Reply to When are Pfizer/moderna submitting data for Under 5s

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[quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][b]I reject the idea this is being “mishandled”.[/b] Pfizer and Moderna both have strong incentives to get these vaccines approved. The FDA has always had these standards for pediatric vaccines — you have to prove that the benefits outweighs the risks. It’s not unreasonable.

The truth is that it is hard to argue in favor of vaccines for this age group because their risk from Covid is so low. The reason Pfizer/Moderna went with such low doses in the trials is that higher doses will result in many kids spiking fevers as a side effect, and fevers in young kids can be very dangerous. Even if only a small percent of those fevers were dangerous, a higher dose vaccine could potentially pose more risk than Covid itself.

Thus the low dose trials, and the low efficacy. Compounded by the fact that the data in the trials is likely noisy because even in the control group, Covid rates are so low, and asymptomatic or extremely mild Covid is much more common than more serious cases. This makes it incredibly hard to show that vaccinated kids experience a benefit. Because they might not!

It’s not done grand conspiracy to keep you from vaccinating your child. It’s not incompetency. It is the normal and appropriate approach to approval of a vaccine for very young children.

Your kids are not at high risk of Covid. You don’t want to give your extremely low risk kid an in effective vaccine, nor do you want to give them a dose that could harm them.[/quote]

The mishandling part is just the communication, not the normal regulation process and need to ascertain a clear benefit.  The regulation process is working as it should, and I do applaud that.  The communication is terrible.

So, Moderna announced weeks ago that they were going to submit data to the FDA &quot;soon&quot; or &quot;in early April&quot;.  Has it been submitted to start the process?  Is the efficacy against infection too low to approve?  Has it been evaluated by experts?  By whom?  Have these conversations been had privately?   Is there any data on efficacy against severe disease or long COVID in &lt;5's, or is it not possible to pull that out given the generally low risk of kids and trial sizes?  Why are we still quarantining my kid for 10 days for exposure and shutting down classes?

My hunch is that it is a fine vaccine and the benefits still outweigh the risks/costs -  but it simply cannot meet the (appropriately) high bar needed for EUA.  But I have no idea why I&quot;m sitting around coming up with hunches.  Can't someone just tell us what is going on?  
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There is every reason to think the FDA will authorize pediatric vaccines as originally planned: based on immunobridging data rather than direct efficacy data. Moderna achieved that, but their application is complicated by their vaccine not already being authorized for kids/teens under 18.

Pfizer failed immunobridging for 2 doses, and we don’t know yet what the results were for 3. The trial description quietly set a higher antibody threshold to meet, so there’s a non-trivial chance it will fail. But FDA could still allow it to move forward if it meets the slightly lower antibody threshold that was set for Pfizer’s other pediatric EUAs.

The trials were small enough you’re not going to see good data on severe illness. And long covid is hard to study because you’re mostly working off of self-reported, common symptoms (like fatigue), so you’re not going to see good data on that, either. I doubt they'd attempt to address it at all in the EUA analysis/application.[/quote]

Well that is good news and I hope you are right.  Do you think that things are complicated by the fact that efficacy against current variants is lower compared to what the (adult) vaccines were originally approved under, and with long term efficacy against infection that wanes (though holds up for severe illness for adults)?  That is my worry about approval.  I agree they can say it is equivalent in efficacy to the adult vaccine. I just wonder if that is enough for EUA in April 2022, accounting for risks in the age group.  Is this an emergency for 4 year olds?  
 
Putting that aside... Did Moderna submit data?  I though they were doing 6 mo to 18 years in one swoop.  What is the latest Pfizer timeline?  Why is no one saying anything?  I think the answer is mostly that they don't want to say the wrong things, but not saying anything at all just leaves a silence for others to fill.  I guess part of it is that Moderna and Pfizer are the ones doing the talking (to the extent there is any talking), since the FDA can't really make any definitive statements until data is submitted.[/quote]

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