Anonymous wrote:Why are you all annoyed at the vaccine approval process when you need to be mad at the CDC and local authorities who recommended and imposed unwarranted restrictions on children? It was stupid to do it before vaccines were available and it’s insane now the actual vulnerable population (adults) has been vaccinated and the restrictions have been lifted on them. The vaccine trials are just proving what we knew already — children were never at risk.

I am. I’ve wrote countless emails. No one cares. Meanwhile our daycare (and likely the other parents there) thinks I’m a horrible parent for not continuing to mask my 3yo “until they can be protected.”

Anonymous wrote:Why are you all annoyed at the vaccine approval process when you need to be mad at the CDC and local authorities who recommended and imposed unwarranted restrictions on children? It was stupid to do it before vaccines were available and it’s insane now the actual vulnerable population (adults) has been vaccinated and the restrictions have been lifted on them. The vaccine trials are just proving what we knew already — children were never at risk.

Finally a thoughtful comment. Totally agree. Move to a red area and these problems do not exist.

Why are you all annoyed at the vaccine approval process when you need to be mad at the CDC and local authorities who recommended and imposed unwarranted restrictions on children? It was stupid to do it before vaccines were available and it’s insane now the actual vulnerable population (adults) has been vaccinated and the restrictions have been lifted on them. The vaccine trials are just proving what we knew already — children were never at risk.

Agree with so many comments. I am a scientist in the healthcare field. I can appreciate how things change, but the lack of communication has been beyond horrible. It’s an emotion roller coaster. To recap what we’ve been told: December, no maybe April, actually great news it’s February now, haha jokes on you back to April, oh did we say April we meant maybe June. And you have to dig for this information. It barely even makes the news.

Anonymous wrote:

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The mishandling part is just the communication, not the normal regulation process and need to ascertain a clear benefit. The regulation process is working as it should, and I do applaud that. The communication is terrible.

So, Moderna announced weeks ago that they were going to submit data to the FDA "soon" or "in early April". Has it been submitted to start the process? Is the efficacy against infection too low to approve? Has it been evaluated by experts? By whom? Have these conversations been had privately? Is there any data on efficacy against severe disease or long COVID in <5's, or is it not possible to pull that out given the generally low risk of kids and trial sizes? Why are we still quarantining my kid for 10 days for exposure and shutting down classes?

My hunch is that it is a fine vaccine and the benefits still outweigh the risks/costs - but it simply cannot meet the (appropriately) high bar needed for EUA. But I have no idea why I"m sitting around coming up with hunches. Can't someone just tell us what is going on?

Exactly. And what happened in February with all the excitement about data submission- which it seems like the FDA encouraged Pfizer to do. Only to cancel the meeting the day before, probably because of low efficacy in ages 2-5 (likely no safety issues). But that was known before. So wtf?

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

It has absolutely been mishandled. The only consistency from the FDA has been backpedaling and conflicting statements. Pfizer and Moderna keep releasing clearly overly optimistic statements about vaccines in January 2022…no maybe by March…well now maybe in June now. We have been told there may be vaccines “in a few weeks” since last fall. If a vaccine is not just a few weeks away, then don’t say that. A lot hinges on these statements. Rightly or wrongly, there are still extreme quarantines in daycares. Many families like mine are barely holding it together because we do not have the leave. And we are told we need to keep doing this because vaccines are really just right around the corner.

This has nothing to do with safety and efficacy and absolutely everything to do with lack of consistent and clear communication from our public health officials. It’s a disaster for families with young children who have working parents.

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The mishandling part is just the communication, not the normal regulation process and need to ascertain a clear benefit. The regulation process is working as it should, and I do applaud that. The communication is terrible.

So, Moderna announced weeks ago that they were going to submit data to the FDA "soon" or "in early April". Has it been submitted to start the process? Is the efficacy against infection too low to approve? Has it been evaluated by experts? By whom? Have these conversations been had privately? Is there any data on efficacy against severe disease or long COVID in <5's, or is it not possible to pull that out given the generally low risk of kids and trial sizes? Why are we still quarantining my kid for 10 days for exposure and shutting down classes?

My hunch is that it is a fine vaccine and the benefits still outweigh the risks/costs - but it simply cannot meet the (appropriately) high bar needed for EUA. But I have no idea why I"m sitting around coming up with hunches. Can't someone just tell us what is going on?

I guess I think about this differently because I am used to tracking pharmaceutical trials and therefore very accustomed to shifting deadlines. It's very typical, largely due to data. Pediatric trial, in particular, tend to have a lot of fits and starts because the process of recruiting trial participants is more complicated and the trials themselves tend to be more labor intensive. And then of course the standards are always higher for pediatric vaccines. So nothing about the Covid vaccines has surprised me in terms of dates shifting or the companies coming out later and saying "oh we haven't submitted yet for x,y, z reasons." This is all very standard. And the Covid trials have been extremely expedited, so if anything I would expect worse communication, but honestly this is about standard.

The main difference between the Covid vaccines and other pharmaceutical approval processes is that the general public is MUCH more interested in it, as is the general interest media. That creates a problem that is hard to solve, because it means you have lots of people who don't know or understand the science (including journalists) talking about the process with authority. I think that's contributed to the sense of being mislead or lied to more than anything else. The communication from Pfizer/Moderna and the FDA has been pretty standard and I think fair. The media coverage and social media chatter... well, it's not great. People see a misleading headline, get excited and tell everyone they know, and then are disappointed a month later. But that's not because the FDA or the Pharma companies miscommunicated. It's because a copywriter somewhere wrote an unnuanced headline about a report they didn't fully grasp. The media has really failed the public on this, and the scientific literacy of many of the people reporting on these matters is upsettingly low.

The thing I tell myself and other parents is that parents of young kids are incredibly fortunate in many ways with this virus. I know that's really hard to hear after the last two years (trust me, I know -- I have a 4 yo and it's been a rough couple years here), but if you take a step back and really look at the numbers, young kids are remarkably fortunate. Yes, even after Omicron and the higher rates of transmission and increased hospitalizations. Even now, an unvaccinated 3 yo has less risk from Covid than a triple-vaccinated 45 year old, based on statistics. Now, those numbers shift if the 3yo has an underlying condition that poses a risk factor, and the people I feel the most for are those with high risk kids under 5 (though I should also say that some of these kids have actually gotten access to vaccines, either through trials or other means). But if your kid is otherwise healthy, their risk is really very, very low, probably on par with their risk from RSV.

Your kid will get vaccinated. It won't be tomorrow. There are very smart people who want nothing more than to get these vaccines available working on this every day. Sometimes with medical miracles (and yes, this one) we have to have patience. No one is trying to trick you for keep you away from a functional vaccine. We're all on the same side.

I don't think anyone is trying to trick me. I understand things often get delayed, or don't go as planned. That happens in most any big and significant project/effort, and I understand what you say about pediatric trials being particularly prone to delays. Still, they should recognize that there is a lot of interest, and having more communication and clearer communication would go a long way. If they don't want a media non-expert to write an un-nuanced headline that overpromises, someone with authority should put out their press release and try to drive the messaging. I get this is how they always do things, but it is inspiring a lot of frustration, and even some distrust. Most parents are moving on w/out the vaccine (which I think makes sense giving risk), but many are going further, saying they don't plan to vaccinate their kids at all, and some even are claiming their pediatricians are saying not to vaccinate (??? based on what?).

It is fine if timelines shift. They could say that "we are hoping for results in December, and if they are good, it will be about 2 months before they are available". Then when things change, they could say "Results are delayed due to difficulties in recruiting - now we expect January." Then they could say "The immunobriding fell short of our goal, so we are testing 3 shots next, results expected in X" (They did say that third part, and it was really disappointing news for many parents, but at least it was a clear update.) In January, parents found out that the Moderna trial was delayed. This came not via a headline or an update from Moderna, but via a comment from one of the studies co-PIs to a local news outlet. An update from Moderna would have made a lot more sense. J

I agree completely with the rest. Since my kid is not school aged, she had a pretty normal time during COVID. She went to daycare/preschool and had normal-ish social interactions. Her risk is low. Her parents are vaccinated and not particularly high risk. Childcare policies don't reflect the "very very low risk" and I think part of that is their distinction as "unvaccinated" - but I think this will catch up soon enough.

Anonymous wrote:

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The main benefit I’m looking for is the standard exemption from symptom-free quarantines, which kids under 5 are still stuck with in many, many preschools and daycares.

That being said, I think there’s good reason to expect the vaccines will reduce the risk of severe illness from covid in kids, just as they've done for adults. The risk is somewhat small for kids without the vaccine, but that's when compared against adults rather than when compared to other common illnesses (e.g., the flu). I'll be curious to see if the trials were large enough to see a benefit. I suspect they're going to be too small, with too few cases to see severe illnesses in the control group. The rate of severe illness in kids is low enough that you probably can't realistically measure those rates in controlled trials.

ITA about the quarantines, and hope to see a (further) reduction in risk for severe illness. Our daycare still recommends masks for unvaccinated kids too- it’s not required so we don’t have our kids wear them anymore but we are in the minority (by a lot). I’d love to get to a point where my toddler and preschooler can see the faces of their classmates and teachers. But that won’t happen until the vaccine is authorized.

Anonymous wrote:

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The mishandling part is just the communication, not the normal regulation process and need to ascertain a clear benefit. The regulation process is working as it should, and I do applaud that. The communication is terrible.

So, Moderna announced weeks ago that they were going to submit data to the FDA "soon" or "in early April". Has it been submitted to start the process? Is the efficacy against infection too low to approve? Has it been evaluated by experts? By whom? Have these conversations been had privately? Is there any data on efficacy against severe disease or long COVID in <5's, or is it not possible to pull that out given the generally low risk of kids and trial sizes? Why are we still quarantining my kid for 10 days for exposure and shutting down classes?

My hunch is that it is a fine vaccine and the benefits still outweigh the risks/costs - but it simply cannot meet the (appropriately) high bar needed for EUA. But I have no idea why I"m sitting around coming up with hunches. Can't someone just tell us what is going on?

I guess I think about this differently because I am used to tracking pharmaceutical trials and therefore very accustomed to shifting deadlines. It's very typical, largely due to data. Pediatric trial, in particular, tend to have a lot of fits and starts because the process of recruiting trial participants is more complicated and the trials themselves tend to be more labor intensive. And then of course the standards are always higher for pediatric vaccines. So nothing about the Covid vaccines has surprised me in terms of dates shifting or the companies coming out later and saying "oh we haven't submitted yet for x,y, z reasons." This is all very standard. And the Covid trials have been extremely expedited, so if anything I would expect worse communication, but honestly this is about standard.

The main difference between the Covid vaccines and other pharmaceutical approval processes is that the general public is MUCH more interested in it, as is the general interest media. That creates a problem that is hard to solve, because it means you have lots of people who don't know or understand the science (including journalists) talking about the process with authority. I think that's contributed to the sense of being mislead or lied to more than anything else. The communication from Pfizer/Moderna and the FDA has been pretty standard and I think fair. The media coverage and social media chatter... well, it's not great. People see a misleading headline, get excited and tell everyone they know, and then are disappointed a month later. But that's not because the FDA or the Pharma companies miscommunicated. It's because a copywriter somewhere wrote an unnuanced headline about a report they didn't fully grasp. The media has really failed the public on this, and the scientific literacy of many of the people reporting on these matters is upsettingly low.

The thing I tell myself and other parents is that parents of young kids are incredibly fortunate in many ways with this virus. I know that's really hard to hear after the last two years (trust me, I know -- I have a 4 yo and it's been a rough couple years here), but if you take a step back and really look at the numbers, young kids are remarkably fortunate. Yes, even after Omicron and the higher rates of transmission and increased hospitalizations. Even now, an unvaccinated 3 yo has less risk from Covid than a triple-vaccinated 45 year old, based on statistics. Now, those numbers shift if the 3yo has an underlying condition that poses a risk factor, and the people I feel the most for are those with high risk kids under 5 (though I should also say that some of these kids have actually gotten access to vaccines, either through trials or other means). But if your kid is otherwise healthy, their risk is really very, very low, probably on par with their risk from RSV.

Your kid will get vaccinated. It won't be tomorrow. There are very smart people who want nothing more than to get these vaccines available working on this every day. Sometimes with medical miracles (and yes, this one) we have to have patience. No one is trying to trick you for keep you away from a functional vaccine. We're all on the same side.

Not terribly comforting...

https://www.axios.com/parents-of-kids-under-5-still-waiting-for-covid-shots-6a2a0685-241f-4be2-9edd-24273598f96b.html

Pfizer CEO Albert Bourla said this week said his company aimed to get vaccines out by June if regulators agree.

Moderna CEO Stephane Bancel likewise told Yahoo Finance late last month that his company's vaccine likely won't be available for "a couple of months...not a couple of weeks" and needs to be shown to be safe and effective for kids before Moderna applies to the FDA.

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The mishandling part is just the communication, not the normal regulation process and need to ascertain a clear benefit. The regulation process is working as it should, and I do applaud that. The communication is terrible.

So, Moderna announced weeks ago that they were going to submit data to the FDA "soon" or "in early April". Has it been submitted to start the process? Is the efficacy against infection too low to approve? Has it been evaluated by experts? By whom? Have these conversations been had privately? Is there any data on efficacy against severe disease or long COVID in <5's, or is it not possible to pull that out given the generally low risk of kids and trial sizes? Why are we still quarantining my kid for 10 days for exposure and shutting down classes?

My hunch is that it is a fine vaccine and the benefits still outweigh the risks/costs - but it simply cannot meet the (appropriately) high bar needed for EUA. But I have no idea why I"m sitting around coming up with hunches. Can't someone just tell us what is going on?

There is every reason to think the FDA will authorize pediatric vaccines as originally planned: based on immunobridging data rather than direct efficacy data. Moderna achieved that, but their application is complicated by their vaccine not already being authorized for kids/teens under 18.

Pfizer failed immunobridging for 2 doses, and we don’t know yet what the results were for 3. The trial description quietly set a higher antibody threshold to meet, so there’s a non-trivial chance it will fail. But FDA could still allow it to move forward if it meets the slightly lower antibody threshold that was set for Pfizer’s other pediatric EUAs.

The trials were small enough you’re not going to see good data on severe illness. And long covid is hard to study because you’re mostly working off of self-reported, common symptoms (like fatigue), so you’re not going to see good data on that, either. I doubt they'd attempt to address it at all in the EUA analysis/application.

Well that is good news and I hope you are right. Do you think that things are complicated by the fact that efficacy against current variants is lower compared to what the (adult) vaccines were originally approved under, and with long term efficacy against infection that wanes (though holds up for severe illness for adults)? That is my worry about approval. I agree they can say it is equivalent in efficacy to the adult vaccine. I just wonder if that is enough for EUA in April 2022, accounting for risks in the age group. Is this an emergency for 4 year olds?

Putting that aside... Did Moderna submit data? I though they were doing 6 mo to 18 years in one swoop. What is the latest Pfizer timeline? Why is no one saying anything? I think the answer is mostly that they don't want to say the wrong things, but not saying anything at all just leaves a silence for others to fill. I guess part of it is that Moderna and Pfizer are the ones doing the talking (to the extent there is any talking), since the FDA can't really make any definitive statements until data is submitted.

Moderna hasn’t filed for kids yet. They filed last year for kids 12-17, but that's been on hold over myocarditis concerns. They held off on the 6-11 age group. As you said, they intend to file for EUA for all of these age groups together. They're not late on doing so, so I don't think there's any extra reason to be concerned. But I don't understand how they're going to argue for safety given that they can't make the de-escalation argument that Pfizer did in their EUAs.

Pfizer isn't significantly behind. They just got the raw data earlier this month, and they need time to analyze and package it. I don't think you should read anything into a delay when it is only a few days at this point.

Will the lower efficacy of the vaccines against the newer variants overall complicate things? It will certainly complicate things, but the basic idea of immunobridging is that you're expecting a similar response in the younger kids as older kids and adults. We know the vaccines have lower efficacy against Omicron infection, but we also know they reduce the risk of severe illness. So I don't think the lower efficacy numbers will prevent EUA.

The unfortunate thing, though, is that it seems plausible that we're simply going to authorize something with similar characteristics to the 2-dose Pfizer trial, which could have been done a couple months ago.

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The mishandling part is just the communication, not the normal regulation process and need to ascertain a clear benefit. The regulation process is working as it should, and I do applaud that. The communication is terrible.

So, Moderna announced weeks ago that they were going to submit data to the FDA "soon" or "in early April". Has it been submitted to start the process? Is the efficacy against infection too low to approve? Has it been evaluated by experts? By whom? Have these conversations been had privately? Is there any data on efficacy against severe disease or long COVID in <5's, or is it not possible to pull that out given the generally low risk of kids and trial sizes? Why are we still quarantining my kid for 10 days for exposure and shutting down classes?

My hunch is that it is a fine vaccine and the benefits still outweigh the risks/costs - but it simply cannot meet the (appropriately) high bar needed for EUA. But I have no idea why I"m sitting around coming up with hunches. Can't someone just tell us what is going on?

There is every reason to think the FDA will authorize pediatric vaccines as originally planned: based on immunobridging data rather than direct efficacy data. Moderna achieved that, but their application is complicated by their vaccine not already being authorized for kids/teens under 18.

Pfizer failed immunobridging for 2 doses, and we don’t know yet what the results were for 3. The trial description quietly set a higher antibody threshold to meet, so there’s a non-trivial chance it will fail. But FDA could still allow it to move forward if it meets the slightly lower antibody threshold that was set for Pfizer’s other pediatric EUAs.

The trials were small enough you’re not going to see good data on severe illness. And long covid is hard to study because you’re mostly working off of self-reported, common symptoms (like fatigue), so you’re not going to see good data on that, either. I doubt they'd attempt to address it at all in the EUA analysis/application.

Well that is good news and I hope you are right. Do you think that things are complicated by the fact that efficacy against current variants is lower compared to what the (adult) vaccines were originally approved under, and with long term efficacy against infection that wanes (though holds up for severe illness for adults)? That is my worry about approval. I agree they can say it is equivalent in efficacy to the adult vaccine. I just wonder if that is enough for EUA in April 2022, accounting for risks in the age group. Is this an emergency for 4 year olds?

Putting that aside... Did Moderna submit data? I though they were doing 6 mo to 18 years in one swoop. What is the latest Pfizer timeline? Why is no one saying anything? I think the answer is mostly that they don't want to say the wrong things, but not saying anything at all just leaves a silence for others to fill. I guess part of it is that Moderna and Pfizer are the ones doing the talking (to the extent there is any talking), since the FDA can't really make any definitive statements until data is submitted.

Anonymous wrote:

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The mishandling part is just the communication, not the normal regulation process and need to ascertain a clear benefit. The regulation process is working as it should, and I do applaud that. The communication is terrible.

So, Moderna announced weeks ago that they were going to submit data to the FDA "soon" or "in early April". Has it been submitted to start the process? Is the efficacy against infection too low to approve? Has it been evaluated by experts? By whom? Have these conversations been had privately? Is there any data on efficacy against severe disease or long COVID in <5's, or is it not possible to pull that out given the generally low risk of kids and trial sizes? Why are we still quarantining my kid for 10 days for exposure and shutting down classes?

My hunch is that it is a fine vaccine and the benefits still outweigh the risks/costs - but it simply cannot meet the (appropriately) high bar needed for EUA. But I have no idea why I"m sitting around coming up with hunches. Can't someone just tell us what is going on?

There is every reason to think the FDA will authorize pediatric vaccines as originally planned: based on immunobridging data rather than direct efficacy data. Moderna achieved that, but their application is complicated by their vaccine not already being authorized for kids/teens under 18.

Pfizer failed immunobridging for 2 doses, and we don’t know yet what the results were for 3. The trial description quietly set a higher antibody threshold to meet, so there’s a non-trivial chance it will fail. But FDA could still allow it to move forward if it meets the slightly lower antibody threshold that was set for Pfizer’s other pediatric EUAs.

The trials were small enough you’re not going to see good data on severe illness. And long covid is hard to study because you’re mostly working off of self-reported, common symptoms (like fatigue), so you’re not going to see good data on that, either. I doubt they'd attempt to address it at all in the EUA analysis/application.

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The main benefit I’m looking for is the standard exemption from symptom-free quarantines, which kids under 5 are still stuck with in many, many preschools and daycares.

That being said, I think there’s good reason to expect the vaccines will reduce the risk of severe illness from covid in kids, just as they've done for adults. The risk is somewhat small for kids without the vaccine, but that's when compared against adults rather than when compared to other common illnesses (e.g., the flu). I'll be curious to see if the trials were large enough to see a benefit. I suspect they're going to be too small, with too few cases to see severe illnesses in the control group. The rate of severe illness in kids is low enough that you probably can't realistically measure those rates in controlled trials.

Anonymous wrote:I reject the idea this is being “mishandled”. Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.

The mishandling part is just the communication, not the normal regulation process and need to ascertain a clear benefit. The regulation process is working as it should, and I do applaud that. The communication is terrible.

So, Moderna announced weeks ago that they were going to submit data to the FDA "soon" or "in early April". Has it been submitted to start the process? Is the efficacy against infection too low to approve? Has it been evaluated by experts? By whom? Have these conversations been had privately? Is there any data on efficacy against severe disease or long COVID in <5's, or is it not possible to pull that out given the generally low risk of kids and trial sizes? Why are we still quarantining my kid for 10 days for exposure and shutting down classes?

My hunch is that it is a fine vaccine and the benefits still outweigh the risks/costs - but it simply cannot meet the (appropriately) high bar needed for EUA. But I have no idea why I"m sitting around coming up with hunches. Can't someone just tell us what is going on?