Pediatric COVID hospitalizations reports thread
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Anonymous
While that's true, that's been the case all along. The rate of serious COVID hospitalizations will track with that. So it is troubling. Though, people need to understand what is does and doesn't mean. There's no evidence that cases are more likely to be serious in kids. We're seeing an increase in cases in kids, but the rate of hospitalizations per case has not significantly changed. If only we had an effective treatment to prevent serious illness in kids... Though, apparently Jeff doesn't like people talking about the pediatric vaccine trials, given he deleted the other thread criticizing the FDA. |
Anonymous
Why did the other thread get deleted? I'm not interested in criticism, I just want to know if there's a chance that the FDA will authorize the vaccines before the expected February 2022 timeframe. |
Anonymous
No idea. Jeff has a history of deleting threads that are critical of the FDA or NIH. In this case, the thread was starting to criticize the FDA's decision to delay the pediatric trial by requiring more participants than originally planned. The FDA has not explained that decision. The original plan was proposed and discussed in public, but the delay was done privately. Presumably it was tied to looking for rare side effects, but that was already addressed in the original plan. It's not clear why they later wanted to change it. Pfizer is still expecting to submit for EUA this fall. And Moderna seems to think they'll still be able to submit for EUA for the 5-11 group by the end of the year. |
Anonymous
Is that fall pfizer eua for 5-11 yr olds only or also under-6 yr olds? |
Anonymous
Anonymous
But only in states with high covid hospitalization rates for the general public? |
Anonymous
This is true (at least based on the data we see right now). But it is not helpful when assessing risk. Risk is the probability of something happening multiples by the severity of the outcome. So the severity doesn’t change, but if you are much more likely to contract COVID (for example if you are unvaccinated in schools with no mitigation strategies), your risk of bad outcomes also goes up. The FDA and everyone else should be considering risk to the population not just severity on a case by case basis. |
Anonymous
While this is true, the risk to healthy kids is overwhelmingly driven by the severity, or lack thereof. So yes, a 5x increase in cases would still roughly mean a 5x increase in risk, but it's still a small risk because severity is so low. |
Anonymous
But I have heard the under 5 group is only "weeks" behind the 5-11, according to other media articles. They started trials a few weeks later, so if data progresses similarly (and that is a big if), it should still be something like November. I'm setting myself up for disappointment, but I"m hopeful for it to be offered by thanksgiving... |
Anonymous
I hope you are right  . I will say to think your under 5 will be vaccinated by Thanksgiving is a pretty big stretch though. I would set your sights on Valentine's Day!
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Anonymous
It's not clear how the FDA's delay of the pediatric trials will impact the 2-5 age group. For a variety of reasons, it may take Pfizer and Moderna longer to go back out and double the size of the 2-5 trial compared to the 5+ trial. And it's not clear what other changes the FDA made to the trials and EUA criteria. How long will those new trial enrollees need to be followed before the companies can submit for EUA? |
Anonymous
| Is it absolutely certain that pfizer will give 5-11 yr olds 10 mcg? Or is it a good chance they will stick with the 30mcg dose like for everyone else so far? Because there is so much more data for that dose? Has there been any evidence that the 5-11 yr olds already in the trial who got the 30 mcg did poorly? I thought the myocarditis was just in older than 12yr old boys? |
Anonymous
there’s zero way I’m giving my 9 yr old boy the adult dosage. |
Anonymous
We don't have data for younger kids yet. But for older individuals, yes, the 12-17 year-old-boy demographic had the highest observed frequency of myocarditis and pericarditis, estimated at <70 cases per million second doses. Though, that should probably be taken with a grain of salt. When the VRBPAC discussed this, they noted that it doesn't take much to come back with a finding of myocarditis if you go out looking for one. So, if they looked harder for it in kids, of course they'd find a lot more there. And yes, the Pfizer phase 2/3 trials used 10mcg in the 5-11 group, and 3mcg in the <5 group. |
Anonymous
Why? |