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(NBC New York)   Pfizer says its Covid vaccine is safe and effective in kids aged 5 to 11. The company will submit the data to the FDA "as soon as possible." No rush, it's not like we're in the middle of a pandemic or anything   (nbcnewyork.com) divider line
    More: Spiffy, Vaccination, Vaccine, BioNTech's Covid-19 vaccine, Pfizer CEO Albert Bourla, Pfizer-BioNTech coronavirus vaccine, clinical trial of kids ages, advisory committee, Immune system  
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1258 clicks; posted to Main » and STEM » on 20 Sep 2021 at 7:57 AM (11 weeks ago)   |   Favorite    |   share:  Share on Twitter share via Email Share on Facebook



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2021-09-20 7:36:29 AM  
Pffff. "Science." Whatevs..

/s
 
2021-09-20 7:40:35 AM  
Good news for my 11 year old nephew.
 
2021-09-20 7:42:55 AM  
Now do six months to five years!
 
2021-09-20 7:44:35 AM  
I briefly considered waiting for the more effective Moderna, but the extra 3-5 weeks of wait isnt worth it.  The second they allow us to make appointments I'll be there with my 10 year old.
 
2021-09-20 7:45:34 AM  

Sabreace22: Now do six months to five years!


Please!  When that happens it will be such a burden lifted.  Though the release of 5-11 yr old vaccine will be too, since that will (hopefully) drastically reduce the number of possible vectors....at least in a sane world it would.  This world.....who knows.
 
2021-09-20 7:49:26 AM  
They only have to hit the "submit" button.

Wipe hands on pants and repeat.

They already have the data.
 
2021-09-20 8:00:36 AM  

weddingsinger: I briefly considered waiting for the more effective Moderna, but the extra 3-5 weeks of wait isnt worth it.  The second they allow us to make appointments I'll be there with my 10 year old.


I mean, with kids, I wouldn't wait at all. They already handle covid far better than adults, so even Johnson and Johnson would be fine by me for them. Hell, one shot probably put them on the same risk level as a vaccinated adult
 
2021-09-20 8:03:10 AM  
First you have to create the report then the report Hass to be reviewed by 37 different people and approved then it must be submitted to the government where it's read by 45 people before it reaches the board that approves it then the board will take three weeks to look at it this is the condensed version because we're in a pandemic
 
2021-09-20 8:04:51 AM  
Antivax Trumpers aren't going to like that, it will make it harder to kill kids.
 
2021-09-20 8:06:38 AM  

Sabreace22: Now do six months to five years!


The article says to expect that in the 4th quarter of this year! Gotta spread those profits around, ya know.
 
2021-09-20 8:08:40 AM  
They could call it "Preventing COVID-19 post-birth Abortion in 5-11 year olds" when marketed to Red states... hypocrisy aside
 
2021-09-20 8:08:46 AM  

Dack48: Sabreace22: Now do six months to five years!

The article says to expect that in the 4th quarter of this year! Gotta spread those profits around, ya know.


The fourth quarter of this year starts in 10 days. Hardly a conspiracy.
 
2021-09-20 8:08:52 AM  

plecos: Sabreace22: Now do six months to five years!

Please!  When that happens it will be such a burden lifted.  Though the release of 5-11 yr old vaccine will be too, since that will (hopefully) drastically reduce the number of possible vectors....at least in a sane world it would.  This world.....who knows.


Usually that means there's a Few loose ends to tie up that do influence the numbers.I'm okay with making sure the grad student calculated the death rate in 6 year olds correctly.  Was that .002 or .000002?  Mild and micros ... who would mix those up?!  Nanos is preferable!
 
2021-09-20 8:09:04 AM  
They are still working the wording to tap dance around that autism thing.
 
2021-09-20 8:09:04 AM  

Publikwerks: weddingsinger: I briefly considered waiting for the more effective Moderna, but the extra 3-5 weeks of wait isnt worth it.  The second they allow us to make appointments I'll be there with my 10 year old.

I mean, with kids, I wouldn't wait at all. They already handle covid far better than adults, so even Johnson and Johnson would be fine by me for them. Hell, one shot probably put them on the same risk level as a vaccinated adult


It's more than just how they handle having Covid.  The big advantage to that age group getting vaccinated is to significantly curtail the spread in schools, and therefore, the community at large.
 
2021-09-20 8:09:37 AM  
Promising news. It's beyond awesome how scientists have been working on mRNA vaccines for years so we have them in the toolbox for this pandemic. Chalk another one up for the boffins.

https://www.nature.com/articles/d4158​6​-021-02483-w
 
2021-09-20 8:10:14 AM  

marsoft: FTFA: Bourla said last week that Pfizer could submit data on children ages 5 to 11 by the end of this month.

So within the next 10 days.

If you had ever seen the amount of paperwork and data required for a submission like this, you would understand this is moving very quickly.


Yes.

Probably crossing the tees on safety and data related paperwork (resolving queries and database locks).  I mean, you have to do that stuff, even in a pandemic.  And these trials have been moving like machines.
 
2021-09-20 8:10:52 AM  

weddingsinger: I briefly considered waiting for the more effective Moderna, but the extra 3-5 weeks of wait isnt worth it.  The second they allow us to make appointments I'll be there with my 10 year old.


I would just go now.  They're not checking IDs.  They only rely on the parents to vouch.
 
2021-09-20 8:12:58 AM  

plecos: Sabreace22: Now do six months to five years!

Please!  When that happens it will be such a burden lifted.  Though the release of 5-11 yr old vaccine will be too, since that will (hopefully) drastically reduce the number of possible vectors....at least in a sane world it would.  This world.....who knows.


With the amount of head-asploding bullshiat that adult antivaxxers spew, I predict an extremely low vaccination rate in kids in red areas. So some school districts will be protected while others will pretend to be protected by magic Jesus juice but will be hotzones of COVID until every student and faculty member has had it.
 
2021-09-20 8:14:46 AM  

Sabreace22: Now do six months to five years!


The studies are running concurrently. The data for that age group should be done later this fall.
 
2021-09-20 8:21:01 AM  

thisispete: Promising news. It's beyond awesome how scientists have been working on mRNA vaccines for years so we have them in the toolbox for this pandemic. Chalk another one up for the boffins.


Counterpoint: Terrifying news! It's beyond suspicious how scientists just happened to have DNA-altering 5G killswitch vaccines ready just in time for a convenient pandemic! Chalk another one up for the reptilian overlords!

/Will feel a lot more comfortable once my nephew can get the vaccine in a few months
 
2021-09-20 8:25:41 AM  

namegoeshere: plecos: Sabreace22: Now do six months to five years!

Please!  When that happens it will be such a burden lifted.  Though the release of 5-11 yr old vaccine will be too, since that will (hopefully) drastically reduce the number of possible vectors....at least in a sane world it would.  This world.....who knows.

With the amount of head-asploding bullshiat that adult antivaxxers spew, I predict an extremely low vaccination rate in kids in red areas. So some school districts will be protected while others will pretend to be protected by magic Jesus juice but will be hotzones of COVID until every student and faculty member has had it.


Our schools are a hotzone, so we're homeschooling right now.  It sucks!  We did orientation and told the teachers we were going to wait for the shot, but 14 days after the second dose they'll have a new little blonde kid in their class.  The NYT article was optimistic that shots would begin by October, so kids would be fully vaccinated by Halloween, which would be absolutely amazing.
 
2021-09-20 8:26:44 AM  

Sabreace22: Now do six months to five years!


first we are going to have to ask you to have a seat over there.
 
2021-09-20 8:27:49 AM  
LETS GOOOOOO
 
2021-09-20 8:28:57 AM  

namegoeshere: plecos: Sabreace22: Now do six months to five years!

Please!  When that happens it will be such a burden lifted.  Though the release of 5-11 yr old vaccine will be too, since that will (hopefully) drastically reduce the number of possible vectors....at least in a sane world it would.  This world.....who knows.

With the amount of head-asploding bullshiat that adult antivaxxers spew, I predict an extremely low vaccination rate in kids in red areas. So some school districts will be protected while others will pretend to be protected by magic Jesus juice but will be hotzones of COVID until every student and faculty member has had it.


5-11 yr olds will not have great autonomy to vax themselves.  I anticipate the kid vax rate will mirror the local population.

with trade-offs of Aunts and Uncles taking kids to be vaxxed off-set by vax-neutral parents that are hesitant with children.
 
2021-09-20 8:29:14 AM  
Fark user imageView Full Size
 
2021-09-20 8:29:51 AM  
The FDA will need to independently verify some of the stats.  I think that is mostly have someone enter the major data into a excel and make sure they numbers are correct.  There was a story that the numbers had already been sent in so they only need to send in the most recent updates like the last month or day of the trial or something like that.  The old way required sending in everything only after the study was complete and then the data checking would start.  There will be stuff like "7 kids developed fever in last week of the trial" and a bunch of stuff about their outcomes and why it wasn't related to the vaccine.  With kids being germ vectors and delta looking like allergies in so many, that is going to be a pain in the statistics.

Meanwhile Cuba is vaccinating 2+ year olds with their home grown vaccine.
 
2021-09-20 8:29:55 AM  
I'm excited for my 5 year old niece who is in school in a Florida county where masks are not required. Can't come soon enough.
 
2021-09-20 8:29:57 AM  
That explains why Matt Gaetz called my hospital yesterday asking if we still were looking for volunteers.
 
2021-09-20 8:33:20 AM  
I know that many of you are there are frustrated but I can pretty much promise you that they are not skimping on the budget to have multiple consultants helping to write up the data, double and triple check their figures, and make sure their counter-parts at the FDA are being kept informed of their progress, fed draft reports, and ultimately doing everything reasonable to make this happen quickly without cutting dangerous corners.
 
2021-09-20 8:36:18 AM  

Hyjamon: 5-11 yr olds will not have great autonomy to vax themselves.  I anticipate the kid vax rate will mirror the local population.


Oh 100%, but at least I'll know that my vaccinated kids will be MUCH less likely to suffer long term consequences from other people being unwilling to help their neighbors (at least through COVID).  It also means when I fly I won't have to be very consciously staying in my room and hiding from everyone due to my unvaccinated kids I'll be seeing in a few hours.  It's going to help, it should blunt the ensuing holiday wave, and it might even help us have an ICU bed available by the end of the year.
 
2021-09-20 8:37:01 AM  
I look forward to my youngest niece finally getting vaccinated, I have been worrying about her a lot and my brother is a nurse and my SiL works in a dental office so they have been waiting for this too/ And my idiot sister still probably wont get it or let her family get it.
 
2021-09-20 8:38:20 AM  

thisispete: Promising news. It's beyond awesome how scientists have been working on mRNA vaccines for years so we have them in the toolbox for this pandemic. Chalk another one up for the boffins.

https://www.nature.com/articles/d41586​-021-02483-w


mRNA vaccines are such a game changer that my heart leaps for joy thinking about it.
 
2021-09-20 8:42:13 AM  
Damnit!
 
2021-09-20 8:43:03 AM  
What, are they collating copies? Let's gooooo!
 
2021-09-20 8:51:50 AM  

NewportBarGuy: They only have to hit the "submit" button.

Wipe hands on pants and repeat.

They already have the data.


It's not as easy as all that (though I wish it were).  At my last company there were about seven layers of reviews and approvals for anything sent to FDA. And if any, and I mean any (put in a comma, changed font size, changed loose to lose) the entire approval process started all over again.

I was getting blown up at 2 am on Saturdays to re-re approve so that we could make a drug that was only for like 50 people in the US, so I'm sure that this team is basically 'all hands' right now.

/Didn't work for Pfizer though so their processes might be different.
 
2021-09-20 8:52:49 AM  
I will breathe a huge sign of relief when my 6yo gets the jab. Then I will punch an antivaxxer in the face, just because.
 
2021-09-20 8:57:37 AM  
My 11yo is looking forward to getting it.  We told her as soon as she's eligible we'll take her.
 
2021-09-20 8:59:48 AM  

namegoeshere: plecos: Sabreace22: Now do six months to five years!

Please!  When that happens it will be such a burden lifted.  Though the release of 5-11 yr old vaccine will be too, since that will (hopefully) drastically reduce the number of possible vectors....at least in a sane world it would.  This world.....who knows.

With the amount of head-asploding bullshiat that adult antivaxxers spew, I predict an extremely low vaccination rate in kids in red areas. So some school districts will be protected while others will pretend to be protected by magic Jesus juice but will be hotzones of COVID until every student and faculty member has had it.


Not really.  We have one kid-less school board member and a gang of loud-mouthed idiots who is holding our entire district hostage.  Incidentally, the side of the district he is on has the worst school covid cases.  I just want my 11 year old vaccinated so I can ramp down the worry about what these careless idiots do.
 
2021-09-20 9:07:47 AM  

DON.MAC: The FDA will need to independently verify some of the stats.  I think that is mostly have someone enter the major data into a excel and make sure they numbers are correct.  There was a story that the numbers had already been sent in so they only need to send in the most recent updates like the last month or day of the trial or something like that.  The old way required sending in everything only after the study was complete and then the data checking would start.  There will be stuff like "7 kids developed fever in last week of the trial" and a bunch of stuff about their outcomes and why it wasn't related to the vaccine.  With kids being germ vectors and delta looking like allergies in so many, that is going to be a pain in the statistics.

Meanwhile Cuba is vaccinating 2+ year olds with their home grown vaccine.


The FDA's big concern is myocarditis and pericarditis upon the 2nd injection which has been a rare but real side-effect seen at a greater level in young males. The effect seems to resolve rather quickly. There isn't a very good mechanistic explanation yet or at least I couldn't find one as of last week.

It will be interesting to see how they publish any warnings to monitor for chest pains and what to do about it.
 
2021-09-20 9:11:52 AM  

plecos: Sabreace22: Now do six months to five years!

Please!  When that happens it will be such a burden lifted.  Though the release of 5-11 yr old vaccine will be too, since that will (hopefully) drastically reduce the number of possible vectors....at least in a sane world it would.  This world.....who knows.


5-11 means schools can get back to normal.  Which means people who are dealing with kids in at-home or hybrid schedules can get back to their normal work lives.  Huge boon for working-class parents, especially single parents.  The unemployment stats are skewed due to the fact that a lot of moms dropped out of the workforce during the last 18 months.

6mo-5yrs means the same for daycare, but just getting the 5-11 cohort back to normal will go a long way to unblocking a big structural issue.
 
2021-09-20 9:14:31 AM  
Can we call CPS on people that won't vaccinate their kids?
 
2021-09-20 9:19:15 AM  

plecos: Sabreace22: Now do six months to five years!

Please!  When that happens it will be such a burden lifted.  Though the release of 5-11 yr old vaccine will be too, since that will (hopefully) drastically reduce the number of possible vectors....at least in a sane world it would.  This world.....who knows.


i would hope so.... but then i flipped through the channels all day saturday and saw numerous packed college football stadiums with everyone screaming...   same thing on Sunday with the NFL...  and MLB....
Unless most get vaccinated, and its not going to happen...   we will be getting boosters yearly, probably similar to the annual flu shot....

\idiots..
 
2021-09-20 9:21:11 AM  

groppet: I look forward to my youngest niece finally getting vaccinated, I have been worrying about her a lot and my brother is a nurse and my SiL works in a dental office so they have been waiting for this too/ And my idiot sister still probably wont get it or let her family get it.


My cousin is a pediatric nurse at a busy Orlando hospital. She said it is awful. Her unit is filled to capacity. She said kids on ventilators and despite what people are saying, children do die. Obviously not at the same rate as adults, but this Delta variant has been much worse for children than the original one. I don't understand not getting a child vaccinated. I can't wait for my 5 year old niece to get vaccinated. We're in Florida and there is no mask mandate here. I constantly worry about her.
 
2021-09-20 9:21:41 AM  
There will be plenty of lazy people that wait. Just like all the adults that didn't get it last January. There were ways to get it if you wanted it enough. I did.
 
2021-09-20 9:22:32 AM  

standardeviation: NewportBarGuy: They only have to hit the "submit" button.

Wipe hands on pants and repeat.

They already have the data.

It's not as easy as all that (though I wish it were).  At my last company there were about seven layers of reviews and approvals for anything sent to FDA. And if any, and I mean any (put in a comma, changed font size, changed loose to lose) the entire approval process started all over again.

I was getting blown up at 2 am on Saturdays to re-re approve so that we could make a drug that was only for like 50 people in the US, so I'm sure that this team is basically 'all hands' right now.

/Didn't work for Pfizer though so their processes might be different.


Nah, that's probably how it is... It's the government. They are probably afraid of the Agency using any formatting errors or ommissions etc from delaying approval.

Makes a ton of sense. Though, I imagine any tiny thing they find on something like this would be glossed over in the need to get to approval on the FDA's part. Regular filings? I'm sure they look for any reason to hold it up if they are having a bad Monday. lol
 
db2
2021-09-20 9:26:53 AM  

weddingsinger: I briefly considered waiting for the more effective Moderna, but the extra 3-5 weeks of wait isnt worth it.  The second they allow us to make appointments I'll be there with my 10 year old.


Yeah, they're both excellent, get whichever one you can first.
 
2021-09-20 9:48:57 AM  
Been waiting what feels like forever for this for our six-year-old. I feel like relief is in sight. I'd like to just not have to worry about her getting seriously sick from the plague rat children no wearing masks (difficulty: Florida)
 
2021-09-20 9:49:46 AM  
I read the FB comments this morning about this. Glad I bought futures in tiny caskets. Holy crap people were mad as hell about this.
 
2021-09-20 9:56:35 AM  
Gov. DeathSentence to ban vaccinated students in schools in  3...2...1
 
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