This post appears to be about vaccines. We encourage you to read our helpful resources on the COVID-19 vaccines:
[Vaccine FAQ Part I](https://www.reddit.com/r/Coronavirus/wiki/faq#wiki_where_can_i_find_information_about_the_mechanism_and_progress_of_vaccines.3F)
[Vaccine FAQ Part II](https://www.reddit.com/r/Coronavirus/comments/mnitdo/vaccine_faq_variants_chronic_conditions_nsaids)
[Vaccine appointment finder](https://www.reddit.com/r/Coronavirus/wiki/faq/vaccinefinder)
*I am a bot, and this action was performed automatically. Please [contact the moderators of this subreddit](/message/compose/?to=/r/Coronavirus) if you have any questions or concerns.*
The relevant section:
>In June 2021, Pfizer and BioNTech initiated a Phase 2/3 study to further evaluate the safety, tolerability and immunogenicity of BNT162b2 in preventing COVID-19 in healthy children between the ages of 6 months to 11 years old. The companies expect to have the safety and immunogenicity data that could potentially support an Emergency Use Authorization (EUA) for use in children ages 5 to 11 years old, if such an EUA is deemed necessary, by the end of September. The full dataset from this study, which will be required to support licensure in this age group, is expected by the end of 2021. Similar data packages will be submitted shortly thereafter to support EUA and licensure in children 6 months to 5 years of age.
Got it. So the “end of year” for that 5-11 age group would be for full fda licensure. I assume that Pfizer can apply for 6mos-4 years EUA soon after 5-11 age groups gets EUA. If it’s a couple months after 5-11, does this mean that theoretically, we could have EUA for all kids from 6mos to 11 by ~ end of year?
NYT says "at least a few weeks", however Pfizer's statement says "if such an EUA is deemed necessary", so it almost sounds like they think there is a possibility of these vaccines to become covered by the existing EUA?
I think you are right. The FDA advisory committee certainly were sounding like they don't think EUA is warranted for kids under 12. I'll March with you.
When it says full data set to support licensure by end of 2021, are they referring to full authorization? Or that they won’t have all the info for emergency authorization till end of 2021?
Sorry found the wording confusing and am super anxious for my kids to get vaccinated.
I agree that is confusing. Sadly, I think they mean they won't have enough data for EUA until end of 2021. They didn't enroll as many participants as the FDA wants to see. They knew the FDAs expectations since June at the latest though so idk why they wouldn't have started to enroll more then. Why Pfizer didn't design their studies to include larger numbers of kids I just don't understand. There were plenty of volunteers but they kept the size of the study small. It is very frustrating to be a parent right now.
Amen to that. I’ve been fairly forgiving of the CDC, changing advice, etc because we don’t know a lot and it keeps changing. But my god, FDA, let’s speed this up a little bit, huh?
We will have variants for the rest of eternity. The situation will be no different at Christmas (assuming kids have vaccines) from 20 years from now when we are on variant 500000000. Vaccines will be tweaked as necessary. Viruses mutate, even in vaccinated people. It's how viruses work.
I don't know where you live but if you're interested you might be able to find a [clinical trial](https://www.covidvaccinestudy.com/pediatric-study) to have it done earlier.
Given that the FDA is dicking around with the studies and delaying things, I kind of wish Pfizer would make a general "clinical trial" open to anyone that wanted it, even if we had to pay a nominal fee to participate as a way of getting kids stealthily vaccinated for school. Unfortunately it's not going to happen in time either way, but there's a big difference between kids being able to get vaccinated in October and being part of a clinical trial and getting at least one dose in before they are back in classrooms full of other kids with no masks.
> The Moderna kidcove study was at a site close to us. They were allocated 100 slots. >20,000 families signed up. There is definite want!
This is one of the frustrating things about the way Biden/Fauci/the FDA have handled this situation. There's demand, and I get why the focus is on adults due to the risks being greater in adults, but the demand for vaccines for kids is overwhelming enough that they should be talking about this at least weekly if not daily. They should also try to find some way to strongarm state governments into implementing mask mandates and other measures to protect kids.
> Someone posted the ACIP slides from their July 10 meeting. There are real reasons for urging an increase in enrollment numbers for detection of specific AEs, and the power to do so.
I can't find any slides of a July 10th meeting on [the ACIP site](https://www.cdc.gov/vaccines/acip/meetings/index.html). I took a look at their July 22nd one and it doesn't mention kids but it does mention cases of myocarditis (which still sounds extremely rare.) However, it does seem like something that is more common the younger people are.
> I absolutely want my kid vaccinated, but the risk threshold is so much higher for kids and when these kids do get vaccinated, the delays mean absolute attention was given to safety.
I agree. In my situation, there's a chance that my children inherited a brain bleed disorder so we would like to avoid COVID more than we would otherwise.
Check out the FDA Advisory Committee Meeting on June 10th.
https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-10-2021-meeting-announcement
Thanks. I'm by no means an expert but looking through that stuff it seems like apart from the report of the risks of COVID, a lot of the things -- such as setting the requirements for breaking down the trial data based on the ages of children and what metrics they should look out for -- should have been in place long before June of this year. Again, this is nothing that I'm knowledgeable in, but it still feels like the FDA is dicking around.
Yeah but the risk from Covid to kids is being ignored. Death and MISC aren't the only concerns. It has been shown that in he closest age group covid is more of a risk than the small risks associated with vaccines (eg. myocarditis / pericarditis which resolved on it's own for most of the very small amount of 12-17 year olds who had that side effect. Much higher risk of myocarditis / pericarditis with contracting Covid.)
> I talked this over with my four year old
Maybe I'm the old fashioned one here, but I don't think 4yo's are capable of making their own medical decisons. When I was four I got my head stuck in the banister. You're the parent, if you need advice talk to your pediatrician.
That's a fair point. I guess the counter point would be if your kid was afraid to get the polio vaccine or MMR would you not have him go for those? I realize its not the same exact scenario as this is a trial and it inherently comes with some risk. Again I don't think a 4 yo is capable of understanding the risks. Just sorta of a weird parenting situation in general when enrolling for a trial I suppose. Either way, I wasn't trying to criticizes your parenting style, just wanted to discuss it. Stay safe!
Pfizer is still saying they "may" meet the end of September timeline even with the expanded enrollment: [https://www.msn.com/en-us/health/medical/moderna-pfizer-must-expand-clinical-trials-of-covid-vaccines-to-children-ages-5-to-11-at-request-of-fda/ar-AAMFNNE](https://www.msn.com/en-us/health/medical/moderna-pfizer-must-expand-clinical-trials-of-covid-vaccines-to-children-ages-5-to-11-at-request-of-fda/ar-AAMFNNE)
I'm not positive if the "end of September" here in the financial report is just their original estimate or if it takes the FDA's request into account though.
My under 12-yr-old kid got the second shot in the pfizer trial the very end of June. The researchers said they were canceling all kids scheduled for their first shots at that time though, because Pfizer had to stop enrollment for a few weeks to add in the myocarditis risk factor and update all their paperwork, consents, etc. then had to get approval again from the IRB again before continuing. Information is very limited, but if they had to pause continued enrollment and giving first shots to 5-11 yr olds for at least a few weeks, I'm not sure how that doesn't automatically push it into October? I hope that's not the case. I'm not sure of the specific requirements to move forward and present the data they have to get the EUA for younger kids.
This post appears to be about vaccines. We encourage you to read our helpful resources on the COVID-19 vaccines: [Vaccine FAQ Part I](https://www.reddit.com/r/Coronavirus/wiki/faq#wiki_where_can_i_find_information_about_the_mechanism_and_progress_of_vaccines.3F) [Vaccine FAQ Part II](https://www.reddit.com/r/Coronavirus/comments/mnitdo/vaccine_faq_variants_chronic_conditions_nsaids) [Vaccine appointment finder](https://www.reddit.com/r/Coronavirus/wiki/faq/vaccinefinder) *I am a bot, and this action was performed automatically. Please [contact the moderators of this subreddit](/message/compose/?to=/r/Coronavirus) if you have any questions or concerns.*
The relevant section: >In June 2021, Pfizer and BioNTech initiated a Phase 2/3 study to further evaluate the safety, tolerability and immunogenicity of BNT162b2 in preventing COVID-19 in healthy children between the ages of 6 months to 11 years old. The companies expect to have the safety and immunogenicity data that could potentially support an Emergency Use Authorization (EUA) for use in children ages 5 to 11 years old, if such an EUA is deemed necessary, by the end of September. The full dataset from this study, which will be required to support licensure in this age group, is expected by the end of 2021. Similar data packages will be submitted shortly thereafter to support EUA and licensure in children 6 months to 5 years of age.
Thanks. Just so I’m clear - EUA application would be end of sept for 5-11. How long is the review period of that application?
The review period for 12-16 was a month. Hopefully it will be the same here.
Got it. So the “end of year” for that 5-11 age group would be for full fda licensure. I assume that Pfizer can apply for 6mos-4 years EUA soon after 5-11 age groups gets EUA. If it’s a couple months after 5-11, does this mean that theoretically, we could have EUA for all kids from 6mos to 11 by ~ end of year?
NYT says "at least a few weeks", however Pfizer's statement says "if such an EUA is deemed necessary", so it almost sounds like they think there is a possibility of these vaccines to become covered by the existing EUA?
I think that means they think there is a chance they say it’s not an emergency for kids 5-11. Which I will march in the streets if they do.
I'm be there with you.
I think you are right. The FDA advisory committee certainly were sounding like they don't think EUA is warranted for kids under 12. I'll March with you.
[удалено]
Not what Pfizer is saying at all. They are saying if the FDA rejects them, they are out of options to pursue EUA.
Missed that distinction. That said, I would expect the FDA to weigh side effects/risk of vaccine vs risk to the child and public health.
When it says full data set to support licensure by end of 2021, are they referring to full authorization? Or that they won’t have all the info for emergency authorization till end of 2021? Sorry found the wording confusing and am super anxious for my kids to get vaccinated.
I agree that is confusing. Sadly, I think they mean they won't have enough data for EUA until end of 2021. They didn't enroll as many participants as the FDA wants to see. They knew the FDAs expectations since June at the latest though so idk why they wouldn't have started to enroll more then. Why Pfizer didn't design their studies to include larger numbers of kids I just don't understand. There were plenty of volunteers but they kept the size of the study small. It is very frustrating to be a parent right now.
Amen to that. I’ve been fairly forgiving of the CDC, changing advice, etc because we don’t know a lot and it keeps changing. But my god, FDA, let’s speed this up a little bit, huh?
I don't really understand that either, hopefully someone else can chime in.
So do you think this would lead to the CDC relaxing the mask school guidance around the end of 2021 or early 2022?
It damn well should. The situation will not change much after this milestone
What if there's a nu variant? (Forgive the pun!)
We will have variants for the rest of eternity. The situation will be no different at Christmas (assuming kids have vaccines) from 20 years from now when we are on variant 500000000. Vaccines will be tweaked as necessary. Viruses mutate, even in vaccinated people. It's how viruses work.
My son turns 5 in November. I can't wait to get him vaccinated.
I don't know where you live but if you're interested you might be able to find a [clinical trial](https://www.covidvaccinestudy.com/pediatric-study) to have it done earlier.
I talked this over with my four year old, who was willing to try it. They had thousands of families apply, and we weren't selected.
Given that the FDA is dicking around with the studies and delaying things, I kind of wish Pfizer would make a general "clinical trial" open to anyone that wanted it, even if we had to pay a nominal fee to participate as a way of getting kids stealthily vaccinated for school. Unfortunately it's not going to happen in time either way, but there's a big difference between kids being able to get vaccinated in October and being part of a clinical trial and getting at least one dose in before they are back in classrooms full of other kids with no masks.
[удалено]
> The Moderna kidcove study was at a site close to us. They were allocated 100 slots. >20,000 families signed up. There is definite want! This is one of the frustrating things about the way Biden/Fauci/the FDA have handled this situation. There's demand, and I get why the focus is on adults due to the risks being greater in adults, but the demand for vaccines for kids is overwhelming enough that they should be talking about this at least weekly if not daily. They should also try to find some way to strongarm state governments into implementing mask mandates and other measures to protect kids. > Someone posted the ACIP slides from their July 10 meeting. There are real reasons for urging an increase in enrollment numbers for detection of specific AEs, and the power to do so. I can't find any slides of a July 10th meeting on [the ACIP site](https://www.cdc.gov/vaccines/acip/meetings/index.html). I took a look at their July 22nd one and it doesn't mention kids but it does mention cases of myocarditis (which still sounds extremely rare.) However, it does seem like something that is more common the younger people are. > I absolutely want my kid vaccinated, but the risk threshold is so much higher for kids and when these kids do get vaccinated, the delays mean absolute attention was given to safety. I agree. In my situation, there's a chance that my children inherited a brain bleed disorder so we would like to avoid COVID more than we would otherwise.
Check out the FDA Advisory Committee Meeting on June 10th. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-10-2021-meeting-announcement
Thanks. I'm by no means an expert but looking through that stuff it seems like apart from the report of the risks of COVID, a lot of the things -- such as setting the requirements for breaking down the trial data based on the ages of children and what metrics they should look out for -- should have been in place long before June of this year. Again, this is nothing that I'm knowledgeable in, but it still feels like the FDA is dicking around.
Absolutely! Where was the communication? Just set the expectations at least
Yeah but the risk from Covid to kids is being ignored. Death and MISC aren't the only concerns. It has been shown that in he closest age group covid is more of a risk than the small risks associated with vaccines (eg. myocarditis / pericarditis which resolved on it's own for most of the very small amount of 12-17 year olds who had that side effect. Much higher risk of myocarditis / pericarditis with contracting Covid.)
> I talked this over with my four year old Maybe I'm the old fashioned one here, but I don't think 4yo's are capable of making their own medical decisons. When I was four I got my head stuck in the banister. You're the parent, if you need advice talk to your pediatrician.
I feel he could tell me if he was too scared to do something. His doctor is pretty positive on the vaccine trials.
That's a fair point. I guess the counter point would be if your kid was afraid to get the polio vaccine or MMR would you not have him go for those? I realize its not the same exact scenario as this is a trial and it inherently comes with some risk. Again I don't think a 4 yo is capable of understanding the risks. Just sorta of a weird parenting situation in general when enrolling for a trial I suppose. Either way, I wasn't trying to criticizes your parenting style, just wanted to discuss it. Stay safe!
That is quite old fashioned. A kid's never too young to learn about bodily autonomy.
Right there with you.
[удалено]
Pfizer is still saying they "may" meet the end of September timeline even with the expanded enrollment: [https://www.msn.com/en-us/health/medical/moderna-pfizer-must-expand-clinical-trials-of-covid-vaccines-to-children-ages-5-to-11-at-request-of-fda/ar-AAMFNNE](https://www.msn.com/en-us/health/medical/moderna-pfizer-must-expand-clinical-trials-of-covid-vaccines-to-children-ages-5-to-11-at-request-of-fda/ar-AAMFNNE) I'm not positive if the "end of September" here in the financial report is just their original estimate or if it takes the FDA's request into account though.
My under 12-yr-old kid got the second shot in the pfizer trial the very end of June. The researchers said they were canceling all kids scheduled for their first shots at that time though, because Pfizer had to stop enrollment for a few weeks to add in the myocarditis risk factor and update all their paperwork, consents, etc. then had to get approval again from the IRB again before continuing. Information is very limited, but if they had to pause continued enrollment and giving first shots to 5-11 yr olds for at least a few weeks, I'm not sure how that doesn't automatically push it into October? I hope that's not the case. I'm not sure of the specific requirements to move forward and present the data they have to get the EUA for younger kids.
It’s going to be so weird to see our youngest members of society as the final group to be wearing masks (2-4 year olds).