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

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[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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I guess I think about this differently because I am used to tracking pharmaceutical trials and therefore very accustomed to shifting deadlines. It's very typical, largely due to data. Pediatric trial, in particular, tend to have a lot of fits and starts because the process of recruiting trial participants is more complicated and the trials themselves tend to be more labor intensive. And then of course the standards are always higher for pediatric vaccines. So nothing about the Covid vaccines has surprised me in terms of dates shifting or the companies coming out later and saying "oh we haven't submitted yet for x,y, z reasons." This is all very standard. And the Covid trials have been extremely expedited, so if anything I would expect worse communication, but honestly this is about standard.

The main difference between the Covid vaccines and other pharmaceutical approval processes is that the general public is MUCH more interested in it, as is the general interest media. That creates a problem that is hard to solve, because it means you have lots of people who don't know or understand the science (including journalists) talking about the process with authority. I think that's contributed to the sense of being mislead or lied to more than anything else. The communication from Pfizer/Moderna and the FDA has been pretty standard and I think fair. The media coverage and social media chatter... well, it's not great. People see a misleading headline, get excited and tell everyone they know, and then are disappointed a month later. But that's not because the FDA or the Pharma companies miscommunicated. It's because a copywriter somewhere wrote an unnuanced headline about a report they didn't fully grasp. The media has really failed the public on this, and the scientific literacy of many of the people reporting on these matters is upsettingly low.

The thing I tell myself and other parents is that parents of young kids are incredibly fortunate in many ways with this virus. I know that's really hard to hear after the last two years (trust me, I know -- I have a 4 yo and it's been a rough couple years here), but if you take a step back and really look at the numbers, young kids are remarkably fortunate. Yes, even after Omicron and the higher rates of transmission and increased hospitalizations. Even now, an unvaccinated 3 yo has less risk from Covid than a triple-vaccinated 45 year old, based on statistics. Now, those numbers shift if the 3yo has an underlying condition that poses a risk factor, and the people I feel the most for are those with high risk kids under 5 (though I should also say that some of these kids have actually gotten access to vaccines, either through trials or other means). But if your kid is otherwise healthy, their risk is really very, very low, probably on par with their risk from RSV.

Your kid will get vaccinated. It won't be tomorrow. There are very smart people who want nothing more than to get these vaccines available working on this every day. Sometimes with medical miracles (and yes, this one) we have to have patience. No one is trying to trick you for keep you away from a functional vaccine. We're all on the same side.[/quote]

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