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(PennLive)   Full FDA approval of COVID-19 vaccines might lead more people to get them. What's holding things up?   (pennlive.com) divider line
    More: Interesting, Vaccine, Vaccination, Moderna COVID-19 vaccines, full approval, Drug Administration, FDA's career, U.S. Food, coming months  
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423 clicks; posted to Discussion » on 28 Jul 2021 at 6:18 AM (8 weeks ago)   |   Favorite    |   share:  Share on Twitter share via Email Share on Facebook



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2021-07-28 4:09:09 AM  
Science?
 
2021-07-28 5:02:03 AM  
Yeah, we should treat this like a new flavor of fruit by the foot. Just slap FULLY APPROVED ABD AWESOME on it and let the kids go nuts.

Jesus f*cking Christ.
 
2021-07-28 6:23:44 AM  

foo monkey: Science?


More likely the legal department.
 
2021-07-28 6:33:23 AM  
If the standard is something like "we need to see if it has any long-term issues with (organ) after five years" then just start planning for the inevitable "So, it turns out the Sigma Variant eludes all the existing vaccines"
 
2021-07-28 7:07:04 AM  

NewportBarGuy: Yeah, we should treat this like a new flavor of fruit by the foot. Just slap FULLY APPROVED ABD AWESOME on it and let the kids go nuts.

Jesus f*cking Christ.


Yeah, what if 2 billion people got vaccinated? What would happen? It's impossible to know.
 
2021-07-28 7:10:08 AM  
NewportBarGuy: Jesus f*cking Christ.

he's not helping. not after the side effects of those palm jabs.
 
2021-07-28 7:15:38 AM  
I guess in terms of pure existential nightmare risks would be to wait for mothers who had the shot to conceive and give birth and see if you end up with thalidomide babies before FDA gives it approval. That's something they look at it for sure. Teratogens.

But we're probably coming up on what would be the first possibly viable premature births from women who conceived after taking the vaccine in a month or so. Statistically. So.

IDK just take the damn vaccine.
 
2021-07-28 7:25:38 AM  
I'd say that they should consider renaming these categories, so as not to alarm the pearl-clutchers.

There's a big difference between the quick-turnaround compassionate use one-off 'experimental' authorization and these vaccines.

But you know the die-hard anti-vax people would just switch their justifications to match the new nomenclature anyway.  So it might only work on the 'hesitant' portion of the population.
 
2021-07-28 7:27:41 AM  
When you have idiots like Walensky in charge, it won't matter anyways.
 
2021-07-28 7:28:20 AM  
If the FDA approved a vaccine today, by tomorrow the anti-vaxxers would be saying "I still don't trust the scientists."

You can't fix stupid.
 
2021-07-28 7:31:47 AM  
Much like we knew the vaccines would get emergency authorization, we know they will get full approval, there is just a long process that they have to take.

It will likely be that at least one will be given full approval by the end of the year. The FDA may actually be waiting until the last major candidate goes through all the hurdles before approving all of them at once just to avoid a "competitive advantage" for one of the companies. It shouldn't work like that, but it is theoretically possible.
 
2021-07-28 7:34:13 AM  
I don't know enough to be able to formulate a scientific reason why it was so easy to know that the vaccine was safe and effective for diabetic grandma with the heart condition, but so hard to know if the vaccine is safe and effective for healthy children.

It makes even less sense to me when I've been hearing "kids can just tank this crap no problem" for the last 18 months.

Somebody make this make sense please.
 
2021-07-28 7:39:44 AM  

BeesNuts: I don't know enough to be able to formulate a scientific reason why it was so easy to know that the vaccine was safe and effective for diabetic grandma with the heart condition, but so hard to know if the vaccine is safe and effective for healthy children.

It makes even less sense to me when I've been hearing "kids can just tank this crap no problem" for the last 18 months.

Somebody make this make sense please.


Because they didn't start clinical trials with kids until well after they'd done clinical trials on adults.  FDA approvals are about mountains of evidence; there is very little room for chains of logic based on 'should'.
 
2021-07-28 7:43:02 AM  

jasonvatch: If the FDA approved a vaccine today, by tomorrow the anti-vaxxers would be saying "I still don't trust the scientists."

You can't fix stupid.


The FDA only approved it because Biden made them,
 
2021-07-28 7:44:49 AM  

BizarreMan: jasonvatch: If the FDA approved a vaccine today, by tomorrow the anti-vaxxers would be saying "I still don't trust the scientists."

You can't fix stupid.

The FDA only approved it because Biden made them,


Yes, this makes total sense. Lol
 
2021-07-28 7:46:55 AM  

FrancoFile: BeesNuts: I don't know enough to be able to formulate a scientific reason why it was so easy to know that the vaccine was safe and effective for diabetic grandma with the heart condition, but so hard to know if the vaccine is safe and effective for healthy children.

It makes even less sense to me when I've been hearing "kids can just tank this crap no problem" for the last 18 months.

Somebody make this make sense please.

Because they didn't start clinical trials with kids until well after they'd done clinical trials on adults.  FDA approvals are about mountains of evidence; there is very little room for chains of logic based on 'should'.


I mean ... aren't chains of logic based on *should* basically how we have been handling this entire pandemic at the highest levels, including the FDA?  I just find it strange that "and then we completely take our foot off the gas for a few months while we figure out what to do with Elementary School kids." was part of the plan.
 
2021-07-28 7:49:45 AM  
yohohogreengiant:

The missus is 7 months pregnant. She got the vaccine shortly after we found out we were pregnant. So far both are totally fine. Maybe this one will have superpowers, who knows.
 
2021-07-28 7:51:10 AM  

jasonvatch: If the FDA approved a vaccine today, by tomorrow the anti-vaxxers would be saying "I still don't trust the scientists."

You can't fix stupid.


If they don't trust science, we should take away all their belongs. Being most of them where created with science of some discipline.
 
2021-07-28 7:54:36 AM  
No, FDA approval will NOT lead to any more people getting the vaccine. In fact, I think that's the most naïve statement I have heard yet. The unvaccinated are not highly selective health-minded individuals carefully monitoring the situation and awaiting for long-term studies and data. They're morons-- we all know this. "Last Week Tonight" showed an interview some news program did with a recovering covid patient. He had been hospitalized and ventilated but was recovering and about to be released from the hospital. They asked what his thoughts were on vaccination and he proudly proclaimed he would NOT get one. It went something like:

"Why is that?"
"Because I won't bow to their agenda!"
"Who's agenda?"
"Federal, state, and local government. This is just part of their agenda."
"What's their agenda?"
"To ram this thing down our throats!"

Those are the people who aren't getting vaccinated. They're terrible, terrible people. I will stop just short of saying the quicker these people die the better.
 
2021-07-28 7:55:55 AM  

foo monkey: Science?


Thread's done in one. Anyone got an idea when the XBox Series X is gonna restock?
 
2021-07-28 7:57:20 AM  

hubiestubert: foo monkey: Science?

Thread's done in one. Anyone got an idea when the XBox Series X is gonna restock?


Just find one of the unvaccinated that owns one and camp outside their house.
 
2021-07-28 8:01:36 AM  

BeesNuts: FrancoFile: BeesNuts: I don't know enough to be able to formulate a scientific reason why it was so easy to know that the vaccine was safe and effective for diabetic grandma with the heart condition, but so hard to know if the vaccine is safe and effective for healthy children.

It makes even less sense to me when I've been hearing "kids can just tank this crap no problem" for the last 18 months.

Somebody make this make sense please.

Because they didn't start clinical trials with kids until well after they'd done clinical trials on adults.  FDA approvals are about mountains of evidence; there is very little room for chains of logic based on 'should'.

I mean ... aren't chains of logic based on *should* basically how we have been handling this entire pandemic at the highest levels, including the FDA?  I just find it strange that "and then we completely take our foot off the gas for a few months while we figure out what to do with Elementary School kids." was part of the plan.


They didn't take their foot off the pedal.  Instead of a pure waterfall approach (full approval for adults before even beginning trials for children), they did a staggered start.  Hence why vaccines were provisionally approved for the 12-17 cohort a few months ago.  And trials for 6 months to 12 years have been underway for some time.

It took ~6 months to go from approval for adults to approval for teens.  I expect approval for 5-11 before the end of the year, and possibly as early as September, and for <5 another 6 months after that.
 
2021-07-28 8:03:00 AM  
Full FDA approval of COVID-19 vaccines might lead more people to get them.

Fark user imageView Full Size
 
2021-07-28 8:08:05 AM  

kozlo: yohohogreengiant:

The missus is 7 months pregnant. She got the vaccine shortly after we found out we were pregnant. So far both are totally fine. Maybe this one will have superpowers, who knows.


Congratulations. And good luck.
 
2021-07-28 8:09:38 AM  

yohohogreengiant: kozlo: yohohogreengiant:

The missus is 7 months pregnant. She got the vaccine shortly after we found out we were pregnant. So far both are totally fine. Maybe this one will have superpowers, who knows.

Congratulations. And good luck.


Yea, hopefully it's a cool mutation like speed or flying, and not something lame like being an empath.
 
2021-07-28 8:11:22 AM  

NewportBarGuy: hubiestubert: foo monkey: Science?

Thread's done in one. Anyone got an idea when the XBox Series X is gonna restock?

Just find one of the unvaccinated that owns one and camp outside their house.


But I've already got a prepper under surveillance to take HIS stuff if we go all Apocalypso. How many idjits I gotta keep watch over? I don't want to get a shelter TOO early, you know just in case someone will case my new joint to take ME out early, but the Series X does look sweet.

You think I could just rob a prepper of their video game equipment and THEN come back for the five years of freeze dried rigatoni?
 
2021-07-28 8:11:38 AM  
No it won't.  This is just a sciency way to show allegiance to Donald Trump while at the same time trying to be innocent about it.  Nobody waiting for full approval is up late at night researching vaccine trial data.
 
2021-07-28 8:13:18 AM  
Not that this is any sort of defense for the anti-vaxxer, but it seems that the biggest excuse most people use is that "it's not FDA approved."

That is a weak excuse by any measure.  The FDA approval at this point is a technicality.  But that is their excuse and they are sticking to it.

Having said that, since we KNOW that that is one of the biggest excuses being used, what the hell is the hold-up?  Is there not enough data to show that it's safe and effective?  Does bureaucracy just move that slowly?
 
2021-07-28 8:15:48 AM  

hubiestubert: NewportBarGuy: hubiestubert: foo monkey: Science?

Thread's done in one. Anyone got an idea when the XBox Series X is gonna restock?

Just find one of the unvaccinated that owns one and camp outside their house.

But I've already got a prepper under surveillance to take HIS stuff if we go all Apocalypso. How many idjits I gotta keep watch over? I don't want to get a shelter TOO early, you know just in case someone will case my new joint to take ME out early, but the Series X does look sweet.

You think I could just rob a prepper of their video game equipment and THEN come back for the five years of freeze dried rigatoni?


Wait

Why would you freeze dry rigatoni? The macaroni keeps great in a dry container provided it isn't infested with weevils.

I understood everything else.

Deja Vu. Didn't we have this conversation about noodles before?
 
2021-07-28 8:19:14 AM  

Leader O'Cola: When you have idiots like Walensky in charge, it won't matter anyways.


media.tenor.comView Full Size
 
2021-07-28 8:21:40 AM  

hubiestubert: foo monkey: Science?

Thread's done in one. Anyone got an idea when the XBox Series X is gonna restock?


Keep an eye on the GameStop twitter. Back in June they did one big day where every store got inventory, just had to be early in the line. It's how I got mine.

/Flight Simulator just came out yesterday
 
2021-07-28 8:23:32 AM  

BizarreMan: yohohogreengiant: kozlo: yohohogreengiant:

The missus is 7 months pregnant. She got the vaccine shortly after we found out we were pregnant. So far both are totally fine. Maybe this one will have superpowers, who knows.

Congratulations. And good luck.

Yea, hopefully it's a cool mutation like speed or flying, and not something lame like being an empath.


"I heard a rumour you took all your recommended vaccines."

Fark user imageView Full Size
 
2021-07-28 8:27:22 AM  

yohohogreengiant: hubiestubert: NewportBarGuy: hubiestubert: foo monkey: Science?

Thread's done in one. Anyone got an idea when the XBox Series X is gonna restock?

Just find one of the unvaccinated that owns one and camp outside their house.

But I've already got a prepper under surveillance to take HIS stuff if we go all Apocalypso. How many idjits I gotta keep watch over? I don't want to get a shelter TOO early, you know just in case someone will case my new joint to take ME out early, but the Series X does look sweet.

You think I could just rob a prepper of their video game equipment and THEN come back for the five years of freeze dried rigatoni?

Wait

Why would you freeze dry rigatoni? The macaroni keeps great in a dry container provided it isn't infested with weevils.

I understood everything else.

Deja Vu. Didn't we have this conversation about noodles before?


Hey, I don't make these MREs, I am just watching a neighbor stockpile ammunition and gasoline that is going to go either get siphoned for his truck in a month or so, or go bad in the tank.
 
2021-07-28 8:29:11 AM  

durbnpoisn: Having said that, since we KNOW that that is one of the biggest excuses being used, what the hell is the hold-up?  Is there not enough data to show that it's safe and effective?  Does bureaucracy just move that slowly?


"Move fast, break things" is the motto of Facebook.  Fortunately, it is not the motto of the FDA.
 
2021-07-28 8:29:44 AM  

durbnpoisn: Not that this is any sort of defense for the anti-vaxxer, but it seems that the biggest excuse most people use is that "it's not FDA approved."

That is a weak excuse by any measure.  The FDA approval at this point is a technicality.  But that is their excuse and they are sticking to it.

Having said that, since we KNOW that that is one of the biggest excuses being used, what the hell is the hold-up?  Is there not enough data to show that it's safe and effective?  Does bureaucracy just move that slowly?


Too bad there isn't an article linked to this thread with an explanation.
 
2021-07-28 8:31:05 AM  

hubiestubert: yohohogreengiant: hubiestubert: NewportBarGuy: hubiestubert: foo monkey: Science?

Thread's done in one. Anyone got an idea when the XBox Series X is gonna restock?

Just find one of the unvaccinated that owns one and camp outside their house.

But I've already got a prepper under surveillance to take HIS stuff if we go all Apocalypso. How many idjits I gotta keep watch over? I don't want to get a shelter TOO early, you know just in case someone will case my new joint to take ME out early, but the Series X does look sweet.

You think I could just rob a prepper of their video game equipment and THEN come back for the five years of freeze dried rigatoni?

Wait

Why would you freeze dry rigatoni? The macaroni keeps great in a dry container provided it isn't infested with weevils.

I understood everything else.

Deja Vu. Didn't we have this conversation about noodles before?

Hey, I don't make these MREs, I am just watching a neighbor stockpile ammunition and gasoline that is going to go either get siphoned for his truck in a month or so, or go bad in the tank.


Ok. Now I understand.

I still have a half a case of veggie MRE (they exist!) left over from Maria relief.

They're expired by date now, I was about to throw them out and figured, nah, wait until hurricane season is over.

But seriously, by some noodles, store them somewhere dry with desiccant of necessary. Future you will thank you.
 
2021-07-28 8:45:57 AM  

FrancoFile: BeesNuts: FrancoFile: BeesNuts: I don't know enough to be able to formulate a scientific reason why it was so easy to know that the vaccine was safe and effective for diabetic grandma with the heart condition, but so hard to know if the vaccine is safe and effective for healthy children.

It makes even less sense to me when I've been hearing "kids can just tank this crap no problem" for the last 18 months.

Somebody make this make sense please.

Because they didn't start clinical trials with kids until well after they'd done clinical trials on adults.  FDA approvals are about mountains of evidence; there is very little room for chains of logic based on 'should'.

I mean ... aren't chains of logic based on *should* basically how we have been handling this entire pandemic at the highest levels, including the FDA?  I just find it strange that "and then we completely take our foot off the gas for a few months while we figure out what to do with Elementary School kids." was part of the plan.

They didn't take their foot off the pedal.  Instead of a pure waterfall approach (full approval for adults before even beginning trials for children), they did a staggered start.  Hence why vaccines were provisionally approved for the 12-17 cohort a few months ago.  And trials for 6 months to 12 years have been underway for some time.

It took ~6 months to go from approval for adults to approval for teens.  I expect approval for 5-11 before the end of the year, and possibly as early as September, and for <5 another 6 months after that.


I can buy that.  Thanks.  Maybe I'm just feeling the late-race impatience.
 
2021-07-28 8:53:09 AM  
Full FDA approval isn't going to change too many minds. The military will require it, and some with "hesitancy" will get it, but the people who have turned the pandemic and vaccine into a political grudge match won't change their minds. The Qnuts will remain Qnuts.
 
2021-07-28 8:53:16 AM  

BizarreMan: yohohogreengiant: kozlo: yohohogreengiant:

The missus is 7 months pregnant. She got the vaccine shortly after we found out we were pregnant. So far both are totally fine. Maybe this one will have superpowers, who knows.

Congratulations. And good luck.

Yea, hopefully it's a cool mutation like speed or flying, and not something lame like being an empath.


Or...
i.ytimg.comView Full Size
 
2021-07-28 8:56:50 AM  

Ambivalence: Full FDA approval isn't going to change too many minds. The military will require it, and some with "hesitancy" will get it, but the people who have turned the pandemic and vaccine into a political grudge match won't change their minds. The Qnuts will remain Qnuts.


That's why I'm advocating we give them a homeland of their own.  I think Missouri is perfect.  We can call it Qba.
 
2021-07-28 8:57:28 AM  

Groupon boob job: No, FDA approval will NOT lead to any more people getting the vaccine. In fact, I think that's the most naïve statement I have heard yet.


It would allow a lot more places to mandate out for schools, etc.

Those are the people who aren't getting vaccinated. They're terrible, terrible people. I will stop just short of saying the quicker these people die the better.

I won't stop there.  I'll shout it from the rooftops.
 
2021-07-28 9:17:45 AM  
while it won't change the mind of the MAGAvirus crowd, it will allow the military to require it, which would be a good start. It will also get the "movable" vaccine-hesitant onboard, which is also a good thing.
 
2021-07-28 9:19:26 AM  

FlashHarry: while it won't change the mind of the MAGAvirus crowd, it will allow the military to require it, which would be a good start. It will also get the "movable" vaccine-hesitant onboard, which is also a good thing.


Exactly.
 
2021-07-28 9:35:34 AM  

foo monkey: Science?


1.  "might" make them get vaccinated -- but any other  excuse will do too.
2.  Grow the fark up and get a vaccine.

I heard this story that out of 3 hospitals that required vaccines, or lose your job, 98-99% of them got a shot.
 
2021-07-28 9:40:42 AM  

Rapmaster2000: "Move fast, break things" is the motto of Facebook.  Fortunately, it is not the motto of the FDA.


Since the "things" that Facebook uses the best are  people, I guess we should have listened.
 
2021-07-28 9:44:36 AM  
The deadly epidemic.
The race for the cure.
The cure is found!
All that remains is to- what's that now?
Oh.
The deadly epidemic.
 
2021-07-28 9:53:43 AM  

cloverock70: durbnpoisn: Not that this is any sort of defense for the anti-vaxxer, but it seems that the biggest excuse most people use is that "it's not FDA approved."

That is a weak excuse by any measure.  The FDA approval at this point is a technicality.  But that is their excuse and they are sticking to it.

Having said that, since we KNOW that that is one of the biggest excuses being used, what the hell is the hold-up?  Is there not enough data to show that it's safe and effective?  Does bureaucracy just move that slowly?

Too bad there isn't an article linked to this thread with an explanation.


Article shmarmicle.  Ain't nobody got time for that.
 
2021-07-28 10:06:59 AM  

durbnpoisn: cloverock70: durbnpoisn: Not that this is any sort of defense for the anti-vaxxer, but it seems that the biggest excuse most people use is that "it's not FDA approved."

That is a weak excuse by any measure.  The FDA approval at this point is a technicality.  But that is their excuse and they are sticking to it.

Having said that, since we KNOW that that is one of the biggest excuses being used, what the hell is the hold-up?  Is there not enough data to show that it's safe and effective?  Does bureaucracy just move that slowly?

Too bad there isn't an article linked to this thread with an explanation.

Article shmarmicle.  Ain't nobody got time for that.


Plenty of time to biatch/argue about it here though.
 
2021-07-28 10:21:54 AM  

cloverock70: durbnpoisn: cloverock70: durbnpoisn: Not that this is any sort of defense for the anti-vaxxer, but it seems that the biggest excuse most people use is that "it's not FDA approved."

That is a weak excuse by any measure.  The FDA approval at this point is a technicality.  But that is their excuse and they are sticking to it.

Having said that, since we KNOW that that is one of the biggest excuses being used, what the hell is the hold-up?  Is there not enough data to show that it's safe and effective?  Does bureaucracy just move that slowly?

Too bad there isn't an article linked to this thread with an explanation.

Article shmarmicle.  Ain't nobody got time for that.

Plenty of time to biatch/argue about it here though.


This guy gets it.
 
2021-07-28 10:23:29 AM  

cloverock70: durbnpoisn: cloverock70: durbnpoisn: Not that this is any sort of defense for the anti-vaxxer, but it seems that the biggest excuse most people use is that "it's not FDA approved."

That is a weak excuse by any measure.  The FDA approval at this point is a technicality.  But that is their excuse and they are sticking to it.

Having said that, since we KNOW that that is one of the biggest excuses being used, what the hell is the hold-up?  Is there not enough data to show that it's safe and effective?  Does bureaucracy just move that slowly?

Too bad there isn't an article linked to this thread with an explanation.

Article shmarmicle.  Ain't nobody got time for that.

Plenty of time to biatch/argue about it here though.


In case you are not understanding my snarkiness, I know there is an explanation for it.  I just don't accept it.  I think it's farking ridiculous how long stuff like this takes.
 
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