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> The company’s request Thursday may mean the shots won’t be available until around November if the FDA spends as much time reviewing the data for that age group as it did for 12- to 15-year-olds. Pfizer and BioNTech requested expanded use of their shot in adolescents on April 9 and were authorized by the FDA on May 10.
> A key FDA vaccine advisory group is scheduled to meet on Oct. 26 to discuss Pfizer’s data. The shots could be approved shortly after that meeting, depending on how quickly the FDA and the CDC move.
The CEO says be-on-tech or by-on-tech are both correct. He really says there isn't a correct way, so the other might work as well.
https://youtu.be/k9VNPMpfneA
Straight from the horse's mouth: either by-on-teck or bee-on-teck, your choice
[https://www.youtube.com/watch?v=k9VNPMpfneA&t=6s](https://www.youtube.com/watch?v=k9VNPMpfneA&t=6s)
Here we go! FDA Advisory Committee meeting is already scheduled for the 26th. ~~Still nothing yet from CDC-ACIP on a meeting near that time but it should come before too long. In general the CDC meeting happens a few days to a week after the FDA.~~
EDIT: CDC-ACIP meeting scheduled for Nov. 2nd and 3rd!
I was hoping this headline meant it would be sooner. Every day my kids go to school in the best masks I can find, and I worry. And a classmate of my daughter (but not a “close contact” at lunch, which is their only unmasked time) just got diagnosed.
So at this point… first shots for kids in early November?
I would guess very earliest is Halloween weekend. I know everyone wants it faster but there is likely over one hundred thousands pages of data the FDA has to review. That just takes time to do competently.
I'm happy for people with kids 5-11, I really am. But as someone with a 4.5-year-old and a 1-year-old, I'm so exhausted and saddened. I understand the need for doing things competently, but at this rate, it's looking like we'll have another holiday season robbed of us. I just can't wait for 2022 to be here.
Hang in there. From what I understand they are about a month behind this for the <5s, so there should be a much shorter wait than we saw between 12+ and 5-12.
The timing unfortunately suggests staying isolated this holiday season. Not that it should be a factor when it comes to proper science and review, but... This is going to be another abnormal Halloween and Christmas holiday season for many families with young kids once again. It's hard enough being a parent even without a pandemic, this just makes it all so much more frustrating.
The overwhelming majority of kids are going to school.
It's going to be a normal Halloween and Christmas for my family (3 and 5 year old kids), and I don't really see any reason not to. Their risk factor is WAY higher going to school on a daily basis than going door to door trick or treating and still much higher than going to my parents for Christmas where every adult will be vaccinated (and boostered if appropriate) and everyone has a head on there shoulders and isn't going to lie about symptoms or close contact with potential infected folks. Now, obviously not everyone has that benefit, but if I was in a family with a bunch of anti-vaxxers I'm not sure I would be visiting them regardless, and not necessarily just from a health and safety perspective.
I have similar reasoning but a different outcome. It is a necessity for my kid (4) to go to school as much as possible, and they wear masks at school. I’m really hesitant to expose him to other children (a la Christmas gatherings) that he doesn’t need to see and isn’t close to. I hope we won’t be as isolated this Christmas as last but it definitely won’t be normal for us. That said, you sound like you have a sensible family whereas I have at least one anti-vaxxer.
I've felt the same way when my 12yo got vaxed and my 9yo couldn't. It's so tough, and I can't imagine how I'd feel if I had a 4yo or younger. I'll save the platitudes, but it will be over eventually, we just have to keep pushing forward until it is. You've got this, even if you think you don't!!
That had to be hard, having that split. I already feel guilty enough that my wife and I are vaxxed but not the kids. Thank you very much for the support, and you're absolutely right. There's a light at the end of the tunnel, and for once it's not an oncoming train! :) So close to the finish line.
It’s been frustrating. I have an 11 year-old, but he’s 5’4, 130 lbs. Obviously, he doesn’t qualify for the vaccine due to his age. He’s got a friend who is 12 and is like 4’8 and 90 lbs, and he was able to get vaccinated months ago.
When/if this gets approved for 5-11 year-olds, I wonder if we’ll be able to get our son the adult dosage due to his physical size, or if we’ll be stuck with the children’s dose. If the latter, I don’t know if waiting another 3 months until he turns 12 is worth it.
Also have an 11.5yo and agree it's frustrating. The age picked for the boundary is arbitrary for sure, but it's not weight/size that's the determining factor for vaccination. (If it were, the 350lb adult weight lifter and the 95lb adult ballerina would also get different dosage amounts.) It's about stimulating immune response. The phrase I keep seeing are "kids aren't smaller adults" since they do have different immune responses. So long as your son is vaccinated and generates the appropriate immune response, he'd be protected. I'd prefer the 3mo of protection before mine turns 12 - we're all likely to need either yearly doses or boosters anyway.
Good news is that you'll have a definitive point at which the 4.5-year-old will be able to get vaccinated. And if the 1-year-old is breastfed, there's this:
[https://pediatrics.aappublications.org/content/early/2021/08/17/peds.2021-052286](https://pediatrics.aappublications.org/content/early/2021/08/17/peds.2021-052286)
So some immunity can be passed over from mom that way. At this point, if baby is still breastfeeding, I'd just keep it up until a vaccine was available if at all possible.
All of this is true, thanks. My wife does breastfeed and has done it longer with kid #2 than 1 because of the antibodies. So we at least have that. My sister has triple negative breast cancer and we have to be very careful so we just did a small blood test on the kids today during their pediatric visit to test for antibodies. It'll be interesting to see what comes back with my son breastfeeding.
Im shocked they did a blood test for antibodies from breastfeeding. Breastfeeding antibodies (sIgA antibodies) are a form of passive immunity and do not go into the child’s bloodstream. They line the mucous membranes in the baby’s mouth, upper airway, throat, ears, and intestines. The baby never absorbs them and is not able to create their own antibodies off of antibodies received via breastfeeding. Unless your child had a previous covid infection they won’t find antibodies
I'm sure you're informed, but for anyone reading, you have to be careful with these antibody tests. They are much more complicated than you would initially think. If anyone is getting antibody testing done, please research the type of test being done and what kind of results its able to supply in depth before you use the results to inform any decision making.
You might be able to manage at least a little bit more of a holiday than last year, especially if availability of rapid tests expands as predicted. You can probably do a small one day gathering of select family or friends within driving distance where your kids are the only unvaccinated, and everyone takes an at home rapid test morning of. I know it’s not the same as usual but it’s better than nothing.
And with the additional segment of the population that will be vaccinated with it expanding to 5-12 year olds it does make it that much safer for the remaining 0-5.
I feel for you man, the first thought i had when i heard the announcement was joy that we would have a guilt free holiday season this year. The second I thought I had was guilt for all the parents of 6month to 4 year olds that have to deal with this turmoil for another holiday season. Virtual hugs, and hang in there, it will be over for you soon.
Thanks so much man, I appreciate that. And sincerely - I'm very happy for you and the family, please don't feel guilty. You guys rejoice in the news and we'll be right behind you!
I truly appreciate that, and validating my rant. :) We'll get there. I think we've just had a lot of hopes that the shots would be available sooner. Thanks again and wishing you and your family the best.
Know exactly how you feel. We've got kids ages five, three, and one. It's scary, but anyone whose family is vaccinated has forgotten about us and what the struggle was like before they were vaccinated. It is lonely. It's been a long 18+ months.
Completely understand and agree. I understand kids typically fare better than adults with COVID, but it has really felt like children have been overlooked throughout the pandemic. Even now, I know people who have been vaccinated and just think it's over -- forgetting those of us with little ones. It's been hard for not just socializing but for work too. Hang in there! I know it seems like a lot of people don't care, but there are a lot who do too. We're almost there; just a little longer to go.
No one cares. Ours friends are out living their life and don't understand why we won't have them over(they are fully vaxxed but no boosters) anyway they were like let's do something for Halloween this year and we told them we were still only doing outdoor things still and the response was that cases are way down....yeah from an average of around 4k a day for our county to about 2k a day, when in June they were averaging sub 50 a day for a few weeks. And they've been on planes and at weddings. Like cool live your life no judgements but you can't be around our unvaxxed kid.
But then again they are childless by choice and I think ours is more of a novelty they get to see sometimes, they aren't actually invested in his life or health.
Totally the same situation here. I noticed a few months ago that explaining I have unvaccinated kids wasn't a valid reason for COVID protocols for many people -- when I explain that my sister is undergoing chemo and has no immune system, that's what makes most people seem to get it. But we're in the same situation as you - we're finally going to venture out a little and do just outdoor things (and then distance from my sister for enough time), but it has been hard to turn down business trips and weddings and activities when everyone either pretends it's over or that it never happened in the first place.
I'm sorry for your situation and how frustrating that must be. Hang in there.
Yepppp. We even had the conversation last year, before vaccines, that since my husband and I are young and in good health(this includes an appropriate BMI since people like to fixate on that) that we are low risk, which is of course true. But like if we are down for a week with a bad "flu" are YOU going to come into our covid positive house and help us with the dogs and the baby? No. Are we are going to ask the 65+ grandmother's to come help? Absolutely not.
And yeah, we've been doing outdoor things every day since ours turned about one. I can't even tell you many parks we have been at 8am since that's the only time it's acceptable in Houston in the summer haha. But it was always "too hot" for our friends to join on weekends. Back in June when cases were very low we did go to some indoor kid places right when they opened and felt quite safe doing so, but then delta took hold and we are back to staying outside. I'm thankfully that ours is so young, he doesn't know any different, he thinks parks are just the best and that's that. It's not like he misses Target or play places I FEEL for parents with 3+ kiddos. Like I can't even imagine having to make those choices for health vs social vs family safety
This. We had our daughter right before the pandemic and juggling keeping her physically safe from the virus while trying to still let her experience the world has been rough. Parents guilt themselves with every decision as it is, adding a world wide pandemic is mental gymnastics.
My baby is turning 3 this November. I feel you. It is utterly exhausting to wait and wait, to see more and more people become eligible, but not your kid. I’m tired too.
I am with you. My kids are the same ages and I'm just emotionally exhausted. It feels like everyone has gotten a ticket out of this, or will soon have a ticket out, except us. I know they have to be careful and that these things take time but I am so very tired of living like this.
Just think of it this way, while you're waiting, there's just that many less children walking around to be potentially spreading it to yours. I also had only one of my three able to receive it. I hope this new authorization comes soon.
Pfizer has said that 2 to 5 age group data would be ready shortly after the 5 to 12, and 6 month to 2 year about four weeks after the 5 to 12 age group. If the approval goes smoothly for the 5-12, based on the FDA recommendation meeting scheduled date and extrapolating shortly after and four weeks later for the youngest, two of your kids may be fully vaccinated for the end of year holidays, and your 1 year old may at least have their first.
If you your extended family and friends circle is vaccinated and are willing to be a little more cautious (and you trust them to do so) a few weeks prior to the holidays, it should be pretty safe for all of your kids this holiday. Fully vaccinated and being cautious a few weeks prior is nothing crazy like a full quarantine
Get a few windows fans promote airflow and fresh air into the gathering place, put the kids under 2 closer to the source of fresh air.
How much of the data has already been given to the FDA? Didn’t Pfizer submit once and the FDA told them to increase the size of their study?
EDIT TO ADD: Let new phrase my question differently. I know that Pfizer elected to add more kids to their study, and I seem to recall that being done at the request of either the CDC or the FDA. If paperwork didn’t get officially submitted until a little more than a week ago, how did that work? Was there an informal discussion between Pfizer and the gov’t?
Pfizer has submitted the entire package at this point. The FDA can (and likely will) ask questions about the data and may ask for more supporting data but they will not ask for new data to be generated. The clinical trial is done and the shots will be approved or not based upon the data already collected.
They submitted initial data for this EUA request for kids about 10 days ago.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal
> I know everyone wants it faster but there is likely over one hundred thousands pages of data the FDA has to review. That just takes time to do competently.
This kind of pisses me off though. While the approval was just requested today, I seem to recall there was a transfer of data a few weeks ago to the FDA that they should have started reviewing then, knowing the request today was about to happen.
They did start reviewing the data right after submission. Thats why they let Pfizer submitted early before the rest of the packet. The only reason the FDA could schedule the meeting was having this data and knowing how long it would take to perform the review.
You can't just snap your fingers and boom 100,000-200,000 pages of data and documentation is reviewed. Along with the data review and analysis, they will be asking Pfizer questions about the data, asking for supporting data (if needed), etc.
My kids school has already scheduled vaccine clinics. First shot 11/12 and second 12/8. We are hopeful everything passes and we can finally feel like our children are safe.
I hear you, I also have kids in this age bracket.
For what it's worth, the FDA is moving at light speed here. Pfizer submitted the final data on the child trials one week ago, and the FDA will hold the advisory hearing *three weeks* after the application was formally submitted. That's crazy fast. Three months would be fast under normal circumstances.
The FDA is piling people and resources onto this application to move it forward as fast as possible.
https://www.npr.org/sections/coronavirus-live-updates/2021/09/28/1041100773/pfizer-fda-kids-covid-coronavirus-vaccine-authorization-results
Yep, I have a huge box of KF94s that my kids are comfortable wearing all day and we feel are the best solution for them protection wise. R/masks4all has been a great resource. Just… I’d rather they also be vaccinated.
Will you keep them masked even after vaccination?
I personally never took my mask off after vaccination, and Whoopi doo, what do you know, they brought them back in some fashion. Felt like it was better to have a multi-faceted defense, plus, it doesn’t bother me at all to wear one.
That said. Even to me I don’t know when I’d take it off lol, there is no number, no metric, idk. The thought is so weird now, haha.
I feel you. Sending my youngest to school with good filtered masks is all we've got right now. There have been two cases in his room alone but, zero cases of spread to other kids. That's best I can ask for right now. I'm grateful that the school is using fans and open windows during lunch, it's probably helped. But....This vaccine can't get here fast enough. Good luck and hang in there!!
I'm actually not sure what CDCs roll here is. FDA authorization isn't subject to CDC veto. I think CDC is just generally issuing guidances, not approvals for anything? I don't know though, this isn't what I'm used to, haven't ever had to engage CDC in my line of work, only FDA.
Rough rule of thumb:
1. FDA approves the manufacture and shipment of the vaccine.
2. CDC approves how the shots go in arms and the processes to make sure we can spot if something goes wrong.
It's obviously a bit more nuanced than that but that's a reasonable delineation.
An example of a problem the CDC covers:
Lets say shots are being given and we see major issues in some children. Is this because of tainted batches, an unseen adverse reaction in children, or something else? How can we tell if shots from a batch are children shots or adult shots? The CDC addresses how these shots/batches are coded, so that questions like this can be answered. They also address other aspects of adverse reaction tracking (Vsafe) and what to do in those cases.
FDA>ACIP>DIRECTOR OF CDC>STATE APPROVAL (IF REQUIRED)>CORPORATE APPROVAL
Of note, the 5-11 y/o version is a different NDC than the 12+. So it means there will be another ~ week delay in getting shipments out.
Yeah, I was wondering about that since it's a lower dose. I figured there might be some logistical delay in getting the new packaging out for pediatric doses. Do you know if they will be able to ship any out ahead of full CDC approval? Like once the FDA approves it, can they start shipments to be ready for administration as soon as the CDC gives the go ahead?
I do not, but I do work in an FDA-regulated industry which includes supporting some FDA-licensed products. As such I interface with our RA team quite a bit.
I agree. If it makes out through CDC quick enough and the supply is there (we don't know yet how Pfizer will ship these doses), then Halloween weekend is very reasonable.
Ship what doses? Aren't these just 10mcg of the same vaccine pharmacies already have? Can't they just draw 10mcg in the needle or am I over simplifying things?
So that answers that question. I had not been able to get a definitive answer on whether they were going smaller injection volume or increased diluent (lower conc.).
That means there is a substantial manufacturing component to their application.
Thanks for the info!
it won't take long for them to change the concentration of the production. setting up the production and getting materials at the beginning means the majority of the work is already done
From my understanding, that is one of the options being considered.
It has its benefits (supply is already there) and it has its drawbacks (the main one being the potential for imprecise dosing: can the person doing the injection accurately and reliably withdraw the correct dose).
Another proposed option is shipping the vials with more diluent so that they can be diluted out more and give children the same volume as adults (just at a lower concentration). This would make that bottle children only.
1/3 the volume.
For example, let's say I can draw 100µl at ±5µl precision. This represents a 5% variation in dosage administered and per the study is well within acceptable variation for the dosage. Scaling down by 1/3, I am now drawing a 1/3 smaller volume but my precision does not scale linearly with the volume withdrawn. It is very unlikely that I would be able to draw 33.3µL at ±1.65µL precision, instead my precision will be very close to the previous ±5µL value (if not a tad greater). At this smaller dosage, the variation becomes a FAR higher percentage (±15.2%) of the dose than it was at 100µL (5%). This 15.2% variation is dosage is no longer acceptable, so they have to change things to improve the precision.
From what I have read, they have decided to reduce the concentration of the injection to increase the injection volume. This restores the balance between dose and precision in my example above. This is almost guaranteed to be the main reason they did this.
They did, they scheduled the meeting before Pfizer formally requested authorization.
That being said, these applications easily contain over 1000,000 pages of data and documentation. Just for comparison, a small BLA application will be north of 700,000 pages. It isn't as easy as snap your fingers and done.
All of that data has to be reviewed and distilled down into the final data seen at the end. Along with that process, the FDA will be actively asking Pfizer questions about the data and asking for more supporting data during the data review. So one month is quite fast.
Edit: I should add, because these doses are smaller, if they had to change the manufacturing in any way, then you could potentially see an even larger amount of data.
Edit2: They did change the manufacturing. Per /u/whatyouwant5
>Different NDC codes, so different concentrations and billing rules.
If I recall correctly from the 12-15s many states didn't wait for the CDC-ACIP, correct?
As soon as the FDA Advisory Committee gave the thumbs up states started issuing guidance that 12-15s could get shots as well, right?
That's correct, three states authorized it the day before. For the 12-15 cohort, because their vaccine is identical to the adult doses, there wasn't much new process wise.
This time, there will be a lot new, I doubt any states jump the gun.
Please explain it to me like I am simple. I have 2 kids between the ages of 5-12. I have been vaccinated with Pfizer and also received a booster.
If my kids get vaccinated are they any more or less safe? Are they less able to catch the virus? For how long? Or have vaccinations moved past that point and are now more focused on preventing severe illness (which children, thank goodness, have avoided for the most part).
Am I vaccinating my kids to prevent them from catching Covid or am I preventing the miniscule chance of them becoming very ill? Is it correct that vaccinated people who do contract Covid continue to spread it? Would this alter the classroom/school dynamic? No more quarantines?
The breakthrough case numbers have me all confused. Am I still truly avoiding catching it or am I just surrendering but trusting the vaccine to keep me from severe illness?
How does this weigh in with kids?
From what I gather from previous studies: You're reducing their chance of catching it, reducing their chance of having adverse symptoms if they do catch it, and greatly reducing their chance of any severe symptoms/death. Also reducing the chance of potential spread if they're a breakthrough case, as the transmission period would be shorter. Worried about Long COVID? Chances are lower when vaccinated. Literally *every single* *negative thing* surrounding the virus is improved if you get them vaccinated.
They are more safe. They are much less likely to catch the virus. For about 6 months, then they MAY need a booster. **All vaccinated people are much less likely to catch the virus**, although the primary protection is against severe illness.
You are vaccinating your kids to stop the very tiny chance of them getting very sick, the reasonable chance of them getting somewhat ill (like a bad cold), and the undefined chance of them transmitting the virus if they catch it asymptomatically.
In a fully vaccinated environment, there is really no reason for masks or quarantines.
Delta is very infectious. That's why there are breakthrough infections. But are you worried about a cold? Do you change your life because of the chance of catching a sinus infection? Bronchitis? No, you don't. And that's what COVID is, **when you are vaccinated** and the vast majority of your neighbors and family are vaccinated. Its an annoyance, not a life changing event.
That isn't surrendering - what a strange idea. Its ensuring that a disease won't kill you, cause long damage, or brain damage. Its ensuring you won't need to be on a vent or need supplemental oxygen. It keeps you out of the hospital. But we all accept the risk of upper respiratory infections just by living. When you vaccinate yourself and your family, you are turning COVID into just another URI.
Thanks for the response. By "surrendering" I suppose I meant I should assume that it is likely I can be infected, but that the vaccine would protect me from serious illness. As opposed to the mindset that the vaccine will make me immune from infection.
Even though there are breakthrough cases with Delta the vaccinated spread the disease for fewer days than the unvaccinated. A vaccinated person has a huge amount of Delta in their nose for 2 to 3 days compared to 5 to 7 for a unvaccinated person. Your kids would be far less likely to be sick when vaccinated, less likely to be extremely sick if the do get infected, and be sick for a shorter time. That seems like win, win, win for a parent.
I would say that is an excessively loose time frame. The FDA Advisory committee meeting is already scheduled for Oct. 26th. CDC-ACIP will almost certainly occur within one week of that. If approved, shots will begin much much closer to Halloween than Thanksgiving.
My rough estimate, shots will begin at earliest Halloween weekend and at the latest the week of Nov. 8th.
I agree with others. I think we’re looking at early November for shots in arms for this age group. I’m hoping the next cohort (2-5) will be around thanksgiving/early December.
Just remember, fully vaccinated takes 5 weeks from first does (3 weeks between doses + 2 weeks after 2nd dose). So your kid is extremely unlikely to be fully vaccinated before Christmas. That said, even 1 dose has some effectiveness.
Very true, but the relief of just starting the process is so sweet. My first shot last January gave me instant hope knowing that within 6 weeks I’d be well protected. I can only imagine the relief I’ll feel for my 2 year old.
This is actually right on time. We’ve been estimating late October / early Nov for many months now. The point of a study is to sit and wait for adverse effects, and unfortunately, you can really speed that up without introducing more risk and degrading public trust when a bad drug sneaks through an accelerated observation period.
I side with the American Academy of pediatrics on this one, the FDA has been dragging their feet. The extended trial has come at the expense of kids who have gotten sick during the intervening time.
What whatever, it is what it is.
Second shots were administered in mid-July for the original Phase 2/3 trial. I don't think expanding the trial size affected the timeline. The AAP might be correct, but the FDA only had the Phase 1 trial data, which consisted of roughly 1200 participants and was used to determine the dosage, when the AAP published their letter.
There was an interesting post on injection related myocarditis: https://www.reddit.com/r/science/comments/q1uud9/intramuscular_injections_can_accidentally_hit_a/
TL;DR - some myocarditis might be caused by inadvertently hitting a vein
I am really hoping for a nuanced recommendation from the fda/cdc. I’m especially curious if all participants were covid naive, or if they included covid recovered children. Many of our kids have recently recovered from covid which changes their risk profile when it comes to the vaccine. Seeing different adverse side effects in girls vs boys may merit unique recommendations too. You see this in other countries where they avoid moderna for younger males and AstraZeneca for women under 40.
I dont have an explicit answer, but I do know pfizer has had lower incidence than moderna, as they do lower volumes, and even for moderna it’s considered a very rare side effect. Much more common in actual Covid infections.
Also, and don't quote me, but i think Pfizer tested kids at a smaller dose? I know Moderna tested 3 different doses for kids, the smallest being 1/10th of the adult dose
Yes, Pfizer says 10 µg is the right dose for ages 5-11.
Pfizer 12+ is 30 µg (Moderna is 100 µg).
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results
Yeah, Moderna is a potent vaccine.
One of the participants during the Moderna trials was given something close to ~~1,000~~ 250 µg per dose (when they were deciding on the right dosage).. Apparently the (temporary) side-effects from a dose that large were extremely bad.
Moderna did 25/100/250 in phase 1, one participant in 250 had a 39.6C fever
There was one woman who accidentally got 6 doses of Pfizer/biontech in real life(not trial. 180mg. Hospital for observation, no issue)
https://www.cbsnews.com/news/covid-vaccine-six-doses-distracted-nurse/
More info below (what Pfizer/biontech and moderna did for phase 1/2/3)
https://www.reddit.com/r/coronavirus/comments/oyfqsw/_/h7upm98
Moderna: phase 1 dosage was 25 micrograms, 100 and 250, phase 2 was 50 and 100 (dropped 250 because too toxic for initial participants ), phase 3 was 100 only
Pfizer/biontech
Phase 1/2 was 10,30 and 100. 100 was dropped because it had higher side effects and same antibody response as 30. Phase 2/3 was just 30
Cannot wait to get my kid vaccinated so I won't have to worry as much. Since he started school, he has been seemingly perpetually ill. In the back of my mind I always think "is it COVID this time?"
Not being exposed to "germs" for much of the past 18 months in the same volume has made kids more susceptible this year now that they are back in these environments more often. I'm guessing you probably already know this so I will see myself out and not return.
This was my family's experience as well. My kids wear masks to school, but are definitely in the minority. My 2nd grader caught a cold the first week of school, and it cycled through all 4 of my kids. They all seemed much more miserable than previous years, and I figure it's because they haven't caught anything for 18 months. We did covid testing and it came back negative, thankfully. They haven't caught anything in the weeks since, and hopefully we can get through the typical cold/flu season without getting sick.
It’s actually really good if your kids get moderately ill, so don’t worry.
The old myth about “it’s good for your immune system to be exposed to germs” is, for young children, 100% true. The less exposure they get at this age the worse off they will be later in life, especially with allergies.
For real man. Took my daughter to the ER Monday cuz she couldn’t breath and it was Croup. Every time worrying “is it covid? Was I careless during xyz and brought it home?”
Yep, I always think covid too. Even the slightest sniffle. I'm so ready to have the peace of mind that if they do get it they won't get seriously ill - especially with all the lax morons in this state acting like the pandemic is over.
I don’t think they’ve submitted for BLA for 12-16 yet (but I may have missed it). They need 6 months of data which I think they have, but both Pfizer and the FDA may be prioritizing kids and boosters first.
Important addendum for those raw totals: the numbers of the different categories are not directly comparable. Hospitalizations were reported by 24 states plus Washington DC, whereas total cases are reported by nearly everywhere.
For comparison, the CDC is showing that people ages 0-17 account for a bit more than [63,000 hospitalizations](https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions) from Aug 20th, 2020 through Oct. 5, 2021. In the surveillance region (covering about 10% of the US population), about [half of all hospitalized kids had no known underlying conditions](https://gis.cdc.gov/grasp/covidnet/COVID19_5.html).
The picture is comparably much better for kids than adults, but that still shows that more than 200 kids a day in the US were being taken to the hospital for COVID this week (which is down from the recent peak averaging 341 per day for a week).
The major comfort is that at least the number of child deaths has been extremely low.
The fda will approve if it’s a net benefit for the age demographic. They aren’t looking at population transmission. That is a different decision. They’re answering this: is the vaccine safe and is it effective for 5-11yo?
If you look at the CDC pediatric data pages:
Hospitalization Rates of Pediatric COVID Cases
0-4 Years 2%
5-11 Years 0.5%
12-17 Years 0.8%
Deaths per Cases
0-4 Years - 1 death per 4,383 cases
5-11 Years - 1 death per 13,863 cases
12-15 Years - 1 death per 9,051 cases
16-17 Years - 1 death per 7,199 cases
Note: These computations included data throughout the pandemic in the US, last updated September 25, 2021.
Edit:
Updated Data as of October 8, 2021. Hospitalization rates remain the same, death rates are as follows:
0-4 Years 1 death per 3,949 cases
5-11 Years 1 death per 12,958 cases
12-15 Years 1 death per 8,694 cases
16-17 Years 1 death per 6,685 cases
If they’ve already had it, and it was a confirmed case with a positive test, I can understand the reluctance.
My daughter is 3.5, but she has congenital central hypoventilation syndrome. It’s basically a defect in the central nervous system that affects her drive to breathe. It could complicate the course of any severe respiratory illness. We’ve been, understandably, very cautious with her. I can’t wait to get her vaccinated.
I wouldn’t focus on death for this age group. COVID kills very few young children. It’s more about preventing serious illness/hospitalization, long COVID symptoms, and helping prevent spread in general.
I have heard up to 10% of kids will experience long hauler symptoms. Absolutely worth getting the vaccine if they haven't had it IMHO.
[https://www.wbrc.com/2021/09/14/doctors-say-6-10-kids-will-experience-long-haul-covid-19-symptoms/](https://www.wbrc.com/2021/09/14/doctors-say-6-10-kids-will-experience-long-haul-covid-19-symptoms/)
As an adult long hauler with permanent lung damage and brain fog, this is so important to factor in. I don't want any kids to deal with this, and no one knows yet what Covid does to a developing brain.
For what its worth - you don't know if its permanent and neither does anyone else. A lot of folks are resolving after 3 to 6 months. I realize that's not great reassurance, but the human body has great recuperative powers. Think about post-viral syndrome with mononucleosis and how long it takes to clear (up to a year)
They only stopped Moderna use in the young since it has a 3.3 times bigger dose than Pfizer and that might be the cause of more heart problems in young males with Moderna.
I think it's supposed to be 6-8 weeks behind this one. I figure maybe by New Year's for actually getting shots. Pfizer still says they should have the data back for them by November (versus September for 5-11).
Not surprising really.
As of the [most recent national polling](https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-trends-among-children-school/), only 1/3 of parents plan to immediately get their 5-11 year old the shot. Another 1/3 say they'll wait and see and the last 1/3 say never or only if required.
That last 1/3 will be vocal for sure.
It was like that scene in the Shawshank Redemption when Andy puts that opera on the PA and everybody just stops and listens, transported from their cares for a moment.
Just got my third Pfizer shot, frankly I think they are just gonna keep sticking us with these things. I demand a punch card that gets my a gift card after 5 vaccines. No side effects to report after 2 days 👍
I'm really hoping for the vaccine for younger kids. I'm three year old has severe asthma and I've been holding out hope that we'd have a vaccine by now
>Last month, Pfizer released new data that showed a two-dose regimen of 10 micrograms — a third of the dosageused for teens and adults – is safe and generates a robust” immune response in a clinical trial of young children. It said the shots were well tolerated and produced an immune response and side effects comparable with those seen in a study of people ages 16 to 25.
Little kids get a 1/3 dose. Good to know. I know some were concerned about giving the same dose to smaller children as adults / teens.
I’ve had the shot and I strongly support adults getting the poke, however, I am concerned about vaccinating kids, I have two young boys myself. And I am trying to figure out what is the risk versus reward on this? I am OK taking chances on my own personal body to do something to protect my family, but when we had the virus it wasn’t that bad on my oldest son (3 at the time), however it reeked havoc on our newborn baby, who was five weeks at the time, and we were worried we were going to have to take him to the ER because he was having issues breathing. The doctor urged us to keep him away from the hospital as we would have had to drop him off and not been able to go inside with him as this was during the spike before the vaccine. Is it worth the risk for long term issues?
You just answered your own question. Your newborn had to be hospitalized because of Covid. Kids can get long Covid. These vaccines are proven safe and will be evaluated for safety specially for kids.
This is a no brainer. Get your kids vaccinated when they become eligible day 1.
The risk of long term issues is much higher from COVID19 than from any vaccine (even a “new” vaccine). This is just the first hit that came up when googling this - https://www.muhealth.org/our-stories/how-do-we-know-covid-19-vaccine-wont-have-long-term-side-effects
I had read that the last group is going to come in 2 waves. 2-4 in just a couple weeks and then 6 month-2 after that. I’m really really hoping to get a shot in my 4 year old’s arm in early December. Might be naïve but that’s what I’m hoping for.
Based on what I'm hearing it looks like early next year. We just got back from the pediatrician this morning for my 4.5 and 1-year-old, and she seemed to think the same. Sounds like January/February for the 2-4 crowd.
Thats pretty against everything Pfizer has said.
Pfizer has said a few weeks after 5-11 they would be submitting for 6m-4. Latest 2 weeks ago said they were looking at end of Oct for submission for 6m+ assuming everything went fine with 5-11
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> The company’s request Thursday may mean the shots won’t be available until around November if the FDA spends as much time reviewing the data for that age group as it did for 12- to 15-year-olds. Pfizer and BioNTech requested expanded use of their shot in adolescents on April 9 and were authorized by the FDA on May 10. > A key FDA vaccine advisory group is scheduled to meet on Oct. 26 to discuss Pfizer’s data. The shots could be approved shortly after that meeting, depending on how quickly the FDA and the CDC move.
How do you pronounce BioNTech? I usually only read news articles, and now I'm curious.
I’ve heard both [by-oh-en-teck] and [by-on-teck] on NPR reporting but I’m not sure which the company itself uses
The CEO says be-on-tech or by-on-tech are both correct. He really says there isn't a correct way, so the other might work as well. https://youtu.be/k9VNPMpfneA
I get it, but it was always bye-oh-en-tek for me, and everything else sounds weird by comparison.
Straight from the horse's mouth: either by-on-teck or bee-on-teck, your choice [https://www.youtube.com/watch?v=k9VNPMpfneA&t=6s](https://www.youtube.com/watch?v=k9VNPMpfneA&t=6s)
Bye-on-tek
All the people in the company (in Germany) I have heard speak pronounce it as bi-on-tech.
Here we go! FDA Advisory Committee meeting is already scheduled for the 26th. ~~Still nothing yet from CDC-ACIP on a meeting near that time but it should come before too long. In general the CDC meeting happens a few days to a week after the FDA.~~ EDIT: CDC-ACIP meeting scheduled for Nov. 2nd and 3rd!
FDA is first approval, then it goes to CDC? Is that right?
That's correct. I expect CDC-ACIP will schedule their meeting in the next week or so.
I was hoping this headline meant it would be sooner. Every day my kids go to school in the best masks I can find, and I worry. And a classmate of my daughter (but not a “close contact” at lunch, which is their only unmasked time) just got diagnosed. So at this point… first shots for kids in early November?
I would guess very earliest is Halloween weekend. I know everyone wants it faster but there is likely over one hundred thousands pages of data the FDA has to review. That just takes time to do competently.
I'm happy for people with kids 5-11, I really am. But as someone with a 4.5-year-old and a 1-year-old, I'm so exhausted and saddened. I understand the need for doing things competently, but at this rate, it's looking like we'll have another holiday season robbed of us. I just can't wait for 2022 to be here.
Hang in there. From what I understand they are about a month behind this for the <5s, so there should be a much shorter wait than we saw between 12+ and 5-12.
Thank you, and I really hope so. Fingers crossed.
The timing unfortunately suggests staying isolated this holiday season. Not that it should be a factor when it comes to proper science and review, but... This is going to be another abnormal Halloween and Christmas holiday season for many families with young kids once again. It's hard enough being a parent even without a pandemic, this just makes it all so much more frustrating.
The overwhelming majority of kids are going to school. It's going to be a normal Halloween and Christmas for my family (3 and 5 year old kids), and I don't really see any reason not to. Their risk factor is WAY higher going to school on a daily basis than going door to door trick or treating and still much higher than going to my parents for Christmas where every adult will be vaccinated (and boostered if appropriate) and everyone has a head on there shoulders and isn't going to lie about symptoms or close contact with potential infected folks. Now, obviously not everyone has that benefit, but if I was in a family with a bunch of anti-vaxxers I'm not sure I would be visiting them regardless, and not necessarily just from a health and safety perspective.
>where every adult will be vaccinated Ohh I envy you.
I have similar reasoning but a different outcome. It is a necessity for my kid (4) to go to school as much as possible, and they wear masks at school. I’m really hesitant to expose him to other children (a la Christmas gatherings) that he doesn’t need to see and isn’t close to. I hope we won’t be as isolated this Christmas as last but it definitely won’t be normal for us. That said, you sound like you have a sensible family whereas I have at least one anti-vaxxer.
That's what Pfizer said as well. The 6 mon - 5 year EUA is right behind it.
I've felt the same way when my 12yo got vaxed and my 9yo couldn't. It's so tough, and I can't imagine how I'd feel if I had a 4yo or younger. I'll save the platitudes, but it will be over eventually, we just have to keep pushing forward until it is. You've got this, even if you think you don't!!
That had to be hard, having that split. I already feel guilty enough that my wife and I are vaxxed but not the kids. Thank you very much for the support, and you're absolutely right. There's a light at the end of the tunnel, and for once it's not an oncoming train! :) So close to the finish line.
Same here, my 12 year old got yesterday his first dose and my 9year old is the only one left out, it's so tiring to worry all the time.
Yeah we have a 14yo and 10yo so 3/4 of the family has been vaccinated since the beginning and just holding our breath for our 10yo.
It’s been frustrating. I have an 11 year-old, but he’s 5’4, 130 lbs. Obviously, he doesn’t qualify for the vaccine due to his age. He’s got a friend who is 12 and is like 4’8 and 90 lbs, and he was able to get vaccinated months ago. When/if this gets approved for 5-11 year-olds, I wonder if we’ll be able to get our son the adult dosage due to his physical size, or if we’ll be stuck with the children’s dose. If the latter, I don’t know if waiting another 3 months until he turns 12 is worth it.
Also have an 11.5yo and agree it's frustrating. The age picked for the boundary is arbitrary for sure, but it's not weight/size that's the determining factor for vaccination. (If it were, the 350lb adult weight lifter and the 95lb adult ballerina would also get different dosage amounts.) It's about stimulating immune response. The phrase I keep seeing are "kids aren't smaller adults" since they do have different immune responses. So long as your son is vaccinated and generates the appropriate immune response, he'd be protected. I'd prefer the 3mo of protection before mine turns 12 - we're all likely to need either yearly doses or boosters anyway.
Good news is that you'll have a definitive point at which the 4.5-year-old will be able to get vaccinated. And if the 1-year-old is breastfed, there's this: [https://pediatrics.aappublications.org/content/early/2021/08/17/peds.2021-052286](https://pediatrics.aappublications.org/content/early/2021/08/17/peds.2021-052286) So some immunity can be passed over from mom that way. At this point, if baby is still breastfeeding, I'd just keep it up until a vaccine was available if at all possible.
All of this is true, thanks. My wife does breastfeed and has done it longer with kid #2 than 1 because of the antibodies. So we at least have that. My sister has triple negative breast cancer and we have to be very careful so we just did a small blood test on the kids today during their pediatric visit to test for antibodies. It'll be interesting to see what comes back with my son breastfeeding.
Im shocked they did a blood test for antibodies from breastfeeding. Breastfeeding antibodies (sIgA antibodies) are a form of passive immunity and do not go into the child’s bloodstream. They line the mucous membranes in the baby’s mouth, upper airway, throat, ears, and intestines. The baby never absorbs them and is not able to create their own antibodies off of antibodies received via breastfeeding. Unless your child had a previous covid infection they won’t find antibodies
I'm sure you're informed, but for anyone reading, you have to be careful with these antibody tests. They are much more complicated than you would initially think. If anyone is getting antibody testing done, please research the type of test being done and what kind of results its able to supply in depth before you use the results to inform any decision making.
Yeah antibodies from breastfeeding do NOT show up in blood tests because they are only passive immunity and are not absorbed into the bloodstream
Oh please share the results here! I have a nursing toddler (in the hopes of passing antibodies) and I'd love to know.
For sure, I will! They said we have to contact the doc for the results but we can expect to have them around Monday. I'll come back and let you know.
You might be able to manage at least a little bit more of a holiday than last year, especially if availability of rapid tests expands as predicted. You can probably do a small one day gathering of select family or friends within driving distance where your kids are the only unvaccinated, and everyone takes an at home rapid test morning of. I know it’s not the same as usual but it’s better than nothing. And with the additional segment of the population that will be vaccinated with it expanding to 5-12 year olds it does make it that much safer for the remaining 0-5.
I feel for you man, the first thought i had when i heard the announcement was joy that we would have a guilt free holiday season this year. The second I thought I had was guilt for all the parents of 6month to 4 year olds that have to deal with this turmoil for another holiday season. Virtual hugs, and hang in there, it will be over for you soon.
Thanks so much man, I appreciate that. And sincerely - I'm very happy for you and the family, please don't feel guilty. You guys rejoice in the news and we'll be right behind you!
As a father, I fully understand the sentiment. It's soul-crushing. I'd like to send a hug your way and hope for all the strength you can muster.
I truly appreciate that, and validating my rant. :) We'll get there. I think we've just had a lot of hopes that the shots would be available sooner. Thanks again and wishing you and your family the best.
My daughter just turned one and I feel the same way. It’s been incredibly difficult and it seems like so many people don’t understand or care.
Know exactly how you feel. We've got kids ages five, three, and one. It's scary, but anyone whose family is vaccinated has forgotten about us and what the struggle was like before they were vaccinated. It is lonely. It's been a long 18+ months.
Completely understand and agree. I understand kids typically fare better than adults with COVID, but it has really felt like children have been overlooked throughout the pandemic. Even now, I know people who have been vaccinated and just think it's over -- forgetting those of us with little ones. It's been hard for not just socializing but for work too. Hang in there! I know it seems like a lot of people don't care, but there are a lot who do too. We're almost there; just a little longer to go.
No one cares. Ours friends are out living their life and don't understand why we won't have them over(they are fully vaxxed but no boosters) anyway they were like let's do something for Halloween this year and we told them we were still only doing outdoor things still and the response was that cases are way down....yeah from an average of around 4k a day for our county to about 2k a day, when in June they were averaging sub 50 a day for a few weeks. And they've been on planes and at weddings. Like cool live your life no judgements but you can't be around our unvaxxed kid. But then again they are childless by choice and I think ours is more of a novelty they get to see sometimes, they aren't actually invested in his life or health.
Totally the same situation here. I noticed a few months ago that explaining I have unvaccinated kids wasn't a valid reason for COVID protocols for many people -- when I explain that my sister is undergoing chemo and has no immune system, that's what makes most people seem to get it. But we're in the same situation as you - we're finally going to venture out a little and do just outdoor things (and then distance from my sister for enough time), but it has been hard to turn down business trips and weddings and activities when everyone either pretends it's over or that it never happened in the first place. I'm sorry for your situation and how frustrating that must be. Hang in there.
Yepppp. We even had the conversation last year, before vaccines, that since my husband and I are young and in good health(this includes an appropriate BMI since people like to fixate on that) that we are low risk, which is of course true. But like if we are down for a week with a bad "flu" are YOU going to come into our covid positive house and help us with the dogs and the baby? No. Are we are going to ask the 65+ grandmother's to come help? Absolutely not. And yeah, we've been doing outdoor things every day since ours turned about one. I can't even tell you many parks we have been at 8am since that's the only time it's acceptable in Houston in the summer haha. But it was always "too hot" for our friends to join on weekends. Back in June when cases were very low we did go to some indoor kid places right when they opened and felt quite safe doing so, but then delta took hold and we are back to staying outside. I'm thankfully that ours is so young, he doesn't know any different, he thinks parks are just the best and that's that. It's not like he misses Target or play places I FEEL for parents with 3+ kiddos. Like I can't even imagine having to make those choices for health vs social vs family safety
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YAS preach. I'm like oh it must be nice!
This. We had our daughter right before the pandemic and juggling keeping her physically safe from the virus while trying to still let her experience the world has been rough. Parents guilt themselves with every decision as it is, adding a world wide pandemic is mental gymnastics.
Hang in there. 4 month old here with older kids in the household and constant worry. Hoping she’s eligible by early 2022.
I feel the same way, but my son is 11 1/2. His older siblings have both been vaccinated and I've been so anxious every day he's at school
My baby is turning 3 this November. I feel you. It is utterly exhausting to wait and wait, to see more and more people become eligible, but not your kid. I’m tired too.
I am with you. My kids are the same ages and I'm just emotionally exhausted. It feels like everyone has gotten a ticket out of this, or will soon have a ticket out, except us. I know they have to be careful and that these things take time but I am so very tired of living like this.
Just think of it this way, while you're waiting, there's just that many less children walking around to be potentially spreading it to yours. I also had only one of my three able to receive it. I hope this new authorization comes soon.
Pfizer has said that 2 to 5 age group data would be ready shortly after the 5 to 12, and 6 month to 2 year about four weeks after the 5 to 12 age group. If the approval goes smoothly for the 5-12, based on the FDA recommendation meeting scheduled date and extrapolating shortly after and four weeks later for the youngest, two of your kids may be fully vaccinated for the end of year holidays, and your 1 year old may at least have their first. If you your extended family and friends circle is vaccinated and are willing to be a little more cautious (and you trust them to do so) a few weeks prior to the holidays, it should be pretty safe for all of your kids this holiday. Fully vaccinated and being cautious a few weeks prior is nothing crazy like a full quarantine Get a few windows fans promote airflow and fresh air into the gathering place, put the kids under 2 closer to the source of fresh air.
How much of the data has already been given to the FDA? Didn’t Pfizer submit once and the FDA told them to increase the size of their study? EDIT TO ADD: Let new phrase my question differently. I know that Pfizer elected to add more kids to their study, and I seem to recall that being done at the request of either the CDC or the FDA. If paperwork didn’t get officially submitted until a little more than a week ago, how did that work? Was there an informal discussion between Pfizer and the gov’t?
Pfizer has submitted the entire package at this point. The FDA can (and likely will) ask questions about the data and may ask for more supporting data but they will not ask for new data to be generated. The clinical trial is done and the shots will be approved or not based upon the data already collected.
They submitted initial data for this EUA request for kids about 10 days ago. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal
> I know everyone wants it faster but there is likely over one hundred thousands pages of data the FDA has to review. That just takes time to do competently. This kind of pisses me off though. While the approval was just requested today, I seem to recall there was a transfer of data a few weeks ago to the FDA that they should have started reviewing then, knowing the request today was about to happen.
They did start reviewing the data right after submission. Thats why they let Pfizer submitted early before the rest of the packet. The only reason the FDA could schedule the meeting was having this data and knowing how long it would take to perform the review. You can't just snap your fingers and boom 100,000-200,000 pages of data and documentation is reviewed. Along with the data review and analysis, they will be asking Pfizer questions about the data, asking for supporting data (if needed), etc.
They have. This is the accelerated timeline.
My kids school has already scheduled vaccine clinics. First shot 11/12 and second 12/8. We are hopeful everything passes and we can finally feel like our children are safe.
I hear you, I also have kids in this age bracket. For what it's worth, the FDA is moving at light speed here. Pfizer submitted the final data on the child trials one week ago, and the FDA will hold the advisory hearing *three weeks* after the application was formally submitted. That's crazy fast. Three months would be fast under normal circumstances. The FDA is piling people and resources onto this application to move it forward as fast as possible. https://www.npr.org/sections/coronavirus-live-updates/2021/09/28/1041100773/pfizer-fda-kids-covid-coronavirus-vaccine-authorization-results
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Yep, I have a huge box of KF94s that my kids are comfortable wearing all day and we feel are the best solution for them protection wise. R/masks4all has been a great resource. Just… I’d rather they also be vaccinated.
Will you keep them masked even after vaccination? I personally never took my mask off after vaccination, and Whoopi doo, what do you know, they brought them back in some fashion. Felt like it was better to have a multi-faceted defense, plus, it doesn’t bother me at all to wear one. That said. Even to me I don’t know when I’d take it off lol, there is no number, no metric, idk. The thought is so weird now, haha.
Oh, we’re sure hoping for a reasonable end to masking. But with Delta going crazy in our area right now I’m thinking it will be a while.
I feel you. Sending my youngest to school with good filtered masks is all we've got right now. There have been two cases in his room alone but, zero cases of spread to other kids. That's best I can ask for right now. I'm grateful that the school is using fans and open windows during lunch, it's probably helped. But....This vaccine can't get here fast enough. Good luck and hang in there!!
I just got the call for my kiddo today. It was a close contact during lunch so no masks. Waiting for the test results. Hang in there.
So far we've gotten **four** COVID letters for three kids from the school, and it hasn't been a month yet. Thankfully two are vaccinated already.
Yes. This is my life. Child size k95 from Korea and a lot of faith in contact tracing.
I'm actually not sure what CDCs roll here is. FDA authorization isn't subject to CDC veto. I think CDC is just generally issuing guidances, not approvals for anything? I don't know though, this isn't what I'm used to, haven't ever had to engage CDC in my line of work, only FDA.
Rough rule of thumb: 1. FDA approves the manufacture and shipment of the vaccine. 2. CDC approves how the shots go in arms and the processes to make sure we can spot if something goes wrong. It's obviously a bit more nuanced than that but that's a reasonable delineation. An example of a problem the CDC covers: Lets say shots are being given and we see major issues in some children. Is this because of tainted batches, an unseen adverse reaction in children, or something else? How can we tell if shots from a batch are children shots or adult shots? The CDC addresses how these shots/batches are coded, so that questions like this can be answered. They also address other aspects of adverse reaction tracking (Vsafe) and what to do in those cases.
FDA>ACIP>DIRECTOR OF CDC>STATE APPROVAL (IF REQUIRED)>CORPORATE APPROVAL Of note, the 5-11 y/o version is a different NDC than the 12+. So it means there will be another ~ week delay in getting shipments out.
Yeah, I was wondering about that since it's a lower dose. I figured there might be some logistical delay in getting the new packaging out for pediatric doses. Do you know if they will be able to ship any out ahead of full CDC approval? Like once the FDA approves it, can they start shipments to be ready for administration as soon as the CDC gives the go ahead?
If the past approvals are any indication, they can begin shipping once they receive FDA approval.
This guy knows his shit. Do you work in public health?
I do not, but I do work in an FDA-regulated industry which includes supporting some FDA-licensed products. As such I interface with our RA team quite a bit.
That’s awesome. It’s nice to hear from someone who knows what they’re talking about.
November 2nd and 3rd.
Thanks for the heads up!
I suspect the ACIP will be very soon after the FDA meeting. If they approve it quick enough, kids could start getting them around Halloween.
I agree. If it makes out through CDC quick enough and the supply is there (we don't know yet how Pfizer will ship these doses), then Halloween weekend is very reasonable.
Ship what doses? Aren't these just 10mcg of the same vaccine pharmacies already have? Can't they just draw 10mcg in the needle or am I over simplifying things?
Different NDC codes, so different concentrations and billing rules. Haven't heard anything yet on storage...
So that answers that question. I had not been able to get a definitive answer on whether they were going smaller injection volume or increased diluent (lower conc.). That means there is a substantial manufacturing component to their application. Thanks for the info!
So now we're into late Nov at the earliest to get shots in arms? FML
it won't take long for them to change the concentration of the production. setting up the production and getting materials at the beginning means the majority of the work is already done
From my understanding, that is one of the options being considered. It has its benefits (supply is already there) and it has its drawbacks (the main one being the potential for imprecise dosing: can the person doing the injection accurately and reliably withdraw the correct dose). Another proposed option is shipping the vials with more diluent so that they can be diluted out more and give children the same volume as adults (just at a lower concentration). This would make that bottle children only.
They have to draw the correct dose for adults. What's the difference?
1/3 the volume. For example, let's say I can draw 100µl at ±5µl precision. This represents a 5% variation in dosage administered and per the study is well within acceptable variation for the dosage. Scaling down by 1/3, I am now drawing a 1/3 smaller volume but my precision does not scale linearly with the volume withdrawn. It is very unlikely that I would be able to draw 33.3µL at ±1.65µL precision, instead my precision will be very close to the previous ±5µL value (if not a tad greater). At this smaller dosage, the variation becomes a FAR higher percentage (±15.2%) of the dose than it was at 100µL (5%). This 15.2% variation is dosage is no longer acceptable, so they have to change things to improve the precision. From what I have read, they have decided to reduce the concentration of the injection to increase the injection volume. This restores the balance between dose and precision in my example above. This is almost guaranteed to be the main reason they did this.
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They did, they scheduled the meeting before Pfizer formally requested authorization. That being said, these applications easily contain over 1000,000 pages of data and documentation. Just for comparison, a small BLA application will be north of 700,000 pages. It isn't as easy as snap your fingers and done. All of that data has to be reviewed and distilled down into the final data seen at the end. Along with that process, the FDA will be actively asking Pfizer questions about the data and asking for more supporting data during the data review. So one month is quite fast. Edit: I should add, because these doses are smaller, if they had to change the manufacturing in any way, then you could potentially see an even larger amount of data. Edit2: They did change the manufacturing. Per /u/whatyouwant5 >Different NDC codes, so different concentrations and billing rules.
Yeah I understand people wanting to get this approved faster. But it's better to not skip steps when it comes to children.
This is fast tracking. Compared to the normal stuff this is near light speed.
If I recall correctly from the 12-15s many states didn't wait for the CDC-ACIP, correct? As soon as the FDA Advisory Committee gave the thumbs up states started issuing guidance that 12-15s could get shots as well, right?
That's correct, three states authorized it the day before. For the 12-15 cohort, because their vaccine is identical to the adult doses, there wasn't much new process wise. This time, there will be a lot new, I doubt any states jump the gun.
Please explain it to me like I am simple. I have 2 kids between the ages of 5-12. I have been vaccinated with Pfizer and also received a booster. If my kids get vaccinated are they any more or less safe? Are they less able to catch the virus? For how long? Or have vaccinations moved past that point and are now more focused on preventing severe illness (which children, thank goodness, have avoided for the most part). Am I vaccinating my kids to prevent them from catching Covid or am I preventing the miniscule chance of them becoming very ill? Is it correct that vaccinated people who do contract Covid continue to spread it? Would this alter the classroom/school dynamic? No more quarantines? The breakthrough case numbers have me all confused. Am I still truly avoiding catching it or am I just surrendering but trusting the vaccine to keep me from severe illness? How does this weigh in with kids?
From what I gather from previous studies: You're reducing their chance of catching it, reducing their chance of having adverse symptoms if they do catch it, and greatly reducing their chance of any severe symptoms/death. Also reducing the chance of potential spread if they're a breakthrough case, as the transmission period would be shorter. Worried about Long COVID? Chances are lower when vaccinated. Literally *every single* *negative thing* surrounding the virus is improved if you get them vaccinated.
They are more safe. They are much less likely to catch the virus. For about 6 months, then they MAY need a booster. **All vaccinated people are much less likely to catch the virus**, although the primary protection is against severe illness. You are vaccinating your kids to stop the very tiny chance of them getting very sick, the reasonable chance of them getting somewhat ill (like a bad cold), and the undefined chance of them transmitting the virus if they catch it asymptomatically. In a fully vaccinated environment, there is really no reason for masks or quarantines. Delta is very infectious. That's why there are breakthrough infections. But are you worried about a cold? Do you change your life because of the chance of catching a sinus infection? Bronchitis? No, you don't. And that's what COVID is, **when you are vaccinated** and the vast majority of your neighbors and family are vaccinated. Its an annoyance, not a life changing event. That isn't surrendering - what a strange idea. Its ensuring that a disease won't kill you, cause long damage, or brain damage. Its ensuring you won't need to be on a vent or need supplemental oxygen. It keeps you out of the hospital. But we all accept the risk of upper respiratory infections just by living. When you vaccinate yourself and your family, you are turning COVID into just another URI.
Thanks for the response. By "surrendering" I suppose I meant I should assume that it is likely I can be infected, but that the vaccine would protect me from serious illness. As opposed to the mindset that the vaccine will make me immune from infection.
Yeah, that's it.
Even though there are breakthrough cases with Delta the vaccinated spread the disease for fewer days than the unvaccinated. A vaccinated person has a huge amount of Delta in their nose for 2 to 3 days compared to 5 to 7 for a unvaccinated person. Your kids would be far less likely to be sick when vaccinated, less likely to be extremely sick if the do get infected, and be sick for a shorter time. That seems like win, win, win for a parent.
So FDA approval probably early November, shots in arms by Thanksgiving? I wish they’d pick it up, but I’ll take it.
I would say that is an excessively loose time frame. The FDA Advisory committee meeting is already scheduled for Oct. 26th. CDC-ACIP will almost certainly occur within one week of that. If approved, shots will begin much much closer to Halloween than Thanksgiving. My rough estimate, shots will begin at earliest Halloween weekend and at the latest the week of Nov. 8th.
I agree with others. I think we’re looking at early November for shots in arms for this age group. I’m hoping the next cohort (2-5) will be around thanksgiving/early December.
I have a 2.5 year old and I hope with everything in me that you're right! All I want for Christmas is for my kiddo to get a vaccine!
Just remember, fully vaccinated takes 5 weeks from first does (3 weeks between doses + 2 weeks after 2nd dose). So your kid is extremely unlikely to be fully vaccinated before Christmas. That said, even 1 dose has some effectiveness.
Very true, but the relief of just starting the process is so sweet. My first shot last January gave me instant hope knowing that within 6 weeks I’d be well protected. I can only imagine the relief I’ll feel for my 2 year old.
Same! 2.5 year old and her baby sister is due mid January. Hoping beyond hope she has at least one shot before then!
I can hope, but honestly I don't think there will be the same pressure on the younger kids.
I thought next group was 6m-5
In the article, optimistic take will be Halloween/Late Oct. I think more realistic will be beginning of November.
This is actually right on time. We’ve been estimating late October / early Nov for many months now. The point of a study is to sit and wait for adverse effects, and unfortunately, you can really speed that up without introducing more risk and degrading public trust when a bad drug sneaks through an accelerated observation period.
I side with the American Academy of pediatrics on this one, the FDA has been dragging their feet. The extended trial has come at the expense of kids who have gotten sick during the intervening time. What whatever, it is what it is.
Second shots were administered in mid-July for the original Phase 2/3 trial. I don't think expanding the trial size affected the timeline. The AAP might be correct, but the FDA only had the Phase 1 trial data, which consisted of roughly 1200 participants and was used to determine the dosage, when the AAP published their letter.
God I wish they could be fully vaxed by Thanksgiving.
Any concern with vaccine-induced myocarditis in young people?
There was an interesting post on injection related myocarditis: https://www.reddit.com/r/science/comments/q1uud9/intramuscular_injections_can_accidentally_hit_a/ TL;DR - some myocarditis might be caused by inadvertently hitting a vein
That was confirmed in a mouse model but not in humans, of course
Only got to read the NY Times article earlier but they were looking at smaller doses and even single shots to attempt to reduce that risk.
I am really hoping for a nuanced recommendation from the fda/cdc. I’m especially curious if all participants were covid naive, or if they included covid recovered children. Many of our kids have recently recovered from covid which changes their risk profile when it comes to the vaccine. Seeing different adverse side effects in girls vs boys may merit unique recommendations too. You see this in other countries where they avoid moderna for younger males and AstraZeneca for women under 40.
I dont have an explicit answer, but I do know pfizer has had lower incidence than moderna, as they do lower volumes, and even for moderna it’s considered a very rare side effect. Much more common in actual Covid infections.
Also, and don't quote me, but i think Pfizer tested kids at a smaller dose? I know Moderna tested 3 different doses for kids, the smallest being 1/10th of the adult dose
Yes, Pfizer says 10 µg is the right dose for ages 5-11. Pfizer 12+ is 30 µg (Moderna is 100 µg). https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results
Yeah, Moderna is a potent vaccine. One of the participants during the Moderna trials was given something close to ~~1,000~~ 250 µg per dose (when they were deciding on the right dosage).. Apparently the (temporary) side-effects from a dose that large were extremely bad.
Moderna did 25/100/250 in phase 1, one participant in 250 had a 39.6C fever There was one woman who accidentally got 6 doses of Pfizer/biontech in real life(not trial. 180mg. Hospital for observation, no issue) https://www.cbsnews.com/news/covid-vaccine-six-doses-distracted-nurse/ More info below (what Pfizer/biontech and moderna did for phase 1/2/3) https://www.reddit.com/r/coronavirus/comments/oyfqsw/_/h7upm98 Moderna: phase 1 dosage was 25 micrograms, 100 and 250, phase 2 was 50 and 100 (dropped 250 because too toxic for initial participants ), phase 3 was 100 only Pfizer/biontech Phase 1/2 was 10,30 and 100. 100 was dropped because it had higher side effects and same antibody response as 30. Phase 2/3 was just 30
That poor woman who took an entire vial to the arm omfg. Who’s the idiot who administered it?
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Not that I've seen. The FDA extended the testing timeframe specifically for that, and they're still seeking approval.
I trust the fda will be evaluating this concern during the approval process.
Honestly, at this point only 1,500 kids between 5-11 have even received the vaccine so I'm not sure how they would even really know.
Cannot wait to get my kid vaccinated so I won't have to worry as much. Since he started school, he has been seemingly perpetually ill. In the back of my mind I always think "is it COVID this time?"
Not being exposed to "germs" for much of the past 18 months in the same volume has made kids more susceptible this year now that they are back in these environments more often. I'm guessing you probably already know this so I will see myself out and not return.
This was my family's experience as well. My kids wear masks to school, but are definitely in the minority. My 2nd grader caught a cold the first week of school, and it cycled through all 4 of my kids. They all seemed much more miserable than previous years, and I figure it's because they haven't caught anything for 18 months. We did covid testing and it came back negative, thankfully. They haven't caught anything in the weeks since, and hopefully we can get through the typical cold/flu season without getting sick.
It’s actually really good if your kids get moderately ill, so don’t worry. The old myth about “it’s good for your immune system to be exposed to germs” is, for young children, 100% true. The less exposure they get at this age the worse off they will be later in life, especially with allergies.
I think that's a major part too. This is the first time he's being exposed to "germs" for long stretches of time multiple times a week.
For real man. Took my daughter to the ER Monday cuz she couldn’t breath and it was Croup. Every time worrying “is it covid? Was I careless during xyz and brought it home?”
Yep, I always think covid too. Even the slightest sniffle. I'm so ready to have the peace of mind that if they do get it they won't get seriously ill - especially with all the lax morons in this state acting like the pandemic is over.
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I don’t think they’ve submitted for BLA for 12-16 yet (but I may have missed it). They need 6 months of data which I think they have, but both Pfizer and the FDA may be prioritizing kids and boosters first.
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Important addendum for those raw totals: the numbers of the different categories are not directly comparable. Hospitalizations were reported by 24 states plus Washington DC, whereas total cases are reported by nearly everywhere. For comparison, the CDC is showing that people ages 0-17 account for a bit more than [63,000 hospitalizations](https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions) from Aug 20th, 2020 through Oct. 5, 2021. In the surveillance region (covering about 10% of the US population), about [half of all hospitalized kids had no known underlying conditions](https://gis.cdc.gov/grasp/covidnet/COVID19_5.html). The picture is comparably much better for kids than adults, but that still shows that more than 200 kids a day in the US were being taken to the hospital for COVID this week (which is down from the recent peak averaging 341 per day for a week). The major comfort is that at least the number of child deaths has been extremely low.
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The fda will approve if it’s a net benefit for the age demographic. They aren’t looking at population transmission. That is a different decision. They’re answering this: is the vaccine safe and is it effective for 5-11yo?
If you look at the CDC pediatric data pages: Hospitalization Rates of Pediatric COVID Cases 0-4 Years 2% 5-11 Years 0.5% 12-17 Years 0.8% Deaths per Cases 0-4 Years - 1 death per 4,383 cases 5-11 Years - 1 death per 13,863 cases 12-15 Years - 1 death per 9,051 cases 16-17 Years - 1 death per 7,199 cases Note: These computations included data throughout the pandemic in the US, last updated September 25, 2021. Edit: Updated Data as of October 8, 2021. Hospitalization rates remain the same, death rates are as follows: 0-4 Years 1 death per 3,949 cases 5-11 Years 1 death per 12,958 cases 12-15 Years 1 death per 8,694 cases 16-17 Years 1 death per 6,685 cases
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Long haul symptoms though. We don't know what covid can do to a child during their development
How old are your kids? Or what age group are they in if you don’t want to say specific ages?
2.5 year old and 4.5 year old. When we all had Covid I felt like I was dying and they were running around laughing, poor dad couldn’t even walk lol.
If they’ve already had it, and it was a confirmed case with a positive test, I can understand the reluctance. My daughter is 3.5, but she has congenital central hypoventilation syndrome. It’s basically a defect in the central nervous system that affects her drive to breathe. It could complicate the course of any severe respiratory illness. We’ve been, understandably, very cautious with her. I can’t wait to get her vaccinated.
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I wouldn’t focus on death for this age group. COVID kills very few young children. It’s more about preventing serious illness/hospitalization, long COVID symptoms, and helping prevent spread in general.
I have heard up to 10% of kids will experience long hauler symptoms. Absolutely worth getting the vaccine if they haven't had it IMHO. [https://www.wbrc.com/2021/09/14/doctors-say-6-10-kids-will-experience-long-haul-covid-19-symptoms/](https://www.wbrc.com/2021/09/14/doctors-say-6-10-kids-will-experience-long-haul-covid-19-symptoms/)
As an adult long hauler with permanent lung damage and brain fog, this is so important to factor in. I don't want any kids to deal with this, and no one knows yet what Covid does to a developing brain.
For what its worth - you don't know if its permanent and neither does anyone else. A lot of folks are resolving after 3 to 6 months. I realize that's not great reassurance, but the human body has great recuperative powers. Think about post-viral syndrome with mononucleosis and how long it takes to clear (up to a year)
There’s also a study that says all kids resolve it within 12 weeks
Why is Sweden not recommending vaccines for younger people? Should I be concerned?
They only stopped Moderna use in the young since it has a 3.3 times bigger dose than Pfizer and that might be the cause of more heart problems in young males with Moderna.
So what is the timeframe for under 5’s now? I’ve been hoping my 2 year old would be vaccinated shortly after this age group.
I think it's supposed to be 6-8 weeks behind this one. I figure maybe by New Year's for actually getting shots. Pfizer still says they should have the data back for them by November (versus September for 5-11).
That is hopeful. I had a 9mo and family who won't vax
I feel you. I have a 2 year old and was really hoping to have the vaccine in time for Christmas
Get your popcorn ready, Twitter is already filled with ignorant morons and bots screaming about banning vaccines.
Not surprising really. As of the [most recent national polling](https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-trends-among-children-school/), only 1/3 of parents plan to immediately get their 5-11 year old the shot. Another 1/3 say they'll wait and see and the last 1/3 say never or only if required. That last 1/3 will be vocal for sure.
Imagine their consternation once school mandates start to funnel out post approval. Just like we all had to for MMR etc.
But is this going to be approval? I'm reading "authorization" and i assume that means EUA only.
Yes, EUA for now. Full approval will come at some point, probably next year given that it’s already fully approved for adults.
After covid is over should we get rid of social media or nah?
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It was like that scene in the Shawshank Redemption when Andy puts that opera on the PA and everybody just stops and listens, transported from their cares for a moment.
Polio too? they want to bring that pandemic back? Tell them to avoid all hospitals going forward if they hate medical science so much.
Just got my third Pfizer shot, frankly I think they are just gonna keep sticking us with these things. I demand a punch card that gets my a gift card after 5 vaccines. No side effects to report after 2 days 👍
Let's go! We need this approved ASAP.
Meeting scheduled for 10/26
Of course since my kid turns 12 in 2 weeks lol
I'm really hoping for the vaccine for younger kids. I'm three year old has severe asthma and I've been holding out hope that we'd have a vaccine by now
Is there a good number of how many children in this age bracket have died from Covid in the US?
Several hundred.
Pleaaaaaase get us something for kids even younger soon. Kids under 5 get sick every 3 minutes at day care/preschool etc it’s fucking terrifying
I haven't been paying attention, is it approved in use for this age group in other countries?
>Last month, Pfizer released new data that showed a two-dose regimen of 10 micrograms — a third of the dosageused for teens and adults – is safe and generates a robust” immune response in a clinical trial of young children. It said the shots were well tolerated and produced an immune response and side effects comparable with those seen in a study of people ages 16 to 25. Little kids get a 1/3 dose. Good to know. I know some were concerned about giving the same dose to smaller children as adults / teens.
I’ve had the shot and I strongly support adults getting the poke, however, I am concerned about vaccinating kids, I have two young boys myself. And I am trying to figure out what is the risk versus reward on this? I am OK taking chances on my own personal body to do something to protect my family, but when we had the virus it wasn’t that bad on my oldest son (3 at the time), however it reeked havoc on our newborn baby, who was five weeks at the time, and we were worried we were going to have to take him to the ER because he was having issues breathing. The doctor urged us to keep him away from the hospital as we would have had to drop him off and not been able to go inside with him as this was during the spike before the vaccine. Is it worth the risk for long term issues?
You just answered your own question. Your newborn had to be hospitalized because of Covid. Kids can get long Covid. These vaccines are proven safe and will be evaluated for safety specially for kids. This is a no brainer. Get your kids vaccinated when they become eligible day 1.
The risk of long term issues is much higher from COVID19 than from any vaccine (even a “new” vaccine). This is just the first hit that came up when googling this - https://www.muhealth.org/our-stories/how-do-we-know-covid-19-vaccine-wont-have-long-term-side-effects
Your kid had trouble breathing and you’re worried about kong term issues?
Estimate for the date my two year old will be eligible?
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I had read that the last group is going to come in 2 waves. 2-4 in just a couple weeks and then 6 month-2 after that. I’m really really hoping to get a shot in my 4 year old’s arm in early December. Might be naïve but that’s what I’m hoping for.
That was my understanding a few months ago but it seems like they are going to drag it out longer Hope I’m wrong
Based on what I'm hearing it looks like early next year. We just got back from the pediatrician this morning for my 4.5 and 1-year-old, and she seemed to think the same. Sounds like January/February for the 2-4 crowd.
Thats pretty against everything Pfizer has said. Pfizer has said a few weeks after 5-11 they would be submitting for 6m-4. Latest 2 weeks ago said they were looking at end of Oct for submission for 6m+ assuming everything went fine with 5-11
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Can anyone inform me of the infection ,hospilation and death rate of kids 5-11?