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Comment by timr | Hacker News Reader

The approval letter and supporting data is here:

https://www.fda.gov/news-events/press-announcements/coronavi...

(EDIT: side-effect data for 12-15yo are pages 25-27 in this: https://www.fda.gov/media/144413/download)

I have to be honest...this strikes me as poor risk analysis by the FDA. This approval is based on a study of ~1100 children over two months, of which the absolute risk reduction was ~1.6% (16 cases -> 0). However, about 2% of kids had severe reactions to the vaccine itself.

(EDIT 2: a further 0.4% had life-threatening reactions, which are labeled as "severe adverse events")

They don't report the number of severe infections, but I'm guessing that the number is zero, based on what we know about Covid in children.

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I'm looking at the table you cite, and it's listing side effects such as headache, fatigue, and chills. "Severe reactions" makes it sounds like they had serious adverse events. If 2% of kids get severe headache, fatigue, or chills for a day or so, so what? And I say that as the mother of a 14-year-old who is planning to get vaccinated as soon as possible.

So what? The chance of getting severe reactions from the actual virus is much lower for kids. Why would you make your children take something that is riskier than the thing it protects against?

Because Covid kills grandma.

Then grandma can get the vaccine. Why is this still an issue? Everyone in the US that wanted a vaccine, got it. Only a tiny portion of people are incapable of receiving it. The death toll dropped immediately. We don’t need herd immunity since the vaccine is so effective.

But that's the thing. If everyone isn't helping, then this virus continues to mutate and spread through the human reservoir. We won't reach herd immunity.

By not vaccinating, you're contributing to the problem at some nonzero level. Unless you're on an island away from the world.

From what I understand, this ain’t going away. All the medical experts are saying this will be a seasonal thing like the flu.

One of the primary reasons experts are predicting that herd immunity won't happen because too many people are reluctant to get the vaccine. https://www.nytimes.com/2021/05/03/health/covid-herd-immunit...

1. The virus has less of an impact (~0% fatal and very likely to have minimal to no symptoms)

2. We don’t know the long term effects of the vaccine. But we do know the long term effects of corona viruses (not specifically COVID19, but we can infer).

3. The vaccine isn’t 100% effective as it is, so while you mitigate short term risk, long term is likely higher with the vaccine given the estimated short term protection (implying multiple / yearly vaccines necessary) and relative risk of the virus (basically 0%) vs the vaccine (2% risk of severe incident)

> not specifically COVID19, but we can infer

You can’t do this with the vaccines too? Especially in the realm of long-term-sleeper side effects?

> relative risk of the virus (basically 0%) vs the vaccine (2% risk of severe incident)

I guess the problem here is your time frame is one month, rather than years out.

mRNA is a new vaccine type, need at least 3-5 years imo

Careful using the word 'approval'. That isn't the same thing as Emergency Use Authorization. The PDF states:

> The issuance of an EUA is not an FDA approval (licensure) of a vaccine.

Very true. Though given the number of children who will now get the vaccine, I think it's a distinction without much practical meaning.

From a regulatory perspective, you are saying that the FDA has done something that they did not do. “Approved”, “cleared”, “granted”, and “authorized” all have distinct meanings.

This is a pedantic debate. The door is now open for millions of kids to get the vaccine. This was not possible yesterday.

Did you read their analysis on page 27?

0.4% had severe adverse events, with no pattern.

Yes, I read it. I also read the data on pages 25-27. "Severe adverse event" is different than what I'm referring to, and are defined on page 9:

> Serious adverse events are defined as: • Death; • A life-threatening adverse event; • Inpatient hospitalization or prolongation of existing hospitalization; • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; • A congenital anomaly/birth defect; • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

It would not take very many such "serious adverse events" in a trial of 1100 before I'd argue that the vaccine is not safe for children.

Right, you're are making a big deal out of a kid getting a headache sometime in a month.

Not "sometime in a month". Immediately after the vaccine.

And yes -- for an illness that is essentially asymptomatic in children, that's a legitimate concern.

Another way of putting it: this vaccine will make at least as many children as sick as getting Covid itself.

Yes, I misremembered the 30 day follow period.

But it was indeed the 7 days following administration, not immediately after.

I guess I don't see a headache or fever from the vaccine as the same kind of sick as Covid, so no need to pursue the conversation if we disagree on that.

0.4% had life threatening side effects... more than a headache

Sure, other poster is not talking about 0.4%.

A serious adverse event doesn't have to be life threatening.[1] The difference between groups wasn't statistically significant. And there was no pattern either.

[1] https://news.ycombinator.com/item?id=27114261

I’m having trouble finding where the numbers for severe reactions are given. Can you point me in the right direction?

Page 26 in this: https://www.fda.gov/media/144413/download

Thanks! I appreciate it

It’s important to be clear here—these “severe” side effects are not life-threatening. We’re talking about a really bad headache or bout of diarrhea. Unpleasant, for sure, but not likely to have any long-term consequences.

As a parent, I’m ok with those odds even if my kids don’t get much direct benefit. Contributing to reduced community transmission is worth it.

Well, 0.4% of trial participants actually did have life-threatening reactions, so there's that. The risk is small, but not zero.

As far as mild side-effects go, another way of putting it is that at least as many kids will experience side effects from the vaccine as from Covid itself.

...and millions of kids are going to get this vaccine in the coming months.

My understanding is that Serious Adverse Events are not necessarily reactions that can easily be attributed to the vaccine (unlike a headache occurring soon after the vaccination), so we have to check whether these results are statistically significant and/or whether any patterns can be found in terms of what these events actually are.

I don't think 0.4% vs. 0.1% with n=1127 is significant, and the study mentions no patterns were observed.

We still have systems like VAERS to ensure side-effects that are too rare to be caught by a study of this size still get caught.

A serious adverse event doesn't have to be life threatening.[1] The difference between groups wasn't statistically significant. And there was no pattern either.

[1] https://news.ycombinator.com/item?id=27114261

Did you see all of the side effects from the vaccine vs the placebo? Here it is in percentages:

* Redness 5.8 vs 1.1

* Swelling 6.9 vs 1

* Pain 86 vs 23

* Fever 10 vs 1

* Fatigue 60 vs 46

* Headache 55 vs 35

* Chills 28 vs 10

* Vomiting 3 vs 1

* Use of pain med 37 vs 10

Only 1100 kids in the study and only 660 of them were followed up at least 2 months after the 2nd dose. These numbers seem unreasonably low.

This means that hundreds of kids had worse reactions than the placebo. All of this to prevent 11 symptomatic cases. I couldn't find the prognosis of these 11 symptomatic cases, but its highly likely that all of them were mild. To me, it seems like the overall health and well being of the vaccinated group was less than the placebo.

That 0.4% category includes simply taking a sick day from work/school. I would hardly call that life-threatening. You are also using the word “reaction” when it’s not clear that the SAEs were due to the vaccine and not something else.

Where did you see it includes simply taking a sick day?

Page 9, “A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions”

VAERS forms sometimes have more wording for that category: https://medcom.uiowa.edu/theloop/covid-19-vaccination-requir...

The fact sheet doesn't define substantial. The University of Iowa page says a sick day counts though. Thanks.

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