Covid-19 News/Discussion

[ramssuperbowl99]

1 minute ago, LETSGOBROWNIES said:

*reads post

”lemme go on ahead and like this so people think I understood what I just looked at.”

An analogy for IT inclined people would be a full validation of software versus a change-log.

[Forge]

30 minutes ago, BobbyPhil1781 said:

And the FDA approval might make a small dent in the unvaccinated but I wouldn't expect too much from it. I saw a response on Twitter or Reddit or something that was along the lines of "my baby daddy ODd on Fentanyl and that's FDA approved. I'm not taking ****" so don't get your hopes up too much. The excuses are already in flight. I know it's only one person but, call it a hunch, there's probably more people who don't care. Some will, sure, but I don't think that number is large. This goes back to what I've stated before that a lot of people are too stubborn to change their views. Admitting you're wrong is hard. Keeping you head in the sand and using the "block" button on social media is easy. Most people will choose "easy" instead of "hard".

I obviously hope I'm wrong but we'll see.........

I wish I could remember the account, but I swear on my twitter timeline I came across someone quoting another account that said that the person found it suspicious that the virus was being directed at and "targeting" the unvaccinated more so than the vaccinated to force people to take the vaccine. Hilarious. 

[LETSGOBROWNIES]

11 minutes ago, ramssuperbowl99 said:

An analogy for IT inclined people would be a full validation of software versus a change-log.

 

13 minutes ago, LETSGOBROWNIES said:

*reads post

”lemme go on ahead and like this so people think I understood what I just looked at.”

 

[Xenos]

5 minutes ago, Forge said:

I wish I could remember the account, but I swear on my twitter timeline I came across someone quoting another account that said that the person found it suspicious that the virus was being directed at and "targeting" the unvaccinated more so than the vaccinated to force people to take the vaccine. Hilarious. 

Targeting the unvaccinated?

[Turnobili]

if i was a virus, i'd target the unvaccinated too

[Xenos]

8 minutes ago, Turnobili said:

if i was a virus, i'd target the unvaccinated too

[BobbyPhil1781]

1 hour ago, ramssuperbowl99 said:

We are more cautious, that's why we waited until we had established safety data in adults before we started dosing.

We still have to demonstrate safety before we dose the first human of a specific population. Obviously, safety in other humans is a big data point in the plus column, but then we have to demonstrate why the differences between the two populations won't impact the safety, correct the dose level if body weight changes, etc.

This applies for every population, so what we do with pediatrics is we compare the physiology with how the drug interacts with the body, and adjust accordingly. So let's use Advil as an example. It's metabolized by specific liver enzymes that we call CYPs or Cytochrome P450's or P450's.

That's Advil's metabolism. See all the CYPs? Those are the important enzymes.

Then we find or collect data comparing the relative amounts of each type of enzyme in each child versus adult, and scale the dose not only based on body weight/body surface area, but also based on those enzymes. 

 

 

I'm not using the vaccine here because biologics are working with the immune system and I don't know as much about how the immune system changes with age. But the same general ideas apply.

I actually understand a little bit of this which I'm surprised about. Thanks for taking the time to explain.

Can you elaborate more on the timeline w/ children like this? We all experienced the length the Phase 1-3 trials went w/ us over the age of 18. Are there more phases for children this young? Do the phases typically last longer? I get that adults are guinea pigs (for lack of a better term) as far as safety goes but didn't know if the length of approval will be a little bit more, substantially more etc. I saw the timetables posted for the age groups to receive EUA so I'm lead to believe that there have been children in these trials for quite some time. 

W/ this variant hitting the younger generation far more than the previous variants, I just hope they can get the data they need to successfully start vaccinating that crowd. The amount of pushback we've seen from some adults leads me to believe we'll see even more when it comes to children, even from those that are pro-vaccine. I'm no parent but I've seen some overly cautious (putting it lightly) parents and I would expect a lot of "wait and see" approaches being taken. That's just a personal opinion though.

[BobbyPhil1781]

1 hour ago, Forge said:

I wish I could remember the account, but I swear on my twitter timeline I came across someone quoting another account that said that the person found it suspicious that the virus was being directed at and "targeting" the unvaccinated more so than the vaccinated to force people to take the vaccine. Hilarious. 

I don't post much on Twitter, I mainly just read. I find a lot of non-extreme people on both sides of the spectrum and read what they post to gain a lot of info. At times I read comments and usually feel the braincells leaving my body so I try not to do that often lol. There's a lot of people out there who confirm that sustaining life isn't very hard b/c if it were anything that was any sort of challenge, the amount of people on this planet would be much smaller lol. 

[mission27]

6 hours ago, vikesfan89 said:

Comparing people not getting vaccinated to lions eating a baby.  Nice

It’s the same thing tbh

Except we used to expect people to know better 

[Xenos]

5 hours ago, WizeGuy said:

I recommend everyone read this thread. It's full of great information, and gives more evidence that vaccinated folks are less likely to transmit the virus even if infected. Just note- this study compared fully vaxxed healthcare workers who a strong majority were infected with Delta to unvaxxed individuals who were infected with previous (less contagious) variants, so it only adds to the positivity of these results:

 

I’m sure his data is scientifically sound. I’m just not sure I can take a furry seriously 😂.

I kid btw.

Edited August 23, 2021 by Xenos

[DontTazeMeBro]

https://www.google.com/amp/s/www.cnbc.com/amp/2021/08/19/florida-and-texas-open-covid-antibody-treatment-centers-as-delta-surge-overwhelms-hospitals.html
 

Hadn’t heard about antibody treatment centers. That’s excellent news. Hopefully that takes some of the strain off the hospitals.

[ramssuperbowl99]

55 minutes ago, BobbyPhil1781 said:

I actually understand a little bit of this which I'm surprised about. Thanks for taking the time to explain.

Can you elaborate more on the timeline w/ children like this? We all experienced the length the Phase 1-3 trials went w/ us over the age of 18. Are there more phases for children this young? Do the phases typically last longer? I get that adults are guinea pigs (for lack of a better term) as far as safety goes but didn't know if the length of approval will be a little bit more, substantially more etc. I saw the timetables posted for the age groups to receive EUA so I'm lead to believe that there have been children in these trials for quite some time. 

W/ this variant hitting the younger generation far more than the previous variants, I just hope they can get the data they need to successfully start vaccinating that crowd. The amount of pushback we've seen from some adults leads me to believe we'll see even more when it comes to children, even from those that are pro-vaccine. I'm no parent but I've seen some overly cautious (putting it lightly) parents and I would expect a lot of "wait and see" approaches being taken. That's just a personal opinion though.

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.

Edited August 23, 2021 by ramssuperbowl99

[Deadpulse]

20 minutes ago, DontTazeMeBro said:

https://www.google.com/amp/s/www.cnbc.com/amp/2021/08/19/florida-and-texas-open-covid-antibody-treatment-centers-as-delta-surge-overwhelms-hospitals.html
 

Hadn’t heard about antibody treatment centers. That’s excellent news. Hopefully that takes some of the strain off the hospitals.

This assumes people actually go and attempt to be preventative. Given the state of both of those states, I would say that isnt something most people seem willing to do. 

[ramssuperbowl99]

1 minute ago, Deadpulse said:

22 minutes ago, DontTazeMeBro said:

https://www.google.com/amp/s/www.cnbc.com/amp/2021/08/19/florida-and-texas-open-covid-antibody-treatment-centers-as-delta-surge-overwhelms-hospitals.html
 

Hadn’t heard about antibody treatment centers. That’s excellent news. Hopefully that takes some of the strain off the hospitals.

This assumes people actually go and attempt to be preventative. Given the state of both of those states, I would say that isnt something most people seem willing to do. 

This is not good news. We're having to dole out massive amounts of drug earmarked for people who can't get the vaccine, because idiots won't get the vaccine. 

This is a waste of tens of millions of dollars or life-saving medication for the most vulnerable people of society, depending on whether we use the supply out or not. 

[AFlaccoSeagulls]

17 minutes ago, ramssuperbowl99 said:

This is not good news. We're having to dole out massive amounts of drug earmarked for people who can't get the vaccine, because idiots won't get the vaccine. 

This is a waste of tens of millions of dollars or life-saving medication for the most vulnerable people of society, depending on whether we use the supply out or not. 

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