FDA Clears Pfizer COVID-19 Vaccine For Kids Ages 12 To 15 (cnbc.com) 79
The Food and Drug Administration on Monday approved Pfizer and BioNTech's request to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis, allowing states to get middle school students vaccinated before the fall. The two-dose vaccine is already authorized for use in people 16 and older. CNBC reports: Acting FDA Commissioner Dr. Janet Woodcock said the decision brings "us closer to returning to a sense of normalcy and to ending the pandemic." She assured parents that the agency "undertook a rigorous and thorough review of all available data" before clearing it for use in the teens. The companies said in late March that the vaccine was found to be 100% effective in a clinical trial of more than 2,000 adolescents. They also said the vaccine elicited a "robust" antibody response in the children, exceeding those in an earlier trial of older teens and young adults. Side effects were generally consistent with those seen in adults, they added.
Vaccinating children is seen as crucial to ending the pandemic. The nation is unlikely to achieve herd immunity -- when enough people in a given community have antibodies against a specific disease -- until children can get vaccinated, health officials and experts say. Children make up around 20% of the total U.S. population, according to government data. Between 70% and 85% of the U.S. population needs to be vaccinated against Covid to achieve herd immunity, experts say, and some adults may refuse to get the shots. Though more experts now say herd immunity is looking increasingly unlikely as variants spread. The report notes that the same two-dose regimen that's use for people 16 years of age and older will also be used for kids ages 12 to 15. FDA approval for kids under age 12 could come in the second half of the year.
Vaccinating children is seen as crucial to ending the pandemic. The nation is unlikely to achieve herd immunity -- when enough people in a given community have antibodies against a specific disease -- until children can get vaccinated, health officials and experts say. Children make up around 20% of the total U.S. population, according to government data. Between 70% and 85% of the U.S. population needs to be vaccinated against Covid to achieve herd immunity, experts say, and some adults may refuse to get the shots. Though more experts now say herd immunity is looking increasingly unlikely as variants spread. The report notes that the same two-dose regimen that's use for people 16 years of age and older will also be used for kids ages 12 to 15. FDA approval for kids under age 12 could come in the second half of the year.
Re:It's about time... (Score:5, Insightful)
No, now we can vaccinate an entire group that, even though they themselves are low risk for fatality, has been shown to spread it to other vulnerable groups!
Re: It's about time... (Score:2)
Re:It's about time... (Score:5, Insightful)
Why would she care about spreading it to vulnerable groups?
Maybe she just doesn't want to grow up to be a douchebag like her parent(s)?
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Because every time the virus spreads through your kid, to other kids, it has the chance of mutating into a new variant that will resist the vaccine, kill millions of people and put us in that same shit again.
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Now we can vaccinate an entire group that had 0 causalities!
LOL, you might want to do a google search for "teenager died from covid" and then contact all the parents with the good news.
Your post is even stupider than the ones that suggest death is the only adverse outcome we should concern ourselves with.
Re: It's about time... (Score:2)
The word you meant to write was casualties, of which they had relatively few (not zero).
Re: It's about time... (Score:2)
So I assume you are just a dumb-as-fuck anti-vaxxer that cannot spell, and cannot comprehend why groups at minor risk would wish to be vaccinated.
mRNA vaccines are magnificent in that age group (Score:5, Interesting)
Moderna's trials found 96% efficacy before the second dose.
https://www.marketwatch.com/st... [marketwatch.com]
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12 year olds are the least susceptible to nCoV-19 of any demographic - 96% may be a minimal effect. Wait, are they doing challenge tests on children now?
Re: mRNA vaccines are magnificent in that age grou (Score:2)
Jesus fucking christ.
It's probably more about stopping the spread (Score:3)
Re:It's probably more about stopping the spread (Score:5, Interesting)
People focus too much on death rates regardless. 60% of post-covid patients have detectable heart enlargement [heart.org], and 78% with signs of impairment, in a study reaching out to several months after infection - including those with only minor infections. One third [medpagetoday.com] of COVID patients describe lingering symptoms, including brain fog, chronic fatigue, etc; one in ten [sciencedaily.com] who had only a mild case of COVID describe lingering symptoms 8 months after infection. There's a veritable laundry list [mayoclinic.org] of long-term effects from COVID, including lung damage, strokes, seizures, Guillain-Barre syndrome, possible increased future odds of developing Parkinson's disease and Alzheimer's disease, greatly elevated odds of thromboembolism, mood disorders, PTSD from severe cases, and on and on.
When it comes to children in particular, one potential side effect is multisystem inflammatory syndrome. Rarely short-term fatal, but it can do heart damage. It was initially described as Kawasaki's Disease, and appears to be very similar. I had Kawasaki's as a child. Very rare. Woke up one day and couldn't walk because of the pain. High fever. Blood vessels visible through my skin. Came on overnight, and ultimately disappeared nearly as quickly. It's a vascular inflammatory disease believed to be due to the body reacting poorly to an unknown viral infection that in most people is harmless, due to genetic factors.
While people tend to think of COVID as being a respiratory disease - because it spreads through respiratory droplets and kills (mostly) through pneumonia - it actually targets cells through ACE-2, which is a blood pressure regulation protein. Unlike typical cold and flu viruses, sarbecoviruses like SARS-CoV-2 can be found throughout the body. Pretty much anywhere that processes blood in some way can be a target of SARS-CoV-2 - lungs, liver, kidneys, heart, etc etc. The loss of taste and smell is a result of the attack on blood vessels that feed sensory nerves (among other support cells). One has to ask themselves: if it's doing this damage there, what's it doing in other places that I don't have sensory nerve endings to detect the damage?
Early in the pandemic, I made two mistakes. One was listening to WHO, the "professionals" who proved themselves to be staggeringly incompetent. The other was focusing too much on the question of, "What's the infection fatality rate for the disease?" - the question everyone was endlessly arguing over. Focusing only on the fatality rate runs a serious risk of not seeing the forest through the trees.
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But Former sez it's just a really bad flu!
Re: It's probably more about stopping the spread (Score:2)
Selection bias.
Estimates of total infections not caught by testing in the US alone are on the order of 80 million. There are not 8 million (or even 3 million) long covid patients in the US and there are not tens of millions of people with covid caused heart enlargement.
If these studies sampled hospitalized patients only, I could believe these ratios. If these studies were based on patients from the first wave when the doctors didn't know how to treat it, then I could believe these ratios.
But guess what: ave
Re: It's probably more about stopping the spread (Score:2)
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This is like arguing which is faster round the track, a Ferrari a Porsche or Lamborghini, when the real comparison is any of them against a truck.
Whatever number you pick in the end, millions of people are suffering the effects of long COVID with really detrimental impacts on quality of life. It has long been clear that just because you didn't die doesn't mean you are not going to suffer for many years.
Re: It's probably more about stopping the spread (Score:1)
Millions?
I'd need some hard data, not an extrapolation from hospitalized patients (by definition more severe) to believe that.
About 5 million people have been through the hospital for covid in the US.
Re: It's probably more about stopping the spread (Score:2)
1) Hospitalisation is more severe, and therefore rarer, than long covid (by your own statement).
2) US hospitalisations were 5 million (by your own statement).
I'm pretty sure that's going to be a really short mathematical proof!
Re: It's probably more about stopping the sprea (Score:1)
Not all hospitalizations end with long covid.
Poster above claims it's like 1/3 or 1/4.
And the studies are older when medical treatments weren't up to speed. They were intubating people just because in the first few weeks and intentionally avoiding patients because they were short on ppe and scared out of their minds.
Extrapolations are not datapoints.
Re: It's probably more about stopping the spread (Score:2)
Re: It's probably more about stopping the spread (Score:1)
Severe results from COVID are also mostly prevalent in the (morbidly) obese, smokers etc. Enlarged hearts, lung problems and most of the problems described in those studies is also a byproduct of obesity and unhealthy living.
It is basically self-selecting a group of people that were already in poor health, and then blaming those issues not on past personal choices but some newfangled disease. So take those studies with a large helping of sodium until the results can be replicated in healthy adults with asym
Re:mRNA vaccines are magnificent in that age group (Score:5, Insightful)
The recent variants - UK, India, South African are far more infectious than the China/Italy strain.
And under-20s are the next group - there are recorded deaths in the under-20 age group now - it's not big, but we don't know if it'll grow or if it's an outlier.
The main problem is the 12-30 age group are the more likely to disregard precautions and spread it - there have more than a few examples where a teenaged kid goes out and brings COVID back to their family. Sure they survive, but the same cannot be said for the rest of their family.
Re:mRNA vaccines are magnificent in that age group (Score:5, Informative)
12 year olds are the least susceptible to nCoV-19 of any demographic - 96% may be a minimal effect. Wait, are they doing challenge tests on children now?
Not true [cdc.gov] and no. Where I live distribution of cases is equal for all age groups except for the 0-9 year olds, but they are tested significantly less frequently. Teens are less likely to die but they are not less likely to get the disease. There are plenty of cases to evaluate the vaccine without a need to do a challenge.
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One reason the trial groups are large (there are several) is to make sure a statistically significant number of people in the control group will catch COVID-10 naturally.
The only human challenge trial I know if is on adults in the UK. If memory serves they were chosen from people previously exposed and recovered.
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Do you really have absolutely zero awareness of how medical science works? 96% is a measured relative to a placebo group, as always. It means 96% fewer of those kids spreading the virus.
Re: mRNA vaccines are magnificent in that age grou (Score:2)
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You just know that is going to be a forward from someone's crazy relative who really does believe that -expletive-.
Solves the problem (Score:2)
of poor cell reception for zoom school too
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Will Microsoft share the tracking chip data with the school? Would be useful! ;)
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I'm not sure how to calibrate my ARM chip.
each time I move my ARM, it automatically logs me in, and I'm not sure I want that feature enabled at all times.
driver issue, maybe? should I be using the 32 or 64bit version of the driver?
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should I be using the 32 or 64bit version of the driver?
Well, it depends; how many fingers do you have on your vaccine ARM?
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Re: Why vaccinate kids? (Score:2)
Only a matter of time before under-16 death rates climb as well, if measures are not taken
https://covid.cdc.gov/covid-da... [cdc.gov]
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The data is unequivocally clear - COVID is not dangerous to kids. Vaccine is also likely not dangerous, but any rational analysis of ' known to be not dangerous' vs. 'unlikely to be dangerous' would be against the later case. Considering we talking about KIDS, I don't see h
Re: Why vaccinate kids? (Score:1)
200 million doses to adults with almost no real problems kinda puts a fairly high confidence in the "probably" of "probably safe."
I have yet to see a down side to vaccinating kids beyond the hour or so it takes to do it.
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It's the precautionary principle. This is a very new technology. It does gene therapy, and there is no long term data, particularly for pre-reproduction children.
I agree, there is no sign of a downside yet. I think it likely that there will not be one, and i sincerely hope i am right in that.
But the precautionary principle remains. As much as sars-cov-2 is novel, the mRNA vaccines are even newer and more unknown at this point.
So i will not be vaccinating my children. Too many decades ahead, including major
Re: Why vaccinate kids? (Score:1)
Your house your rules.
But I'm pretty much at peace with the fact that this is just one of those pieces of information that can only be learned the hard way.
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"set of instructions that show your body how to... create... proteins"
Umm, those "instructions" are *genetic* instructions, and the intent is therapeutic. :) Yes, it doesn't directly modify the body to create antibodies and t-cells. But the fact that the route of training is indirect changes nothing about the fact that it is gene therapy, nor that it is incredibly new tech. I adore the technology and think it is a game changer, but the precautionary principle holds firm. I will not abandon logic and careful
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Pray tell, what is the "entirely different method" implied by JJJ/AZ?
Finally, while I might have been mistaken about whether the first dose provo
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Google "modified adenovirus vaccines" for more on J&J and AZ. Short version is that they genetically modify a harmless adenovirus to have key sections of the target virus' genes (spike protein for coronavirus) and infect you with it. Your immune system beats it easy and will now recognize the target virus as a threat. This is also very cool tech and is essentially the same as most viral vaccines, introducing a weakened version of the virus. It just happens to be a lab-created version. No need to teach y
Re: Why vaccinate kids? (Score:2)
Should we really call the fire department? Should we really stop the mission and perform an emergency landing? Should we really vaccinate children?
The burden of proof for selecting an option applies to both possible decisions (vaccinate or don't vaccinate).
The choice is not between doing something (requiring evidence and justification) and doing nothing (which always to get a free pass).
The choice is between deciding
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You are welcome to dispute the precautionary principle, but please do at least be sure you understand it: https://en.wikipedia.org/wiki/... [wikipedia.org]
Doing nothing does not ever get a free pass. Not with me, and not societally. https://en.wikipedia.org/wiki/... [wikipedia.org]
Absurdly manipulative and reductionist false dichotomies do not, however, get a free pass. https://en.wikipedia.org/wiki/... [wikipedia.org]
There are multiple vaccines in question for widely varying demographics and situations.
I am most definitely evaluating and comparing risks
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Coronavirus: COVID Deaths In U.S. By Age, Race [acsh.org]
COVID-19 Deaths by Age [heritage.org]
To me, the data is clear. Now, situation may change in the future with variants, but as of right now, COVID is not dangerous to kids ages 12 to 15.
Re: Why vaccinate kids? (Score:4, Insightful)
The real answer is because not enough adults will get it, and we need to stop the spread of the virus.
Also, they did studies before getting this approval, and the vaccine has been shown safe and effective for that age group.
And perhaps more importantly, the benefits outweigh the side effect risks.
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The real answer is because not enough adults will get it, and we need to stop the spread of the virus.
This should not be on KIDS. Essentially you are suggesting child abuse as a solution to adults making stupid decision to not vaccinate. EMERGENCY authorization falls VERY SHORT of acceptable standard when we talking about administering medical treatment to KIDS that are known to not be at risk from COVID.
Re: Why vaccinate kids? (Score:2)
If there were anything obviously wrong with it, the way there might be with the viral vector vaccines I might agree with your characterization of this as child abuse.
But 200 million+ doses of mrna vaccines in adults with almost no serious problems and nothing obvious in the trial makes that characterization inappropriate.
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The fact that not enough adults is getting the shot means that kids are more likely to get it, justifying their vaccination.
Anyways, even for that age group the benefits outweigh the risks, at least for the Pfizer-BioNTech vaccine.
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Re: Why vaccinate kids? (Score:1)
Teachers? Easy. If they get vaxxed then they have one less excuse to get off their asses and get back to work.
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There exist people who cannot get vaccinated due to potential allergic reactions, as well as people going through treatments like chemo and transplant recipients who have their immune systems rendered pretty worthless through other medication so even though they're vaccinated it wouldn't help them. Please get vaccinated if you are able.
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I always find it amazing when people argue about the unknown risks of the vaccine (despite lack of evidence) while simultaneously ignoring the known risks of getting covid, including the non-death long term issue that a not-insignificant percentage will encounter, even among kids.
It would be kind of like arguing that we ought to let kids have heroin, because we might one day discover that using heroin reduces the risk of cancer. Yeah, that sounds pretty dumb, doesn't it. Yet it's only a more extreme version
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Let me google that for you. We'll even live dangerously and go with the "I'm Feeling Lucky" button: "long covid children"
https://www.ncbi.nlm.nih.gov/p... [nih.gov]
And now I will await your evidence that shows anywhere near the same level of risks with the vaccine...
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Glad you found it interesting. And I suppose I should apologize for my snippy-ness in replies. I guess I've become too accustomed to people not actually wanting to have an honest discussion. Sorry.
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Ever heard of the "precautionary principle"?
Do some looking back at history on new technologies in medicine. Maybe thalidomide 2nd generation infertility? Or even in agriculture, you may have heard about DDT and raptor fertility issues?
SARS-COV-2 maybe "novel" in the sense that it's new in our population. But it isn't anywhere near as novel as mRNA gene therapy vaccinations. Not even close to as new and unknown. Coronaviruses are really quite common and well-studied and have been jumping into humans for age
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raptor fertility issues?
Don't worry. Life finds a way. [google.com]
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LOL, perfect.
Emergency basis (Score:2)
How long before they lose the "emergency basis" status, which scares the hell out of a lot of people?
Re:Emergency basis (Score:5, Informative)
Pfizer recently applied for full approval, but from what I understand it could still be a 6 month review process from that. I'm not sure if we can afford to wait that long to knock over one more obstacle, so we'll see how it actually goes.
However, I'm not convinced that the people currently harping all over the EUA status will do anything but move the goalposts and change their FUD if it does get past an EUA into full normal approval.
FDA links (Score:1)
press release: https://www.fda.gov/news-event... [fda.gov]
press briefing: https://youtu.be/npjhwpConSw [youtu.be]
general announcements: https://www.fda.gov/emergency-... [fda.gov]
Vaccine fear (Score:2)
I can't believe so many people are afraid of being vaccinated. It's a tiny injection you ninnies, it can't do anything to you. Man up bro.
Re:Vaccine fear (Score:5, Funny)
"I won't live in fear!"
"Great, take this vaccine."
"Ah! Keep your poison away from me! It hasn't been tested yet!"
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Nailed it!
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I just got my 2nd dose of Pfizer this past Friday at 8:30 AM. At about 5 in the afternoon, I suddenly felt like I got hit with a sledgehammer: severe fatigue, followed by body aches and a decent fever. This lasted all of Saturday and most of Sunday; yesterday was the first day I started feeling like myself again. Talk to people getting one of the two shot vaccines and you'll find this is common.
For me, it's still obviously worth it if it means I get my life back; however, I'd have to think long and hard
Wheres the science (Score:1)
Phisser has paid more than $ 4.7 billion in fines over the past 20 years for 80 different crimes and violations, including off-label or unapproved promotion of medical products, foreign corrupt practices, bribery, government-contracting-related offenses and drug or medical equipment safety violations.
But this time it seems Fizers scammy marketing is a benefit for the government.
We're not sure if someone can transmit the virus after vaccination' pic.twitter.com/Ps91uMMZVP
— Spiro (@o_rips) December 5,