago, AFlaccoSeagulls said:

all while the people who peddle these drugs publicly (DeSantis) get kickbacks from these companies.

If you don’t have proof you’re peddling a conspiracy theory.

[AkronsWitness]

23 hours ago, vikesfan89 said:

Apparently Trump was booed for advocating for the vaccine at a rally 

Why is he still having rallies when he is no longer the president is my concern. Traveling around the country doing rallies when you are not a person in position of power and peddling your extreme beliefs seems...awfully...lot...like..a............cult.

Its a cult.

Edited August 23, 2021 by AkronsWitness

[BobbyPhil1781]

51 minutes ago, ramssuperbowl99 said:

Happy to do it!

Okay, so the short answer to all 3 of those questions are "it depends". 

1. Pharma does not have the option of not pursuing a treatment for children unless they can demonstrate a reason that it wouldn't make sense (e.g. fertility treatment). The FDA requires a Pediatric Study Plan within a few months after the end of their Phase 2 meeting. It could be earlier than that, but you're going to need both safety and efficacy in adults, which we usually call Phase 2 (though pharma is deviating from that more and more on a case by case basis - as we all saw with how Pfizer/Moderna vaccines which were basically Phase 1/2 combo studies). That Pediatric Study Plan is basically a road map for every study being run in children, and the endpoints that are going to be used to get a successful application. In general, the idea here is that you save the most vulnerable populations (children and pregnant women) for the end so there's the smallest window for surprises
   
   That said, you can get somewhat ahead of the game by knocking out some studies in younger animals, which Pfizer and Modern already did. That includes Juvenile toxicity studies where we dose young animals directly, but for biologics there is also a requirement to do a study on the impact of dosing a pregnant animal through gestation, then stop dosing at birth and monitor the health, behavior, and immune activity of the infant. That study takes a solid year just to get through the gestation+observation period, so delaying those could waste time if someone doesn't know what they're doing.
2. There aren't more phases, but you need to demonstrate every bit of the safety if anything changes. The dose route (IV, oral, etc.), new disease, new formulation of dosage (e.g. regular Advil versus an "extended release" version) etc.. So if Pfizer develops a new version of the vaccine that is more stable or something, they'll have to re-prove safety and efficacy not only in adults but in pediatrics too.
3. The phases don't tend to last a ton longer, but for example one common strategy we do is called dose escalation. If we're concerned about safety, we'll lower the dose by a little bit, wait, see how someone does, then step it up a little bit for the next patient. With kids and expecting mothers, we start lower and tend to ramp it up slower. So while the answer is that there aren't any special requirements that would force them longer, practically, yes they tend to take longer. 

The safety studies for this vaccine in general get to be super short because the vaccine is short acting. So they didn't start dosing kids until a few months ago, but are wrapping it up because the vaccine is a single dose that gets cleared fast, and then the immune system monitoring period is 90 days (or back to baseline, but that happens earlier). So it feels like this goes from zero to 60 really quickly, but really that's because we were so cautious before we dosed the first kid.

 

To your last point, I agree. I think a lot of vaccine hesitant parents (not anti-vaxx, the sincerely curious people) could feel pressured into taking a "middle ground" approach where they get it themselves, but won't risk their kid. Part of this is going to be making sure people understand the risk in the risk-reward assessment of whether it's worth getting the child a vaccine. The challenge will be how to do that without sounding like its more delta variant fearmongering.

A lot of good info here, thanks.

So did the companies start doing their PSP prior to conducting phase 3 of the traditional approval process? I'm assuming that the tests they did were in juvenile rhesus macaques? I remember way back when that when the initial tests that came out against these primates, everyone was fairly happy to read the results. That is why I'm guessing that would be the case. If this is the case, we can assume that they have already conducted some form of testing on infants then, correct? This leads to another question: will they even use this vaccine on infants if they're not contracting the virus? In jump ahead in your post, we agreed that there will be hesitation w/ younger children and if you put infants in the picture, I would expect that hesitancy to skyrocket TBH. At least initially. 

To you third point, that is what I assumed would be happening. Taking some sort of ratio on what they determined was the best dosage amount for adults and using math to determine what would be the best for children and I'm guessing that could be based on weight and age. I would be lead to believe that since young kids are still developing and growing that this might differ based on a 5 year old to a 12 year old but I don't know any better. Like I said, it's a guess.

That's good that things can move "fast" now but it makes sense why people might think it's a fast overall process. I think conveying that to adults might be a big challenge as well, adding to the challenges that will already exist.

Thanks again for this info.

[BobbyPhil1781]

15 minutes ago, AkronsWitness said:

Why is he still having rallies when he is no longer the president is my concern. Traveling around the country doing rallies when you are not a person in position of power and peddling your extreme beliefs seems...awfully...lot...like..a............cult.

Its a cult.

No, it's toxic tribalism and both sides have it. So if that's a cult, the people I know w/ life-sized cutouts, "action" figures, etc of the current administration, are also a cult.

I would provide my personal opinion to why he's doing it but we're toeing the line again so I will refrain.

EDIT: Regardless, this mindset is what's wrong w/ people these days. You should be praising the fact that he's going around and trying to get his base, a lot of which are against the vaccine, to get vaccinated. Instead, you used this opportunity to insult the group. That's corny.

Edited August 23, 2021 by BobbyPhil1781

[ramssuperbowl99]

29 minutes ago, BobbyPhil1781 said:

A lot of good info here, thanks.

So did the companies start doing their PSP prior to conducting phase 3 of the traditional approval process? I'm assuming that the tests they did were in juvenile rhesus macaques? I remember way back when that when the initial tests that came out against these primates, everyone was fairly happy to read the results. That is why I'm guessing that would be the case. If this is the case, we can assume that they have already conducted some form of testing on infants then, correct? This leads to another question: will they even use this vaccine on infants if they're not contracting the virus? In jump ahead in your post, we agreed that there will be hesitation w/ younger children and if you put infants in the picture, I would expect that hesitancy to skyrocket TBH. At least initially. 

No problem. 

Yes, companies start it earlier, how early depends on how important pediatric treatment is. If the drug is specifically made for kids and not for adults, they still have to dose in healthy adult volunteers first, but in that case the company would run all of the pediatric-related studies as early as possible to have the best idea whether it will work or not as early as they can to minimize risk.

Juvenile studies are not done in rhesus monkeys (or macques, they look like Rafiki and weigh 10 to 20 pounds), because they age too slowly. The studies would take years, so we have to use rats and mice, which become fully grown adults in ~90 days. Same reason we have to use rats and mice in studies to figure out if a drug causes cancer, dosing the whole lifespan of a monkey would outlast the patent protection.

And yes, when the primate data came out it was a big deal. The Phase 1 data was the slam dunk put the rent on it day, but primate data is usually more valuable than any other species except human since it's the species closest to us by a country mile. No substitute for human data though.

And yes, it sounds like they've gotten approval to dose down to 6 months. I would hope this is a very small group of infants, and that most of them are getting antibodies from mom's double jab. That's part of why I group gestational studies and juvenile studies together mentally; two different approaches to get immunity in infants.

29 minutes ago, BobbyPhil1781 said:

To you third point, that is what I assumed would be happening. Taking some sort of ratio on what they determined was the best dosage amount for adults and using math to determine what would be the best for children and I'm guessing that could be based on weight and age. I would be lead to believe that since young kids are still developing and growing that this might differ based on a 5 year old to a 12 year old but I don't know any better. Like I said, it's a guess.

That's good that things can move "fast" now but it makes sense why people might think it's a fast overall process. I think conveying that to adults might be a big challenge as well, adding to the challenges that will already exist.

Thanks again for this info.

100% correct, and a critically important point. The slogan we use to illustrate this is "children are not small adults"; it's at the top of the first slide of every Powerpoint presentation ever about pediatric drug development. And yes, we have physiological data for every single year so we can treat them all separately, all the way down to 0 week newborn, 1 month infant, etc. There are people who advertise being able to do stuff with -4 week old babies (mom is 8 months pregnant), but I think it's a reach.

Edited August 23, 2021 by ramssuperbowl99

[Blackstar12]

So if things are this bad during summer it's going to be a **** show during the fall/winter isn't it? 

[Deadpulse]

27 minutes ago, Blackstar12 said:

So if things are this bad during summer it's going to be a **** show during the fall/winter isn't it? 

hopefully people do less stuff

[Xenos]

24 minutes ago, Blackstar12 said:

So if things are this bad during summer it's going to be a **** show during the fall/winter isn't it? 

The hope is that there will be more vaccinations before the worse happens. Some reasons to be optimistic are more mandates, companies making it more difficult for people to go unvaccinated because insurance is so expensive, and stupid people realizing that they should get vaccinated after seeing their loved ones die from Covid. Additionally, there may be some natural immunity from all the Delta infections.

[LETSGOBROWNIES]

1 hour ago, BobbyPhil1781 said:

No, it's toxic tribalism and both sides have it. So if that's a cult, the people I know w/ life-sized cutouts, "action" figures, etc of the current administration, are also a cult.

I would provide my personal opinion to why he's doing it but we're toeing the line again so I will refrain.

Trying to toe the same line, but if you think the tribalism is a 1:1 you’re delusional.  Most of the current dude’s supporters don’t even like him.  He’s there because he’s not the other guy.

1 hour ago, BobbyPhil1781 said:

EDIT: Regardless, this mindset is what's wrong w/ people these days. You should be praising the fact that he's going around and trying to get his base, a lot of which are against the vaccine, to get vaccinated. Instead, you used this opportunity to insult the group. That's corny.

Why should I be praising someone for taking 30 seconds to clean up the mess they spent a year making?
 

He’s trying to put the toothpaste back in the tube at this point, and even then, one comment is hardly a committed effort.

This is comparable to someone lighting your home on fire and then grabbing a fire extinguisher after the blaze has been raging for an hour.  
 

Thanks man, incredible work.

[AFlaccoSeagulls]

3 hours ago, ramssuperbowl99 said:

My understanding is that it's not a kickback, but that DeSantis and a hedge fund CEO invested in Regeneron and used DeSantis' platform to advocate for it. Regeneron is publicly traded, so I'm not sure what their responsibility would be in a case like that. But it certainly warrants investigation.

Not disagreeing with the intent of your post at all. Just trying to be super clear since we want to be giving their drug to as many immunosuppressed COVID-19 patients as possible. 

Sorry yes, my bad. He makes more money the more treatments they give, and since Florida is staunchly anti-mask and anti-vaccine and those treatments are being touted by Desantis and being widely distributed in Florida, he's jut going to make bank on it.

[DontTazeMeBro]

Florida is pretty close to California and ahead of Illinois in vaccination rates. This Florida anti-vax stuff is a hoax. 
 

Just for ****s and giggles I’m looking at vaccination rates because half this country fawns over the rest of the world and thinks this is exclusively happening to us.

Finland, Norway, and Sweden are all behind us. France is just a little bit ahead at 55%. 
Saudi Arabia way behind at 37%.

Japan 41%
South Korea 22%
 

and these two are my favorites 

Australia 24%
New Zealand 19%

 

Edited August 24, 2021 by DontTazeMeBro

[Kiwibrown]

Just now, DontTazeMeBro said:

 

and these two are my favorites 

Australia 24%
New Zealand 19%

 

We took a different approach though, We have had less than 5k total cases IIRC. 
Also we vaccinated 1% of our population in a day. Yesterday. 

[kingseanjohn]

4 minutes ago, DontTazeMeBro said:

This Florida anti-vax stuff is a hoax. 

My works travels to the Keys, Tampa, and PCB say different. I saw many handmade signs on the doors of restaurants and businesses saying things like "Enter for 'FREEDOM'", "No Mask Required, this is AMERICA", among other things. I'd ask the Uber drivers about it and they all said that masks weren't really worn and vaccination rates were low. I distinctly remember getting to the door of one chain restaurant that had a sign saying masks were required and then stepping inside only to be heckled for wearing one. It was a little surreal.

[LETSGOBROWNIES]

9 minutes ago, Kiwibrown said:

We took a different approach though, We have had less than 5k total cases IIRC. 
Also we vaccinated 1% of our population in a day. Yesterday. 

I mean, I’m no expert, but I do know a couple RN’s in NZ, both kiwi and a lady I used to work with at UC.

Lets just say comparing us to NZ is laughable.