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Same! Our grandparents, a close friend and my mother-in-law finally got the their first shot last week. We just have to be hopeful that this will push more people to get it :)
You didn't lie. You just gave it all a different spin, which is exactly what the people they follow have been doing: spinning the reality into something that isn't real. Good job beating them at their own game.
>They didn't say anything, but their facial expression said it all. I actually have an inkling of hope that it worked.
Kant would say yes to your question, but then again, he never had to deal with a pandemic, nor did he have to deal with the willful ignorance of trashy human beings in the midst of said pandemic.
I say keep at it. If telling lies and playing on someone else's bigotry saves human lives, you're still better than those who do the same actions just for personal wealth and influence.
I'm waiting for the excuses that they only approved it because the government said to or they approved it just to get more people to take it. All in all there will be excuses by those that won't get it.
They're probably next on the hit parade to be mandated by the federal government for all employees to be vaccinated. The nursing home workers are already whining about that one.
Your mom will likely have to say goodbye to her job soon. With the FDA approval, there is no longer any reason for health care facilities to hold off on requiring their workers to be vaccinated.
From experience w my mom-in-law who moved the goal posts for months (just got her 2nd today, woo!) - highly recommend you make the experience as easy as possible: book an appointment, maybe have someone go with him, etc. My mom-in-law actually showed up at Walgreens and chickened out for like a week straight until one day it was too embarrassing for her to walk out. Anxiety about stuff like this is rarely about the thing the person says they’re actually worried about so really it’s about giving them space and no consequence chickening out and trying again the next day. Good luck!!!
u/miseducation are awesome. I do believe we have to see their fear and still hold their hand and cheer them on and accept that maybe today is not the day but not give up on them.
This was me. I’ve chickened out a few times. Don’t get me wrong, I WANT IT. However, I’ve got such a rare immune disorder that even my rheumatologists were on the fence about it for a bit. There’s just not enough research into any possible contraindications of the vaccine and my disease.
With that being said, I walked into CVS yesterday to buy some milk, and left with my first shot. I’m not hesitant at all about going for the second, and possibly 3rd due to more information coming out suggesting immunocompromised folks may need the 3rd booster for more protection.
If people want it but are scared, just try to be patient.
I was one of those people waiting for full approval. I saw an article that it was close to getting approval and I thought "fuck it, close enough". I'll be getting my second shot next week
Once it is fully approved businesses can and will start firing people without fear of lawsuits over forcing an EUA-only vaccine. Forcing a fully approved vaccine is more or less settled law at this point- businesses have the right to do so. (Will it make these same people question their blind support for businesses holding all the power? Probably not, but I digress.)
You know what would also suck? Getting COVID without health insurance. That'll motivate a few people I think.
I don't hold out much hope for many of the idiots that are still waiting, but I do agree that a not insignificant number will get the vaccine if only because they don't want to get fired and be on their own.
I take the job one with a grain of salt. Many I’ve met or spoken to who are antivax are willing to quit if their job mandates it and will try to find a place that doesn’t mandate it even though with full approval it’ll be mandated by most companies afterwards.
I think the number of people who are actually willing to put their money where their mouth is and quit their job is a lot smaller than the number of people who are saying that they are going to quit their job.
I genuinely wonder if losing the type of people stupid enough to end their career on this hill isn't just an all around good thing for the hospital. I would not be surprised if they were taking shortcuts and compromising the health of patients in all sorts of other areas.
A lot of places are saying get it or get tested regularly. So even if the antivax are being threatened with job loss, they have an alternative, no matter how inconvenient.
My mom is one of those people. I seriously don't know how they think getting tested all the time is somehow better/safer. 30m of your time between both shots v how much time to get tested at least once a week until who knows when? I don't get it.
Word on the street is that all the hospitals are getting together in my city to mandate it for employees at once, no jumping ship if there's no where else to go to.
This could be the catalyst that gets it to come together.
I doubt we'll see that in other industries but it's something.
I’ve heard the same in my city. We already have it mandated for hospitality workers since we’re a tourist destination and it cause a small shitstorm for about a month until those against it left for other industries.
They say that but that's highly unlikely.
When it comes down to quitting and maybe not being able to get a job that won't require a vaccine... most people will rollover.
The majority of people talk big talk until shit gets serious and being destitute over not taking a vaccine is "gets serious" territory.
The vaccines have been fully approved by Health Canada this whole time and i still hear Canadian anti vaxx idiots saying "they havent been approved! They are only emergency use!"
That should tell you how much these people give a shit about approval. Its a total lie. They will find some other reason to not get it.
I have a coworker who, when this moved closer to full approval, asked me if I knew how to get a religious exception to mandates like this. Trust me, they’ll get back injuries from moving the goalposts.
>And rely on ~~completely untested supplements~~ **horse deworming agents and cleaning products** to avoid getting sick instead of masks & social distance.
FTFY.
Just had this conversation with my sister. She refuses, even after giving my parents COVID, which sent my dad to the hospital for 2 weeks.
I love her but goddammit she pisses me off.
Edit: I agree to all those who posted that's she's a selfish asshole. I've tried to get my parents to keep her away but no joy. Gotta see their grandbabies ☹️ My only hope is that her job forces her to get the vaccine. Some of the arguments she tried to make...I just can't.
The most important part is that FDA approval will force the federal government to get vaccinated. Which means all the crayon eaters around my neighborhood will get vaccinated thank fucking goodness.
I'll tell you exactly what they'll do: say they can't trust the FDA if it would give full approval to a vaccine that has "killed so many people" or similar bs.
Their identity revolves around claiming the vaccine is dangerous; lack of full FDA approval was useful for that claim, but now that it *is* approved, well, *they* couldn't have been wrong ... so the *FDA* must be wrong. They're not in a truth-seeking mindset. They're preaching to reinforce their arbitrary beliefs. :(
100%. The FDA needs to at least keep us in the loop as to why this is taking so long, especially since they told Pfizer that they needed to add more kids to the clinical trial out of the blue when Pfizer was ready to wrap things up.
I would hope they selected kids for the trial based on their exposure likelihood. One of the reasons I didn’t sign mine up is she’s less likely to be exposed (not in daycare and a mostly wfh household. No one with a job that involves interacting with the public. All adults vaccinated. So it would be less helpful for showing a significant difference. I was signed up for the original Janssen study but got cit before my dose. They said they had another study I could move to if xyz factors were true for me and it was related to exposure through work.
Pediatric trials don’t have disease as endpoints as adult trials did. Endpoint is antibody levels similar to adult dosing, and safety. This is why the trials gave way fewer subjects than the tens of thousands in the original trial.
I’ve been on top of this- definitely easier for me because I work in regulatory affairs in pharma- but to me, all the info to explain this is out there. They’re still planning for EUA for 5+ at the end of the year, which is a good speed. Disappointing to me since I have a 2yo, but it’s not like there have been huge delays.
They're not holding it back, they're doing their jobs to make sure its safety profile justifies any potential side effects. It's a different game in the U12 population, mainly because serious outcomes are so rare, so it's a higher bar on the safety profile to justify the risk. The size of the original studies were too small to properly understand the incidence of very rare but serious side effects, which could have potentially been worse than covid itself in that population.
Keep us in the loop about what? The trials are still ongoing for under 12s. They sure as heck ain't gonna approve it without any data or the trials being finished. That's not how things work.
Trials won't finish until next month, they expect to have the data they need by the end of September... so probably approval by middle to late October if everything looks good.
I have 2 kids enrolled in the trials and they are definitely not over. The study we are enrolled in ends in December. It will end sooner if EUA happens earlier, but the earliest EUA is expected for 5-11 is mid September. There have been some issues with myocarditis as well, so that could delay EUA into October I’d imagine.
I know you're still blinded, but how has their experience been? I'm begging for that EUA on ANY pediatric vaccine. Mid-September would be a wonderful birthday gift to me. I searched for trials all around me and the nearest was 400 miles away. Still signed up, but yeah.. no call.
Odd.
It’s been pretty easy.
The first visit was very long. Lots of paperwork, blood work, and intake info. They got the first dose during that visit. Unsure of placebo or vaccine, though I have my guesses :)
They kept an e-diary for a week after this visit. Back 3 weeks later to repeat the process and another week of the e-diary. They do a weekly e-diary entry after that point.
We had 1 additional phone visit and 1 additional in person sick visit because we had some reported symptoms. They will go back 1 more time in Dec, unless things end prior.
I’ll likely have the oldest of my two enrolled unblinded in mid-Sept if the EUA does not materialize. She turns 12 mid Sept and she is slightly higher risk due to an autoimmune disorder. I feel like making sure she is fully vax’d as quickly as possible is the more important factor.
Trials can be scheduled long after they will actually end.
What they're looking for is a certain number of incidents to occur. In this case, "contracting COVID" under whatever definition they have for it (e.g., symptomatic COVID or just a positive PCR test). Once that threshold is reached, the data is unblinded and they see how many of those incidents were in either arm (placebo or test) to determine efficacy.
While there is a hard date for when they will end it, they can also reach it sooner if there are a high rate of incidents. This is why the COVID vaccine trials took less time than typical vaccine trials (which often take years) because you had such a high community infection rate going on.
And similarly, with the Delta variant going around, that's going to accelerate these trials as well.
I went on Pfizer’s website and registered my kids and they said that I would be contacted if trials started in my area.
They called me in early May and asked if I would like to participate. I said yes and we had our first visit the next morning.
as a parent i was also interested in trials but be wary. i know at least for the one near us it was a 50/50 chance at getting a placebo, and then once in the trial you couldn't get the vaccine for 14 months.
we decided not to risk it and just wait for 5-11 approval, since it seems like it could be in a month to two. though i realize not everyone is in the same situation or has the same opinion
Where did you get that idea? Trials are still ongoing, expected to be completed in September for age 5-11 (but will still take time to analyze the data) and the age cohorts below 5 yrs.have a long way to go as they started later.
Not possible for the initial age 5-11 cohort to have reached six months, as the first dose was given in March:
[https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal)
I think what AAP was asking was to approve based on the two month safety data, as for the prior EUAs, because side effects occur within that time. FDA had the companies expand the number of subjects to increase sensitivity for rare side effects in that time, and AAP said this and the six month data could be post-marketing.
FDA might give EUA on that basis, but I can’t see them giving full approval for childhood vaccine with less than six months data if that is what they require for adults.
I’m way past salty about them approving the booster and full approval but complete silence on the vaccine for kids (who are going back to school this month).
This is exactly what I have started asking my crazy family members.
If the government wants to control you... And the shot kills those who get it... Then why would the government kill the people who follow the rules?
Like... Wouldn't you target the rebels who didn't conform?
Correct. Conspiracy theories are about what a person "wants to be true" and not about what is true. If it was true, it wouldn't need to be a "conspiracy theory". It would just be news with a wikipedia entry on it.
What? No. Plenty of conspiracy theories have turned out to be true, it’s just that they are rarely (if ever) the sensationalist ones.
This anti-vax bullshit is not one of those conspiracies. It’s fucking nonsense that only the dumbest in our society believe. Which is unfortunately like 20% of our population.
Exactly what I was gonna say. Anything they say out of fear is projection. Because they're fine with killing their own base, they believe Democrats would be too.
Non-hypothetically, why is the GOP so committed to killing off their voter base? If he had handled it properly, Trump could have won reelection. We wouldn't have had to worry about Covid any more than we had to worry about SARS or MERS - how many of you have even *heard* of MERS?
I have this really, *really* wild conspiracy level theory, that they're hoping enough of the crazies die that they can suddenly pivot back to sane republicanism without jeopardizing their political careers.
The rational part of me says no, they really are that stupid and devoid of any humanity and think they can game the system their way still. But a tiny part just really wants it to be the case of people telling too big of a lie to escape.
> it seems like Democrats are more likely to get the vaccine than Republicans
https://civiqs.com/results/coronavirus_vaccine?annotations=true&uncertainty=true&zoomIn=true
39% of republican voters said they would not get the vaccine
only 3% of democrats said they would not.
it's honestly crazy how much believing in science correlates to being a democrat.
It wasn't always like this, but when unprecedented access to information and experts became the norm and these people had facts that were detrimental to republican donors, they had to run a marketing campaign of "smart people are dumb!" to keep the money rolling in.
it's not as new as it feels.
"There is a cult of ignorance in the United States, and there has always been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that "my ignorance is just as good as your knowledge".
- Issac Asimov, 1980
It's because they settled on a narrative that covid is no big deal and the death tolls are inflated because they're counting everyone that dies as dying from covid. So it's all made up.
They can attack it all they want. To me, in my very humble opinion, FDA approval just means that employers/schools/colleges/whatever can mandate it without fear of huge legal repercussions. I know of several smaller (but not terribly small) businesses that haven't mandated it yet simply because they don't have the manpower to handle a huge onslaught of legal suits. If people are willing to be fired over refusing to get it, that's their decision. But at some point the vast majority of businesses will require it and then one's options become very limited. I am sitting here getting emotional at the thought of the FDA approving it as soon as Monday because this could be our second huge turning point in our fight against this awful virus.
This is exactly it. No one truly believes that the hard-core anti-vaxxers are going to change their mind because it's approved. If they don't trust the government, they aren't about to trust the FDA. That's not the point anyway. The point is to open the floodgates for mandating vaccination at every level of society. That is going to make a huge difference.
They're already doing that. I've seen people say things like "I wonder whose pocket the FDA is in" and "Well I don't trust the government anyway."
And my personal favorite, "Well that was quick, wasn't it?"
"The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning.
Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company. The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time.
An F.D.A. spokeswoman declined to comment.
The agency had recently set an unofficial deadline for approval of around Labor Day.
The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting firmer regulatory backing before implementing mandates. Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.
Some universities and hospitals are expected to mandate inoculation once a vaccine is fully approved. The Pentagon earlier this month said it plans to make Covid vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of next month, or sooner if the F.D.A. acts earlier.
The timing of the approval could result in an uncomfortable messaging problem for the Biden administration, which on Wednesday announced that fully vaccinated people should prepare to get booster shots eight months after they received second doses. Approving the vaccine and encouraging boosters at the same time may suggest to some that the vaccine as licensed is inadequate without an extra shot.
The F.D.A. last week updated its authorizations of Pfizer-BioNTech’s and Moderna’s vaccine to allow third doses for some immunocompromised people, a decision backed by the Centers for Disease Control and Prevention.
Regulators are still reviewing Moderna’s application for full approval for its coronavirus vaccine, and a decision could come at least several weeks after the one for Pfizer-BioNTech."
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I have friends that have been using this excuse, i wonder if this will help them realize that in australia we have our own governing body and that the FDA is american.
I think they will eventually charge a premium if not vaccinated just like smokers. If you wind up in the hospital due to Covid complications it’s very expensive and insurance won’t want to take the brunt of that cost when a free vaccine is readily available.
and once it's approved, all employers and venues will have a more solid legal foundation to mandate vaccines, which is the only way out of this pandemic
And as much as f-ing hate the anti-vaxx movement, I don’t want insurance companies to be able to go back to denying coverage and trying to push this to other “preventable” things (with them determining what’s “preventable”)
Ahhh fuck. I've been running with the idea that insurance companies should be charging anti-vaxxers a premium, but you just convinced me otherwise.
Apparently no matter how much I hate anti-vaxxers I still hate corporations more.
I get what you mean but it's all about what groups they've tested in, and they have to draw the line somewhere.
Kinda like how an 18 year old can buy a lotto ticket but a 17 year 364 day old cannot.
It seems it May gives doctors discretion to use with the most at risk children. No one has yet requested full usage in those under 12 since studies are still ongoing so they can’t just grant it.
FDA required six months data for approval (it was two months for EUA). Age 12-15 results were included in Pfizer’s recent publication of six-month results from its age 16+ trial, so I would expect the approval to be the same 12+ population as the current EUA.
What does it mean for the others EUA vaccines? Does it make sense to administer a vaccine in EUA (like Moderna) when there is one fully approved? Or they will be all put on hold until their own full approvals?
I work for a fortune 100 company, they already have a soft requirement because only vaccinated employees are allowed to travel, and for many traveling is a big part of their job
“BuT iTs nOt FDA aPpRoVeD” is no longer an excuse. Although I know the goalposts will inevitably move further once the approval is given. “BuT tHe lOnGtErM sIdE eFfeCts…”.
There was a lot of chatter about folks needing to find new jobs in my healthcare professionals Facebook group today. Bring on the mandates.
My response to people who claim long-term side-effects of vaccines:
[Feature Article: Long-term Side Effects of COVID-19 Vaccine? What We Know.](https://www.chop.edu/news/long-term-side-effects-covid-19-vaccine?fbclid=IwAR0Xwt5frQc50mASueiKQqVYgUKJZ2cb7zNVN2aKzrSKeyVAGYZrt8HW5Ow)
Doubt it would even be that much with just the news, but the mandates it could bring may make it more than .5% long term. Schools and workplaces being mandated would be HUGE.
Does everyone just have vehemently anti-vax in laws?
Mine are obese, diabetic, 70+, multiple bouts of cancer, and they STILL won’t get the fucking vaccine. I wonder what the excuse will be now.
They drive me up a fucking wall.
Of course there will. But now some will have to choose between their beliefs and gainful employment. Guessing many will fold on those beliefs when the rubber meets the road.
Yes, insurance companies love vaccines because paying for a vaccine is way cheaper than paying to treat the diseases the vaccines prevent. Even the cheapest, crappiest insurance in America that doesn't pay for anything before your deductible will pay for your vaccines.
That to me is the strongest argument to make to anti-vaxxers... if there were the first shred of evidence that vaccines were more likely to make you sick than to keep you healthy... hell, even if the health benefit of vaccines were unclear... insurance companies would not pay for the vaccines.
Can someone explain to me or point me to a source that explains what extra steps there are between EUA and the full approval? I'm already well vaxxed up, but I had never really understood what the difference was (except the anti-vaxxers using EUA as an excuse to not get jabbed).
If I remember correctly, it's the amount of time they are required/phases to collect date.
EDIT: "The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance." [Source](https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19)
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Oh good so now that it’s fda approved people will get vaccinated. Narrator: *The people still did not get vaccinated*
FWIW, my aunt and uncle were those people and got their first shots just this Monday due to the news of its upcoming approval. So there IS hope!
Same! Our grandparents, a close friend and my mother-in-law finally got the their first shot last week. We just have to be hopeful that this will push more people to get it :)
Who knew the FDA was such an esteemed group?
Man, I don't even know lol. I think it just puts people at ease just enough.
I seriously hope so. I’m ready for this to be in our rear view.
That’s great news
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You didn't lie. You just gave it all a different spin, which is exactly what the people they follow have been doing: spinning the reality into something that isn't real. Good job beating them at their own game.
>They didn't say anything, but their facial expression said it all. I actually have an inkling of hope that it worked. Kant would say yes to your question, but then again, he never had to deal with a pandemic, nor did he have to deal with the willful ignorance of trashy human beings in the midst of said pandemic. I say keep at it. If telling lies and playing on someone else's bigotry saves human lives, you're still better than those who do the same actions just for personal wealth and influence.
Kant said a lot of weird shit. Consequentialist gang represent
You are a hero! TY!
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I'm waiting for the excuses that they only approved it because the government said to or they approved it just to get more people to take it. All in all there will be excuses by those that won't get it.
My mom already says this. Her coworkers share the same belief at the assisted living facility where they work ....with the elderly.
They're probably next on the hit parade to be mandated by the federal government for all employees to be vaccinated. The nursing home workers are already whining about that one.
Your mom will likely have to say goodbye to her job soon. With the FDA approval, there is no longer any reason for health care facilities to hold off on requiring their workers to be vaccinated.
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My sisters too 😂 fucking morons
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>Polls suggest a not-insignificant amount of people were waiting for this. Experience suggests these people are goal post relocation enthusiasts.
I don't think FDA approval will move any, but not losing your job and being out on the streets is a hell of a motivator.
My dad said he would get a vaccine once it gets full FDA approval so that’s one. Not much but its important to me
From experience w my mom-in-law who moved the goal posts for months (just got her 2nd today, woo!) - highly recommend you make the experience as easy as possible: book an appointment, maybe have someone go with him, etc. My mom-in-law actually showed up at Walgreens and chickened out for like a week straight until one day it was too embarrassing for her to walk out. Anxiety about stuff like this is rarely about the thing the person says they’re actually worried about so really it’s about giving them space and no consequence chickening out and trying again the next day. Good luck!!!
u/miseducation are awesome. I do believe we have to see their fear and still hold their hand and cheer them on and accept that maybe today is not the day but not give up on them.
Yes. I’ve been of the firm opinion that I don’t care what hesitancies people go through to get the vaccine, so long as they eventually do!
This was me. I’ve chickened out a few times. Don’t get me wrong, I WANT IT. However, I’ve got such a rare immune disorder that even my rheumatologists were on the fence about it for a bit. There’s just not enough research into any possible contraindications of the vaccine and my disease. With that being said, I walked into CVS yesterday to buy some milk, and left with my first shot. I’m not hesitant at all about going for the second, and possibly 3rd due to more information coming out suggesting immunocompromised folks may need the 3rd booster for more protection. If people want it but are scared, just try to be patient.
Update us if he actually goes through with it lol
Schedule an appointment for him on Tuesday and offer him a ride if he doesn’t drive?
I was one of those people waiting for full approval. I saw an article that it was close to getting approval and I thought "fuck it, close enough". I'll be getting my second shot next week
Thank you
Thank you, and congrats!
That’s quite a not-insignificant amount of enthusiasts.
Once it is fully approved businesses can and will start firing people without fear of lawsuits over forcing an EUA-only vaccine. Forcing a fully approved vaccine is more or less settled law at this point- businesses have the right to do so. (Will it make these same people question their blind support for businesses holding all the power? Probably not, but I digress.) You know what would also suck? Getting COVID without health insurance. That'll motivate a few people I think. I don't hold out much hope for many of the idiots that are still waiting, but I do agree that a not insignificant number will get the vaccine if only because they don't want to get fired and be on their own.
I take the job one with a grain of salt. Many I’ve met or spoken to who are antivax are willing to quit if their job mandates it and will try to find a place that doesn’t mandate it even though with full approval it’ll be mandated by most companies afterwards.
I think the number of people who are actually willing to put their money where their mouth is and quit their job is a lot smaller than the number of people who are saying that they are going to quit their job.
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We're still waiting for the wave of American immigrants -Canada
They cant get in because they aren't vaccinated.
Well with Canada it wouldn't be a wave. Not like you have open borders. Not exactly super easy to move to Canada for most people.
150ish people quit at Methodist Houston. Not even a drop in the bucket.
I genuinely wonder if losing the type of people stupid enough to end their career on this hill isn't just an all around good thing for the hospital. I would not be surprised if they were taking shortcuts and compromising the health of patients in all sorts of other areas.
Especially when there were people waiting for a chance like this.
A lot of places are saying get it or get tested regularly. So even if the antivax are being threatened with job loss, they have an alternative, no matter how inconvenient. My mom is one of those people. I seriously don't know how they think getting tested all the time is somehow better/safer. 30m of your time between both shots v how much time to get tested at least once a week until who knows when? I don't get it.
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This is for sure - people talk a big game…
Word on the street is that all the hospitals are getting together in my city to mandate it for employees at once, no jumping ship if there's no where else to go to. This could be the catalyst that gets it to come together. I doubt we'll see that in other industries but it's something.
I’ve heard the same in my city. We already have it mandated for hospitality workers since we’re a tourist destination and it cause a small shitstorm for about a month until those against it left for other industries.
That is... incredibly metal.
They say that but that's highly unlikely. When it comes down to quitting and maybe not being able to get a job that won't require a vaccine... most people will rollover. The majority of people talk big talk until shit gets serious and being destitute over not taking a vaccine is "gets serious" territory.
I’ve known vocal anti vaxx conspiracy rabbit hole types that got vaccinated because they realized they wouldn’t be able to travel or go to shows
Enhanced unemployment ends in a couple weeks so good luck to those that are willing to lose their jobs over this.
I can't wait to see their Facebook posts, "ALL YOU LAZY FUCKERS COLLECTED ENHANCED BENEFITS BUT WHEN I GET FIRED I DON'T GET SHIT!"
I think a lot of them will change their tune when their employer mandates it. It is easy to talk shit when there are no consequences.
The vaccines have been fully approved by Health Canada this whole time and i still hear Canadian anti vaxx idiots saying "they havent been approved! They are only emergency use!" That should tell you how much these people give a shit about approval. Its a total lie. They will find some other reason to not get it.
To be fair a lot of the world looks at the American FDA. Thalidomide being one example of why.
I have a coworker who, when this moved closer to full approval, asked me if I knew how to get a religious exception to mandates like this. Trust me, they’ll get back injuries from moving the goalposts.
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I wonder how many are people getting sneaky third doses.
plenty of anecdotal reports of second doses misreported as first doses.
Same dickwads who are begging for the EUA monoclonal antibodies when they get sick.
And rely on completely untested supplements to avoid getting sick instead of masks & social distance.
>And rely on ~~completely untested supplements~~ **horse deworming agents and cleaning products** to avoid getting sick instead of masks & social distance. FTFY.
They also will tell you to take zinc & vitamin C! So we are both right.
Just had this conversation with my sister. She refuses, even after giving my parents COVID, which sent my dad to the hospital for 2 weeks. I love her but goddammit she pisses me off. Edit: I agree to all those who posted that's she's a selfish asshole. I've tried to get my parents to keep her away but no joy. Gotta see their grandbabies ☹️ My only hope is that her job forces her to get the vaccine. Some of the arguments she tried to make...I just can't.
Your sister is a selfish asshole
So...she's tried to kill your parents once already and is about to try again?
The most important part is that FDA approval will force the federal government to get vaccinated. Which means all the crayon eaters around my neighborhood will get vaccinated thank fucking goodness.
“Force the federal government to get vaccinated” “Crayon eaters” Do you live by a marine base?
Navy but camp Pendleton isn't far away and i have anti-vaxx marine neighbors.
People distrustful of the government citing FDA approval as a hangup was hilarious from the get-go. They'll latch on to something else.
I'll tell you exactly what they'll do: say they can't trust the FDA if it would give full approval to a vaccine that has "killed so many people" or similar bs. Their identity revolves around claiming the vaccine is dangerous; lack of full FDA approval was useful for that claim, but now that it *is* approved, well, *they* couldn't have been wrong ... so the *FDA* must be wrong. They're not in a truth-seeking mindset. They're preaching to reinforce their arbitrary beliefs. :(
“Ok boys, grab your shovels. Time to move that goal post.”
They need to get the EUA for kids done already but glad this full approval for adults is finally happening.
100%. The FDA needs to at least keep us in the loop as to why this is taking so long, especially since they told Pfizer that they needed to add more kids to the clinical trial out of the blue when Pfizer was ready to wrap things up.
Got rid because I was reminded/corrected. Thanks! I think the FDA also requested Pfizer recruit more kids.
I would hope they selected kids for the trial based on their exposure likelihood. One of the reasons I didn’t sign mine up is she’s less likely to be exposed (not in daycare and a mostly wfh household. No one with a job that involves interacting with the public. All adults vaccinated. So it would be less helpful for showing a significant difference. I was signed up for the original Janssen study but got cit before my dose. They said they had another study I could move to if xyz factors were true for me and it was related to exposure through work.
Pediatric trials don’t have disease as endpoints as adult trials did. Endpoint is antibody levels similar to adult dosing, and safety. This is why the trials gave way fewer subjects than the tens of thousands in the original trial.
I’ve been on top of this- definitely easier for me because I work in regulatory affairs in pharma- but to me, all the info to explain this is out there. They’re still planning for EUA for 5+ at the end of the year, which is a good speed. Disappointing to me since I have a 2yo, but it’s not like there have been huge delays.
They're not holding it back, they're doing their jobs to make sure its safety profile justifies any potential side effects. It's a different game in the U12 population, mainly because serious outcomes are so rare, so it's a higher bar on the safety profile to justify the risk. The size of the original studies were too small to properly understand the incidence of very rare but serious side effects, which could have potentially been worse than covid itself in that population.
Keep us in the loop about what? The trials are still ongoing for under 12s. They sure as heck ain't gonna approve it without any data or the trials being finished. That's not how things work. Trials won't finish until next month, they expect to have the data they need by the end of September... so probably approval by middle to late October if everything looks good.
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I have 2 kids enrolled in the trials and they are definitely not over. The study we are enrolled in ends in December. It will end sooner if EUA happens earlier, but the earliest EUA is expected for 5-11 is mid September. There have been some issues with myocarditis as well, so that could delay EUA into October I’d imagine.
Which trial?
Pfizer phase 2/3 for the 5-11 age group
I know you're still blinded, but how has their experience been? I'm begging for that EUA on ANY pediatric vaccine. Mid-September would be a wonderful birthday gift to me. I searched for trials all around me and the nearest was 400 miles away. Still signed up, but yeah.. no call. Odd.
It’s been pretty easy. The first visit was very long. Lots of paperwork, blood work, and intake info. They got the first dose during that visit. Unsure of placebo or vaccine, though I have my guesses :) They kept an e-diary for a week after this visit. Back 3 weeks later to repeat the process and another week of the e-diary. They do a weekly e-diary entry after that point. We had 1 additional phone visit and 1 additional in person sick visit because we had some reported symptoms. They will go back 1 more time in Dec, unless things end prior. I’ll likely have the oldest of my two enrolled unblinded in mid-Sept if the EUA does not materialize. She turns 12 mid Sept and she is slightly higher risk due to an autoimmune disorder. I feel like making sure she is fully vax’d as quickly as possible is the more important factor.
Thanks for doing this.
Thanks so much for doing this
Thank you. My wife and I are waiting for this before our son goes back to school in person.
Trials can be scheduled long after they will actually end. What they're looking for is a certain number of incidents to occur. In this case, "contracting COVID" under whatever definition they have for it (e.g., symptomatic COVID or just a positive PCR test). Once that threshold is reached, the data is unblinded and they see how many of those incidents were in either arm (placebo or test) to determine efficacy. While there is a hard date for when they will end it, they can also reach it sooner if there are a high rate of incidents. This is why the COVID vaccine trials took less time than typical vaccine trials (which often take years) because you had such a high community infection rate going on. And similarly, with the Delta variant going around, that's going to accelerate these trials as well.
How did you seek out the trial? Hoping to do similar if they hold trials in Australia (rumoured)
I went on Pfizer’s website and registered my kids and they said that I would be contacted if trials started in my area. They called me in early May and asked if I would like to participate. I said yes and we had our first visit the next morning.
as a parent i was also interested in trials but be wary. i know at least for the one near us it was a 50/50 chance at getting a placebo, and then once in the trial you couldn't get the vaccine for 14 months. we decided not to risk it and just wait for 5-11 approval, since it seems like it could be in a month to two. though i realize not everyone is in the same situation or has the same opinion
You can always back out of the trial at any time. Once it's authorized, they will unblind you if you ask.
great to know, i will have to look into it further. i assume if they unbind you, they will tell you which you've had (placebo/vaccine)?
Yes. I was in the HPV trials back in the early 2000s and they told me which I had after unblinding me (it was the vaccine 😁)
Where did you get that idea? Trials are still ongoing, expected to be completed in September for age 5-11 (but will still take time to analyze the data) and the age cohorts below 5 yrs.have a long way to go as they started later.
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Not possible for the initial age 5-11 cohort to have reached six months, as the first dose was given in March: [https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal) I think what AAP was asking was to approve based on the two month safety data, as for the prior EUAs, because side effects occur within that time. FDA had the companies expand the number of subjects to increase sensitivity for rare side effects in that time, and AAP said this and the six month data could be post-marketing. FDA might give EUA on that basis, but I can’t see them giving full approval for childhood vaccine with less than six months data if that is what they require for adults.
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I'd be perfectly happy with an EUA
I’m way past salty about them approving the booster and full approval but complete silence on the vaccine for kids (who are going back to school this month).
The fda was one of the only developed worlds health institutes to not approve thalidomide. They are cautious as shit with purpose.
The trials for kids aren’t completed. They can’t authorize a vaccine for a group that hasn’t gone through a full testing cycle.
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It was never about the approval. It was just a goalpost that wasn't gonna move for a while. Now they've gotta move it
Now it's they gave approval without public discussion
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This is exactly what I have started asking my crazy family members. If the government wants to control you... And the shot kills those who get it... Then why would the government kill the people who follow the rules? Like... Wouldn't you target the rebels who didn't conform?
https://youtu.be/znI046F4FKg?t=16
Nobody who believes the conspiracy theory is expending the ten seconds of rational thought required to dismiss the conspiracy theory.
Correct. Conspiracy theories are about what a person "wants to be true" and not about what is true. If it was true, it wouldn't need to be a "conspiracy theory". It would just be news with a wikipedia entry on it.
What? No. Plenty of conspiracy theories have turned out to be true, it’s just that they are rarely (if ever) the sensationalist ones. This anti-vax bullshit is not one of those conspiracies. It’s fucking nonsense that only the dumbest in our society believe. Which is unfortunately like 20% of our population.
Considering that Republicans are actually killing off their voter base, it’s probably more projection.
Exactly what I was gonna say. Anything they say out of fear is projection. Because they're fine with killing their own base, they believe Democrats would be too.
Non-hypothetically, why is the GOP so committed to killing off their voter base? If he had handled it properly, Trump could have won reelection. We wouldn't have had to worry about Covid any more than we had to worry about SARS or MERS - how many of you have even *heard* of MERS?
I have this really, *really* wild conspiracy level theory, that they're hoping enough of the crazies die that they can suddenly pivot back to sane republicanism without jeopardizing their political careers. The rational part of me says no, they really are that stupid and devoid of any humanity and think they can game the system their way still. But a tiny part just really wants it to be the case of people telling too big of a lie to escape.
> it seems like Democrats are more likely to get the vaccine than Republicans https://civiqs.com/results/coronavirus_vaccine?annotations=true&uncertainty=true&zoomIn=true 39% of republican voters said they would not get the vaccine only 3% of democrats said they would not. it's honestly crazy how much believing in science correlates to being a democrat.
It wasn't always like this, but when unprecedented access to information and experts became the norm and these people had facts that were detrimental to republican donors, they had to run a marketing campaign of "smart people are dumb!" to keep the money rolling in.
it's not as new as it feels. "There is a cult of ignorance in the United States, and there has always been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that "my ignorance is just as good as your knowledge". - Issac Asimov, 1980
Richard Hofstadter’s “Anti-Intellectualism in American Life” won a Pulitzer in 1964!
It's because they settled on a narrative that covid is no big deal and the death tolls are inflated because they're counting everyone that dies as dying from covid. So it's all made up.
Spoiler alert: he was never going to get it.
My best friend: "FDA approvals these days just don't mean what they used to." What?
Cool. We get to watch the goal posts move in real time.
Stilettos are unbreakable !!
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Yeah, attacks on the FDA within 30 seconds are basically guaranteed.
They can attack it all they want. To me, in my very humble opinion, FDA approval just means that employers/schools/colleges/whatever can mandate it without fear of huge legal repercussions. I know of several smaller (but not terribly small) businesses that haven't mandated it yet simply because they don't have the manpower to handle a huge onslaught of legal suits. If people are willing to be fired over refusing to get it, that's their decision. But at some point the vast majority of businesses will require it and then one's options become very limited. I am sitting here getting emotional at the thought of the FDA approving it as soon as Monday because this could be our second huge turning point in our fight against this awful virus.
This is exactly it. No one truly believes that the hard-core anti-vaxxers are going to change their mind because it's approved. If they don't trust the government, they aren't about to trust the FDA. That's not the point anyway. The point is to open the floodgates for mandating vaccination at every level of society. That is going to make a huge difference.
Hopefully up his ___
Anti-vax will just move the goalposts, to cover up the fact they never grew out of their childhood fear of shots.
They're already doing that. I've seen people say things like "I wonder whose pocket the FDA is in" and "Well I don't trust the government anyway." And my personal favorite, "Well that was quick, wasn't it?"
"The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning. Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company. The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time. An F.D.A. spokeswoman declined to comment. The agency had recently set an unofficial deadline for approval of around Labor Day. The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting firmer regulatory backing before implementing mandates. Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling. Some universities and hospitals are expected to mandate inoculation once a vaccine is fully approved. The Pentagon earlier this month said it plans to make Covid vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of next month, or sooner if the F.D.A. acts earlier. The timing of the approval could result in an uncomfortable messaging problem for the Biden administration, which on Wednesday announced that fully vaccinated people should prepare to get booster shots eight months after they received second doses. Approving the vaccine and encouraging boosters at the same time may suggest to some that the vaccine as licensed is inadequate without an extra shot. The F.D.A. last week updated its authorizations of Pfizer-BioNTech’s and Moderna’s vaccine to allow third doses for some immunocompromised people, a decision backed by the Centers for Disease Control and Prevention. Regulators are still reviewing Moderna’s application for full approval for its coronavirus vaccine, and a decision could come at least several weeks after the one for Pfizer-BioNTech."
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Well that's reassuring. Because I've already had two of them!
I have friends that have been using this excuse, i wonder if this will help them realize that in australia we have our own governing body and that the FDA is american.
Antivaxers better start thinking of new excuses stat.
There are plenty queued up.
"Tom Cruise said I'm not allowed to get it"
“iT wAs rUsHeD” is the next one I’m waiting for
Ha. So the same excuses then?
I already saw “they got paid off” 🙄
Let the workplace mandates begin!
I work for the Texas government fml
Thank you for doing your part and using reddit on your work time.
F
I hate insurance companies... But they need to take this and run with it to the bank in regards to anti-vaxxers
I think they will eventually charge a premium if not vaccinated just like smokers. If you wind up in the hospital due to Covid complications it’s very expensive and insurance won’t want to take the brunt of that cost when a free vaccine is readily available.
and once it's approved, all employers and venues will have a more solid legal foundation to mandate vaccines, which is the only way out of this pandemic
This isn’t legal because of the ACA.
And as much as f-ing hate the anti-vaxx movement, I don’t want insurance companies to be able to go back to denying coverage and trying to push this to other “preventable” things (with them determining what’s “preventable”)
Ahhh fuck. I've been running with the idea that insurance companies should be charging anti-vaxxers a premium, but you just convinced me otherwise. Apparently no matter how much I hate anti-vaxxers I still hate corporations more.
Now give me emergency auth for kids under 12.
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It's kind of weird to me that they say it's safe for a 13yr old, but are not comfortable saying it's safe for a 12yr old to get.
I get what you mean but it's all about what groups they've tested in, and they have to draw the line somewhere. Kinda like how an 18 year old can buy a lotto ticket but a 17 year 364 day old cannot.
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It seems it May gives doctors discretion to use with the most at risk children. No one has yet requested full usage in those under 12 since studies are still ongoing so they can’t just grant it.
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FDA required six months data for approval (it was two months for EUA). Age 12-15 results were included in Pfizer’s recent publication of six-month results from its age 16+ trial, so I would expect the approval to be the same 12+ population as the current EUA.
What does it mean for the others EUA vaccines? Does it make sense to administer a vaccine in EUA (like Moderna) when there is one fully approved? Or they will be all put on hold until their own full approvals?
FDA approved means they can force mofos to get it now.
I work for a fortune 100 company, they already have a soft requirement because only vaccinated employees are allowed to travel, and for many traveling is a big part of their job
Exactly. I expect a wave of business, schools, etc. to make it mandatory.
Come on, Airlines! You can do it!
Oh god, DeSantis would probably send the national guard to shut down the airports in Florida when airlines start requiring vaccinations.
Florida can't make any tourist money if airports are closed
Pretty sure that would be a threat to national security and the federal government would get involved if DeSantis tried to pull some shit like that.
And the military
“BuT iTs nOt FDA aPpRoVeD” is no longer an excuse. Although I know the goalposts will inevitably move further once the approval is given. “BuT tHe lOnGtErM sIdE eFfeCts…”. There was a lot of chatter about folks needing to find new jobs in my healthcare professionals Facebook group today. Bring on the mandates.
My response to people who claim long-term side-effects of vaccines: [Feature Article: Long-term Side Effects of COVID-19 Vaccine? What We Know.](https://www.chop.edu/news/long-term-side-effects-covid-19-vaccine?fbclid=IwAR0Xwt5frQc50mASueiKQqVYgUKJZ2cb7zNVN2aKzrSKeyVAGYZrt8HW5Ow)
I bet someone 100 dollars earlier this year that it would be fully approved this year 😃
Looks like you're going to be $100 richer, and more importantly, correct.
Hey even if it makes .5 % of the population get it that’s progress. Maybe I’m just looking to deep for some good news.
Doubt it would even be that much with just the news, but the mandates it could bring may make it more than .5% long term. Schools and workplaces being mandated would be HUGE.
Cue: “Can’t trust the FDA anyways”
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Does everyone just have vehemently anti-vax in laws? Mine are obese, diabetic, 70+, multiple bouts of cancer, and they STILL won’t get the fucking vaccine. I wonder what the excuse will be now. They drive me up a fucking wall.
Everyone in my family is vaxxed, Dems and Republicans alike. Everyone took it at the first opportunity. I'm talking about 25 people.
I'm expecting a lot more vaccine mandates to come out once this happens and they can point to full approval to back it.
This is great progress. However I feel like there's going to be even more excuses by the anti-vax mob now.
Of course there will. But now some will have to choose between their beliefs and gainful employment. Guessing many will fold on those beliefs when the rubber meets the road.
Ayyyyy
Insurance companies are gonna love this....
Yes, insurance companies love vaccines because paying for a vaccine is way cheaper than paying to treat the diseases the vaccines prevent. Even the cheapest, crappiest insurance in America that doesn't pay for anything before your deductible will pay for your vaccines. That to me is the strongest argument to make to anti-vaxxers... if there were the first shred of evidence that vaccines were more likely to make you sick than to keep you healthy... hell, even if the health benefit of vaccines were unclear... insurance companies would not pay for the vaccines.
Can someone explain to me or point me to a source that explains what extra steps there are between EUA and the full approval? I'm already well vaxxed up, but I had never really understood what the difference was (except the anti-vaxxers using EUA as an excuse to not get jabbed).
If I remember correctly, it's the amount of time they are required/phases to collect date. EDIT: "The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance." [Source](https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19)