FDA Authorizes Pfizer Booster Shots For Older and At-Risk Americans (nytimes.com) 85
After weeks of internal strife at the Food and Drug Administration, the agency on Wednesday authorized people over 65 who had received Pfizer-BioNTech's coronavirus vaccine to get a booster shot at least six months after their second injection. The New York Times reports: The F.D.A. also authorized booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming severely ill with Covid-19 or are at risk of serious complications from the disease due to frequent exposure to the coronavirus at their jobs. The authorization sets up what is likely to be a staggered campaign to deliver the shots, starting with the most vulnerable Americans. It opens the way for possibly tens of millions of vaccinated people to receive boosters at pharmacies, health clinics, doctors' offices and elsewhere. Roughly 22 million Americans are at least six months past their second dose of the Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention. About half of them are 65 and older. Millions of Americans who received the Moderna and Johnson & Johnson vaccines are still waiting to learn whether they, too, can get boosters.
The F.D.A.'s decision will be followed as soon as Thursday by a recommendation from the C.D.C., which issues guidance on vaccine policy for clinicians and public health officials throughout the United States. An advisory committee of the C.D.C. is now in the midst of a two-day meeting on the issue. But even if the C.D.C. takes a different stance, health care providers are now authorized to offer third shots to Pfizer-BioNTech recipients who meet the F.D.A.'s eligibility criteria. The ruling followed weeks of internal disagreement at the F.D.A., where some vaccine regulators openly challenged the idea of offering booster shots to the general population. Public health experts and state officials have criticized what they said were confusing public messages from the Biden administration about who should be eligible for a booster shot and when.
The F.D.A.'s decision will be followed as soon as Thursday by a recommendation from the C.D.C., which issues guidance on vaccine policy for clinicians and public health officials throughout the United States. An advisory committee of the C.D.C. is now in the midst of a two-day meeting on the issue. But even if the C.D.C. takes a different stance, health care providers are now authorized to offer third shots to Pfizer-BioNTech recipients who meet the F.D.A.'s eligibility criteria. The ruling followed weeks of internal disagreement at the F.D.A., where some vaccine regulators openly challenged the idea of offering booster shots to the general population. Public health experts and state officials have criticized what they said were confusing public messages from the Biden administration about who should be eligible for a booster shot and when.
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Sorry, but I didn't see anything about children in the article you linked. And one paragraph seems to contradict the point I think you're trying to imply:
The source did not suggest that there was any disagreement between Gruber and her superiors over the safety and efficacy of COVID vaccines, but rather that she was frustrated with inter-agency turf struggles.
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>> "Wait until the pressures off and we'll see"
> Sorry, but I didn't see anything about children in the article you linked.
I think the key words were "wait" and "we'll see". Your reading ability matches your foresight.
> “Pull the wool over your own eyes!” -- the irony :)
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So a "random" anon poster came back to an aged thread to reply to you getting burned.
It definitely wasn't you childishly deflecting, Haha. Well, I guess you showed me OrangeTide.
6 Months? (Score:1)
Why all the confusing and misleading messaging from the Biden Government?
They wonder why some people don't believe what they say.
Shop around and another part of the Executive branch will give you a better deal!?!
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> the very public fact he suffers from stuttering that he tries to hide, contributing to said gaffes
I've seen older videos of him promoting segregation of African Americans in schools and he seems very coherent. Maybe it's just because it's a topic he is passionate about that his stuttering goes away?
What are your thoughts? Not on his racism, but on his lack of past stuttering.
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The people making the recommendation were debating multiple options. Biden spoke before they made a final decision on which timeline to recommend.
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Why do you consider Biden an expert on when vaccine boosters are appropriate? Even if he were, and as far as I understand, the experts are still hashing over exactly when and to what extent boosters are desirable.
FWIW, what's fading quickly are the antibodies, which are easy to measure. What provided durable resistance are the TCells, which are a real pain to measure. Almost no studies measure the TCell duration, and it's quite possible that booster shots aren't needed. Do you feel lucky?
(OTOH, high lev
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It's not just neutralization data that suggests they're needed, but also real-world efficacy data. All issues of how clearly R isn't being kept low enough to prevent surges, and mortality rates are proportional to IFR * (1 - 1 / R), not simply IFR. To say nothing of hospital overload and post-viral syndrome risks, which are also relative to (1 - 1 / R). Or the fact that the virus spreading through a partially-immune population creates selective pressure for immune escape.
Also, the efficacy data coming out
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How can people still not understand that professionals are figuring things out as they go along? Nobody has a crystal ball and global vaccine supplies are limited, so nobody wants to advise any more than is needed (there's also generally a greater immune broadening advantage with greater delay on boosters, and there's the possibility of better types of vaccines becoming available in the future).
8 months was initially chosen based on some limited early data, and
Other than being Something (Score:2, Insightful)
And we all know that we have to Do Something...is there any reason to believe this move will unclog the ICUs...given that the ICUs are conspicuously clogged with unvaccinated people?
There's probably no harm in getting a booster (unless you happen to treat the stuff like heroin and go in for a hit every day or so) but again, is it going to help in any real way?
Discuss.
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The boosters are a given.
But I'd avoid being too optimistic about it being a "flu type situation". This was never like the flu. Polio is a much better analogy. For a large number of people Covid is a bad time and a quick although unpleasant, recovery. But for another large number of people Covids going to leave them with a lifetime of disability and sickness, and the projections of those numbers go as high as 50% of the unvaxxed. Worse, a recent study found the numbers of people sick at 6 with long covid lo
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Uttar Pradesh, India [google.com] is 3/4 the population of the USA and they've managed to achieve an astoundingly low 20 new cases/day. They've done that with less than half of their population vaccinated.
The USA needs to stop worshipping mRNA vaccine manufacturers and take a hard look at what India is doing that achieves so much better results.
Re: Other than being Something (Score:2)
Unbelievable that 'Uttar Pradesh' keeps getting mentioned on slashdot as an example for the 1st world countries ! Who would've thunk!
But this all too common thought process that some country / state is doing Better or Worse because they have higher or lower covid nos is exactly how Superstitions come into existence - specially when its clearly established we dont fully understand most of the things involved in the process.
One day its XYZ country has screwed up and next day its ABC has done a brilliant job.
A
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Mexico President vs You
You: TV = ABSOLUTE TRUTH
Mexico President: https://twitter.com/mammieboco... [twitter.com]
*Stupidity: You think you know everything, without questioning.
*Intelligence: You question everything you think you know.
Prof. Feynman
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Re:there is a risk of harm of the third shot (Score:5, Informative)
Outcomes for vaccine caused myocarditis and pericarditis are generally good, but warrants some tests and observation. After the immune response and fever subside it is unlikely that myocarditis or pericarditis will persist.
For mild cases they resolve themselves and a patient may be offered little more than an over-the-counter anti-inflammatory and recommend bed rest.
These complications occur with many vaccines in a very small number of people. It's not a COVID-19 or mRNA vaccine specific problem. What is important is that healthcare professionals and parents weigh the risks appropriately together. Parents thinking their child will have a heart attack from a vaccine is not weighing risks, even the drive to the doctor's office was statistically more significant. What is important is that everyone recognizes that complications are possible and act quickly in the rare even that they do occur.
Having your kid on an EKG and getting chest X-ray or echocardiograms is terrifying for parents, but for most families your hospital trip will be over in a few hours. You'll go home and maybe a few rough nights where you're propping your child up with pillows because it hurts to lay down but they can't get comfortable sleeping sitting up. Still beats weeks with COVID-19. Or, God forbid, days or weeks in the hospital your child is probably isolated and you cannot visit them and they can't even talk on the phone because they are on a ventilator. Sorry for the nightmare fuel, reality is painful.
Re: there is a risk of harm of the third shot (Score:2)
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I'd rather address the obvious problem with parents' vaccine hesitancy early rather than late.
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And a few weeks to a few months after that hospital trip, the parents will end up paying several thousands to tens of thousands of dollars for "their" portion of the bill. A relative of mine had a heart attack for which the hospital charged $50k for a day of monitoring. With most 80/20 insurance, that's a $10k/day bill for the patient.
But it was worth it, right? Knowing that you've reduced a miniscule risk to almost non-existent, right?
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Yet when you point out the real risk is so very low, at least one of your circle knows of one case, and use it to prove you were wring, the risk is real. Even if it is .002% or so, they were impacted, and any, ANY measure is justified. Any.
Or, is that either reasonable or appropriate?
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You've identified the birthday paradox.
the risk is real.
Did I not explain the complications and how to address them in great detail? That it is treatable but needs to be taken seriously.
and any, ANY measure is justified. Any.
I don't think you mean literally any.
For example, misjudging a risk and refusing to take the safest course of action is not reasonable. As for my circle of friends, I know people who won't let their children eat canned tuna because of mercury, but lets them swim without a life guard. Parents are responsible for their own children as no one e
Re: there is a risk of harm of the third shot (Score:2)
I do actually agree with you. The paradox.
And some of my circle thought I ought to be banned from the internet, should be quarantined despite not even asking about my inoculation status/medical history, and a couple thought I could benefit from suffering my own long COVID experience.
I mostly understand their outrage. I don't so much accept their cognitive dissonance on this topic, though I find it hard to detect mine, so I'm more forgiving of that
Now to learn about the birthday paradox...
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ECK and chest X ray shouldn't cost several thousand without insurance. And with insurance, that depends on just how shady your insurance is.
For American parents very concerned about their child's wellbeing, I recommend you buy comprehensive health insurance and start voting for the Democratic Party. If you can't afford first, you can afford the second.
But it was worth it, right? Knowing that you've reduced a miniscule risk to almost non-existent, right?
If you call your doctor's office because your child is having chest pains and difficulty breathing the odds are no longer miniscule that it's myocarditis or p
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Vaccine reactions are reactions against the drug not done statistical chance your body rejects a specific dose. There's been no confirmed cases of people having an adverse reaction to *the second shot* of any of the vaccines currently on the market which didn't also present complications in the first shot. And there's no reason to believe the third shot would be any different.
Stop spreading anti Vax fud.
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And we all know that we have to Do Something...is there any reason to believe this move will unclog the ICUs...given that the ICUs are conspicuously clogged with unvaccinated people?
There's probably no harm in getting a booster (unless you happen to treat the stuff like heroin and go in for a hit every day or so) but again, is it going to help in any real way?
Discuss.
We have the same problem here in Canada where some of our ICUs are clogged with unvaccinated as well.
IMO if boosters keep an older or compromised person from the hospital that is still a win, even if that spot is rapidly filled with an anti-vaxxer. Actually I would consider that a good outcome.
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> Actually I would consider that a good outcome.
The ICUs are usually full of unhealthy people; obese, poor diet, poor exercise which allows diseases to take hold.
Still consider that a good outcome? It was the choice: https://www.imdb.com/title/tt0... [imdb.com]
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The ICUs are usually full of unhealthy people; obese, poor diet, poor exercise which allows diseases to take hold.
I'll bet every single one of them would take a couple of shots instead to prevent that.
OK, some might still take pet meds instead.
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Viruses (like COVID) and parasites are not the same. Viruses and bacteria are not the same either, though I suspect many of the same people wanting ivermectin for COVID probably want antibiotics as well. Stupid is as stupid does.
Re: Other than being Something (Score:2)
Antibiotics are actually prescribed during covid as well as other viral infections by majority of doctors globally, to avoid bacterial infections taking hold while you are compromised with the viral/covid thing.
Medicine is not at all a basic science where you have certain rules & laws you can extrapolate from and make accurate deductions after few experiments, it's an applied science where you may have no clue why it works but enough studies have given statistical confidence to go ahead.
So if it works f
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Antibiotics are actually prescribed during covid as well as other viral infections by majority of doctors globally, to avoid bacterial infections taking hold while you are compromised with the viral/covid thing.
If you are already hospitalized and on a breathing machine.
Otherwise: nope!
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Ivermectin is not a merely a 'pet medicine'. It was discovered in 1975, in part the result of research into animal diseases, and received the 2015 Nobel Prize 'n Physiology or Medicine [slashdot.org] for both animal and human use, where it has greatly reduced the burden of river blindness.
It is prescribed safely and without significant side effects to many people. And there are enough anecdotal reports of effectiveness in treating COVID that it should be permitted off-label, and researched. Just like Hydroxychloroquine, u
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And there are enough anecdotal reports of effectiveness in treating COVID that it should be permitted off-label, and researched. Just like Hydroxychloroquine
Both have/are being researched. The results are not promising for either. And you don't need a million trial participants. Thousands will give you the results you need for a drug whose safety is already established.
There are many tens of thousands of different drugs being produced. Normally we look for off label uses based on mechanism of action, or do you think we should just try them all at random?
Some doctor in Lower Slobovia says hey! Fluconazole is a great treatment for COVID! Other doctors
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And all this time I thought moronic behavior by the morons on social media was just moronic behavior. Oh right, politics.
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Marie Curie won a Nobel Prize for the discover of polonium and radium, but that doesn't mean that we dose people having any sign of any illness with either.
Also, the Pfizer vaccine is fully approved. And not after having skipped or failed animal trials.
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Pfizer and Moderna did not skip animal trials [apnews.com]
Secondly, the COVID vaccines we have are safe and effective at preventing death or serious illness in humans, but there are also COVID vaccines for animals. You are free to find a vet to prescribe you some. Maybe get some horse dewormer at the same time.
https://www.zoetisus.com/produ... [zoetisus.com]
https://news.zoetis.com/press-... [zoetis.com]
OP is misinformation - please mod down (Score:2)
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I recommend sci-hub. You can read actual science, much of which is otherwise behind paywalls.
I suspect you would find actual science to be quite a shock.
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Unclog the ICUs? No.
Prevent the clog from getting worse? Yeah. Apparently there's enough data to suggest a booster for high risk groups is a good idea.
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And we all know that we have to Do Something...is there any reason to believe this move will unclog the ICUs...given that the ICUs are conspicuously clogged with unvaccinated people?
Eh, don't worry about the unvaccinated clogging ICUs. They're killing themselves off quite nicely [imgur.com]. This in turn opens up beds [gadsdentimes.com] for those who truly need medical care so we'll see fewer of these such incidents [cbsnews.com].
Market (Score:1)
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Triple vaccinated and double masked! (Score:2, Funny)
Healthcare Workers (Score:2)
What's really kind of surprising is the number of healthcare workers who don't want to be vaccinated. Technicians, nurses, even doctors don't want to get it.
https://fortune.com/2021/08/30... [fortune.com]
https://fee.org/articles/massi... [fee.org]
I'm sure the reasons are varied, but big pharma has done everything in it's power to portray itself as evil and untrustworthy.
https://www.pharmaceutical-tec... [pharmaceut...nology.com]
https://www.nytimes.com/2021/0... [nytimes.com]
"Pfizer asked for liability protection not only against civil claims from citizens who suffer ser
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Re:Healthcare Workers (Score:5, Informative)
No always, it has been since 1986 when the National Childhood Vaccine Injury Act was put into law. It was introduced due to lawsuits being filed en masse for something that the vaccine was not responsible for and the number of lawsuits made vaccine no longer be profitable in the US and the manufacturers thought about no longer supply vaccines in the US.
In the 1970s and 1980s, a controversy erupted related to the question of whether the whole-cell pertussis component caused permanent brain injury known as pertussis vaccine encephalopathy, in rare cases. No studies showed a causal connection, and later studies showed no connection of any type between the DPT vaccine and permanent brain injury. The alleged vaccine-induced brain damage proved to be an unrelated condition, infantile epilepsy. In 1990, the Journal of the American Medical Association called the connection a "myth" and "nonsense". However, before that point, criticism of the studies showing no connection and a few well-publicized anecdotal reports of permanent disability that were blamed on the DPT vaccine gave rise to 1970s anti-DPT movements.
In the United States, low profit margins and an increase in vaccine-related lawsuits led many manufacturers to stop producing the DPT vaccine by the early 1980s. By 1985, vaccine manufacturers had difficulty obtaining liability insurance. The price of DPT vaccine skyrocketed, leading providers to curtail purchases, limiting availability. Only one company was still manufacturing pertussis vaccine in the US by the end of 1985. Because of this, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986, establishing a federal no-fault system to compensate victims of injury caused by mandated vaccines
So basically, it was anti-vaxxers back in the day that forced the government to react in a way that the anti-vaxxers now use as an argument for why vaccines are bad...
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So natural immunity sometimes works great, other times minor mutations to the parts of the virus that don't affect infectivity cause the virus to escape the naturally-induced antibodies to those parts.
The mRNA vaccines, on the other hand, present the immune system with the spike protein essential to deliver the virus into the human cel
Regeneron doesn't cure covid (Score:4, Insightful)
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You need to define cure narrowly (Score:2)
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On average, 2000 people a day are dying of COVID-19. Clearly, Regeneron is not a cure for COVID.
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Since anyone can carry the virus, vaccinated or not, and since vaccinated folks are returning the public square en-masse, who now poses the greatest risk to the immunocompromised? The unvaccinated, or the social-non-distancing vaccinated?
That's actually a difficult question. If you asked on a per individual basis, I could guess at an answer. And you left out those are are both vaccinated and socially distancing...which in my NSHO medical people should be. And the immunocompromised should already be selec
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Bullshit. The US just donated 1 billion shots to poor countries. And if the world expects the US to donate vaccines to the entire world before offering a third dose to elderly and at-risk people in this country, I'd say that's a problem with their perception, not with US policy.
No need for general public ... (Score:2)
Makes sense to limit it to immuno-compromised people such as organ transplant recipients, immuo-deficients (HIV patients, ...).
For the general public though, several specialists have written a viewpoint in The Lancet [thelancet.com], a respected medical publication, saying that so far there is no need for a 3rd dose.
See the discussion by virologists and an immuologist at TWiV #805 [microbe.tv]