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by georgekv 1625 days ago
The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus. The same issue was there with the 5-11s but pharma, CDC, & FDA just glossed over that to approve the vaccines.
5 comments

>The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus.

How does anyone convince themselves that this is actually a problem?

Especially when the vaccine no longer prevents catching the virus or transmitting it.

What remaining benefit are people so eager to confer upon their toddlers?

Vaccines still lower disease severity.

Also vaccines reduce risk of some post-acute COVID disorders like MIS-C (which can result even from asymptomatic COVID).

https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm

And of course you don't want to infect your child with a disease that has long term consequences which we are still learning about. Diabetes hit the news recently in the US, but it is actually been known for a while in other countries.

https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e2.htm

https://diabetesjournals.org/care/article/43/11/e170/35903/N... (UK)

https://adc.bmj.com/content/early/2021/05/27/archdischild-20... (Finland)

If that wasn't bad enough, diseases that are associated with T1D like celiac disease are on the rise, and show stronger association in COVID patients:

https://onlinelibrary.wiley.com/doi/10.1111/apa.16173

>Vaccines still lower disease severity.

Not for kids under 5. That's why it's not approved.

>And of course you don't want to infect your child with a disease

Breakthrough cases are so common now that the media refuses to use the term anymore. That (lack-of) "preventing-infection" efficacy is baked into the <5 study that showed no benefit.

>that has long term consequences which we are still learning about.

Why is this a valid concern, but potential long-term effects of the vaccines aren't? Especially the known risk of inflammation in still-growing bodies and especially in developing hearts.

>>Vaccines still lower disease severity. >Not for kids under 5. That's why it's not approved.

Wrong. Per the Pfizer press release [0], the immunogenicity analysis of the trial failed in children ages 2 to 4, but succeeded in children ages six months to two years. Given the small dose (3ug) in that study cohort, there was probably not enough rna in the vaccine for the 2-4 age group to show any effect.

>Why is this a valid concern, but potential long-term effects of the vaccines aren't? Especially the known risk of inflammation in still-growing bodies and especially in developing hearts.

The risk of developing myocarditis from the vaccine is about 100-150 in 5 million [1]. The risk of developing myocarditis from COVID-19 is about 150 in 100,000 [2]. I know I'm picking the vaccine for my child.

[0] https://www.pfizer.com/news/press-release/press-release-deta... [1] https://www.nature.com/articles/d41586-021-02740-y [2] https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm

edited for typos.

And what’s the likelihood of a young child developing myocarditis from COVID? You can’t apply whole population statistics to children blindly. If COVID has shown us anything it’s that diseases can discriminate.

I’m all for getting kids vaccinated when it’s deemed safe and effective (my daughter got vaccinated the first week it was available). But the risk to kids is quite low.

The first diagram in the first study you referenced [1] puts the observed rate of myocarditis among patients -without- COVID at 450 per 5 million (9 per 100k). That is much higher than the rate of myocarditis among the entire vaccinated Israeli [2] cohort (125 per 5 million) you mentioned.

The issue is that you're not comparing apples to apples. The Israeli data is looking at the entire population that received the vaccine. The COVID study is only looking at hospitalized patients with/without COVID which is a subset of the entire population restricted entirely to those experiencing the most severe symptoms.

This is not an easy problem to solve. A more apples to apples comparison [3] puts the COVID:vaccine myocarditis ratio at about 6:1, but it also suffers from a bias. In order to measure those rates they relied on the population that tested positive for COVID. This excludes the population of individuals which were infected with COVID but did not received a diagnosis who presumably also had a near 0 rate of myocarditis. This bias [presumably] becomes more pronounced at lower age groups where COVID displays milder symptoms making it less likely to end up diagnosed.

Finally, there is also the consideration that while the vaccines have not yet changed - COVID has. And its likely that the omicron strain will have a different distribution of side effects. It's a difficult problem to solve, and conflicts of interest abound make it all even more challenging.

[1] - https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm [2] - https://www.nature.com/articles/d41586-021-02740-y [3] - https://www.medrxiv.org/content/10.1101/2021.07.23.21260998v...

To be legally 2g compliant I need to boost every 4 months. Apparently the risk for inflammation might even get higher with each boost. If I'd catch COVID every 2 years or so how much does my risk rise for every infection?
What other respiratory virus in human history has caused chronic long term effects to the young and healthy?

Statistically we should be much more worried about something like RSV or the flu (even after vaccination).

We do have knowledge about long-term effects from other coronaviruses (SARS-CoV-1 and MERS).

Despite its name, SARS-CoV-2 is not strictly a "respiratory virus". While it is spread airborne, it attacks multiple tissues besides the respiratory system, and causes multi-system dysfunction (including but not limited to MIS-C, type 1 diabetes, celiac disease, acute kidney injury, erectile dysfunction, ...). Many of the damages are immune-mediated, which is in line with what we know about T1D and celiac as autoimmune disorders.

> What other respiratory virus in human history has caused chronic long term effects to the young and healthy?

Pneumonia.

< https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm

The study you cite specifically excludes those under 5.

> Vaccines still lower disease severity.

As does early treatment, https://c19early.com

Vaccine efficacy decays monthly (Delta/2021), https://www.youtube.com/watch?v=TSZMtSPX3iE

> Especially when the vaccine no longer prevents catching the virus or transmitting it.

The unvaccinated get COVID 400% more than the vaccinated, and the unvaccinated die from COVID 1,200% more than the vaccinated[1].

[1] https://www.nytimes.com/interactive/2021/us/covid-cases.html

This thread is about children under 5.

It is pointless to quote rates without their context (country, age, virus strain, month, etcetera).

Case in point: fully vaccinated boys without medical comorbidities in the US between ages 12 and 17 from January to June 2021 got myocarditis at 370–610% (ages 12–15) / 210–350% (12–17) higher rates than their risk of COVID-19 hospitalization.

(Edit: forgot the source :P) https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v...

I have wondered how much of statistics like this are due to the level of observation.

Post vaxx kid: "I don't feel good." Doctor: Let's check you for this myocarditis thing I've read about.

Pre-2020 kid: "I don't feel good." Doctor: You're probably fine.

That still doesn't disprove the fact, that the 'Vaccine' no longer prevents catching the virus or transmitting it.
It doesn't do as good a job as it used to, but we never had a vaccine that was 100% effective at doing either of those things. It's always been a numbers game where vaccines simply increased the odds in your favor. Before delta the vaccines gave a huge boost to your odds of not catching covid at all, but now with omicron vaccines only provide a small boost. Even now it's still better to use vaccines to increase your changes against catching the virus even though the vaccines are most effective at preventing death and hospitalization.
“Weve never had a vaccine that was 100% effective at doing either of those things” is a huge cop out.

It’s true, but we’ve had plenty of vaccinated that were 90%+ effective compared to the Covid vaccines at 30% for infection risk.

I was responding to a comment which said "the fact, that the 'Vaccine' no longer prevents catching the virus or transmitting it."

My problem with that statement is that it wasn't a fact. The vaccines do prevent catching the virus, just no where near as well as they used to and even at their best they never eliminated the risk of catching and transmitting the virus.

It sucks that the new variants are able to overcome so much of the protection we had from vaccines, but we always knew there was a risk that would happen if we allowed the virus to spread uncontrolled. We didn't do enough to keep the number of infections down and evolution did its thing resulting in poorer vaccine performance.

I really hope that adjustments are able to made to existing vaccines to compensate or new vaccines are developed which do a better job, but it's going to be an arms race until people stop passing this virus around by the millions every day giving it more opportunity to mutate and spread again.

Right now, the vaccines are still the best defense we have. 30% is a hard number to hear when we had 90% but 30% of 7.9 billion people is 2,370,000,000 so it can still prevent a whole lot of infections in the world and if we work harder to bring the number of infections down hopefully we can prevent things getting much worse. My biggest fear was that some variant would evade the protections we have entirely and negate the lessons we've learned in treating the sick and we'd be right back to where we were early 2020. That's still a possibility we have to be ready to face.

"It doesn't do as good a job as it used to, but we never had a vaccine that was 100% effective at doing either of those things."

Oh please. We have a truckload of vaccines that convey multi-decade/life-long immunity. case: the smallpox vaccine, polio vaccine, etc

We truly never had a real Covid Vaccine - we only have "protective boosters" and for Omicron they are utterly in-effective.

We still don’t know the long term effects of the vaccine. So this numbers game is equivalent to Russian roulette.
If you're concerned about the long term effects of the vaccine, you should be double concerned about the long term effects of the much more complex and much less understood virus.
I accept that it's entirely possible that 30 years down the line we'll discover some horrific thing we've all done to ourselves by taking the vaccines. What I can say however is that we don't have any evidence that suggests that we will see major problems in the future caused by the vaccines.

What we do have evidence for are future problems caused by these coronavirus infections along with a long list of immediate problems like deaths, severe (sometimes life altering) symptoms which can at times persist for weeks, months, and years, healthcare systems being overwhelmed preventing or delaying access to care and making accessing health services more risky, etc.

If you have to choose between getting a vaccine which appears to be perfectly safe but maybe could cause harm at some point in the future, and not getting it which we know does cause harm now and is very likely to cause harm in the future the choice is pretty clear. We can only deal with the evidence we have today and our best understanding of our current situation.

Especially when the vaccines benefit us not only by keeping us healthier and helping to eliminate the strain on our healthcare systems, but they are also our best bet to help reduce the need for social restrictions and disruptions in education and the economy.

There's still always that chance that the vaccines will have some negative impact on us later, but anyone in the future looking back and seeing our current situation won't have to wonder "What were they thinking taking their chances with this new vaccine!" It should be very clear to them that because we had no indication that there would be problems with the vaccine and because the vaccines were our best option to keep ourselves and each other healthy in the face of current problems and known future problems caused by the virus it was perfectly reasonable to take the chance on the vaccines and that doing so saved many lives and prevented many problems.

And I hope that should we have to deal with any future consequences from these vaccines that we can once again turn to medical science to find the best available option to treat those problems using the best understanding of them we have at the time. A huge percentage of the global population will be impacted after all so once again we'll be in a position where the entire world has an incentive to work together to find a solution which will hopefully go even smoother next time following the lessons learned here and now.

With more research and time things could change, but until there are indications that the vaccines could cause more harm than the known harms of the virus the vaccines will remain the smartest option we have today, no matter how tragic things turn out decades later.

Historically we know the long term side effects of vaccines (hint: there aren't any).
I suspect that these numbers are probably correct for Delta. For Omicron, the active cases are nearly uniformly distributed with respect to vaccination rates. It still helps to reduce hospitalization rates however which is good.

https://www.alberta.ca/stats/covid-19-alberta-statistics.htm...

This is interesting. PBS indicated that the vaccine is 30-40% protective against omicron infection and that it jumps above 70% with a booster.

https://www.pbs.org/newshour/amp/health/how-effective-are-co...

I wonder if the early data has been proven wrong or if something is wonky about Alberta. At even 30% effectiveness you’d expect to see a big gap between unvaccinated and vaccinated new cases.

Weirdly near the bottom of your link they show nearly 90% effectiveness against all the variants of concern, but omicron isn’t listed. It seems like the vaccines would have to be negatively effective against omicron for all the other data to work out, though.

That certainly used to be the case. In mid December for example (i.e. around the time the PBS article was written) active cases were roughly evenly split between unvaccinated and vaccinated. This is in a highly vaccinated population (85% of 12+, 73% total - out of 4.5M) so prevalence in the unvaccinated group was 3-4X higher than vaccinated at that time.

It seems unlikely that the Alberta population is experiencing a significantly different pandemic than neighbouring regions (demographics and responses are largely the same). I also wouldn't conclude from this data that vaccines are negatively effective as hospitalization rates are lower in the vaccinated group.

> It seems unlikely that the Alberta population is experiencing a significantly different pandemic

I agree. But I don’t understand that data. It doesn’t seem to line up with data from other areas.

e.g. Seattle is seeing 2.5x more infections among the unvaccinated.

https://www.seattletimes.com/seattle-news/health/record-covi...

> It seems like the vaccines would have to be negatively effective against omicron for all the other data to work out, though.

If you search hard enough (and quickly enough, they’ll likely be removed soon as they’re anti-narrative) you’ll find articles of people discussing exactly this. That the vaccine actually increases your chance of infection.

> If you search hard enough

You can find anything online if you search hard enough. That doesn’t mean it’s true. It probably means you’re actively seeking out bias-confirming articles.

> (and quickly enough, they’ll likely be removed soon as they’re anti-narrative)

And now it’s full on conspiracy theory. This stuff is nuts. People like Alex Jones loudly put forward blatant lies that are “anti-narrative” and no one shuts them down. Why does every group imagine they are persecuted?

> you’ll find articles of people discussing exactly this. That the vaccine actually increases your chance of infection.

I would be interested in any relevant reputable articles showing this, but I’m pretty certain there are none.

> Especially when the vaccine no longer prevents catching the virus or transmitting it.

The vaccines never stopped catching or transmission... they lessen the chances of you developing severe symptoms, your immune system still has to work.

Vaccines were more effective at preventing infection, but their effectiveness in that area has declined with newer variants. Lessening the length and severity of symptoms also plays some role in reducing transmission since coughing, sneezing, and runny noses are a great way to spew virus into the world around you.

Although I hope we will see vaccines that do a better job at preventing infection and transmission the benefits we're getting from them right now are enough that everyone who can should be vaccinated and boosted as needed to maintain those benefits.

Well Virtue with a capital 'V' is one big one! And of course they're an excellent source of revenue for Pfizer et al. You wouldn't want to risk it would you?

-- writing this while my toddler is banished from daycare for 10 days because a single kid there tested positive.

It’s not virtue signaling to be terrified for your children’s health. It might not be rational but it should be perfectly understandable.
Terror is rarely coincident with clear decision making.

Hopefully it's transient, soon followed by calm risk-benefit analysis.

Having your children’s lungs scarred to 20% function and not getting to realize it’s even happened until they start a sport or something doesn’t sound fun to me, perhaps that’s why.
Citation please. What children had this happened to? You can’t throw out fear mongering claims about terrible outcomes with no data.

Also, are you aware that children sometimes die from RSV and even the common cold? The problem COVID vaccines for kids are facing is that the problems from COVID in that age are so infrequent that they are essentially in the noise.

I think the very young child (<18 months) is at higher risk, though.

The entire point is that the vaccine didn't improve the risk profile for kids under 5.

Which means that scenario playing in your head is just as likely to happen (or more likely, not happen) whether your children are vaccinated or not.

The success we’re talking about was an analytical measurement of the antigen response in the body. It wasn’t lack of symptoms which ruled that phase a failure.
That is incorrect, the decision making numbers used to test vaccine effectiveness having nothing to do with lab antigen numbers, they are based on how much symptomatic illness is avoided. All of the results such as as 95%-96% efficacy for Phizer and Moderna and 66% for J&J are based on the % reduction of symptomatic illness only. Not the reduction in actual illness or based on lab tests of antigen response.
I believe you are incorrect. What you say was true for the initial adult trials but many recommendations for boosters and lower age groups have been based on antibody response, not clinical outcomes.
Correct or incorrect is sort of irrelevant, because it's a problem itself if they aren't including severity of symptoms in the study.

If they are ignoring symptoms to approve a vaccine who's primary remaining benefit is ... reducing severity of symptoms ... then how exactly has the trial proved anything?

Since antibodies are no longer a reliable indicator of immunity or of preventing transmission, then reduced severity is the primary remaining benefit.

Ideally they'd be looking at a cumulative risk/prevention assessment, but I don't see how they do that while excluding observed symptoms.

If they are using antibody levels as a proxy for this when they could just ... directly observe symptoms... then there would be a bigger problem with the study than just a failure to show sufficient efficacy.

Take it up with the FDA. You're preaching to the choir
I get it.

It's just a fine line between arguing what would justify FDA "approval" vs what merits have changed that actually increase the risk-versus-reward assessment.

Put another way, when the biggest excuse for not getting vaccinated was "it's experimental and not approved", it became a straw-man-esque "gotcha-trap" of a battle to achieve "approval", even though that approval process looked nothing like any before it (no matter how many times "full fda approval" is repeated).

When the metric becomes the goal, it's no longer a metric, and all that.

We get bogged down arguing whether criteria of a definition or standard are being met, while the regulators end up just redefining things.

And we're supposed to pretend the teacher applying a curved grading scale actually represents a difference in the students performance.

I've read that the pfizer study compared rates of positive test cases between the two groups.

BUT, the tests were administered based on self-reported symptoms which were then evaluated by a staff member to decide whether a test was warranted. This absolutely blew my mind.

This kind of avoidable subjective decision making should not be happening in a clinical trial. All participants should have been tested at regular intervals.

Equally... that when they repeat it and get different numbers, the failed trial will be ignored in favor of the passing trial, without first invalidating the previous results[0], and without using any increased burden of proof.

Passed+Failed = "Passed!"

[0] There will be a reason given to ignore that first trial, it just likely won't be a good one.

How does one not self-report symptoms? Some will be externally obvious but how does someone know someone else has chest pain, or a sore throat?
> that they can easily test the efficacy of the virus

I think you meant to type 'vaccine'

> The biggest reason the under 5s vaccine is taking so long is that they don't suffer severe enough symptoms that they can easily test the efficacy of the virus.

Do you have a source on that?

My understanding is the reason it's taking so long is 1) an abundance of caution because the risk/reward calculation is different and 2) young children's immune systems don't work the same as adults').

Do you have a source for this?