Today, Pfizer announced they plan to submit an Emergency Use Authorization (EUA) application for the COVID19 vaccine for children under 5 years of age. Here is my best attempt to explain what is (and is not) known about the bumpy regulatory road to authorization for our youngest kiddos.
I just want to say thank you. As a mom of an under 2 and as an elementary school educator, I am so grateful for your ability to break down the process and explain the variables. As soon as I heard this news today I was anxiously awaiting your post to walk through the details. Thank you.
I understand your perspective and from a best case scenario it all makes sense. But the world is not best case scenario. Its filled with pitfalls.
There are no finish lines, and whatever was a finish line has been moved repeatedly. Success has never been defined, as we remember that we were Stay at Home to flatten the curve not become prisoners with a life sentence.
My kids 10 and 12 were at a swim meet. It was abundantly clear that the age group swimmers under 10 was the lowest census there. Clearly, the past 2 years stunted the younger kids from partaking in the sport. Pools have been closed and lock downs have suspended group activities. I get the feel the 6-7-8-9 year olds lost out of social and physical and mental development. Under 5, i fear the same thing. Just the circumstantial evidence was overwhelming.
Under 5 year olds are not party to the pandemic, except for wearing masks, cloth masks, that were deemed ineffective and probably stunted emotional development.
We are supposed to protect kids!!!!
Every year in the United States there are an estimated:
3,960 fatal unintentional drownings, including boating-related drowning—that is an average of 11 drowning deaths per day.
8,080 nonfatal drownings—that is an average of 22 nonfatal drownings per day.
COVID is not even close to that in fatalities. We would save more lives by hiring more life guards and that would not require shooting drugs into our system hoping for no side effect.
So what is the goal? To protect the elderly? Well, that can be done through all types of mitigation that does not require more and more medication. For goodness sake we just learned that the vaccine was not effective against Omicron.
What is the end game? Its lost on most of the USA except that one political party wants to continue treating COVID with a one size fits all while another wants to target those at risk.
It seems like vaccinating a demographic that has more drownings than COVID deaths is misguided.
Thank you Peggy - Well i had Pfizer and i tested positive - I would guess Moderna and J & J too. If the idea is to get vaccination to avoid contracting COVID or reducing risk.
The preliminary data about omicron and vaccines is coming in quickly and is revealing lower vaccine effectiveness. Best estimates suggest vaccines are around 30%-40% effective at preventing infections and 70% effective at preventing severe disease.
There is no silver bullet and it seems irresponsible to continue to push a one size fits all solution - remember, natural immunity which is reduced by pfizer shots is ignored when we are asked to get boosters. Weird no?
This week Moderna came out with their data showing that their vaccine plus booster obliterates omicron so yes vaccines do work. And yes maybe Pfizer is lower but it can still work to prevent total infection. One of my young not eligible to be vaccinated kids came down with covid last week. The other 4 people in the house were all fully vaccinated and never got sick. We all got PCR tests which were all negative. And believe me there is no way I didn't have the virus sneezed coughed and put directly into my mouth since the child is young and can't help but sneeze everywhere. Everyone was super exposed and ALL our vaccines held up. We have both Moderna and Pfizer so yes they are effective in some people and that makes a difference!
Of course Stephanie it is effective in some people.
Your family was fortunate. I am happy you did not get ill. That is the best case scenario but its not reality across the population.
My family were all vaccinated (Pfizer) and all 4 of us had COVID. It was my second bout and my youngest second bout. Not sure what that means except that we are fine today.
The question is at what cost are we going, in order to mitigate what is a really really small problem with children under 5. Katelyn is even questioning the protocols used - so i ask - is the juice worth the squeeze.
If you are worried then you take your vaccinations and as many boosters as you want since you seem secure in the protection they afford you.
Please check the CDC website - There is an exponential difference in deaths from COVID of children under 17 vs deaths from drowning in children under 5. I think we are at a .00005% chance of death for a child under 17. Influenza and Pneumonia are much worse than COVID.
I am offended by the one size fits all health care position taken by our government and healthcare officials. It has become a religion. You can do it but i will talk to my doctors (Weill Cornell Medical Center) to see what is best for me and my medical conditions. That is how we used to administer healthcare - now its diktats and mandates and no end in sight of government telling YOU what to do.
I find the Twitter post from John Burn-Murdoch sad. If more adults were vaccinated in the US and other countries, so much suffering would have been avoided. Whatever natural immunity is, infections in naive immune systems are just trouble. If kids are suffering, we need to take a look at ourselves.
Una - great info.. thank you. I think its more than just vaccinations. Check population density and co-morbidity.
Kids are suffering not from COVID but because of COVID. Less than 800 kids died in 2 years from COVID and that is not only death from COVID but with COVID. It is also not clear how co-morbidity plays into it. Consider ten times as many kids died from drowning over 2 years (about 4k a year). I dont see us stopping swimming.
I am vaccinated and would be happy if others were. Regardless kids are not at fatal risk from COVID and if they are the data should show that, yet it does not.
If we protected those at risk (and we know the demographics) then we would be far better off as a society.
The social dividend from going for the best outcome that science can provide far outweighs the one based on fear. Vaccinations are a significant part of gaining control over the virus. There is nothing to gain from infections in naive immune systems for anyone. There are other commenters and Dr Jetelina who are qualified to know the risks to children, better than I. But death is not the only risk. Most of us got vaccinations as children because decisions were made in our interests, because our parents wanted a better future for us. Our elders removed polio and smallpox, even considerably reduce the risk from flu for us. I am sure if we keep feeding ourselves with the best information available such as from Dr Jetelina, we will be able to do what they did in the last century and get the best health and social dividend for society, as we move forward.
As far as kids - the theory is simple - not that many are dying. I could have taken suicide or gun shots or anything. .00005% fatality rate is so low that we have to question why 65,000,000 kids take shots for 800 deaths, many with preexisting.
When in history has that been a cause for treatment? And worse the treatment is without individual treatment plan given health status.
I will try to find the analysis of the study - It was the about the control groups on the Pfizer study. Apparently it was not controlled. Also from memory they said that the antibodies from getting covid were reduced by the vaccine.. and that more people that had covid and the vaccine were infected than the covid group without vaccine.
I would love to hear your take on the Moderna trials for these young ages, as I thought they were potentially seeking approval in March and it's fascinating that FDA is eager to get Pfizer to apply and at the same time might step in front of Moderna's approval timeline and end up with children needing to go more months before the 3rd dose of Pfizer provides protection, wheras the Moderna shot would be quicker with just two shots if it is effective and safe. Is there not a realistic way forward for Moderna because of the path they took or is it potentially also a safe possiblity for our little ones?
What does the second graph mean- What level titre is effective? I don't quite get why as a parent I should try to get my 2-4 year old vaccinated if data indicates it is "ineffective" with 2 doses? I want to be excited but don't understand what there is to be excited about a vaccine that "doesn't work". What DOES it do? Why should I sign up for Pfizer right away vs wait for Moderna who seems to be buzzing with more positive results?
Part of the confusion goes back to the Pfizer dosing approach: The minimum necessary to achieve therapeutic effect. I'm not able to comment at this instant because I can't tell if the graph you're referring to is from the Phase I/IIa or IIb/3 trials. I suspect Phase I/IIa which would have insufficient numbers for me to make a call. However, Pfizer, after looking at more data made the determination there was the inadequate response.
I suspect Pfizer and Moderna will both, eventually be recognized as 3-dose vaccines. That the numbers were so spectacular for 2 doses meant a third dose wasn't explored early on. We needed safe and efficacious vaccines NOW, not a year from when they were released.
My personal bias, after seeing the data on response is that the 3- and 4-week dosing intervals originally chosen were almost arbitrary, although they were based on common knowledge of immunity activation through vaccine. But we were extrapolating from data not from a coronavirus. Perhaps, and this is almost as bad as their arbitrary interval picking, if we'd doubled the interval (6 weeks for Pfizer, 8 for Moderna) we'd have elicited a more long-term response (B- and T-cell) and a subsequent 6-month third dose would have reinitiated neutralizing antibody production as well as "reminding" the B and T cells what they need to do to help.
Thanks for your input. I meant the second set of graphs (50% virus titration). When people say 2 dose Pfizer trial for under 5 year olds makes me think there was no or insufficient immune response. That's why I wonder why bother getting just a two series vaccine if it's not generating enough of an immune response? My concern for the community is people will assume it is the same and safety precautions will relax and the kids will still be at risk for long covid and illness.
Thank you for such a clear explanation of the approval process. I don't mean to complicate things, but do you have any thoughts about a child who will turn 5 between getting the second dose of the under 5 vaccine and the third dose expected two months later? I have read that a child should get their first, lower dosage for their current age, and the higher dosage for their new age group, but there seems to be no precedent for crossing the age boundary between a two dose protocol and a three dose protocol. Would the third dose be of the 10mcg vaccine or a third shot of the 3mcg? Or would it be better to allow kids close to 5 to get the 10mcg vaccine early? I hope this will also be considered by the advisory groups.
Does anyone know how to pose a question to VRBPAC? I'm not familiar enough with the approval rules to know, but it seems that perhaps off-label use of the 5 to 11 year old vaccine could be allowed for those kids who would be left in limbo by reaching their 5th birthday during the (3 weeks plus 2 months) time between their first under 5 dose and the third? Is the immune system of a 4yr-10month old, really significantly different from a just-turned 5 year old? (It would be interesting to see if the reported data was broken out by year and if there were actually too many side effects in 4 year olds getting the 10mcg dose vs in 2 and 3 year olds ). This whole new situation is one more example of how anxiety producing all of this is for parents, worrying and waiting and waiting and then having to make choices against logic because of perhaps too rigid regulations.
The results Pfizer cited were for the sample population they enrolled in the trials. Breaking those down further isn't likely to change the results significantly, and with the number of people they're trying to affect with a new vaccine, they'd look at a population estimate rather than single patients.
>And, what are the implications for long COVID and MIS-C
...what is the difference between long COVID and MIS-C? I thought they meant the same thing, and one was a layman's way of referring to the other. Now I'm not so sure based on your post.
I have really enjoyed your extremely informative and dense, yet understandable newsletters. When my daughter turned 4.5 and speaking to our pediatrician if it was a matter of parental consent to get her vaccinated as she was still attending daycare, I was told it was guideline to not give her although our pediatrician has seen some parents lie the age of their kid to get vaccinated. I waited patiently only to have our daughter tested COVID positive from her teacher (very like Omicron) a week before Christmas which was a bit gut-wrenching as I thought about if I made the right decision to forego getting her vaccinated as a "5 yr old". Hoping some of your outstanding concerns get clarified in the next few weeks since the expected roll-out seems to be starting first week of March for under 5. Thank you as always for keeping us safe with shared knowledge.
I am desperate for a vaccine for my 4.5 year old. Have fantasized about just passing him off as 5 before this news came out. Is antigenic imprinting as big of an issue with too high of a dose as with too low of a dose?
How many kids were in the trial? Your newsletter says a couple of thousand —are we looking at 2,000? 8,000? Is that something Pfizer can share with the public?
If I recall, it was on the order of 2400, but I'm still early in my coffee. The study wasn't large, as it doesn't need to be for an amendment for an EUA.
Looks like VRBAP has already been scheduled for 2/15. Does this change your thinking about the likely timeline and/or likelihood of approval?
it moves the timeline up! Probably end of Feb now
I just want to say thank you. As a mom of an under 2 and as an elementary school educator, I am so grateful for your ability to break down the process and explain the variables. As soon as I heard this news today I was anxiously awaiting your post to walk through the details. Thank you.
Thanks for the comprehensive "cliff notes"...
I understand your perspective and from a best case scenario it all makes sense. But the world is not best case scenario. Its filled with pitfalls.
There are no finish lines, and whatever was a finish line has been moved repeatedly. Success has never been defined, as we remember that we were Stay at Home to flatten the curve not become prisoners with a life sentence.
My kids 10 and 12 were at a swim meet. It was abundantly clear that the age group swimmers under 10 was the lowest census there. Clearly, the past 2 years stunted the younger kids from partaking in the sport. Pools have been closed and lock downs have suspended group activities. I get the feel the 6-7-8-9 year olds lost out of social and physical and mental development. Under 5, i fear the same thing. Just the circumstantial evidence was overwhelming.
Under 5 year olds are not party to the pandemic, except for wearing masks, cloth masks, that were deemed ineffective and probably stunted emotional development.
We are supposed to protect kids!!!!
Every year in the United States there are an estimated:
3,960 fatal unintentional drownings, including boating-related drowning—that is an average of 11 drowning deaths per day.
8,080 nonfatal drownings—that is an average of 22 nonfatal drownings per day.
https://www.cdc.gov/drowning/facts/index.html
COVID is not even close to that in fatalities. We would save more lives by hiring more life guards and that would not require shooting drugs into our system hoping for no side effect.
So what is the goal? To protect the elderly? Well, that can be done through all types of mitigation that does not require more and more medication. For goodness sake we just learned that the vaccine was not effective against Omicron.
What is the end game? Its lost on most of the USA except that one political party wants to continue treating COVID with a one size fits all while another wants to target those at risk.
It seems like vaccinating a demographic that has more drownings than COVID deaths is misguided.
What vaccine is not effective against omicron?
Thank you Peggy - Well i had Pfizer and i tested positive - I would guess Moderna and J & J too. If the idea is to get vaccination to avoid contracting COVID or reducing risk.
The preliminary data about omicron and vaccines is coming in quickly and is revealing lower vaccine effectiveness. Best estimates suggest vaccines are around 30%-40% effective at preventing infections and 70% effective at preventing severe disease.
https://www.pbs.org/newshour/health/how-effective-are-covid-19-vaccines-against-omicron
There is no silver bullet and it seems irresponsible to continue to push a one size fits all solution - remember, natural immunity which is reduced by pfizer shots is ignored when we are asked to get boosters. Weird no?
This week Moderna came out with their data showing that their vaccine plus booster obliterates omicron so yes vaccines do work. And yes maybe Pfizer is lower but it can still work to prevent total infection. One of my young not eligible to be vaccinated kids came down with covid last week. The other 4 people in the house were all fully vaccinated and never got sick. We all got PCR tests which were all negative. And believe me there is no way I didn't have the virus sneezed coughed and put directly into my mouth since the child is young and can't help but sneeze everywhere. Everyone was super exposed and ALL our vaccines held up. We have both Moderna and Pfizer so yes they are effective in some people and that makes a difference!
Of course Stephanie it is effective in some people.
Your family was fortunate. I am happy you did not get ill. That is the best case scenario but its not reality across the population.
My family were all vaccinated (Pfizer) and all 4 of us had COVID. It was my second bout and my youngest second bout. Not sure what that means except that we are fine today.
The question is at what cost are we going, in order to mitigate what is a really really small problem with children under 5. Katelyn is even questioning the protocols used - so i ask - is the juice worth the squeeze.
If you are worried then you take your vaccinations and as many boosters as you want since you seem secure in the protection they afford you.
Please check the CDC website - There is an exponential difference in deaths from COVID of children under 17 vs deaths from drowning in children under 5. I think we are at a .00005% chance of death for a child under 17. Influenza and Pneumonia are much worse than COVID.
I am offended by the one size fits all health care position taken by our government and healthcare officials. It has become a religion. You can do it but i will talk to my doctors (Weill Cornell Medical Center) to see what is best for me and my medical conditions. That is how we used to administer healthcare - now its diktats and mandates and no end in sight of government telling YOU what to do.
If the US had Denmark's vaccination rates, thousands would have avoided hospitalisation: https://mobile.twitter.com/jburnmurdoch/status/1488084513829924867.
Prof Sam McConkey in Ireland sounding cautiously optimistic, thanks to vaccination rates in Ireland with US vaccines: https://www.goloudplayer.com/episodes/should-we-proceed-cautiously-as--aHR0cHM6Ly9jZG4ucmFkaW9jbXMubmV0L3JhZGlvLWNtcy91cGxvYWRzLzIwMjIvMDIvMDIxMDM1MjQvMDIwMi1zYW0ubXAz.
I find the Twitter post from John Burn-Murdoch sad. If more adults were vaccinated in the US and other countries, so much suffering would have been avoided. Whatever natural immunity is, infections in naive immune systems are just trouble. If kids are suffering, we need to take a look at ourselves.
Una - great info.. thank you. I think its more than just vaccinations. Check population density and co-morbidity.
Kids are suffering not from COVID but because of COVID. Less than 800 kids died in 2 years from COVID and that is not only death from COVID but with COVID. It is also not clear how co-morbidity plays into it. Consider ten times as many kids died from drowning over 2 years (about 4k a year). I dont see us stopping swimming.
I am vaccinated and would be happy if others were. Regardless kids are not at fatal risk from COVID and if they are the data should show that, yet it does not.
If we protected those at risk (and we know the demographics) then we would be far better off as a society.
The social dividend from going for the best outcome that science can provide far outweighs the one based on fear. Vaccinations are a significant part of gaining control over the virus. There is nothing to gain from infections in naive immune systems for anyone. There are other commenters and Dr Jetelina who are qualified to know the risks to children, better than I. But death is not the only risk. Most of us got vaccinations as children because decisions were made in our interests, because our parents wanted a better future for us. Our elders removed polio and smallpox, even considerably reduce the risk from flu for us. I am sure if we keep feeding ourselves with the best information available such as from Dr Jetelina, we will be able to do what they did in the last century and get the best health and social dividend for society, as we move forward.
As far as kids - the theory is simple - not that many are dying. I could have taken suicide or gun shots or anything. .00005% fatality rate is so low that we have to question why 65,000,000 kids take shots for 800 deaths, many with preexisting.
When in history has that been a cause for treatment? And worse the treatment is without individual treatment plan given health status.
I will try to find the analysis of the study - It was the about the control groups on the Pfizer study. Apparently it was not controlled. Also from memory they said that the antibodies from getting covid were reduced by the vaccine.. and that more people that had covid and the vaccine were infected than the covid group without vaccine.
I would love to hear your take on the Moderna trials for these young ages, as I thought they were potentially seeking approval in March and it's fascinating that FDA is eager to get Pfizer to apply and at the same time might step in front of Moderna's approval timeline and end up with children needing to go more months before the 3rd dose of Pfizer provides protection, wheras the Moderna shot would be quicker with just two shots if it is effective and safe. Is there not a realistic way forward for Moderna because of the path they took or is it potentially also a safe possiblity for our little ones?
What does the second graph mean- What level titre is effective? I don't quite get why as a parent I should try to get my 2-4 year old vaccinated if data indicates it is "ineffective" with 2 doses? I want to be excited but don't understand what there is to be excited about a vaccine that "doesn't work". What DOES it do? Why should I sign up for Pfizer right away vs wait for Moderna who seems to be buzzing with more positive results?
Part of the confusion goes back to the Pfizer dosing approach: The minimum necessary to achieve therapeutic effect. I'm not able to comment at this instant because I can't tell if the graph you're referring to is from the Phase I/IIa or IIb/3 trials. I suspect Phase I/IIa which would have insufficient numbers for me to make a call. However, Pfizer, after looking at more data made the determination there was the inadequate response.
I suspect Pfizer and Moderna will both, eventually be recognized as 3-dose vaccines. That the numbers were so spectacular for 2 doses meant a third dose wasn't explored early on. We needed safe and efficacious vaccines NOW, not a year from when they were released.
My personal bias, after seeing the data on response is that the 3- and 4-week dosing intervals originally chosen were almost arbitrary, although they were based on common knowledge of immunity activation through vaccine. But we were extrapolating from data not from a coronavirus. Perhaps, and this is almost as bad as their arbitrary interval picking, if we'd doubled the interval (6 weeks for Pfizer, 8 for Moderna) we'd have elicited a more long-term response (B- and T-cell) and a subsequent 6-month third dose would have reinitiated neutralizing antibody production as well as "reminding" the B and T cells what they need to do to help.
Thanks for your input. I meant the second set of graphs (50% virus titration). When people say 2 dose Pfizer trial for under 5 year olds makes me think there was no or insufficient immune response. That's why I wonder why bother getting just a two series vaccine if it's not generating enough of an immune response? My concern for the community is people will assume it is the same and safety precautions will relax and the kids will still be at risk for long covid and illness.
I am gonna have to research a little bit, unless @Katelyn has a little more data.
Thank you for such a clear explanation of the approval process. I don't mean to complicate things, but do you have any thoughts about a child who will turn 5 between getting the second dose of the under 5 vaccine and the third dose expected two months later? I have read that a child should get their first, lower dosage for their current age, and the higher dosage for their new age group, but there seems to be no precedent for crossing the age boundary between a two dose protocol and a three dose protocol. Would the third dose be of the 10mcg vaccine or a third shot of the 3mcg? Or would it be better to allow kids close to 5 to get the 10mcg vaccine early? I hope this will also be considered by the advisory groups.
VRBPAC will likely make recommendations on that. They're pretty thorough.
Does anyone know how to pose a question to VRBPAC? I'm not familiar enough with the approval rules to know, but it seems that perhaps off-label use of the 5 to 11 year old vaccine could be allowed for those kids who would be left in limbo by reaching their 5th birthday during the (3 weeks plus 2 months) time between their first under 5 dose and the third? Is the immune system of a 4yr-10month old, really significantly different from a just-turned 5 year old? (It would be interesting to see if the reported data was broken out by year and if there were actually too many side effects in 4 year olds getting the 10mcg dose vs in 2 and 3 year olds ). This whole new situation is one more example of how anxiety producing all of this is for parents, worrying and waiting and waiting and then having to make choices against logic because of perhaps too rigid regulations.
The results Pfizer cited were for the sample population they enrolled in the trials. Breaking those down further isn't likely to change the results significantly, and with the number of people they're trying to affect with a new vaccine, they'd look at a population estimate rather than single patients.
That said, look here: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-15-2022-meeting-announcement for the info on submitting questions.
Thank you for the helpful information
This is a bit off-topic, but...
>And, what are the implications for long COVID and MIS-C
...what is the difference between long COVID and MIS-C? I thought they meant the same thing, and one was a layman's way of referring to the other. Now I'm not so sure based on your post.
I have really enjoyed your extremely informative and dense, yet understandable newsletters. When my daughter turned 4.5 and speaking to our pediatrician if it was a matter of parental consent to get her vaccinated as she was still attending daycare, I was told it was guideline to not give her although our pediatrician has seen some parents lie the age of their kid to get vaccinated. I waited patiently only to have our daughter tested COVID positive from her teacher (very like Omicron) a week before Christmas which was a bit gut-wrenching as I thought about if I made the right decision to forego getting her vaccinated as a "5 yr old". Hoping some of your outstanding concerns get clarified in the next few weeks since the expected roll-out seems to be starting first week of March for under 5. Thank you as always for keeping us safe with shared knowledge.
I am desperate for a vaccine for my 4.5 year old. Have fantasized about just passing him off as 5 before this news came out. Is antigenic imprinting as big of an issue with too high of a dose as with too low of a dose?
How many kids were in the trial? Your newsletter says a couple of thousand —are we looking at 2,000? 8,000? Is that something Pfizer can share with the public?
If I recall, it was on the order of 2400, but I'm still early in my coffee. The study wasn't large, as it doesn't need to be for an amendment for an EUA.