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riversedge

(80,814 posts)
Fri Sep 17, 2021, 04:18 PM Sep 2021

BREAKING: The FDA voted 16-2 against a third Pfizer booster shot for Americans 16 and older.

darn. I was hoping to get mine soon.



BrooklynDad_Defiant!
@mmpadellan
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BREAKING: The FDA voted 16-2 against a third Pfizer booster shot for Americans 16 and older.

Not enough data available for them to decide to approve



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BREAKING: The FDA voted 16-2 against a third Pfizer booster shot for Americans 16 and older. (Original Post) riversedge Sep 2021 OP
That is for the general population. They are still deciding it for an older population JohnSJ Sep 2021 #1
This message was self-deleted by its author Chin music Sep 2021 #5
The FDA advisory committee just came out and approved it for those over 65, or those at JohnSJ Sep 2021 #8
This message was self-deleted by its author Chin music Sep 2021 #13
Thank you for sharing that Dreampuff Sep 2021 #23
Israel has been ahead of everyone on this. UK has offered boosters to anyone over 50 a few JohnSJ Sep 2021 #30
There's evidence that there's not much dropoff in efficacy in the under 65s muriel_volestrangler Sep 2021 #42
It's a vote-y thing? That doesn't fill me with confidence. Scrivener7 Sep 2021 #2
Not enough data, eh? Hugin Sep 2021 #3
Had a feeling about this 48656c6c6f20 Sep 2021 #4
I got my third Moderna already. LisaL Sep 2021 #6
So we believe the science or not???? USALiberal Sep 2021 #11
I totally believe the science and the science coming out of Israel says the LisaL Sep 2021 #18
So you no longer trust the FDA? USALiberal Sep 2021 #26
I thought Sanjay Gupta said the opposite. Treefrog Sep 2021 #27
Reports of vaccines' decline have been greatly overstated. Celerity Sep 2021 #38
Israel used only Pfizer vaccines frazzled Sep 2021 #45
This is a decision based on politics...and I for one intend to take a third shot. Demsrule86 Sep 2021 #34
This message was self-deleted by its author USALiberal Sep 2021 #35
Why did you get it? immunocompromised? nt USALiberal Sep 2021 #7
Because at the time I was eligible. 48656c6c6f20 Sep 2021 #41
Ok, thanks! USALiberal Sep 2021 #44
I thought it would be a closer vote PatSeg Sep 2021 #9
Well I dunno how we are going to vaxx the unvaxxed. LisaL Sep 2021 #14
I already offered that option. Hugin Sep 2021 #20
I don't know why, it really could work. LisaL Sep 2021 #22
Not enough data. Hugin Sep 2021 #36
Their thinking appears to be that LisaL Sep 2021 #49
So, an issue other than more antibodies was clouding the question? Hugin Sep 2021 #50
It is a risk/benefit analysis, and it is important to adhere to. Socal31 Sep 2021 #52
Yes and a 16-2 vote indicates PatSeg Sep 2021 #54
Yes! With lawn darts! struggle4progress Sep 2021 #51
We won't get them all, PatSeg Sep 2021 #53
I'm glad that we went ahead and got ours. Crunchy Frog Sep 2021 #10
Yep, same here. LisaL Sep 2021 #16
That's disappointing! Dreampuff Sep 2021 #12
Be that as it may, my wife and I are both 69, and we'll get a booster if it's offered. DFW Sep 2021 #15
Have you gotten signed up to get the booster in Germany yet? Pachamama Sep 2021 #21
No, unfortunately DFW Sep 2021 #29
They just recommended it to over 65. LisaL Sep 2021 #25
If we have to, we'll get it in the USA when we're there next. DFW Sep 2021 #31
Bad decision Pachamama Sep 2021 #17
I'm okay with this central scrutinizer Sep 2021 #19
+1000, Funny how no one trust the FDA now. USALiberal Sep 2021 #24
It's fascinating, isn't it? Treefrog Sep 2021 #28
the cognitive dissonance is off the charts at times Celerity Sep 2021 #40
None So Blind DET Sep 2021 #47
I think that is wrong...too many Trumpers. Demsrule86 Sep 2021 #32
Update dawg Sep 2021 #33
Not sure what to think about the decision peggysue2 Sep 2021 #37
People who fall into a specific group are already eligble, regardless. ColinC Sep 2021 #39
It's not whether to trust the science, it's which ones to trust. Hoyt Sep 2021 #43
👎🏻 Meowmee Sep 2021 #46
What is the risk of doing it? fescuerescue Sep 2021 #48
I'm not sure they are backtracking. Dreampuff Sep 2021 #55
 

JohnSJ

(98,883 posts)
1. That is for the general population. They are still deciding it for an older population
Fri Sep 17, 2021, 04:20 PM
Sep 2021

It is also possible, though rare, that the FDA could over-rule the FDA panel

Response to JohnSJ (Reply #1)

 

JohnSJ

(98,883 posts)
8. The FDA advisory committee just came out and approved it for those over 65, or those at
Fri Sep 17, 2021, 04:26 PM
Sep 2021

high risk


Response to JohnSJ (Reply #8)

Dreampuff

(778 posts)
23. Thank you for sharing that
Fri Sep 17, 2021, 04:30 PM
Sep 2021

Since a few a few of us here fall into the 65 and over category.

What about the reports coming out of Israel? They are a couple of months ahead of us and having a lot of breakthrough infection and are saying the antibodies have gotten very low on those who got their shot first?

 

JohnSJ

(98,883 posts)
30. Israel has been ahead of everyone on this. UK has offered boosters to anyone over 50 a few
Fri Sep 17, 2021, 04:36 PM
Sep 2021

days ago

 

48656c6c6f20

(7,638 posts)
4. Had a feeling about this
Fri Sep 17, 2021, 04:23 PM
Sep 2021

And just got back from getting 3rd Pfizer. Seriously just about 20 minutes ago.

LisaL

(47,423 posts)
6. I got my third Moderna already.
Fri Sep 17, 2021, 04:25 PM
Sep 2021

Not going to wait for FDA to collect their so-called data. How long is that going to take?

LisaL

(47,423 posts)
18. I totally believe the science and the science coming out of Israel says the
Fri Sep 17, 2021, 04:28 PM
Sep 2021

booster works. Israel is boosting everyone.

Celerity

(54,410 posts)
38. Reports of vaccines' decline have been greatly overstated.
Fri Sep 17, 2021, 04:54 PM
Sep 2021


What We Actually Know About Waning Immunity

https://www.theatlantic.com/science/archive/2021/09/waning-immunity-not-crisis-right-now/619965/



Vaccines don’t last forever. This is by design: Like many of the microbes they mimic, the contents of the shots stick around only as long as it takes the body to eliminate them, a tenure on the order of days, perhaps a few weeks. What does have staying power, though, is the immunological impression that vaccines leave behind. Defensive cells study decoy pathogens even as they purge them; the recollections that they form can last for years or decades after an injection. The learned response becomes a reflex, ingrained and automatic, a “robust immune memory” that far outlives the shot itself, Ali Ellebedy, an immunologist at Washington University in St. Louis, told me. That’s what happens with the COVID-19 vaccines, and Ellebedy and others told me they expect the memory to remain with us for a while yet, staving off severe disease and death from the virus at extraordinary rates. That prediction might sound incompatible with recent reports of the “declining” effectiveness of COVID-19 vaccines, and the “waning” of immunity. According to the White House, we’ll all need boosters very, very soon to fortify our crumbling defences. The past few weeks of news have made it seem as though we’re doomed to chase SARS-CoV-2 with shot after shot after shot, as if vaccine protections were slipping through our fingers like so much sand.

The reality of the situation is much more complicated than that. Despite some shifting numbers, neither our vaccines nor our immune systems are failing us, or even coming close. Vaccine effectiveness isn’t a monolith, and neither is immunity. Staying safe from a virus depends on host and pathogen alike; a change in either can chip away at the barriers that separate the two without obliterating them, which is exactly what we’re seeing now. As the hyper-contagious Delta variant continues to blaze across the country and much of the world, more vaccinated people are encountering the virus and occasionally getting infected enough to trip a coronavirus test. But our shots are still guarding against disease and death—the standard our shots were meant to meet, and the most crucial element of making the virus “a much more manageable threat,” Müge Çevik, a medical virologist at the University of St. Andrews, told me. “We need to have much more realistic expectations of these vaccines” and what they can teach our immune systems to do, Çevik said. The good news is, it’s quite a lot. Immune responses don’t last forever. They’re supposed to wane, and the fact that they do works to our advantage. The first time someone meets a virus or a vaccine, defensive cells must scramble. A wave of fast but imprecise fighters—members of the innate immune system—rushes in to wall off the assailant, buying time for the body’s more sophisticated sharpshooters to gather their wits. This latter group, which makes up the body’s adaptive arm, takes several days to really fire up.

But the wait is worth it: After a couple of weeks, the blood is rife with antibodies—molecules, made by B cells, that can sequester viruses outside cells—and aptly named killer T cells, which can blow up cells that have already been infected. Eventually, as the infectious threat passes, our immune response contracts; frontline B and T cells, no longer needed in their amped-up state, start to die off. Antibody levels—one of the easiest immune metrics to measure—slip downward over the course of several months, before roughly levelling off. That’s perfectly normal, Deepta Bhattacharya, an immunologist at the University of Arizona, told me. “You have a big increase at the beginning, then a decline.” Consider the alternative: If humans never quieted any of the immunological furore that follows infections and simply kept accumulating antibodies for every pathogen we came across, we’d all have burst a long time ago. Even attempting to maintain that kind of immune reservoir “would require so much energy—I don’t even know where you’d keep all those cells,” says Marion Pepper, an immunologist at the University of Washington. A downtick in antibody levels can come with consequences. Antibodies are among the few immune actors capable of waylaying a virus before it infiltrates a cell; when present in high-enough amounts, they can quash a developing infection. But where a virus is abundant and speedy and antibodies are relatively scarce, the body’s defenses are much more liable to crack, which is why protection against infection will be the first to erode.

This issue might be especially pronounced after receipt of a COVID-19 vaccine, which is delivered into an arm muscle. Injected vaccines are ace at prompting the production of IgG antibodies in the blood; they’re less good at coaxing out the IgA antibodies that patrol the moist mucosal linings of the nose and mouth and corral respiratory viruses at their natural point of entry. IgG antibodies are good travellers and can eventually flock to the site of a growing infection. That takes time, though, and when fewer of them are bopping about, their eventual arrival may not be enough to pen the pathogen in place. Antibody levels will taper in the months following vaccination or infection, but that doesn’t mean they plummet to zero, Bhattacharya told me. Although most of the B cells die off, some stick around in the bone marrow and keep churning out the virus-fighting molecules at more modest, but still detectable, levels. Though the life span of these long-lived B cells can vary, some studies have hinted that they’re capable of persisting as antibody factories for decades. Another population of immune cells, memory B cells, meanders around the body like sleeper agents, ready to resume making its antibodies whenever necessary. All of these B cells can continue to broaden and intensify their virus-vanquishing powers for months after a vaccine or pathogen leaves the body, in a sped-up form of antibody evolution. “The quality of antibodies in the body improves over time,” Bhattacharya said. “It takes way fewer of them to protect you.”

snip

frazzled

(18,402 posts)
45. Israel used only Pfizer vaccines
Fri Sep 17, 2021, 05:13 PM
Sep 2021

So there’s no data for Moderna. Follow the science.

Demsrule86

(71,542 posts)
34. This is a decision based on politics...and I for one intend to take a third shot.
Fri Sep 17, 2021, 04:40 PM
Sep 2021

I am not getting Covid again if I can help and the new variant may be more deadly for even the vaccinated.

Response to Demsrule86 (Reply #34)

PatSeg

(53,214 posts)
9. I thought it would be a closer vote
Fri Sep 17, 2021, 04:26 PM
Sep 2021

Meanwhile we need to focus more on getting the unvaccinated vaccinated and to wear masks.

LisaL

(47,423 posts)
14. Well I dunno how we are going to vaxx the unvaxxed.
Fri Sep 17, 2021, 04:27 PM
Sep 2021

Should we propose to dart them?

Hugin

(37,848 posts)
36. Not enough data.
Fri Sep 17, 2021, 04:42 PM
Sep 2021

I'm not an expert by any means on anything and I'll readily admit to sometimes not being able to open a container on the perforations.

But, I in my ill informed state am curious to what more data is required for the boosters when the obvious result would be more antibodies? What else is there to know?

LisaL

(47,423 posts)
49. Their thinking appears to be that
Fri Sep 17, 2021, 05:27 PM
Sep 2021

unless infection lands one in the hospital, it's not really a big issue.

Hugin

(37,848 posts)
50. So, an issue other than more antibodies was clouding the question?
Fri Sep 17, 2021, 06:41 PM
Sep 2021

I think if someone wants more antibodies and having more antibodies makes them more comfortable in a global pandemic they should be encouraged to do so.

I never realized the FDA was against home grown antibodies. I guess they want you to get the lab grown sort. Seems a little conflict-of-interest-y to me. Like someone's selling antibodies.

Fortunately, it would appear that President Biden is pro-more-free-antibodies.

Socal31

(2,491 posts)
52. It is a risk/benefit analysis, and it is important to adhere to.
Fri Sep 17, 2021, 11:01 PM
Sep 2021

There is no substance that is zero risk.

PatSeg

(53,214 posts)
54. Yes and a 16-2 vote indicates
Sat Sep 18, 2021, 08:46 AM
Sep 2021

that people who know more than we do, agree with you.

PatSeg

(53,214 posts)
53. We won't get them all,
Sat Sep 18, 2021, 08:43 AM
Sep 2021

but a lot of them will give in and get vaccinated when they realize they can't work, fly on an airplane, go to school, or do pretty much anything.

Darts is an idea though.

Crunchy Frog

(28,280 posts)
10. I'm glad that we went ahead and got ours.
Fri Sep 17, 2021, 04:26 PM
Sep 2021

I don't feel like me or my 82 year old mother being data points.

Dreampuff

(778 posts)
12. That's disappointing!
Fri Sep 17, 2021, 04:26 PM
Sep 2021

I have a routine doctor's visit next week and was planning on getting the flu shot since the prediction is a bad flu season is supposedly heading our way. I remember there being a few weeks of spacing the flu shot and coronavirus shot when they originally started giving the shot. It'd only be a few weeks later & I could get my third Pfizer shot.

I won't get the third shot without a recommendation from health professionals. I personally know a few people who have gone back for their third shot. I was told that Publix only requires that you show your vaccination card and they will give you a shot.

DFW

(60,189 posts)
15. Be that as it may, my wife and I are both 69, and we'll get a booster if it's offered.
Fri Sep 17, 2021, 04:27 PM
Sep 2021

This being the EU, that's a pretty big "IF."

Pachamama

(17,564 posts)
21. Have you gotten signed up to get the booster in Germany yet?
Fri Sep 17, 2021, 04:30 PM
Sep 2021

I have a few older family members who are going to be getting it as they start rolling it out.

DFW

(60,189 posts)
29. No, unfortunately
Fri Sep 17, 2021, 04:35 PM
Sep 2021

The usual German bureaucracy. The Gesundheitsamt said to call my Hausartzt (he's in Dallas). So we called my wife's Hausartzt. He said he'll get back to us, doesn't know anything yet. Same useless confused bag of nothing they gave us in April about our first vaccinations ("maybe late August, maybe later" ) so we went to the USA and got our first shots in 72 hours of asking.

DFW

(60,189 posts)
31. If we have to, we'll get it in the USA when we're there next.
Fri Sep 17, 2021, 04:38 PM
Sep 2021

Germany is extremely slow and cumbersome when it comes to this kind of thing. If I need something like this in Dallas, I get it in less than 3 days. If I need it in Europe, I'm lucky if it's 3 months.

Pachamama

(17,564 posts)
17. Bad decision
Fri Sep 17, 2021, 04:28 PM
Sep 2021

Meanwhile the Germans and the Israelis are moving ahead full steam on boosters.

Sadly, there will be more data and more cases and in a few months likely an additional variant spreading and then it will be clear that a booster is needed and that it should have started being given.

My prediction is that Moderna will get approval in next month and actually the future booster recommendations will be for heterologous vaccine boosters. (Ie if you had Pfizer for first two shots, your booster after 6-9 months will be Moderna.

 

Treefrog

(4,170 posts)
28. It's fascinating, isn't it?
Fri Sep 17, 2021, 04:35 PM
Sep 2021

I wish I could do graphs.

I would be hilarious to see du go up and down on these things.

DET

(2,500 posts)
47. None So Blind
Fri Sep 17, 2021, 05:21 PM
Sep 2021

Please read this best selling book about the FDAs complicity in the Fen-Phen disaster twenty years ago before you criticize those of us who do not trust the FDA.

https://www.amazon.com/Dispensing-Truth-Companies-Dramatic-Fen-Phen/dp/0312253249

It’s shocking.

peggysue2

(12,533 posts)
37. Not sure what to think about the decision
Fri Sep 17, 2021, 04:52 PM
Sep 2021

That being said, I'm happy about the updated booster approval for 65+ age bracket and those with health issues.

I do think the Administration, the FDA and CDC need to get their messaging coordinated. This back and forth, thinking-out-loud approach isn't working. Just leaves to more confusion and fuels the meme that no one in power knows what they're talking about.

The only people who will love this announcement is the right-wing crazies. They'll love it for all the wrong reasons.

ColinC

(11,098 posts)
39. People who fall into a specific group are already eligble, regardless.
Fri Sep 17, 2021, 04:56 PM
Sep 2021

Like those with autoimmune diseases and organ transplants, I believe.

fescuerescue

(4,475 posts)
48. What is the risk of doing it?
Fri Sep 17, 2021, 05:27 PM
Sep 2021

The vaccine has proven to be harmless.

So why are they back tracking?

Dreampuff

(778 posts)
55. I'm not sure they are backtracking.
Sun Sep 19, 2021, 02:24 PM
Sep 2021

I keep hearing news stories that are talking about all of the confusion, but President Biden just recently said he would like to have them out so people can get them 8 months after their last shot. This most recent decision is about boosters six months after the last shot. I'm sure they will continue updating us and will probably make a different decision in 2 months.

Dr. Fauci suggested it is best to not get them so close together unless one is older or immunocompromised or has a job or lifestyle where you are constantly in contact with others. He referred to people who are working in settings where customers are always in and out. He said you will get a bigger boost of antibodies if you wait until the proper time. Chuck Todd was interviewing him this morning.

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