Can the US epidemic of mass shootings (primary targets being schools) be addressed as a public health issue problem, using some of the tools of epidemiology research?
Thank you also for your resources about responding to the school shooting. I'm putting together resources to share with my parish right now. These will be helpful.
The FDA has been so sketchy with review dates for under 5. Why are they waiting for Pfizer? The FDA has all the data, but they are waiting to review together? That is basically sitting on a vaccine that protects our kids. There was not mention that Moderna was tentatively scheduled for June 7-8 but then got pushed back when Pfizer's data came out. And it took weeks for Moderna to get a date, but 1 day after Pfizer comes out with data for only 10 kids, they get a date? It is like they are hamstringing Moderna to let Pfizer catch up at the cost of our kids.
It makes sense to review both at the same committee meeting rather than trying to get them all together. FDA has the data from both groups and knows its internal schedule to complete reviews of the data. Remember, this is some of the fastest moving approval processes in history, and evaluations are occurring at record pace.
It is odd all around. And similar EUA requests were all reviewed within 20 days, but this one is much later. Would love some answers here because it seems red tape, favoritism, or gamesmanship is getting in the way of just reviewing the science.
“Peter Marks @US_FDA: June 14 & 15, FDA will review Moderna & Pfizer for 6 months to 5 yr vaccines. Reviewing both vaccines together will help inform the public. Rob Califf: We'll have 2 kids' vaccines w/ different doses. Physicians & parents need to make a decision about which.”
Thank you for the booster info and for acknowledging the shooting. When I heard the news about the shooting, you were among the first people I thought of in terms of experts who can help us find our way forward. We live in Connecticut and I think about Sandy Hook every day when I put my kindergartner on the bus. It shouldn't feel like a relief, or dumb luck, every time she comes home to me. It's exhausting and things have got to change.
"You won’t screw it up, regardless of what you do decide about the timing for dose 3." This is sage advice and it's so easy to be paralyzed, especially when it comes to your kids.
As always a lucid commentary. I will caution that the data for under 5 is weak. Clinical trials of 1700 is far far less than needed to detect rare ( not even extremely rare ie 1/1000 vs 1/10,000). Can you succinctly analyze the absolute risk reduction ( not relative risks as usually mentioned) in deaths and COVID hospitalizations, ICU hospitalizations for the 6m-5 yo population. I cant seem to readily find them for the 5-11 yo's as well. I realize that hospital data is severely confounded by incidental COVID in this group as well as older children during Omicron.
The NYT has over estimated MIS-C in there recent reports and I feel the actual data on MIS-C in Omicron diminishingly small as recent DMC for PEDS COVID has demonstrated that they cannot recruit- do you have data?
If I had a child in that age group who already had asymptomatic/paucisymptomatic COVID I would be reluctant to vaccinate until the n is far bigger for safety,
There was a strong discussion on the required size of clinical trials for extension to younger populations months ago among vaccinologists and a lucid explanation of how study size is determined. Since larger trials and subsequent use in larger, older populations, what was being evaluated was efficacy, with an eye open for adverse events.
The incidence of MIS-C may have been over-estimated by NYT, but the actual incidence remains open to interpretation. I'm inclined to believe that, because of the multi-organ involvement of SARS-CoV-2, we will see more later-manifesting symptomatology.
I'm afraid I find wanting absolute risk vs relative risk of admission, ICU admission and death a bit of a deflection. Most statistics are related to relative risk, as you're likely aware, because an absolute risk calculation is a bit deceptive when one considers that little things like the case rate and actual penetration of COVID in the overall population are unknown due to inadequate testing.
The lack of reliable data on admissions and severe illness is complicated by the fact that reporting criteria re set by the states, and (mostly) reported to CDC and HHS. I'm aware of one state where certain parameters were not reported, including deaths where children were omitted because the governor believed the concept that children didn't get COVID. In fact, when inquiring as to the incidence of ECMO in adult and pediatric patients, the state health department was restricted from releasing those data. Subsequent discussions indicated but did not state explicitly that the governor didn't want anyone to actually know there were cases severe enough to require virtually all of the ECMO beds to be utilized (as determined by talking to appropriate clinicians at the major health centers.
Appreciate your reply a great deal. As an immunologist who has a special interest in rare AEs from biologic therapies I am in want of better data as we move ahead with more immunizations ( ie 3rd 4th with diminishing safety data in all populations) and new populations where the goals are less clear ( severe illness reduction? infection reduction ? ) Appreciate the complexities. Many unanswered Qs
We also have to factor in the great unmasking, the great capitulation, and the great flying blind. Antisocial social behavior in the US is driving a huge surge right now. Im up until late most nights educating patients about and prescribing antivirals like Paxlovid - at a pace that anecdotally feels more exhausting than the omicron wave.
As an epidemiologist you might enjoy seeing the data in my daughter’s class when masks became optional. They went from 3-4 cases per week in a 100% vaccinated school, to 36! Since the time of my post, the following two weeks produced 33 and then 28 cases, until administrators found their courage and made masks indoors mandatory again during this surge.
Thanks again for a great post for the 5-11 crowd getting boosters. Not sure if saying this helps, but as a physician I got my 11 yo daughter her 3rd shot already
Thank you. For all of this. Includinb/ esp the note. I was one of the people writing yesterday and you answered my very question, and provided a needed dose ( heh) of whatever you pick will be helpful, too.
I too felt the silliness of obsessing about third dose timing for littles given Texas. That you could help us hold both is so helpful, needed, and unsurprising. So much love and gratitude for you. I hope your break was good and you find ways for more rest and love with your family.
Thanks for the note regarding Uvalde. Gun violence is at a frightening level, and there appears little that will happen to reduce it. I concur (for what that's worth) with your conclusions and recommendations on boosters for the 5-11 year range.
Thank you for acknowledging and offering resources for the unspeakable, yet predictable, horror that happened yesterday. And, thank you for your clear info on boosters. We just had our kiddo boosted Monday as her sister is too little to get vaccinated ❤️
We must come together as adults and make our world safer and better for those which me behind. We are way way behind the curve from where we should be. I’m with you for finding a better way.
How do you feel about mixing and matching vaccines? My 8 year old got his first two Pfizer shots as soon as available, had covid in May/June, and now I need to get him a booster. Should I do Moderna booster? Wait until the omicron specific booster comes out for kids?
Thank you as always, for your work. And thank you for your final note, recognizing how paralyzing these decisions can be and assuring us that we parents can and will make the right decision.
Can the US epidemic of mass shootings (primary targets being schools) be addressed as a public health issue problem, using some of the tools of epidemiology research?
Thank you also for your resources about responding to the school shooting. I'm putting together resources to share with my parish right now. These will be helpful.
The FDA has been so sketchy with review dates for under 5. Why are they waiting for Pfizer? The FDA has all the data, but they are waiting to review together? That is basically sitting on a vaccine that protects our kids. There was not mention that Moderna was tentatively scheduled for June 7-8 but then got pushed back when Pfizer's data came out. And it took weeks for Moderna to get a date, but 1 day after Pfizer comes out with data for only 10 kids, they get a date? It is like they are hamstringing Moderna to let Pfizer catch up at the cost of our kids.
It makes sense to review both at the same committee meeting rather than trying to get them all together. FDA has the data from both groups and knows its internal schedule to complete reviews of the data. Remember, this is some of the fastest moving approval processes in history, and evaluations are occurring at record pace.
Thanks for your insight!
Yes, this seems very odd to me, almost like favoritism. I am not in the scientific community, though, so am likely missing something.
It is odd all around. And similar EUA requests were all reviewed within 20 days, but this one is much later. Would love some answers here because it seems red tape, favoritism, or gamesmanship is getting in the way of just reviewing the science.
Also consider how Peter Marks has been:
“Peter Marks @US_FDA: June 14 & 15, FDA will review Moderna & Pfizer for 6 months to 5 yr vaccines. Reviewing both vaccines together will help inform the public. Rob Califf: We'll have 2 kids' vaccines w/ different doses. Physicians & parents need to make a decision about which.”
https://twitter.com/lawrencegostin/status/1529170940424138752?s=21&t=r99mjywaXBVD8nv1LAdnmQ
I have a thread which quote contradictory statements in Washington Post interview.
https://twitter.com/jeffreytran/status/1529200065805488130?s=21&t=r99mjywaXBVD8nv1LAdnmQ
Thank you for the booster info and for acknowledging the shooting. When I heard the news about the shooting, you were among the first people I thought of in terms of experts who can help us find our way forward. We live in Connecticut and I think about Sandy Hook every day when I put my kindergartner on the bus. It shouldn't feel like a relief, or dumb luck, every time she comes home to me. It's exhausting and things have got to change.
"You won’t screw it up, regardless of what you do decide about the timing for dose 3." This is sage advice and it's so easy to be paralyzed, especially when it comes to your kids.
As always a lucid commentary. I will caution that the data for under 5 is weak. Clinical trials of 1700 is far far less than needed to detect rare ( not even extremely rare ie 1/1000 vs 1/10,000). Can you succinctly analyze the absolute risk reduction ( not relative risks as usually mentioned) in deaths and COVID hospitalizations, ICU hospitalizations for the 6m-5 yo population. I cant seem to readily find them for the 5-11 yo's as well. I realize that hospital data is severely confounded by incidental COVID in this group as well as older children during Omicron.
The NYT has over estimated MIS-C in there recent reports and I feel the actual data on MIS-C in Omicron diminishingly small as recent DMC for PEDS COVID has demonstrated that they cannot recruit- do you have data?
If I had a child in that age group who already had asymptomatic/paucisymptomatic COVID I would be reluctant to vaccinate until the n is far bigger for safety,
respectfully submitted
There was a strong discussion on the required size of clinical trials for extension to younger populations months ago among vaccinologists and a lucid explanation of how study size is determined. Since larger trials and subsequent use in larger, older populations, what was being evaluated was efficacy, with an eye open for adverse events.
The incidence of MIS-C may have been over-estimated by NYT, but the actual incidence remains open to interpretation. I'm inclined to believe that, because of the multi-organ involvement of SARS-CoV-2, we will see more later-manifesting symptomatology.
I have not been following specific data for 6 mo-11 years. That age group is peripheral to the group my organization is dealing with, and my time has been limited of late to look into it. That isn't to discount it, but it's relegated to a later timeframe. That said, I'd refer you to the AAP report at https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/
I'm afraid I find wanting absolute risk vs relative risk of admission, ICU admission and death a bit of a deflection. Most statistics are related to relative risk, as you're likely aware, because an absolute risk calculation is a bit deceptive when one considers that little things like the case rate and actual penetration of COVID in the overall population are unknown due to inadequate testing.
The lack of reliable data on admissions and severe illness is complicated by the fact that reporting criteria re set by the states, and (mostly) reported to CDC and HHS. I'm aware of one state where certain parameters were not reported, including deaths where children were omitted because the governor believed the concept that children didn't get COVID. In fact, when inquiring as to the incidence of ECMO in adult and pediatric patients, the state health department was restricted from releasing those data. Subsequent discussions indicated but did not state explicitly that the governor didn't want anyone to actually know there were cases severe enough to require virtually all of the ECMO beds to be utilized (as determined by talking to appropriate clinicians at the major health centers.
Appreciate your reply a great deal. As an immunologist who has a special interest in rare AEs from biologic therapies I am in want of better data as we move ahead with more immunizations ( ie 3rd 4th with diminishing safety data in all populations) and new populations where the goals are less clear ( severe illness reduction? infection reduction ? ) Appreciate the complexities. Many unanswered Qs
Appreciate remarks above. You both might find useful the NIH NCATS GARD site recently launched (and still under construction).
https://rarediseases.info.nih.gov/about
Also for those who like graphical presentations
https://www.cdc.gov/mmwr/va-search/visualAbstract.htm
The link I posted was specifically a COVID update from the American Academy of Pediatrics.
We also have to factor in the great unmasking, the great capitulation, and the great flying blind. Antisocial social behavior in the US is driving a huge surge right now. Im up until late most nights educating patients about and prescribing antivirals like Paxlovid - at a pace that anecdotally feels more exhausting than the omicron wave.
As an epidemiologist you might enjoy seeing the data in my daughter’s class when masks became optional. They went from 3-4 cases per week in a 100% vaccinated school, to 36! Since the time of my post, the following two weeks produced 33 and then 28 cases, until administrators found their courage and made masks indoors mandatory again during this surge.
https://mccormickmd.substack.com/p/the-largest-covid-wave-yetanecdotally?s=w
Thanks again for a great post for the 5-11 crowd getting boosters. Not sure if saying this helps, but as a physician I got my 11 yo daughter her 3rd shot already
If my 11 year old receives her third shot now, does this mean she would no longer be eligible to receive the 12+ shot after she turns 12?
Correct, but her immune system should by then be activated. She won't need the 12+ shot.
Thank you. For all of this. Includinb/ esp the note. I was one of the people writing yesterday and you answered my very question, and provided a needed dose ( heh) of whatever you pick will be helpful, too.
I too felt the silliness of obsessing about third dose timing for littles given Texas. That you could help us hold both is so helpful, needed, and unsurprising. So much love and gratitude for you. I hope your break was good and you find ways for more rest and love with your family.
I was vaccinated with two does of the J&J vaccine. I have been trying to get a third dose but no one will give me one. Why not?
Seek an mRNA dose for an additional booster.
Thanks for the note regarding Uvalde. Gun violence is at a frightening level, and there appears little that will happen to reduce it. I concur (for what that's worth) with your conclusions and recommendations on boosters for the 5-11 year range.
Thank you for acknowledging and offering resources for the unspeakable, yet predictable, horror that happened yesterday. And, thank you for your clear info on boosters. We just had our kiddo boosted Monday as her sister is too little to get vaccinated ❤️
We must come together as adults and make our world safer and better for those which me behind. We are way way behind the curve from where we should be. I’m with you for finding a better way.
Moderna tested during the January wave and Pfizer didn't, so how can we compare the data? Feels like comparing apples and oranges.
How do you feel about mixing and matching vaccines? My 8 year old got his first two Pfizer shots as soon as available, had covid in May/June, and now I need to get him a booster. Should I do Moderna booster? Wait until the omicron specific booster comes out for kids?
Thank you as always, for your work. And thank you for your final note, recognizing how paralyzing these decisions can be and assuring us that we parents can and will make the right decision.