FDA authorizes Pfizer vaccine for kids age 12 to 15
nytimes.com
nytimes.com
https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#Se...
Given that death rates for the elderly are in the thousands per week, while those for kids jump around two to four or so, is this a good idea? Typically you want the benefits of a vaccine to outweigh the risks. I certainly could be missing something, but it doesn't look like this is the case for healthy kids.
I thought there were preliminary studies showing the vaccine is effective at prevention of infection, not just in reduction of severity of symptoms. Assuming that, a good prior to hold IMO (until we have such research) would be that it also prevents long COVID. However, since I can't find where I heard this, may be smart to withhold judgement one way or the other. That being said, what the sibling commentor pointed out seems plausible also to me to put into the prior (i.e. if long COVID is correlated with serious illness, then plausibly the vaccine would also prevent long COVID by reducing the serious response in the first place)
[1] https://news.yale.edu/2021/05/10/study-determine-how-covid-1...
Also, the number of folks who are vaccinated and have needed intensive hospitalization has been found to be approximately zero.
Intensive hospitalization isn't the only bad outcome for individuals. And the potential for vaccine resistant variants is everyone's problem.
The risk of serious adverse events wasn't statistically significant. And there was no pattern either. The evidence we have says the risks of getting vaccinated are things like temporary fatigue.
For example, Rubella is a vaccine commonly given to kids, but it is isn't really a severe disease even if kids catch it. If a pregnant woman contracts Rubella in her first trimester however, it can lead to severe complications for the unborn child. Just vaccinating women of child bearing age against Rubella works a little, but vaccinating kids as well means that that transmission vector is removed, and really improves the overall outcome.
It's highly probable that it helps but I thought we don't have the data proving it yet?
That is true and it's a good thing in it's own right, but it's orthogonal to the responsibility a doctor has to their patient first and foremost.
This conversation of individual vs communal rights is much simpler when we tell smokers they should keep it to designated areas or their private property.
It's a bit of a different animal when we're essentially encouraging and coercing people into taking potentially unnecessary medication for OTHER people's benefit.
It's not an easy question, if you're being intellectually honest. People who are hardliners on one side or the other on this debate, i feel aren't honest about the problems this poses. They're so wrapped up in their side of the individualism/tribialism or collective-safety/freedom dynamic, that they're not giving the other side a fair look.
This is a problem that plague the human species. Our greatest strengths are also our greatest weaknesses. Both our nature as collective/tribal animals, but with a deep since of contradictory individualism leads us to success and survival and wellness, but both of those aspects of us lead to great tyranny.
it's the communism vs capitalism debate - both sides have tons of blood on their hands. Tons of oppression too.
It's the debate played out between Kirk and Spock about the needs of the one vs the many.
And it's an honest, real debate that i don't feel will ever be solved because of the myriad of ways it plays out in a complex society.
1. They still get sick, even if asymptomatic, and can bring it home to the house where older people live 2. I don't know if there are published case report / data yet, but anecdotally the new strains are much more likely to cause complications and require hospitalizations for younger children. 3. Even asymptomatic infectious seem to cause "long covid" (Something like a third of long covid cases were asymptomatic). Potentially life-long alterations to lung or heart function doesn't sound like fun
I see elsewhere you're claiming that long Covid isn't a thing. It is, full stop. Unless you're suggesting that living with lung and heart damage caused by Covid isn't a complication of Covid?
https://www.sciencedaily.com/releases/2009/07/090717150302.h...
https://erj.ersjournals.com/content/45/5/1463
https://www.sciencedaily.com/releases/2000/03/000329090639.h...
https://www.cdc.gov/flu/highrisk/heartdisease.htm#:~:text=St....
https://www.ncbi.nlm.nih.gov/books/NBK8142/
https://www.sciencedirect.com/science/article/pii/S0945053X1...
We had more kids dying of the flu before, so this reasoning is not really accurate: https://www.healthleadersmedia.com/covid-19/true-or-false-de...
The aim of vaccinating everyone is so these kids can grow up in a world without Covid - so they don't die 5-10 too early when do get old. (You've heard kids get older, right?). And as people mention, kids not giving it to their parents, etc.
Forcing kids to pick up the slack to protect those who refused is not fair or a good use of resources, imho.
Certainly technology will be better in ten years as well.
Ill give it to my kid, I dont see a downside. She won't die of a vaccine.
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.
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.
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.
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.
* 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.
> The issuance of an EUA is not an FDA approval (licensure) of a vaccine.
0.4% had severe adverse events, with no pattern.
> 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.
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.
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.
By not vaccinating, you're contributing to the problem at some nonzero level. Unless you're on an island away from the world.
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)
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.
VAERS forms sometimes have more wording for that category: https://medcom.uiowa.edu/theloop/covid-19-vaccination-requir...
But you also don’t know the long term effects of covid lol. At least this has been clinically studied for a year.
https://www.mayoclinic.org/diseases-conditions/coronavirus/i...
I don't know the compounded statistics here and I don't claim to know the "right choice" for everyone, including myself. In general, I never get the latest update in software. I never get the first model years in cars. Without a case of urgency, this seems like a good path forward for this too, but YMMV.
None of this is real - just "science fiction". 1) the mRNA triggers latent gene expression which causes some form of cancer. 2) the mRNA causes some new slow protein generation which accumulates in the blood like cholesterol and has long term health affects.
is this possible? probably as possible as buying a winning lottery ticket and being struck by lightning at the exact same time!
Your choices are either get vaccinated, get COVID (and possibly transmit it), or take extreme precautions indefinitely. Unless you have reason to believe that the vaccine is more dangerous than COVID, and you're not willing to live your life as a shut-in or wear a respirator for the rest of your life, you might as well get vaccinated.
If everybody followed your logic, everybody would’ve had covid by now.
Of course we know that there are some healthy under 40’s that died from covid. If they got the vaccine, would they have died?
How many have died directly from the vaccine?
Answer those last two and you will see.
https://www.fda.gov/news-events/press-announcements/coronavi...
(Edit - side-effect data starts on page 25 here: https://www.fda.gov/media/144413/download)
There are legitimate reasons to question the rapid approval of this vaccine in children. It's certainly not something worth mocking. And I say that as someone who is fully vaccinated.
Maybe I'm missing something obvious, but where are you seeing this in the news release?
I have a "severe" reaction to alcohol every time I drink too much.
Focusing myopically on "transmission rate" misses the broader conversation about risk and benefit. Giving tens/hundreds of thousands of kids an illness on par with the flu to marginally reduce the theoretical risk of illness in an unvaccinated stranger...this is a choice that can be made, but I think it's a tougher decision than you do.
Vaccination of children wouldn’t be needed if most adults got it. But they don’t because they’re dumb. So now they’re saying children can get it if they’re parents want. It’s a choice to do your part to reduce the spread. Pretty simple.
Given that some of the the lowest vaccination uptake rates are in black and latino communities who have historically strained relationships with the medical system -- as well as some of the highest prior infection rates -- your comment is misinformed.
Whatever the current level of immunity may be, cases, hospitalizations and deaths are all rapidly declining across the US. Moreover, the vaccines are all close to 100% effective at preventing severe illness. There are a great many reasons to be optimistic about our current trajectory, and no immediate need to put children at risk to get where we need to go.
[1] https://poll.qu.edu/images/polling/us/us04142021_uscd43.pdf#...
Moreover, empirical reality differs from polling. In New York City, for example (a big, liberal, multi-ethnic city), Latino people lag whites by 12% in vaccination rate; black people lag by 17%:
https://www1.nyc.gov/site/doh/covid/covid-19-data-vaccines.p...
Whatever people are telling pollsters, it differs from their actions. Maybe they have "plans" to get vaccinated, but they're not doing it right now.
A different poll said Hispanic people are the most inclined to get vaccinated. But politics was the strongest correlation still.[1]
Cumulative vaccination rates reflect earlier hesitation. Also scheduling difficulties, transportation difficulties, and wanting to get vaccinated by a trusted provider.[2] But targeted efforts have closed or nearly closed the gaps in many places.[3]
[1] https://abcnews.go.com/Politics/trust-johnson-johnsons-coron...
[2] https://www.npr.org/sections/health-shots/2021/04/26/9899620...
> Focusing myopically on "transmission rate" misses the broader conversation about risk and benefit.
So does focussing myopically on deaths, which aren’t the only thing that costs Quality-Adjusted Life-Years.
> Giving tens/hundreds of thousands of kids an illness on par with the flu to marginally reduce the theoretical risk of illness in an unvaccinated stranger.
That’s not all the vaccine is for. Children have a much lower rate of dying of acute COVID symptoms, but do see more than enough long COVID effects, including MIS-C, to be worth protecting against.
Now you're just fear-mongering.
> Children have a much lower rate of dying of acute COVID symptoms, but do see more than enough long COVID effects, including MIS-C, to be worth protecting against.
There have been 3200 cases of MIS-C in the US. 36 have died.
https://www.cdc.gov/mis-c/cases/index.html
The rate of MIS-C is exceptionally low -- possibly lower than the rate of severe adverse events for the vaccine itself: "Overall, MIS-C is a rare complication of SARS-CoV-2. A May 2020 systematic review from 26 countries reported a MIS-C incidence of 0.14% among all children with SARS-CoV-2 infection"
https://www.bmj.com/content/372/bmj.n385
Give this vaccine to 1M children, and at a rate of 0.4% serious adverse (i.e. life-threatening) reactions, you would expect 4000. An unknowable portion of those will die. Moreover, there will be 20,000 reactions severe enough to put a child out of school for a few days. There are about 25M kids age 12-17 in the US.
Your sense of risk is seriously miscalibrated.
"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."
So 4 out of the 6 criteria are, in fact, life-threatening, one is "your life is permanently altered, sorry", and the final one is irrelevant.
(and no, despite your link to the other thread, "persistent or significant incapacity" does not include "a sick day")
> And there was no pattern either.
They didn't release the raw data, so there's no way for you to know that.
It does, actually. From the UI Medcom link: "symptoms that preclude patient from attending work, school or perform their typical daily activities"
Serious adverse events have to be reported to VAERS. I think the FDA would notice if Pfizer lied about there being no pattern.
"A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; e.g. symptoms that preclude patient from attending work, school or perform their typical daily activities"
We mostly know this vaccine is fine, since it completely leaves the body in a few days anyway… but not completely.
Same thing, mute point in consideration.
Was there a super-spreader event in the placebo group?
> Of the SARS donors, 100% showed T cell responses to cross-reactive and/or specific ECs (HLA class I 86%, HLA-DR 100%; Fig. 5d,e), whereas 81% of PRE donors showed HLA class I (16%) and/or HLA-DR (77%) T cell responses to cross-reactive ECs (Fig. 5d).
> Sample collection date Apr–May 2020
Also 40 cases of MIS-C; corona isn’t benign, but by all counts it’s less harmful than the flu at ages 0-19, though much more harmful for older people.
And a couple of cases of heart attacks and life threatening thrombosis at 16 associated and almost surely resulting from the vaccine. It’s safe, but not perfectly safe as many believe.
In such small numbers, it is incredibly hard to compare short term safety of disease and of vaccine. (And of course impossible to assess long term effects of either as well)
My kids will be getting the vaccine.
:-p
https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/...
If you're licensed in many states (e.g. medical, etc.) you're already required to be vaccinated against flu/TB. With EUA they've put this off, but with full authorization, why treat it differently?
One question, what long term effect of the vaccines are you concerned about, that wouldn't be far less severe than actually being infected?
They think a long term affect has been overlooked or is unknown. Although some people make up long term effects, many other people are just acknowledging the absence of history to tell, and thats valid.
(Very few of the people opting out are distinguishing between any vaccine technology though. But some are.)
What's the bar for when a technology is no longer "new"?
We figured out the basics in 2005, specifically two scientists Karikó and Weissman.
A decade ago there were discussions about how to develop more complex vaccines -- https://www.tandfonline.com/doi/full/10.4161/rna.22269
Given the immense potential to address everything from parasites (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6963228/) to cancer (https://pubmed.ncbi.nlm.nih.gov/28101688/) to allergies (https://pubmed.ncbi.nlm.nih.gov/30063806/), tons of research is being done on this technology.
Scientists have been working on and reporting on dosing strategies, managing immune responses, monitoring long term effects on animals, etc. for a long time now.
Which part is parody? Just because something is new to you doesn't mean it's new.
Like, at some point we have to trust science and accept that studies and test groups will give us some reliable safety guesses. People generally have no idea how much research has already gone into this vaccine because they've been taken in by all the media coverage around the mRNA vaccines claiming the technology is new.
Let me try explaining via an analogy. It's like the folks who are really worried about 5G signals because they are new. On the one hand, yes, humankind has not had long term exposure to 5G signals. On the other hand science has a fairly complete understanding of various electromagnetic spectrums and is the phenomena of using electromagnetic phenomena is hardly new.
So yes, mRNA vaccines are 'new', but only in the way 5G is 'new'. We may not have deployed it widely before, but we're pretty dang sure we understand it.
Im a scientific, rational, atheist moderate person, I fight all day long against idiots spouting conspiracy theories, but still.
This vaccine is the first time I get an mrna vaccine, and I just have this one life. I understand why vaccination is important but in a world where people lie and cheat, I have only one shot. Be nice about it. This is new.
To be a reasonable concern it has to be weighed against the alternatives. People have essentially four options assuming the virus does't just go away soon: get vaccinated using a new technology, wait for an older technology vaccine to be available, mask/isolate until the new vaccines have sufficient long-term data for their ill-defined concerns, get COVID.
Well COVID has high risk for long-term effects for all age-groups including death so any reasonable person will exclude that option. Older technology vaccines for many regions of the world may never be available or be sufficiently efficacious so that and masking/isolating indefinitely and maybe even getting COVID are the same option. Plus, there is no data showing any long-term effects for vaccines that don't become apparent in the first year or 100 million people receiving them.
COVID vaccine hesitancy is no longer a reasonable position to hold.
There were adult women under the age of 50 who had some medical problems with it but, it is much better than getting COVID. If the mRNA vaccine are the obstacle in getting vaccinated I’d go with the J&J.
(Note: I am not a medical doctor and this is not medical advice)
It uses DNA delivered via a non-replicating adenovirus vector, it's the first vaccine of its kind to be given any form of approval in humans in the United States and maybe the fourth in the world all in the last year. It is still "new technology" in a similar fashion to the mRNA vaccines. For the new=scary=bad crowd it isn't much of an improvement.
(I’m fully vaccinated as of today, just as context for what I said above. I came to a different [and I believe rational] calculation of my own risk-balance of complications from the vaccine versus fading the COVID risk unvaccinated for me and my family/colleagues and signed up for the very first shot I could get, a 75 minute drive away.)
I also don't totally agree that it's rational to hold out on vaccination due to blood clot concerns. From the stats I've seen, (even for young people) death from post-vax blood clots seems to be rarer than death from COVID. Although I suppose there's an element of "if everyone else gets vaccinated, maybe I don't need to". It would be ironic if that attitude means that, instead of being eradicated, COVID will be floating around for decades until those now young people become at-risk due to age.
Also, the Pandemrix history teaches us that although adverse effects manifest within 2 months, it can take over a year to figure out problems (spoiler: pandemrix was touted as safe including by Fauci but was associated with 5X increase in Narcolepsy, a deveatatig life altering disease. There is a suspected mechanism but no certainty, so you can’t even say “we incorporated the lessons from that”)
There is a fundamental problem with all of the hesitancy/risk issues, which is that the risk of not being vaccinated is much higher, unless you can personally count on never getting exposed to the virus, which at this point (for people alive now) seems highly unlikely. The classic example is the blood disorders for J&J, which are about as risky as driving 20-100mi (depending on where). It's not that driving is so dangerous (it's certainly not perfectly safe), but that the issues are so rare, and the alternative is worse.
There is no equivalence between naturally getting it and artificially getting it. Almost everything is different about the process.
And everything you say had been said about pandemrix at the time, including the chance of getting the disease vs the vaccine - and historically was wrong.
It's barely been a year. We all hope they're great, but it should remain a choice.
https://www.biospace.com/article/pfizer-biontech-and-moderna...
The reason for EUA was that so many people were dying that some more limited (<1yr clinical safety) data was accepted. Now that many of the original subjects are falling past 1yr post inoculation (and variants have been evaluated) a full authorization in eminent. Previously, people worried that once one vaccine was authorized other EUA (NovaVax, AZ/ChadOx, etc) wouldn't happened, has also been resolved since the FDA realizes people want choice.