When are Pfizer/moderna submitting data for Under 5s

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.”

Have you ever considered maybe you are wrong? Its not so much the children that are at risk but the adults they live with.

If a vaccinated adult member of the house of is that vulnerable, group childcare is probably not the appropriate setting for their child.

This, plus: 1. Masks on 3 year olds don't work (show me the data if you want to disagree), and 2. Vaccines don't prevent mild infections and transmission.

+1. Of the studies I’ve seen, at best masking reduced transmission by ~25% in school settings. Not daycare settings, where the kids are taking their masks off more often and don’t generally wear them as well. Even if that 25% reduction was similar in daycare settings, you could argue while that still may be worthwhile at a community level, that’s not going to be enough of a risk reduction for most truly vulnerable families. The families I know IRL that have significant risks have not returned to daycare. Some have kids in virtual school, another sent their kindergartner in person this year but the kid wears a KN95 at all times and the parents got permission for them to eat lunch outside every day (outside lunch is generally on a rotation).

Have you seen the recent studies from Spain and Finland? They are better (less confounded) than anything this country has put out, and they show zero effect from school mask mandates.

Yes- that’s why I said “at best”.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.”

The die-hard maskers aren’t going to stop masking their kids once they’re vaccinated anyway. I have one DC in a preK program where at this point all the kids in the class are 5 (it’s the older of two preKs at the center) and I know from talking to parents that most if not all of the kids are vaccinated, yet all except 2 are still masked. Similar with my older DC in MCPS although slightly more seem to be unmasked. I’m honestly not sure what will be enough for these people.

It can be a real addiction, as the Japanese (with their masking culture) have known for a long time:

https://www.straitstimes.com/asia/east-asia/mask-appeal

I was in Japan precovid to visit my sister and couldn't believe that young people who appeared to be on a date (taking selfies, snuggling) would wear masks. She said many people wear them for anxiety reasons or even because they didn't have time to do their makeup. I think this has transferred here.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.”

The die-hard maskers aren’t going to stop masking their kids once they’re vaccinated anyway. I have one DC in a preK program where at this point all the kids in the class are 5 (it’s the older of two preKs at the center) and I know from talking to parents that most if not all of the kids are vaccinated, yet all except 2 are still masked. Similar with my older DC in MCPS although slightly more seem to be unmasked. I’m honestly not sure what will be enough for these people.

Lots of 5 year olds have younger siblings. Maybe the vaccinated household members mask to increase protection for the unvaccinated in their home.

In that case I’m curious what the long term strategy will be if an effective vaccine schedule for under 5s is never authorized. Every household member masks until the youngest turns 5? Kids under 5 very rarely need treatment to begin with so even though I know of sone adults who are hoping for better treatments before they ditch masks I’m not sure how this would work for kids.

I think (some) parents and (some) daycare directors will not come up with that strategy until it is clear that the vax for <5's is not happening "soon". We've been about 2 months away from a <5 vax since ~sept/oct now. (I realize the timelines aren't promises and things change, often for good reasons, just saying that there are people out there still waiting for this.) I'm not saying that is correct, but without clear communication from public health leaders saying that we should NOT be waiting for a vaccination to unmask the <5s and let them do most normal activities - this mindset is not going away completely. I really don't expect the CDC to make such a statement unless fully backed into a corner (i.e. FDA declines to approve EUA for <5s) - their charter is to control disease. They can't even clearly communicate that they don't recommend masking in childcare when transmission is low.

[Anonymous]

back to the topic...

https://www.politico.com/news/2022/04/21/biden-kids-vaccine-covid-00026798

Administration health officials had once hoped to authorize first shots for young children at the beginning of this year. But scientific setbacks and broader practical concerns within the Food and Drug Administration have slowed progress, the people with knowledge of the matter said.


Now, regulators are leaning toward postponing any action until the early summer, arguing that it would be simpler and less confusing to simultaneously authorize and promote two vaccines to the public, rather than green-lighting one on a faster timetable and the other down the road.

So they are hesitant to approve Moderna because of some sort of made up "confusion" even though Moderna and Pfizer were approved at different times back in 2020? Makes no sense and incredibly frustration to read knowing that Moderna can theoretically be ready first but has to wait for Pfizer to catch up.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.”

The die-hard maskers aren’t going to stop masking their kids once they’re vaccinated anyway. I have one DC in a preK program where at this point all the kids in the class are 5 (it’s the older of two preKs at the center) and I know from talking to parents that most if not all of the kids are vaccinated, yet all except 2 are still masked. Similar with my older DC in MCPS although slightly more seem to be unmasked. I’m honestly not sure what will be enough for these people.

Lots of 5 year olds have younger siblings. Maybe the vaccinated household members mask to increase protection for the unvaccinated in their home.

In that case I’m curious what the long term strategy will be if an effective vaccine schedule for under 5s is never authorized. Every household member masks until the youngest turns 5? Kids under 5 very rarely need treatment to begin with so even though I know of sone adults who are hoping for better treatments before they ditch masks I’m not sure how this would work for kids.

I think (some) parents and (some) daycare directors will not come up with that strategy until it is clear that the vax for <5's is not happening "soon". We've been about 2 months away from a <5 vax since ~sept/oct now. (I realize the timelines aren't promises and things change, often for good reasons, just saying that there are people out there still waiting for this.) I'm not saying that is correct, but without clear communication from public health leaders saying that we should NOT be waiting for a vaccination to unmask the <5s and let them do most normal activities - this mindset is not going away completely. I really don't expect the CDC to make such a statement unless fully backed into a corner (i.e. FDA declines to approve EUA for <5s) - their charter is to control disease. They can't even clearly communicate that they don't recommend masking in childcare when transmission is low.

Yes, this has been my biggest gripe. I agree with all the posters upset about the poor communication from our public health officials. Because the under five vaccine is always happening “soon,” it means no one has come up with a viable long term, or even medium term, public health strategy for children this age. So parents are left to scrape together a strategy themselves, with more and more limited leave and understanding from the rest of society.

If we all really understood that this isn’t happening soon, it would be a lot harder to tell parents to just keep holding on.

[Anonymous]

Anonymous wrote:back to the topic...

https://www.politico.com/news/2022/04/21/biden-kids-vaccine-covid-00026798

Administration health officials had once hoped to authorize first shots for young children at the beginning of this year. But scientific setbacks and broader practical concerns within the Food and Drug Administration have slowed progress, the people with knowledge of the matter said.


Now, regulators are leaning toward postponing any action until the early summer, arguing that it would be simpler and less confusing to simultaneously authorize and promote two vaccines to the public, rather than green-lighting one on a faster timetable and the other down the road.

So they are hesitant to approve Moderna because of some sort of made up "confusion" even though Moderna and Pfizer were approved at different times back in 2020? Makes no sense and incredibly frustration to read knowing that Moderna can theoretically be ready first but has to wait for Pfizer to catch up.

Doesn't it give you pause that several European countries have pulled Moderna for use in people under 30? I know they are conducting a trial, but the size is again so small that less common adverse events won't be detected until post-market observations (just like it happened in the much larger adult trials). I had no issue giving my 9yo Pfizer in November, but no way would I give this Moderna shot to an under-5yo.

[Anonymous]

Anonymous wrote:

Anonymous wrote:I seriously think it may never happen. The under-5 population very unlikely to experience severe disease, by orders of magnitude. The efficacy against Omicron and whatever comes next is going to be too low to justify the blanket vaccination of under-5s. Basically, unless a kid has some kind of co-morbidity, I think this is going to be a 5-and-up vaccine.

I sort of agree with this. I’m extremely pro vaccine myself and am upset there doesn’t seem to be an effective vaccine for kids, but it doesn’t sound like the current vaccines are doing much to prevent infection, spread or side effects in the under 5s and it seems questionable to enforce mass inoculation if that is the case. If that is true, I hope the CDC just comes out and says it.

I'm in this boat. One reason I am not as bothered as others seem to be about the fact that no vaccine has been made available to under 5s is that everything we know about these vaccines is that they don't do much. I too want to free my child from the burden of constant quarantines and masking, but I don't really understand why the only pathway to do that is to give our kids a vaccine that doesn't protect them.

I'm probably also the wrong person to ask because my kid is now almost 5 and we'll get her the 5-11 vaccine then. Though even that one has turned out to not be very effective! But at least my kid will be in the "vaccine eligible" group and therefore it's slightly more likely that she will be able to go to school without a mask and avoid long quarantines. I think the conclusion I've reached is that there is no point in me pinning hopes for my kids safety on vaccines -- I just have to acclimate to the [albeit small] risk of Covid for her and incorporate it into our day-to-day life, the same way I've incorporated other threats to her health and safety.

[Anonymous]

Anonymous wrote:

Anonymous wrote:back to the topic...

https://www.politico.com/news/2022/04/21/biden-kids-vaccine-covid-00026798

Administration health officials had once hoped to authorize first shots for young children at the beginning of this year. But scientific setbacks and broader practical concerns within the Food and Drug Administration have slowed progress, the people with knowledge of the matter said.


Now, regulators are leaning toward postponing any action until the early summer, arguing that it would be simpler and less confusing to simultaneously authorize and promote two vaccines to the public, rather than green-lighting one on a faster timetable and the other down the road.

So they are hesitant to approve Moderna because of some sort of made up "confusion" even though Moderna and Pfizer were approved at different times back in 2020? Makes no sense and incredibly frustration to read knowing that Moderna can theoretically be ready first but has to wait for Pfizer to catch up.

Doesn't it give you pause that several European countries have pulled Moderna for use in people under 30? I know they are conducting a trial, but the size is again so small that less common adverse events won't be detected until post-market observations (just like it happened in the much larger adult trials). I had no issue giving my 9yo Pfizer in November, but no way would I give this Moderna shot to an under-5yo.

Hooray, thanks for the updates on timeline. Looks like sources were "three people with knowledge of the matter", including "one senior Biden official". I understand why the aren't making official statements, but these soft releases in the media are really frustrating (though better than silence).

I can understand the argument to look at the data of both vaccines together, although that looks like at least a month delay to moderna. Back in 2020, we had NOTHING and elderly were extremely vulnerable to death. The level of emergency is less for this group, perhaps similar to flu and RSV. But I wish there were some clearer communication.

[Anonymous]

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??

[Anonymous]

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.

[Anonymous]

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.

[Anonymous]

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.

[Anonymous]

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.

[Anonymous]

https://www.washingtonpost.com/opinions/2022/04/21/kids-covid-vaccine-delay-insulting/

"At this point in the pandemic, plenty of parents are harried and exhausted and angry. But we’re not idiots."

[Anonymous]

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.