Why did the Pfizer young kids trial fail? | Hacker News Reader

Why did the Pfizer young kids trial fail?

yourlocalepidemiologist.substack.com

32 pointschmaynard31 comments

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What I'm not clear on after reading this is whether a dose that works is expected to still be safe

Unclear, but they must have published early trial data with discussion of why they didn’t go higher?

My read of this article is that we don't know, because Pfizer used a dose which was safe but did not work

My understanding is that Pfizer knows what the safe dose is, and administered it, and it didn't not work

Pfizer believes they know a safe dose.

> My girls were so close to getting their shot. We’ve waited so long and really needed a win.

Why? I don't understand the eagerness to vaccinate young children when they are not at risk. What am I missing?

I’d rather have my kids immune system with advance notice of a virus rather than have it kill cells indiscrimately if they’re infected? Just because they probably won’t die doesn’t mean I also don’t want their disease burden lowered, not to mention helping prevent them from being an unwitting vector to sicken others around them

In the Pfizer trial for children 5-11 there were zero severe cases of covid among the vaccinated group or the placebo.

> not to mention helping prevent them from being an unwitting vector to sicken others around them

The covid vaccines don’t stop you from getting sick or spreading covid.

Combine these two facts and we have a vaccine that doesn’t appear to do anything at all for children.

And before anyone says the vaccine prevents severe covid, Pfizer must prove that. Their own clinical trial provided no such evidence.

> In the Pfizer trial for children 5-11 there were zero severe cases of covid among the vaccinated group or the placebo.

What's severe? being on the ventilator for a few weeks or long covid for the rest of your life?

People need to stop framing death or ICU are the only shitty outcomes of Covid. Long Covid is far worse.

Severe and mild are measurable, clinical terms. It’s not subjective.

Severe Illness: Individuals who have SpO2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, a respiratory rate >30 breaths/min, or lung infiltrates >50%.

https://www.covid19treatmentguidelines.nih.gov/overview/clin...

> People need to stop framing death or ICU are the only shitty outcomes of Covid. Long Covid is far worse.

Long Covid is far worse than ICU or death? Surely that’s a typo on your part.

In the Pfizer clinical trial for 5-11 100% of Covid cases were mild. No ICU, no hospitalization, no death, and no long Covid.

> Severe and mild are measurable, clinical terms. It’s not subjective.

Obviously, but we don't have to re-use the same definitions of some group who wrote a paper. We can think of the impact of a life-long of diminished performance as much more grave than a temporary low oxygenation level. It's up to us to decide what's worse, there is no god-given criterion.

> Obviously, but we don't have to re-use the same definitions of some group who wrote a paper.

I’m not sure what you’re arguing here. We’re not discussing “some group who wrote a paper.” These are accepted standards worldwide, and the link is from the National Institute of Health.

> It's up to us to decide what's worse, there is no god-given criterion.

Sure. Fortunately the Pfizer trial made it easy. Every single case was mild.

It may be true that the Pfizer vaccine is effective in some way for children 5-11, but Pfizer have not proven that.

> These are accepted standards worldwide, and the link is from the National Institute of Health.

That does not mean they are not up for debate, which is the thing I'm trying to raise. Global criteria are mostly there to make comparisons easy, which nebulous things like Long Covid are not. That does not mean the problem does not exist, or that it is not potentially much more severe, and you won't find anyone writing these papers argue that.

You tend to rate your results according to widely accepted standards in your scientific community, unless you're specific in discussing them. Which is why most publications with data don't go into it.

What is Long Covid? People need to stop framing ill-defined terms which include symptoms ranging from insomnia and loss of smell to persistent trouble breathing reported across timelines ranging from 2 weeks to several months as an singular overarching condition.

Part of the challenge is to not mistake as-of-yet unmeasurable or ill-documented conditions for non-existence of the condition. Just because you can readily measure oxygenation levels, and not "Long Covid", does not mean the first is real and the latter is not.

This doesn’t help with decision making though. If long covid is worse than going to the ICU then something must’ve been measured or documented that shows this. Otherwise what’s your point?

That's basically the paradox of evidence based medicine, and there's plenty of published criticism on the subject. Naturally, we haven't measured the effect of decades of Long Covid yet. Yet, we can have strong and logical suspicions that the effect is potentially much more severe than a few weeks ICU (although they probably correlate strongly). I am personally in favor of acknowledging the trap of evidence based medicine, and taking 'softer' risks into account, even without evidence. In retrospective, there are plenty of things for which some sounded early alarms, but only when the evidence was in was policy adjusted. I think we can do better.

This will contribute to deeper understanding of how viruses are related to chronic illness.

> Just because they probably won’t die doesn’t

Forget death, even the chance of becoming seriously ill seems vanishingly small.

> being an unwitting vector to sicken others around them

Any sensible adult should have already gotten vaccinated by now.

Because they are a transmission vector and … some do get seriously ill.

My big concern is kid to grandparent transmission (which incidentally I've observed for a couple cold viruses this season).

We’ve waited so long and really needed a win sounded more like the author's frustration at not being able to get her daughters vaccinated. I could have misread the sentiment considering the author is an epidemiologist.

But still, I find the idea of vaccinating children when they are unlikely to benefit from it uncomfortable.

> some do get seriously ill.

At a vanishingly small rate.

That sounds like a you problem? We vaccinate everyone against rubella solely because it can be serious for pregnant women (and exactly no one else).

> At a vanishingly small rate.

And, critically, at a smaller rate than get seriously ill from the vaccine itself.

As my college roommate used to say, nothing scares me more than an irrational person.

> And, critically, at a smaller rate than get seriously ill from the vaccine itself.

Is this actually true? The rate of serious reactions to COVID vaccines seems to be almost astronomically small. There have been hundreds of millions of COVID-19 vaccine doses given in the US at this point and something like a few thousand total reports of significant adverse effects. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/ad... The main concern appears to be anaphylaxis, at 2-5 cases in a million.

Meanwhile there have been >8000 children ages 5-11 hospitalized, and 94 deaths, with about 2 million reported infections. (As of October) https://www.cnsnews.com/index.php/article/national/susan-jon...

I'm having trouble finding stats about children under 5, but I did find a CDC publication that indicates a hospitalization rate of 4.2 per 100000 population as of July for ages 2-4, and 24.8 per 100k for children <2. https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm COVID seems higher risk than the vaccine even in this population. (Which is not to say the risk is particularly high in this population.)

It’s late and I can’t find a source for this right now (so this comment is basically useless and admittedly irresponsible to even post) but I read recently 15 / 100k myocarditis from the vaccine (Moderna I think?). That stat was probably for a higher dose than they tested with children though.

Multiple governments have paused Moderna for < 29 which I presume means they determined the individual risk/benefit was imbalanced for that cohort.

Here’s a source for myocarditis numbers [0] but without any data for < 12. It looks like my recollection was a bit high (if you trust CDC). This suggests highest risk is males 16-24, after second (!) Moderna dose 38.5 per million, so 3.85 per 100k. It uses a small sample size though.

[0] https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-...

Risk of myocarditis in those same age groups is much higher with COVID than with vaccine.

But it should also be noted that in most cases, the myocarditis cases caused by the vaccine were mild.

What does it mean to have “mild” swelling of the heart? Do those cells heal back as they were before?

> What does it mean to have “mild” swelling of the heart?

Not being a medical specialist, I would assume mild means that hospitalization isn’t necessary and it’s probably treated with anti inflammatory drugs.

> Do those cells heal back as they were before?

Who knows? Probably, but that’s why they’re studying it. Another relevant question is whether myocarditis from COVID is worse or has longer term effects. And is someone more likely to get n myocarditis from the vaccine or from remaining unvaccinated

The hypothesis is that the spike protein is causing the myocarditis. One would assume that the same spike protein in a live virus that proliferates in much higher quantities (since the mRNA version cannot replicate) would be much more damaging. Additionally, a small genetic change has been made to the spike protein code in the mRNA code to make it even less dangerous. So I would say the chances are very good that the myocarditis from COVID is both more common and more severe.

Just, wow!

A supposed trained Epidemiologies agrees to let her own kids be test subjects to FDA trails that don't even follow the FDA's own rules and this without the ADULT Phase 3 even being close to done (2023-2024) and already seeing VAERS indicating 10-20x higher adverse reaction and death rates than ANY OTHER VACCINE IN HISTORY.

She needs to have her children taken and and face child abuse criminal charges! She's grossly irresponsible!

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