When are Pfizer/moderna submitting data for Under 5s

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:Do I have this clear? Moderna has data ready to go now. But we need to wait til June so they can approve pfizer and moderna together. WTF??

Not quite. Moderna is ready to submit data for review "by the end of this month", and would be ready to go "mid-May". Pfizer may not be ready to submit data until late May/June, for approval "mid-June". The FDA is considering the option of waiting to approve both together. I don't think it is decided yet.

I’m not sure they’re going to approve both at all- will probably look at both together and decide which is best. Kind of makes me wonder what’s up with Moderna that they don’t want to evaluate now.

Maybe they are taking a clue from Europe.

Europe and many other countries have approved Moderna for 6-11. It’s the 12-17 group that’s tricky, with a higher dose and higher risk of myocarditis.

Will be interesting to see if they do so for the under-5yo.

[Anonymous]

Anonymous wrote:Every time I read Twitter I get so angry at these self-righteous people tweeting about how everyone should wear masks because of the "under 5s". GTFOOH. Adults should wear masks to protect other adults who are the population at highest risk of death, severe disease and long term disability from COVID. The under 5s are thankfully not at high risk. Of course I worry about DD getting COVID just like I worry about her getting injured but that doesn't mean I deprive her of social experiences or stop her from running and climbing things lest she hurt herself. She is 3 and is just learning how to interact with people and developing gross motor skills. The current CDC guidance that treats young children the same as an unvaxxed elderly person is nonsensical and harmful to young children.

Totally agree. Especially when some of these experts will admit that a healthy unvaxxed toddler is lower-risk than a triple vaxxed middle aged adult. Why are these kids still being subject to masks and quarantines? It makes no sense.

That said, I don’t necessarily have a problem with FDA waiting to authorize (or not) Phizer and Moderna at the same time. Partly because I originally got the J&J because it was the first vaccine available to me. I wished I had waited and got one of the mRNA ones. So if the applications are truly not going to be that far apart, I don’t think it’s a bad idea. But there’s nothing “confusing” about that- they should just say that’s why they want to wait. It’s just an insult because these people seem so out of touch with what parents with young kids are still subjected to.

[Anonymous]

Anonymous wrote:Every time I read Twitter I get so angry at these self-righteous people tweeting about how everyone should wear masks because of the "under 5s". GTFOOH. Adults should wear masks to protect other adults who are the population at highest risk of death, severe disease and long term disability from COVID. The under 5s are thankfully not at high risk. Of course I worry about DD getting COVID just like I worry about her getting injured but that doesn't mean I deprive her of social experiences or stop her from running and climbing things lest she hurt herself. She is 3 and is just learning how to interact with people and developing gross motor skills. The current CDC guidance that treats young children the same as an unvaxxed elderly person is nonsensical and harmful to young children.

This drives me crazy too. I also think people constantly conflate the [understandably] frustrating restrictions on under-5s, which make being a parent of an under-5 particularly stressful right now, with DANGER to under-5s.

I am all ears if someone wants to complain about how nonsensical quarantine requirements are making it hard for them to work or depriving their kids of consistent childcare settings. It sucks, I hate it too. I’m also interested in how other parents of this age group are navigation the new “masks optional” policies because I definitely feel like mask mandates pose bigger issues for my 4 year old than for adults like me.

But when I see people arguing in favor of masking and other (appropriate!) restrictions because the believe their 3yo is at high risk from not just Covid but a lifelong brain or heart disorder caused by long Covid, I get tired. I honestly think it’s self-centered people trying to make the pandemic about themselves. And it only makes it harder to craft appropriate policies for this age group. Young kids are fortunately not at high risk from Covid! Why are people so determined to pretend they are? I don’t get it.

[Anonymous]

Anonymous wrote:

Anonymous wrote:Every time I read Twitter I get so angry at these self-righteous people tweeting about how everyone should wear masks because of the "under 5s". GTFOOH. Adults should wear masks to protect other adults who are the population at highest risk of death, severe disease and long term disability from COVID. The under 5s are thankfully not at high risk. Of course I worry about DD getting COVID just like I worry about her getting injured but that doesn't mean I deprive her of social experiences or stop her from running and climbing things lest she hurt herself. She is 3 and is just learning how to interact with people and developing gross motor skills. The current CDC guidance that treats young children the same as an unvaxxed elderly person is nonsensical and harmful to young children.

Totally agree. Especially when some of these experts will admit that a healthy unvaxxed toddler is lower-risk than a triple vaxxed middle aged adult. Why are these kids still being subject to masks and quarantines? It makes no sense.

That said, I don’t necessarily have a problem with FDA waiting to authorize (or not) Phizer and Moderna at the same time. Partly because I originally got the J&J because it was the first vaccine available to me. I wished I had waited and got one of the mRNA ones. So if the applications are truly not going to be that far apart, I don’t think it’s a bad idea. But there’s nothing “confusing” about that- they should just say that’s why they want to wait. It’s just an insult because these people seem so out of touch with what parents with young kids are still subjected to.

+1 and agree that they waiting to evaluate the vaccines makes sense because it ups the odds that the first vaccine available will also be the best vaccine available. I think that’s extra important for preschoolers who might be required to vaccinate before school starts. If your kid is only getting one vaccine this summer, let’s make sure it’s the most effective one.

The condescension just seems like a permanent feature of the Biden administrations approach to Covid. Like Jen Psaki scoffing at the idea of distributing rapid tests. It’s this attitude like “we’re the smart people we know what we’re doing, don’t worry your pretty head.” Yet they consistently show they don’t know what they are doing.

More transparency is always better, IMO.

[Anonymous]

Anonymous wrote:

Anonymous wrote:Every time I read Twitter I get so angry at these self-righteous people tweeting about how everyone should wear masks because of the "under 5s". GTFOOH. Adults should wear masks to protect other adults who are the population at highest risk of death, severe disease and long term disability from COVID. The under 5s are thankfully not at high risk. Of course I worry about DD getting COVID just like I worry about her getting injured but that doesn't mean I deprive her of social experiences or stop her from running and climbing things lest she hurt herself. She is 3 and is just learning how to interact with people and developing gross motor skills. The current CDC guidance that treats young children the same as an unvaxxed elderly person is nonsensical and harmful to young children.

This drives me crazy too. I also think people constantly conflate the [understandably] frustrating restrictions on under-5s, which make being a parent of an under-5 particularly stressful right now, with DANGER to under-5s.

I am all ears if someone wants to complain about how nonsensical quarantine requirements are making it hard for them to work or depriving their kids of consistent childcare settings. It sucks, I hate it too. I’m also interested in how other parents of this age group are navigation the new “masks optional” policies because I definitely feel like mask mandates pose bigger issues for my 4 year old than for adults like me.

But when I see people arguing in favor of masking and other (appropriate!) restrictions because the believe their 3yo is at high risk from not just Covid but a lifelong brain or heart disorder caused by long Covid, I get tired. I honestly think it’s self-centered people trying to make the pandemic about themselves. And it only makes it harder to craft appropriate policies for this age group. Young kids are fortunately not at high risk from Covid! Why are people so determined to pretend they are? I don’t get it.

TBH, long covid or long term degraded health (for me & kid) does scare me a bit, if I think about it for too long. So I sort of get that. And vaccines may reduce those risks. But looking at the overall costs to ensure I can avoid COVID forever... I have chosen to accept some risk of catching COVID and the adjacent a risk of having long covid symptoms. I do understand the fear. People are terrible at risk assessment

[Anonymous]

Anonymous wrote:The Moderna efficacy was pretty bad. I don’t see how the FDA can grant an EUA for a vaccine that is less than 50% effective. I don’t think you should pin your hopes on this.

Exactly.

[Anonymous]

Anonymous wrote:

Anonymous wrote:Every time I read Twitter I get so angry at these self-righteous people tweeting about how everyone should wear masks because of the "under 5s". GTFOOH. Adults should wear masks to protect other adults who are the population at highest risk of death, severe disease and long term disability from COVID. The under 5s are thankfully not at high risk. Of course I worry about DD getting COVID just like I worry about her getting injured but that doesn't mean I deprive her of social experiences or stop her from running and climbing things lest she hurt herself. She is 3 and is just learning how to interact with people and developing gross motor skills. The current CDC guidance that treats young children the same as an unvaxxed elderly person is nonsensical and harmful to young children.

This drives me crazy too. I also think people constantly conflate the [understandably] frustrating restrictions on under-5s, which make being a parent of an under-5 particularly stressful right now, with DANGER to under-5s.

I am all ears if someone wants to complain about how nonsensical quarantine requirements are making it hard for them to work or depriving their kids of consistent childcare settings. It sucks, I hate it too. I’m also interested in how other parents of this age group are navigation the new “masks optional” policies because I definitely feel like mask mandates pose bigger issues for my 4 year old than for adults like me.

But when I see people arguing in favor of masking and other (appropriate!) restrictions because the believe their 3yo is at high risk from not just Covid but a lifelong brain or heart disorder caused by long Covid, I get tired. I honestly think it’s self-centered people trying to make the pandemic about themselves. And it only makes it harder to craft appropriate policies for this age group. Young kids are fortunately not at high risk from Covid! Why are people so determined to pretend they are? I don’t get it.

It is the classic mechanism of the anxious mind always to retreat to the next trench to keep rationalizing their feelings of anxiety.

[Anonymous]

Anonymous wrote:

Anonymous wrote:Every time I read Twitter I get so angry at these self-righteous people tweeting about how everyone should wear masks because of the "under 5s". GTFOOH. Adults should wear masks to protect other adults who are the population at highest risk of death, severe disease and long term disability from COVID. The under 5s are thankfully not at high risk. Of course I worry about DD getting COVID just like I worry about her getting injured but that doesn't mean I deprive her of social experiences or stop her from running and climbing things lest she hurt herself. She is 3 and is just learning how to interact with people and developing gross motor skills. The current CDC guidance that treats young children the same as an unvaxxed elderly person is nonsensical and harmful to young children.

This drives me crazy too. I also think people constantly conflate the [understandably] frustrating restrictions on under-5s, which make being a parent of an under-5 particularly stressful right now, with DANGER to under-5s.

I am all ears if someone wants to complain about how nonsensical quarantine requirements are making it hard for them to work or depriving their kids of consistent childcare settings. It sucks, I hate it too. I’m also interested in how other parents of this age group are navigation the new “masks optional” policies because I definitely feel like mask mandates pose bigger issues for my 4 year old than for adults like me.

But when I see people arguing in favor of masking and other (appropriate!) restrictions because the believe their 3yo is at high risk from not just Covid but a lifelong brain or heart disorder caused by long Covid, I get tired. I honestly think it’s self-centered people trying to make the pandemic about themselves. And it only makes it harder to craft appropriate policies for this age group. Young kids are fortunately not at high risk from Covid! Why are people so determined to pretend they are? I don’t get it.

The few families I know that are very covid cautious and claim they are concerned about their kids were rather isolated pre-covid. No friend group, usually a SAHM, and a lot of anxiety. In all of these cases the dad seems pretty chill and like he’s just going along with it all.

[Anonymous]

Anonymous wrote:The Moderna efficacy was pretty bad. I don’t see how the FDA can grant an EUA for a vaccine that is less than 50% effective. I don’t think you should pin your hopes on this.

This why I don’t understand why people are angry about the delay. The trials didn’t work. They don’t have a vaccine that works to approve. I see people saying “let parents decide!” But… this is why the FDA exists. Can’t you always argue that patients should be able to decide for themselves whether to get a medical intervention?

I honestly think some parents are demanding access to the vaccines, even knowing they don’t do much, simply so they can say “We’re all vaccinated, so now we can travel, eat in restaurants, sociale at home, safely.” They’ve been criticizing people doing those things for so long they’ve painted themselves into a corner, and they think vaccinating their youngest, lowest-risk kids will be their get out of jail free card.

People scoff about “virtue signaling” but what other purpose is there in getting your child a vaccine that has been proven ineffective? I don’t get it.

[Anonymous]

Anonymous wrote:

Anonymous wrote:The Moderna efficacy was pretty bad. I don’t see how the FDA can grant an EUA for a vaccine that is less than 50% effective. I don’t think you should pin your hopes on this.

This why I don’t understand why people are angry about the delay. The trials didn’t work. They don’t have a vaccine that works to approve. I see people saying “let parents decide!” But… this is why the FDA exists. Can’t you always argue that patients should be able to decide for themselves whether to get a medical intervention?

I honestly think some parents are demanding access to the vaccines, even knowing they don’t do much, simply so they can say “We’re all vaccinated, so now we can travel, eat in restaurants, sociale at home, safely.” They’ve been criticizing people doing those things for so long they’ve painted themselves into a corner, and they think vaccinating their youngest, lowest-risk kids will be their get out of jail free card.

People scoff about “virtue signaling” but what other purpose is there in getting your child a vaccine that has been proven ineffective? I don’t get it.

Another problem with this argument is that once these vaccines are approved for this age group, daycares, preschools, and camps will mandate them. This is a problem that I believe is unique to the US - that individual organizations with no expertise in public health can mandate medical interventions, even those under EUA. In other countries, both mask and vaccine mandates have to come from public health authorities who (at least should) know better what they are doing.

[Anonymous]

Anonymous wrote:

Anonymous wrote:The Moderna efficacy was pretty bad. I don’t see how the FDA can grant an EUA for a vaccine that is less than 50% effective. I don’t think you should pin your hopes on this.

This why I don’t understand why people are angry about the delay. The trials didn’t work. They don’t have a vaccine that works to approve. I see people saying “let parents decide!” But… this is why the FDA exists. Can’t you always argue that patients should be able to decide for themselves whether to get a medical intervention?

I honestly think some parents are demanding access to the vaccines, even knowing they don’t do much, simply so they can say “We’re all vaccinated, so now we can travel, eat in restaurants, sociale at home, safely.” They’ve been criticizing people doing those things for so long they’ve painted themselves into a corner, and they think vaccinating their youngest, lowest-risk kids will be their get out of jail free card.

People scoff about “virtue signaling” but what other purpose is there in getting your child a vaccine that has been proven ineffective? I don’t get it.

That is overstating it a bit. Efficacy against infection from omicron was not as good as hoped (44% AND 38% for under 2 and 2-5 respectively). Not great, but on par with effectiveness in adults against Omicron.

I expect the immunobridging, which the pediatric trails are predicated on, was successful for Moderna (not for 2 dose Pfizer, which is why they did 3 does). That is why they will submit, and the regulators will discuss. I'm not sure if they will approve, though, now that we have omicron, which all vacines have been less protective from. There was a PP here who was very certain they would.

As a parent, I do want a vaccine (probably, depending on what experts reccomend) for my <5, because it will make her already very low risk even lower. It has nothing to do with virtue siganlling. She is vaccinted for the flu yearly, too.

[Anonymous]

Anonymous wrote:

Anonymous wrote:The Moderna efficacy was pretty bad. I don’t see how the FDA can grant an EUA for a vaccine that is less than 50% effective. I don’t think you should pin your hopes on this.

This why I don’t understand why people are angry about the delay. The trials didn’t work. They don’t have a vaccine that works to approve. I see people saying “let parents decide!” But… this is why the FDA exists. Can’t you always argue that patients should be able to decide for themselves whether to get a medical intervention?

I honestly think some parents are demanding access to the vaccines, even knowing they don’t do much, simply so they can say “We’re all vaccinated, so now we can travel, eat in restaurants, sociale at home, safely.” They’ve been criticizing people doing those things for so long they’ve painted themselves into a corner, and they think vaccinating their youngest, lowest-risk kids will be their get out of jail free card.

People scoff about “virtue signaling” but what other purpose is there in getting your child a vaccine that has been proven ineffective? I don’t get it.

From what I understand, the efficacy is right in line with the current adult efficacy against omicron. It's acceptable enough for public use.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:The Moderna efficacy was pretty bad. I don’t see how the FDA can grant an EUA for a vaccine that is less than 50% effective. I don’t think you should pin your hopes on this.

This why I don’t understand why people are angry about the delay. The trials didn’t work. They don’t have a vaccine that works to approve. I see people saying “let parents decide!” But… this is why the FDA exists. Can’t you always argue that patients should be able to decide for themselves whether to get a medical intervention?

I honestly think some parents are demanding access to the vaccines, even knowing they don’t do much, simply so they can say “We’re all vaccinated, so now we can travel, eat in restaurants, sociale at home, safely.” They’ve been criticizing people doing those things for so long they’ve painted themselves into a corner, and they think vaccinating their youngest, lowest-risk kids will be their get out of jail free card.

People scoff about “virtue signaling” but what other purpose is there in getting your child a vaccine that has been proven ineffective? I don’t get it.

From what I understand, the efficacy is right in line with the current adult efficacy against omicron. It's acceptable enough for public use.

For adults, yes. For low risk kids, the evaluation is different. Does it make sense to approve a vaccine with 30-40% efficacy (and likely dropping) for a virus that poses extremely little threat? It’s different for adults because adults are at much higher risk from Covid so even moderate effectiveness is resistance to reduce that higher risk.

What I am guessing is that they will approve for very high risk kids— immunosuppresseurs kids or those with existing lung or heart issues. Which I would embrace because (1) family’s with kids in that category absolutely deserve a chance at a vaccine, and (2) because it might force us to talk about his low the risk to other kids is, and therefore how unreasonable some of the masking/quarantine rules are.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:The Moderna efficacy was pretty bad. I don’t see how the FDA can grant an EUA for a vaccine that is less than 50% effective. I don’t think you should pin your hopes on this.

This why I don’t understand why people are angry about the delay. The trials didn’t work. They don’t have a vaccine that works to approve. I see people saying “let parents decide!” But… this is why the FDA exists. Can’t you always argue that patients should be able to decide for themselves whether to get a medical intervention?

I honestly think some parents are demanding access to the vaccines, even knowing they don’t do much, simply so they can say “We’re all vaccinated, so now we can travel, eat in restaurants, sociale at home, safely.” They’ve been criticizing people doing those things for so long they’ve painted themselves into a corner, and they think vaccinating their youngest, lowest-risk kids will be their get out of jail free card.

People scoff about “virtue signaling” but what other purpose is there in getting your child a vaccine that has been proven ineffective? I don’t get it.

From what I understand, the efficacy is right in line with the current adult efficacy against omicron. It's acceptable enough for public use.

For adults, yes. For low risk kids, the evaluation is different. Does it make sense to approve a vaccine with 30-40% efficacy (and likely dropping) for a virus that poses extremely little threat? It’s different for adults because adults are at much higher risk from Covid so even moderate effectiveness is resistance to reduce that higher risk.

What I am guessing is that they will approve for very high risk kids— immunosuppresseurs kids or those with existing lung or heart issues. Which I would embrace because (1) family’s with kids in that category absolutely deserve a chance at a vaccine, and (2) because it might force us to talk about his low the risk to other kids is, and therefore how unreasonable some of the masking/quarantine rules are.

I dunno - the flu vaccine fluctuates b/w 25%-60% depending on the variant and year. So sure, it's acceptable to go public with a lowish efficacy (I believe Moderna cited 44%?).

I would challenge your assertion that kids under 5 are under any less threat of severe covid symptoms than the 5-11 age group. I'd even say the <1 years are more susceptible than older kids b/c their upper respiratory track is underdeveloped and omicron is reported to go after that area. I dunno - just repeating what my pediatrician said and I know he is held in very high regard. I do agree with the premise that immunocompromised kids should be prioritized - much like we did in the other age group rollouts - with the intent to release to all kids in that age group soon after. It would be silly to NOT allow it for relatively healthy kids. JMO.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:The Moderna efficacy was pretty bad. I don’t see how the FDA can grant an EUA for a vaccine that is less than 50% effective. I don’t think you should pin your hopes on this.

This why I don’t understand why people are angry about the delay. The trials didn’t work. They don’t have a vaccine that works to approve. I see people saying “let parents decide!” But… this is why the FDA exists. Can’t you always argue that patients should be able to decide for themselves whether to get a medical intervention?

I honestly think some parents are demanding access to the vaccines, even knowing they don’t do much, simply so they can say “We’re all vaccinated, so now we can travel, eat in restaurants, sociale at home, safely.” They’ve been criticizing people doing those things for so long they’ve painted themselves into a corner, and they think vaccinating their youngest, lowest-risk kids will be their get out of jail free card.

People scoff about “virtue signaling” but what other purpose is there in getting your child a vaccine that has been proven ineffective? I don’t get it.

From what I understand, the efficacy is right in line with the current adult efficacy against omicron. It's acceptable enough for public use.

For adults, yes. For low risk kids, the evaluation is different. Does it make sense to approve a vaccine with 30-40% efficacy (and likely dropping) for a virus that poses extremely little threat? It’s different for adults because adults are at much higher risk from Covid so even moderate effectiveness is resistance to reduce that higher risk.

What I am guessing is that they will approve for very high risk kids— immunosuppresseurs kids or those with existing lung or heart issues. Which I would embrace because (1) family’s with kids in that category absolutely deserve a chance at a vaccine, and (2) because it might force us to talk about his low the risk to other kids is, and therefore how unreasonable some of the masking/quarantine rules are.

I dunno - the flu vaccine fluctuates b/w 25%-60% depending on the variant and year. So sure, it's acceptable to go public with a lowish efficacy (I believe Moderna cited 44%?).

I would challenge your assertion that kids under 5 are under any less threat of severe covid symptoms than the 5-11 age group. I'd even say the <1 years are more susceptible than older kids b/c their upper respiratory track is underdeveloped and omicron is reported to go after that area. I dunno - just repeating what my pediatrician said and I know he is held in very high regard. I do agree with the premise that immunocompromised kids should be prioritized - much like we did in the other age group rollouts - with the intent to release to all kids in that age group soon after. It would be silly to NOT allow it for relatively healthy kids. JMO.

DP. The flu vaccine didn't come to kids under EUA, and young children are at higher risk from influenza than from Covid.