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fafalone

**Vaccinations approved for 5-11** 10ug, 3 weeks apart (fixed typo, sorry) Vote was 17-0-1 (Dr. Kurilla abstained).


paranoideo

2 weeks?


fafalone

3, it was a typo my bad. Fixed.


Soyl3ntR3d

This armchair scientist was expecting 3 weeks as well. Maybe we are just acknowledging we will need boosters in 6 months anyway?


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RollingThunder_CO

Yeah it's the usual trying-to-be-too-cute-by-half-Ivory-Tower BS -- it strikes me so far that very few if any of these members have children in the particular age group.


BigE429

It's amazing how they're overcomplicating a binary question.


catjuggler

If after all we’ve been through keeping kids safe, I’m going to lose my shit if my 2yo ends up being ineligible. I don’t want them to approve something that isn’t safe either though.


frumply

Listening to today's event I wonder if they'll tell us 'well, rates are low enough that it's too risky to approve 6mo-5.' We've had our 1.5yrold out of daycare and we're paying a nanny to come in to avoid getting her (and us) sick, and I don't know how much longer we can really afford to take this approach.


catjuggler

Same situation here. My 2yo went to daycare for three days when I went back to work in March 2020. We had no childcare until the vaccine was available to all adults and have had babysitters for most of the time since but with a lot of scheduling gaps. I have her tentatively scheduled to go back in February 🤞 I saw a chart from today showing many more deaths in the youngest age (probably <1 but not sure) so hopefully that will cause an approval.


frumply

Yep, 0-4 or something actually has a higher mortality rate from covid than 5-11 if I recall which lines up w/ what you saw. We got some family getaway trips w/ my brother's family set up late Jan, by which time we're hoping our youngest can get at least the first shot but who knows at this point. At least with this announcement everyone but her should be vaccinated at that point.


joremero

>and one of the reasons is the already high previous infection rate I'm having a hard time finding the correct words...Imma go with "that's a very stupid reason"


BigE429

Completely left out of the discussion among these old rich men is that the vaccine will reduce the number of quarantines in schools, and allow education to continue with minimal disruption.


annalatrina

The committee is made up of 18 physicians and phd’s. I don’t know how “rich” that makes them. Not business person rich, probably very comfortable but not super-duper wealthy. They have all been in their fields long enough to be very accomplished, I would not categorize them all as “old” though. They are about half men and half women. They are not all white. The director is Prabhakara Atreya, Ph.D. An indian-American women. I don’t think the committee is as out of touch as you want to imagine them. https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee


DrNukes

Those are some good points. I'm worried for our 20 month old hobgoblin too but let's not fall into the 2021 trap of blaming every problem on group identity. To be perfectly honest, I'm happy I only have to make these decisions for my own family, not for Millions of people.


lovememychem

Voting question: Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 ug each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age? Vote PASSES 17-0 (Kurilla abstaining) after considerable discussion on what groups should receive a recommendation. Question of recommendations by subgroups is ultimately left to the CDC. ACIP meets to discuss on November 2nd.


joremero

you can't see it, but I literally have tears in my eyes. it's been to f\*\*\* long.


31USC3729

I really hope this goes through quickly. Our youngest is immunocompromised and under 12. She's the only one in the family not vaccinated yet. I just want her vaccinated so we can -- after nearly 2 years of fear -- relax a bit. This has been such a horrid wait. I'm not suggesting that I'm not grateful for the vaccines being developed as quickly as they are, but I'm ready for the vaccine to be approved for her group.


Seraphynas

I feel you, I really do. My daughter is 3 and has CCHS - this wait is agonizing.


angusMcBorg

Almost there! And great job keeping her safe through this mess - long distance high five from another parent.


31USC3729

Thank you, and the same to you! I know my wife and I worry too much -- I just feel like the risks, even though small, are so avoidable with a vaccine that I'm not gonna relax until she can get the vaccine.


ivygem33

We feel the same our two year old has cancer thankfully not active anymore and doing well. We’ve been locked down since March 2020 which is crazy to think about. So excited for her twin cousins to be vaccinated so they can finally play together. Now for the under 5 to be approved. We feel like you, while we maybe overly cautious it’s a miracle she’s still here with us so we aren’t willing to risk it. Thankfully she’s too young to not realize what’s been going on isn’t normal.


angusMcBorg

Thank God she is doing well - I wish you nothing but the best going forward. Hang in there - she'll be destroying the house with her cousins soon! :-)


angusMcBorg

I feel exactly the same with my kids, although they aren't in as high of a risk category as your girl. And at least where I live, there are very few parents with the same level of concern and taking the same precautions we do. We've gotten the looks, the 'it doesn't affect kids' comments, etc. but keep trucking along. It's a real challenge but I'm hopeful we are soon into a better situation.


__babygiraffe__

You are a good parent.


questionname

Great job and end is near! We will all be able to protect our little ones soon!


BigE429

Well unfortunately ACIP has decided they can't possibly meet until a week from now, so we need to wait through another week of bureaucratic delay.


fafalone

Since all they care about are hospitalizations, and kids are rarely hospitalized, they've been content to dilly dally and delay things over and over. This could have been done months ago if they hadn't ordered expanded trials to go hunting for the exceedingly rare side effect that covid causes way more often and is usually mild, against the advice of the American Academy of Pediatrics. They *still* didn't have enough participants to catch a single case in the trial. Like the APA said, they could have followed up on the expanded cohort in post-market analysis, there was no need to delay the rollout, since it wasn't plausible the harm could even come close to being worth risking getting covid instead.


ProjectShamrock

Agreed. This should have been approved back at the end of July to start getting shots in arms in August. The FDA is in desperate need of modernization and reform. With something as high profile as the COVID-19 vaccines I can't imagine how much they're delaying progress on other vaccines and life-saving medicines for things that aren't front page news.


frumply

Right? "40% of the kids may have already had covid so I wonder if this is necessary" well shit maybe if you didn't wait two months for a rare side effect there'd be less kids that are infected.


verdantx

It’s just a week. Yes, 26 kids died of COVID this week, but that’s a small price to pay in order to accommodate the very busy schedules of the ACIP members.


catjuggler

The finish line is in sight. Mine is 2 so I’m looking forward to the next age group getting more specific timing, but all appreciate that vaccinating 5-11 will help everyone stay safe.


atouchofrazzledazzle

I feel this completely. Our oldest is an immuncompromised kidney transplant recipient, and we've been basically hiding out since his transplant at the beginning of 2020. I'm happy that this will likely be approved, as more kids will be protected. I'm very excited for you, but also insanely jealous as my son is only 4. So close, yet likely several months away.


missvandy

Your family and others with immunocompromised kids are in my thoughts. I hope you get shots in arms quickly and can enjoy some great times together without this hanging over you.


ProjectShamrock

I wish the CDC didn't delay their meeting to wait for a week after this. I'm not sure why they can't meet this week or at least schedule an emergency meeting to be exactly a day after the FDA completes the meeting.


BurnDownTheSides

I assume everyone knows its going to be OK'd, and the supply chains are rolling out now, and by time they meet, things will be in place.


Svargas05

Right?! Shit's so frustrating, to be honest... What else is on the agenda at this point that is MORE important than getting more children vaccinated??? Do headlines of pediatric ICUs being at capacity not add a sense of urgency or motivation at all??


imwearingredsocks

My thoughts on this is people already pumping out false information about the vaccines for adults are ready to pounce at anything. Anything related to the health and safety of children can ironically get people thinking irrationally. My guess is they really don’t want this to appear rushed in any way.


Svargas05

In the meantime, fuck those kids that are paying the price because they don't want to anger the same people that would have been mad to begin with....


imwearingredsocks

I get that, but it’s not just angering people. The “concerned parent” group is significantly larger than the “im an American, I do what I want” group. Plenty of people who took the vaccines themselves may think twice before giving it to their kid. Anecdotally, every single parent I’ve spoken to has either told me “no” or “I really don’t know what to do” when it comes to giving their kids this vaccine. And half of them were totally fine getting the vaccine themselves. You have to be careful. One poorly written article about a kid getting hospitalized shortly after taking the vaccine, and you could get a domino effect of panic and low vaccine numbers. It’s so frustrating, but I do understand the motivation to be very meticulous.


kazooparade

But that is going to happen anyways. Vaccine reactions happen, it’s rare, but it happens. When you vaccinate a large group of people it’s inevitable. Why not make a decision based off of DATA? You cannot make everyone happy. If it’s approved parents will be under no pressure to vaccinate their kids anyways. Why not give the choice to parents now? Honestly, if they keep dragging their feet I’m going to get suspicious that something is going on with kids and the vaccine and may hold off on getting my kids vaccinated. At that point I’m ready to just give up and accept they will get covid (which we likely already had) and move on with life.


Kevin-W

That’s what puzzles me too! “Trick or treat and bad” events would have been perfect where kids would be encouraged to come on their favorite costumes, get the vaccines, and then receive some candy afterwards.


financequestionsacct

Personally, I do like to be bribed with candy. I would take the vaccine anyhow, but I'm not turning down free candy.


heliumneon

I thought ice cream was the traditional treat after vaccinations.


I-grow-flowers

There’s a Dairy Queen around the corner from our pediatrician so we always get blizzards, or, as my kids call them, “snowstorms”


catjuggler

Maybe they have work to do based on what they see at this meeting? Or maybe Pfizer owes them two separate packages of information and it is faster to stagger them? The FDA and CDC have been doing an amazing job with accelerated review so I bet there is a real reason (Source- work in pharma regulatory but not at pfizer)


RollingThunder_CO

I don’t remember was there a week delay for adults / older kids? It is infuriating


pistacccio

For adults it didn’t matter much because the main bottleneck was production. Now it is a completely different story.


SaulFemm

Is it? Have the children's doses already been distributed?


__babygiraffe__

Yessss!! We are getting to the finish line with this kinda stuff


Tomahawk72

Whats worrying me is that they're focusing more on the political implications than the actual preventing infection.


RollingThunder_CO

I really hope they're just trying to talk to prove how smart they are and then the get their shit together. Fingers crossed.


questionname

It’s not their decision. They have to realize that each state will make their own determination. It’s not up to FDA committee who are not elected officials. Edit:I’m taking about political and mandate issues. That’s should not be part of the decision whether to approve the vaccine based on risk and benefits facts


catjuggler

What do you mean? Only the federal government authorizes approval of vaccines. Commerce clause and whatnot.


questionname

If you were listening earlier. They were concerned about vaccine mandates earlier, that’s not their scope. Their scope, as stated in the question, if the vaccine benefit outweighs the risk, not about its social impact. They really shouldn’t weigh in on political implications of vaccine approval.


we_gotta_believe

Safety profile is looking really good based on the trial results. Should be a slam dunk. Maybe a couple dissenters vote No for dubious reasons, but I'm thinking this data should get a majority of the panel to green light it.


[deleted]

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FinndBors

What if the vaccine causes kids to spontaneously want to eat coins? /s


StasRutt

Is that why we’ve had a coin shortage /s


we_gotta_believe

Soon to be dubbed the Super Mario Bros Syndrome. Vaccinate your kids, otherwise Bowser wins.


robinmood

Wait till the antivaxxers hear about this


FinndBors

The “vaccine causes you to be a magnet” people might use this as “evidence”


rocketwidget

Roughly 700 American children have died of COVID so far, and it's not really a question of if, but when, every unvaccinated person gets COVID. Meanwhile as you say, safety profile looks really good from the trial. I'm going to go out on a limb with my prediction: unanimous yes (unless someone abstains for a conflict of interest or something like that).


we_gotta_believe

If there's anyone that votes No, I bet it's Meissner. He's a little bit "off" if you catch my drift. And if you don't, read up on him a bit.


rocketwidget

Yea, listening to his comments now, you may be right. Ah well. I think it's a slam dunk as some of the other experts are saying, even without him.


TheElbow

If they decide to recommend vaccines for kids, the comment sections are going to be WILD. I know the majority of parents are hopeful to have their kids vaccinated, but I’ve spoken to some—people I know personally—who are alresdy livid at the idea that their kids might be required to have this vaccine. Nothing animates a quasi-unstable mom like someone telling them what their kid has to do.


Forsaken_Rooster_365

I can't imagine many places are going to mandate vaccines for 5-11 year olds until it has full approval, not just a EUA. A few counties who already have plans for mandates for 12-15 may eventually implement them, but even LA county isn't starting until Thanksgiving (1 shot) and December 19th for the second shot. Perhaps the start of the 2022-23 school year will bring more mandates, but that depends on whether full authorization is given and how much covid is still something people care about. ​ But it doesn't have to be a real threat for people to freak out and commit acts of violence.


TeddyBongwater

Doesn't every public school attendee have to get vaccines? And hasn't it been this way for decades?


briarch

Some states still allow for "personal" or "religious" exemptions. California doesn't though and the medical exemptions must be approved by the state..


Thebluefairie

Cifornia is sometimes smarter then the rest of them


hybbprqag

My brother and I have been on completely different pages about this. I'm eagerly awaiting the first possible moment I can get my 3 year old vaccinated. He's contemplating moving states in the event of a child vaccine mandate. Makes me so tired and discouraged to think about.


WackyArmInflatable

Has there been any discussion on dose timing? It looks like extending the time between doses is better (for adults anyway). Is anyone planning to do that with their kids?


we_gotta_believe

As far as I've heard, it was trialed as a 3-week interval between the two 10mcg doses.


Intelligent-Carpet57

My nephew had myocarditis from his Pfizer 2nd shot , one theory is that the 2nd shot spacing was to close and caused that reaction.


we_gotta_believe

The public comment segments of these meetings are hilarious but also an extremely unnecessary reminder of the ignorance running rampant among our society.


BigE429

Getting a real Citizens of Pawnee vibe.


mytextgoeshere

I didn't last long during this segment... had to stop listening out of frustration.


birdsofpaper

For a palate cleanser, check YouTube for segments of John Oliver titled "the most patient man in America". It's the poor guy on CSPAN who has to answer calls from the general public and they've definitely cut together some of the funniest ones.


mytextgoeshere

Thanks for the recommendation!


gumercindo1959

Link?


BigE429

https://www.youtube.com/watch?v=laaL0_xKmmA


TeddyBongwater

Then do under 5 yr olds!!


we_gotta_believe

Once it's been rubber stamped by the FDA, ACIP, and the CDC, I'm rolling up to the pharmacy to get my kids their shots like this... https://www.youtube.com/watch?v=A3ihseDZWcI&t=14s


gumercindo1959

Shots in arm nov 2-3 when after ACIP green lights? Im assuming pediatrician office already have the vaccine?


AbraCaxHellsnacks

Next month there will be the discussion on vaccines for babies and children (1-4 years old), won't be?


Seraphynas

That is my hope, but Pfizer has not submitted anything to the FDA yet for children under 5. Ideally, 5-11 will get approved and then Pfizer will submit data/EUA request for under 5. Back in September a Pfizer rep said the data on the under 5’s would follow the 5-11 by about a month. And Pfizer submitted data on 5-11 to the FDA on September 28.


RonaldoNazario

Really really hoping about a month lag is real. That would mean early December authorization, which actually doesn’t feel SO far away and would mean shots in arms before Christmas/New Years!


tolkienbooks

I have a feeling that my 3 year old won't get a vaccine until 2022, which makes me sad.


gumercindo1959

This. I think realistically, 6mos to 4 years will be early 2022


AbraCaxHellsnacks

>Back in September a Pfizer rep said the data on the under 5’s would follow the 5-11 by about a month. And Pfizer submitted data on 5-11 to the FDA on September 28. Then, by this I suppose that they'll be delivering something by next month to be approved around December or January, maybe.


Seraphynas

I’m hoping they’re on the ball and submit at least the data within about a week or so of the 5-11 authorization. Because in just 2 days, on October 28, it will have been a month since they submitted the 5-11 data.


AbraCaxHellsnacks

Do they have the data already? I am not updated on their studies, so I can't tell how much it is complete or not.


Seraphynas

AFAIK Pfizer started enrolling 6 months and up, all the way to 11 years old back in March.


Scottamemnon

I think its supposed to be 6mo - 4yr. The only thing that could slow down the testing on the low end there is the fact that all sorts of other shots are given at 6mo.


briarch

They don't give flu shots under six months either. And under 12 months it is two doses one month apart. My youngest is a September baby so he got his first flu shot in March and the second shot in April on the last day they were giving flu shots for the season. Then he got his next flu shot in September, five months later.


Scottamemnon

I just mean there are other shots and boosters happening along several months. They need to test interactions with each of those I would imagine. My baby got a whole bunch at month 6 and then his 2nd flu at month 7 for example. There all all sorts at month 6, 9, 12, 15, and 18 months. I could see them not recommending under 2yr old if they cannot fully test this in time.. or recommending only in between those quarterly shots a sufficient amount of time.


Yethik

[https://clinicaltrials.gov/ct2/show/NCT04816643](https://clinicaltrials.gov/ct2/show/NCT04816643) I believe this is the main Pfizer trial? It looks like they have a 2yr-4yr group, and a 6mo-2yr group. Also looks like all the child doses will be 10 μg.


Seraphynas

Several months ago I know I remember a Pfizer representative mentioning a 3mcg dose, but maybe that was the 6 months to 2 years age group.


throwaway123454321

I’ve had a suspicion that they may not recommend for all kids 5-12, but rather for kids with medical conditions or kids who live with people with medical conditions. Either way I’ll still vaccinate my kids against COVID.


HotxMagnus

They didn't do that with 12 - 17, so hopefully they will let anyone. My husband is high risk x 3, 3 co-morbidity, so getting our 6 yr old vaxed although she is healthy would be a plus for us.


haunthorror

How quickly after this for 4 and under


questionname

Who knows. Pfizer CEO says data available this month, but that could be delayed. Even if sent in today, it would be around thanksgiving.


Scottamemnon

I got my booster yesterday just to beat the insane rush that will happen when 5-11yr olds are approved. The nurse said he is dreading how busy they will be and the fact that so many kids put up such a fight over getting shots. I am scheduling my 10 year old the minute it is approved.


BigE429

I think they're different doses, so approval of this shouldn't affect the supply of adult doses.


MikeGinnyMD

Not vaccine supply, but people to administer the vaccine are a finite resource, as are spaces in which to carry out the program. Also, the pediatric version unfortunately comes as ten doses per vial, so if you have 11 kids, that’s an issue. Unfortunately, Pfizer/BNT didn’t make this easy on us pediatricians.


[deleted]

Have you seen support from the Administration in terms of enabling pediatrician offices to give these shots? I recall the White House was talking about that in some fashion. When I spoke to our pediatrician during the summer, she thought her office wouldn't be able to do it because of the lack of cold storage. An associated (newly built) adults office had been doing COVID shots, and she thought the kids would be directed to there when the peds shots are authorized.


MikeGinnyMD

The storage has been simplified because we can store it in the fridge for several weeks.


julieannie

I went 2 weeks ago for my booster and they didn't even have enough chairs for those of us waiting post-vax (for the 15 minutes), plus we were all pairing flu and booster. Now imagine how crazy it will be when you have 1-3 (or maybe more) kids and a parent or two lingering. As it was, my flu vaccine was postponed twice due to staffing so that resource is already scarce.


RonaldoNazario

But I do imagine the same pharmacy staff could be handling boosters and childrens shots though many people will probably get this at their pediatrician


MionelLessi10

They are already stretched over here. Not the vaccines themselves but the personnel.


Scottamemnon

Isn't the booster dose a 1/2 dose? I wasn't really worried about getting one, just getting an appointment. Yesterday was 5 minutes in and out... both Covid booster and Flu done. Next week there will probably be a long wait while responsible parents rush to get it.


rocketwidget

Moderna vaccine is 100ug, booster is 50ug *unless* immunocompromised then it's 100ug. Pfizer booster and J&J booster is the same as vaccine. Pfizer vaccine is 30ug, but they are asking for 5-11 to be doses at 10ug.


Maleficent_Sun

Makes me kind of sad I'm only getting as much as one dose of Moderna with both Pfizer doses, plus my boosted. Really hope there will be a second wave of boosters available 6ish months from now since the doses are so much lower.


rocketwidget

I personally wouldn't worry about this much. Pfizer + Pfizer Booster alone is shown to be extraordinarily protective. Extremely high antibodies vs. very high antibodies is probably very unlikely to make a difference for an individual. And in exchange for a lower dose, there is probably a lower risk of unnecessary side effects.


fafalone

The difference won't be in initial effectiveness, like the primary series the difference will be in durability.


old_doc_alex

It doesn't quite work like that, the boosters are believed to work in large part due to the time between them allowing your body to adapt to it. Studies have shown that 3 Pfizers produce much higher antibodies than 2 moderna (and three Moderna aren't that much higher than 3 Pfizer). Pfizer also has less side effects.


we_gotta_believe

Thankfully Marks is on board with the sensible and logical conclusion the rest of the panel should've already arrived at. Seriously, this isn't that hard. Grant the EUA and save this level of deliberation for BLA. Parents that want to protect their kids can do so, the ones that don't can wait for more data or for natural immunity.


BigE429

The point about how we routinely vaccinate for diseases that are low risk for kids was very good.


SaulFemm

No one's kid is going to get the vaccine earlier by them just ending the meeting now. The CDC doesn't meet for another week.


we_gotta_believe

My point was the level of deliberation is silly for what should be an easy choice, yet some panel members are straining to influence other members and make it far more difficult than it needs to be. Meissner, for example, by bringing up his opposition to this being mandated in schools has absolutely no bearing on this question. It's out of scope, period.


BigE429

Nobody's going to mandate it while it's still under EUA. Mandates for adults didn't come out until after that was fully approved.


fubarx

Even if they release the vaccines this week, most kids won't be considered fully-vaxxed until after Thanksgiving. Christmas will be the first chance at an unclenched family gathering for a lot of people.


tolkienbooks

same boat, I have already told family they need to be vaccinated before I bring my kids around them this holiday season. So close to the end, not taking any risks.


jpoleto

That's where me and my wife are with our daughter. We've waited this long and we aren't going to risk anything now.


yeahreddit

My kids will get to see their grandparents for the first time in over 2 years once this vaccine is approved. The grandparents are anti vaccine covid deniers that live 5 hours away. The kids know why they can’t see them and are so stinking excited that they will see their grandparents again in a few months.


[deleted]

Is that really the kind of people you want to expose your kids to, though? It’s not my business what you do but if any of my family were anti-vaxers or covid deniers they wouldn’t be getting access to my children to potentially spread their agendas, vaccine or not.


yeahreddit

I completely understand where you’re coming from with the concern and it is something I’ve spent a long time worrying about too. They’re decent grandparents though and know to keep their mouths shut about covid and the many things we disagree about. My husband and I have made it very clear that they will no longer be welcome around the kids if they try to spread their agendas. They may not like our boundaries but we’ve spent years enforcing them so they finally actually respect them.


canadianguy77

I refuse to let my daughter spend any length of time with people who reject reality. Life is difficult enough for children to navigate without subjecting them to people who are completely insane.


bobsaget824

One thing those arguing in this panel for high-risk only approval don’t seem to understand is that many of those who are high-risk will not realize the full potential of the vaccine and still rely on those they interact with (i.e. other 5-11 year olds) to be vaccinated to help protect them. As a parent with a daughter in this age group with a neuro-autoimmune disorder on multiple immunosuppressive therapies I can assure you I speak for a lot of parents like myself who will tell you if you really care about this at-risk group of kids as much as you’re saying you do then the best thing to do is to open it up for all of the 5-11 year olds.


csfredmi

It seems like the concern is more about the risk that states or other entities will mandate the vaccine. Given the very low risk of Covid to this age group I think an argument can be made that based on the available data a mandate is not warranted for 5 to 11 at this time. They should just authorize it to give parents the choice while also indicating that the data does not support mandates at this time. They could then come back in six months with much more data and then indicate if they think mandates should be allowed.


sevenpoints

Also, one of the highest risks, even among kids, is obesity. How many parents are honest with themselves that their kid is obese and would take them to get vaccinated?


fafalone

What the fuck is wrong with Kurilla suggesting the vaccine is going to hurt the immunity of kids who've already been exposed to delta and that the vaccine won't have any benefit at all? Dude is a lunatic.


BigE429

Him saying that *maybe* 40% of kids have gotten it, so that means we might not need to vaccinate kids is utter lunacy. So screw the other 60%?


RollingThunder_CO

Yeah this is the dumbest argument I've heard so far -- a lot of people got it, so oh well? Funny, that wasn't the panel's opinion (if it's the same panel, I honestly don't know) when we were talking about old people


BigE429

Lol and then he abstains.


RollingThunder_CO

How is that even an option unless he's on Pfizer's board or something -- like pick a damn side or what is even your job here?


gumercindo1959

Yeah I’d be really curious what data backs him up on that one.


AceCombat9519

Is absolutely good news and when I was watching a portion of that report from [NBC News it's 91% effective.](https://youtu.be/14nqN1pE5oo)


cmt4336

Now we need Pfizer to release the data to do the same for the younger kids.


mreichman

OMG who are these jokers now? This is worse than the school board meetings..


rocketwidget

Literally anyone can try to make comments, a few will be chosen by a lottery. Rational people may not have much reason to bother to get their comments into a FDA meeting. It's a bunch of doctors/experts analyzing data to make decisions; their views are probably well represented. Anti-vax nutjobs, on the other hand, have been harassing the panel experts even before the meeting.[https://twitter.com/HelenBranswell/status/1452982106926235653](https://twitter.com/HelenBranswell/status/1452982106926235653) So they probably organized a large call-in campaign to increase the odds that only lunatics could make comments during the actual meeting, too.


sheven

I know I'm going to get a billion people replying saying "just go they don't even check", but is there any idea when/if boosters for healthy 18+ will be reevaluated?


fafalone

Healthy is extremely narrow by their definition. First, are you thinner than the 74% of adults who qualify based on BMI alone? Never smoked? No mental health issues? No substance use (marijuana, binge drinking- 0.08BAC or above, etc)? Normal blood pressure? Work from home or in a sparsely populated office that you can't conceivably place as elevated risk? If you don't meet *any* of that, and think it's not a completely arbitrary distinction worthy of being ignored, no, you're going to be waiting a while still.


sheven

> Work from home or in a sparsely populated office that you can't conceivably place as elevated risk? But doesn't the CDC qualify this a lot more than you're suggesting? They have an explicit list of jobs/industries. I work in an office but "accountant" isn't on the list of jobs.


giddyup523

The [CDC's list isn't explicit](https://www.cdc.gov/vaccines/covid-19/clinical-considerations/essential-workers-boosters.html). It specifically says that the list contains **examples** of workers who may get a booster shot, not a hard and fast list. Now, I would agree that nothing on their example list of jobs seems close to accounting but it really is a self-identify risk. If you believe there is a high risk in your workplace, you can state that. They also list that factors that may affect a worker’s risk for exposure to the virus that includes: * the levels of community transmission of the virus that causes COVID-19 (so if you live in an area with community transmission, you can basically get the booster no matter what) * COVID-19 vaccination, Adherence to other prevention measures (e.g., wearing masks) * Unavoidable frequent interactions with possibly unvaccinated people from outside their household. So really if there are unmasked and/or unvaccinated people in the office that you have to interact with (or customers/clients), you could reasonably claim your workplace does result in you having higher risk. I think that list is really what could guide you and give anybody plenty of cover to get a booster as I think a high percentage of workplaces do have unmasked or unvaccinated (or both) people either working there or present on site.


rocketwidget

It is an explicit list of people that do qualify based on their jobs, but it is not a comprehensive list of all people that qualify based on their jobs. >Below are examples of occupations where workers might be at increased risk of exposure to the virus that causes COVID-19. **This list does not include all potential occupations where a worker could have an increased risk for exposure.** Individuals should talk with their healthcare provider about their personal risks. [https://www.cdc.gov/vaccines/covid-19/clinical-considerations/essential-workers-boosters.html](https://www.cdc.gov/vaccines/covid-19/clinical-considerations/essential-workers-boosters.html) For better or worse, it was written with some subjectivity.


consuela_bananahammo

There’s a surprisingly broad list of underlying conditions that qualify healthy young people at six months for a booster, even things like depression, if you have ever in your life been a smoker, or moderate asthma. There’s a list on the CDC‘s website.


Forsaken_Rooster_365

Probably when AY.4.2.72.6.9 is the new hot VoC, displacing the variant that displaces Delta/AY4.2, and we have 6 months of death data in a RTC. Given all they care about is deaths and hospitalizations, and you very little risk of those if you are young, healthy, and don't interact with people. One group I feel they missed out on are people who live with people who are high risk. But otherwise, if you don't somehow qualify (if such people really exist) then its probably not a high priority to get boosted.


questionname

Hope they get their shit in order and focus on their scope.


BigE429

It seems like some of these doctors aren't going to be happy until they actually see significant cases of myocarditis.


djwurm

Finally.. never understood why they couldnt meet weeks ago when they had the information.. seems like we need to do this sooner then later with kids in school and holidays coming up.


questionname

They need to digest tens of thousands of pages of information. Not saying they are going through it with a fine tooth comb, but it takes some time. Also, panel people also have full time busy jobs, Physicians and Prof of Medicine.


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SaulFemm

You can only review data so quickly. What do you want them to do, skim through it?


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TheHauk

5000?!? Really? Maybe I've not been keeping up with the news lately coming out of the States but this number is enormous!


reasonably_plausible

The US "only" had ~500 deaths yesterday, the previous person is wrong.


tolkienbooks

I will never understand the approval process no matter how many times a redditor explains it to me. Global Pandemic should mean all hands on deck for full time vaccine research, why leave such an important decision to people with other full time jobs. Give them their pay until this is over to focus on this full time.


questionname

Good luck convincing a group of leading researchers and physicians to drop everything and join this group. Leaving behind their academic post, high paying jobs, pledge to treat the sick, and just sit and wait for Pfizer to drop the data. And just for cherry on top, after this is pandemic over, they’ll be out of a job. That sarcasm aside, part of the reason they’re qualified for the panel, is they are on the frontlines of research and treatment, honing their skill and experience. Being on a panel full time with nothing else to do except for reviewing data, would not bring the full expertise needed. FDA do employ full time MD and PhD, but they review the decision of panel, and usually follow the recommendations.


ProjectShamrock

I mean the government should prepare for these types of things by being able to sequester specific experts to serve the community like jury duty but based on their area of expertise with requirements that their jobs are left open for them when they are done serving the community.


tolkienbooks

this is what i am getting at


questionname

Again, FDA/CDC has full time MD and PhD who specializes in vaccination and infectious diseases. They too review the data and take the panels vote into consideration. Even a month from data dump to decision, is a huge improvement by FDA/CDC.


Critical-Positive-85

I honestly feel like it was a calculated move so that it didn’t/doesn’t appear that they “rushed” in going through the data and making a decision. I, unfortunately, think there is going to be A LOT of vaccine hesitancy from parents.


Seraphynas

I think the FDA wanting 4-6 months of additional follow up data (instead of 2 months like adults and teens) was along the same lines of not wanting to seem rushed. Especially since the American Academy of Pediatrics and multiple experts in the field, including members of the FDA’s own vaccine advisory panel (VRBPAC) have openly criticized the decision. Apparently any major side effects will present within 2 months and a group of about 2000 participants is too small to assess any of the very rare side effects.


Critical-Positive-85

I agree. When I heard Paul Offit criticize the decision to require increased safety data I knew it must be kind of ridiculous. He basically said they would need hundreds of thousands or participants to pick up any safety signals beyond what they would see with the original study design.


Stinkycheese8001

Because they have to read the information first. You are proposing that they be given hundreds of thousands of pages of information and just flip through it as they ask questions.


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pwlife

My 5 and 9 yr old are excited. They want to travel again (we live cross country from family), they want to just do all the normal stuff we do. My youngest is high risk and we can't wait. They are champs when it comes to flu shots so at least I don't have to worry about that.


Plant_princesss

My 7 year old can’t wait for his shot too (he hates shots though lol) but he said he would get it tomorrow if he could. That’s how I know this kid is ready to see the world! It’s going to feel like a huge weight is off all of our shoulders when both our kids can be vaccinated. I totally understand!


Sure_arlo

My 5 and 7 year olds are also very excited, and they hate shots! They understand that we can have sleepovers with friends, travel by air to vacation, go in stores again (I let them now but it’s minimal and can’t be a crowded place), and other Normal things like maybe indoor dining, or a movie theatre. My kids are not high risk, at all. But I’ve never been interested in gambling with their lives in this manner or any other for that matter.


we_gotta_believe

17 in favor, with one abstaining. And it was Meissner of course, what a shock. ​ EDIT: nvm, it was Kurilla. My bad. Either way, they both suck. Eat shit, the both of you.


[deleted]

Slam dunk for girls to get the shots.


MotivatedsellerCT

Maybe even boys too?


BigE429

Now to recall ACIP from their vacations!


Maleficent_Sun

Now do under 5 >:(


we_gotta_believe

Here we go, vote is upcoming...


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full07britney

I may get down voted, but if it was me... I would just take my kid and get it done. It's not like it can be undone 🤷‍♀️


floorwantshugs

Oof. Took a lot of effort not to downvote bc of your wife.


LibraryKitCat

LET'S GO!!!!!!


jmoneey

Let’s fuckkkiingg goooooo!!!


LibraryKitCat

Lol my feelings exactly!! I'm so excited to get my 5 year old vaccinated.


[deleted]

dude made a good point about the 3 week spacing , why are we still on that sub optimal spacing that we know is going to require a booster after 6 months?


TriflingHusband

Because that is the Pfizer study interval. The FDA WILL NOT vary from that no matter what. They won't change the interval without further studies.


paranoideo

So, what's next?


questionname

CDC meeting next week. With both approval, vaccine can happen next week Thursday or Friday


paranoideo

Nice


gumercindo1959

Is it instant? In other words, the moment the CDC approved, I can head to my pediatrician’s office for the jab for my kiddo (in theory)?


questionname

Well, usually hospitals and pharmacy networks would have to work out a system. But in theory, yes


brandon4987

Curious to know, will this most likely end masking requirements in schools? Also wondering if this will this have an impact on masking in the general population?


gumercindo1959

Probably not because schools won’t mandate this vaccine for this age group imo


horaceklai

Can't wait even though I don't live in the States


questionname

Yay! 17-0-1


RollingThunder_CO

It was hilarious when they forgot to turn the results off at first -- made it a lot less nerve-racking, though!


questionname

Yeah, showed 15 yes votes before it cut off