The Politics of Covid 19, mask wearing and the vaccination process

[hepcat]

So why is Trump gunning for Pfizer? Have they said something in the past that he didn't like/didn't praise him? Normally (well...100 percent of the time) he issues these little bon mots when his baby man feelings have been hurt in the past.

[pr0ner]

Trump issued a statement saying the J&J vaccine needs to be put back in use ASAP because Pfizer is secretly behind getting the FDA to pause J&J distribution.

Did he really? In a bizarre way that could be incredibly helpful. If Johnson and Johnson could become the "Republican / Trump" vaccine that the Deep State doesn't want you to be able to get, that could dramatically increase vaccination penetration in conservative areas.

Yep.

[malchior]

Trump issued a statement saying the J&J vaccine needs to be put back in use ASAP because Pfizer is secretly behind getting the FDA to pause J&J distribution.

Did he really? In a bizarre way that could be incredibly helpful. If Johnson and Johnson could become the "Republican / Trump" vaccine that the Deep State doesn't want you to be able to get, that could dramatically increase vaccination penetration in conservative areas.

Or conversely it reinforces the idea that the Government is controlled by a deep state that wants to harm #MAGA and they won't do anything. He needs to say *GET VACCINATED*. Not being clear on this is on brand since he is willing to let people die if it is a road back to power for him. No matter what the guy attempted an autocoup - It'd be best if the media wouldn't amplify him at all.

[Smoove_B]

just saw mention the pause might be only a few days. Hopefully the state can figure that out.

The problems (in theory) could manifest anywhere up to ~21 days after the shot is given. Considering the number of people that were likely vaccinated yesterday, I don't know that they're in any rush to start using it again until they're absolutely sure there aren't any issues.

[malchior]

just saw mention the pause might be only a few days. Hopefully the state can figure that out.

The problems (in theory) could manifest anywhere up to ~21 days after the shot is given. Considering the number of people that were likely vaccinated yesterday, I don't know that they're in any rush to start using it again until they're absolutely sure there aren't any issues.

Here is the story. I heard the comments live. I guess we'll see what the impact is.

[Smoove_B]

Oh, I'm sure J&J believes it's going to be a few days. I'd be amazed if anything is officially announced before next week.

[Max Peck]

So why is Trump gunning for Pfizer? Have they said something in the past that he didn't like/didn't praise him? Normally (well...100 percent of the time) he issues these little bon mots when his baby man feelings have been hurt in the past.

IIRC, Pfizer publicly stated that they didn't receive any research funding under Warp Speed and refuted Trump's claim to take credit for the BioNTech vaccine. He was also bent out of shape because they didn't release their preliminary results prior to the election, thus robbing him of his justly earned victory on the grounds that he cured COVID-19.

[Max Peck]

I read an article about a week ago that anticipated that the J&J vaccine might run into similar problems as AstraZeneca, both in terms of clotting and the resulting blow-back.

The new side effect listing in the EU will only make things more difficult for AstraZeneca. And it’s also likely to cast a shadow over the Johnson & Johnson COVID-19 vaccine, which is authorized in the US and elsewhere and uses the same design as AstraZeneca’s vaccine.

Both vaccines use an adenovirus vector. Adenoviruses are common viruses that can cause cold-like infections and other mild illnesses in people. For vaccine delivery, they’re engineered so they can’t replicate in cells or cause disease, but they can deliver to cells the genetic code of a more dangerous germ. In the case of the COVID-19 vaccines, the engineered adenoviruses deliver the code of the SARS-CoV-2 spike protein, which adorns the outside of the virus’s particle. The spike protein is what SARS-CoV-2 uses to grab onto human cells and get inside—and it’s a key target for potent antibodies and other immune responses. Once the adenovirus vector delivers the code for the spike, our cells can make their own versions of the protein and use it to train immune responses that will recognize and destroy the SARS-CoV-2 virus.

A potential pitfall of adenovirus-based vaccines is that adenoviruses can also bind to platelets and cause problems. In fact, some pre-pandemic data has suggested that adenoviruses can activate platelets and lead to low platelet counts. But the connection between this and the mechanism causing the blood clotting in vaccinees needs far more data to be understood.

Still, the side effects seen in AstraZeneca’s vaccine raise worries about Johnson & Johnson’s. During the clinical trials of the Johnson & Johnson vaccine, there was an early sign of an increased risk of these blood-clotting conditions in vaccinated people, Peter Arlett, head of data analytics at the EMA, said in a press briefing Wednesday. But the link was never confirmed, he added.

Of the approximately 4.5 million people who have received the Johnson & Johnson vaccine worldwide, there have been three reported cases of blood-clotting events similar to those seen in people given the AstraZeneca vaccine, Arlett said. These numbers are “extremely small,” he emphasized. “This is, however, under close scrutiny... I think it would be fair to say there’s intensive monitoring of this issue across the vaccines.”

[Carpet_pissr]

Trump issued a statement saying the J&J vaccine needs to be put back in use ASAP because Pfizer is secretly behind getting the FDA to pause J&J distribution.

Who?

[LordMortis]

Trump issued a statement saying the J&J vaccine needs to be put back in use ASAP because Pfizer is secretly behind getting the FDA to pause J&J distribution.

That sounds like DJT all the way.

Edit:

Perhaps. It looks like this statement went through his lawyers.

[Smoove_B]

I just want to reiterate the idea that he was President is both embarrassing and terrifying. The thought that he could still be President right now? I cannot even imagine what things would be like.

To quote Jules (which is my go-to response for anyone from the GOP that feels the need to chime in), "I don't remember asking you a goddamn thing."

[Zaxxon]

This is the part I don't get. This seems (to my layman's understanding) like it's approximately equally likely to be noise or a very minor issue that's dwarfed by the good that the J&J vaccine does, and therefore the 'pause' is not being undertaken for health reasons but for PR reasons.

Mostly. However, right now they're doing an inventory of the situation. They will be reaching out to vaccinators, health care providers and possibly the public to ask if there have been issues. While this was always happening, this will be a more aggressive review of the data to make sure nothing was missed (to Defiant's point above)

If something had to be done, why not just keep administering but not to anyone 'at risk' of clotting while it's worked out? This seems like a major 'make the perfect the enemy of the good' thingamajigger to me.

They might get there, but only after they can run the numbers. It always has to come back to verifying the study findings and looking at the actual data we have for 6.8+ million people that have received the J&J shot.

But again, I have no idea what I'm talking about, other than a basic understanding of mathematics.

I've learned over 20+ years that math doesn't endear people to public health. I could (and have) provided all kinds of cost/benefit evaluations and worked through thought exercises on what might happen over inaction. The CDC provides a helpful reminder to the public over vaccines,but I don't see if referenced often. I think people (generally) have a difficult time agreeing with the externalized benefits and instead focus on the possible personal negatives.

I really don't know what a realistic timeline is here, but unofficially I'm not expecting anything before next week. Jerz has already locked down the J*J shots and made sure they're not going out anymore. Maybe we'll know more before the weekend (in terms of what it all means), but I just don't know. Not really the news I was expecting to read on a random Tuesday in April, that's for sure.

Gruber's on quite the tirade on this today, just on the numbers themselves rather than the separate PR side of things.

Criminal innumeracy and Do less harm.

After a run of remarkably good news on the COVID vaccination front here in the U.S., this is an utter gut punch, and a horrendously wrong decision. This terrible decision is going to kill tens of thousands of Americans. Six blood clots after 7 million administered Johnson & Johnson vaccines, versus a disease that has a mortality rate of 18,000 per million cases in the U.S., and has killed over 1,700 of every million people.

One death after 7 million J&J vaccinations for these blood clots (which they don’t even know are attributable to the vaccine), versus over 50,000 dead per 7 million cases of COVID in Americans. That’s a ratio of 1 : 50,000. You can fairly argue those mortality numbers are skewed by the fact that COVID has already ripped through our nursing homes, killing a lot of our most vulnerable people, but still, the risk numbers aren’t even in the same ballpark. And mortality numbers don’t include the millions of Americans who suffered or are suffering from severe cases that require hospitalization.

This is criminal innumeracy.

Obviously Smoove's points stand--it makes sense to do a deeper dive on the data and see whether we're really talking about only 6 incidents, whether we should be gating this vaccine in a way that reduces that risk, etc. But even if it turns out there are 10x as many clotting issues as are presently known, I cannot see a way in which this wasn't the wrong decision, simply from an 'overall good' standpoint.

[Zaxxon]

He wasn't done there, either. Relative risks of blood clots.

Again, I am but a plebe. But this seems like a terrible decision on net, since the damage of pausing is significant (and we knew that in advance from the A-Z pause effects).

[Smoove_B]

My current SME for this type of scenario is Dr. Scharfstein, and thankfully he has provided his opinion (and some recent history) on Twitter:

The agency was criticized at the time, by some for over-reacting and by others for under-reacting. But the pause allowed for a thoughtful review and plan (in that case to resume vaccinating), respecting the public interest in vaccine safety. My view is the J&J pause also makes sense ... the time can be well used to gather and analyze critical data, explain the situation to the clinical community and the public, obtain external input, and proceed wisely.

His opinion doesn't come from a vacuum; he's the real deal.

He was Secretary of the Maryland Department of Health from 2011 to 2014, and was principal deputy commissioner of the U.S Food and Drug Administration until he stepped down from his post on January 5, 2011. He is the former health commissioner of Baltimore, Maryland.

[Zaxxon]

I think the disconnect is that I agree with that perspective, in a vacuum where either new COVID infections are paused or there's plenty of alternative vaccines to give everyone that wants one a shot with no delays from pausing J&J. But we don't live in a vacuum, and the public impacts and optics matter. It would take a gigantic discovery that the clotting issue is several orders of magnitude larger than presently known to make this a toss-up call in terms of overall safety impact.

[El Guapo]

That Dr. Sharfstein response is the kind of thing that I was looking for in terms of support for the decision - that's very helpful. Still, even accepting that I am a public health n00b, it seems like the media environment and scale of the needed COVID vaccinations is a world apart from a diarrhea vaccination that very few people need, use, or interact with normally. The costs of a pause when you need so many low information people to get vaccinated seems so much higher.

[Smoove_B]

In truth, we might find that there aren't any increased risks for 99.99% of the population taking the J&J shot. However, if this pause can find something - a previously unrecognized risk that isn't common for all vaccination screening (i.e. questions we already ask prior to injecting someone), that has value. In practice then, they'd add another item to the list of screening questions and advise accordingly.

The fact that it's being potentially linked to a known health condition instead of people seemingly dropping dead for unknown reasons post-vaccination is likely going to be the biggest factor here in determining how to proceed.

If there's zero risk to men or women above the age of 50 (zero cases found after ~7 million shots), that's going to be great. If there's a specific birth control medication risk (as observed above), that's something else.

I guess at the end of the day, when you just look at the risk it's low. However, if there's information to be learned and any way to make sure someone at elevated risk is being properly screened, I think it's hard to argue against that (overall). I don't think I'd ever want to be in a position where I'd need to get in front of a crowd and say I knew that [specific category of people] had a slightly elevated risk of [condition] and we just didn't report it. Overall that erodes trust and would have longer-term impacts for future efforts, undermining our ability to be reliable.

[El Guapo]

Trump issued a statement saying the J&J vaccine needs to be put back in use ASAP because Pfizer is secretly behind getting the FDA to pause J&J distribution.

Did he really? In a bizarre way that could be incredibly helpful. If Johnson and Johnson could become the "Republican / Trump" vaccine that the Deep State doesn't want you to be able to get, that could dramatically increase vaccination penetration in conservative areas.

Or conversely it reinforces the idea that the Government is controlled by a deep state that wants to harm #MAGA and they won't do anything. He needs to say *GET VACCINATED*. Not being clear on this is on brand since he is willing to let people die if it is a road back to power for him. No matter what the guy attempted an autocoup - It'd be best if the media wouldn't amplify him at all.

Yeah, I mean ideally Trump would say that. I'm just saying that it seems plausible that someone reading "Trump criticizes FDA for pausing Johnson and Johnson vaccination" might well take away from that that Trump thinks that people should get the J&J vaccine. Even if that persuades a small number (say 5% - 10%) of Trumpworld members that they should get the J&J vaccine, that seems like a potentially helpful thing.

[El Guapo]

In truth, we might find that there aren't any increased risks for 99.99% of the population taking the J&J shot. However, if this pause can find something - a previously unrecognized risk that isn't common for all vaccination screening (i.e. questions we already ask prior to injecting someone), that has value. In practice then, they'd add another item to the list of screening questions and advise accordingly.

The fact that it's being potentially linked to a known health condition instead of people seemingly dropping dead for unknown reasons post-vaccination is likely going to be the biggest factor here in determining how to proceed.

If there's zero risk to men or women above the age of 50 (zero cases found after ~7 million shots), that's going to be great. If there's a specific birth control medication risk (as observed above), that's something else.

I guess at the end of the day, when you just look at the risk it's low. However, if there's information to be learned and any way to make sure someone at elevated risk is being properly screened, I think it's hard to argue against that (overall). I don't think I'd ever want to be in a position where I'd need to get in front of a crowd and say I knew that [specific category of people] had a slightly elevated risk of [condition] and we just didn't report it. Overall that erodes trust and would have longer-term impacts for future efforts, undermining our ability to be reliable.

It seems like a lot depends on what you think the impact of this pause will be on vaccine hesitancy. I tend to assume that it will have a significant negative effect, mostly regardless of what the FDA does next. If that's not the case, then I think the decision starts to make more sense. I guess we'll see.

[hepcat]

Trump issued a statement saying the J&J vaccine needs to be put back in use ASAP because Pfizer is secretly behind getting the FDA to pause J&J distribution.

Who?

[Smoove_B]

It seems like a lot depends on what you think the impact of this pause will be on vaccine hesitancy. I tend to assume that it will have a significant negative effect, mostly regardless of what the FDA does next. If that's not the case, then I think the decision starts to make more sense. I guess we'll see.

I think this is probably the core issue. I'm of the mind that we're not convincing anyone anymore; I'm a cynical bastard. I think those that are on board with vaccines have already been vaccinated or will be when they're given the opportunity. I believe there's a portion of vaccine hesitant that might be convinced in 1:1 scenarios - interactions with close family members where they realize a benefit and/or there's significant social pressure to get vaccinated (I'll call them H1)

Then there's another group of vaccine hesitant that won't get vaccinated until it inconveniences them. Can't go to the movies? Can't get on a plane? Attend a concert? Get a job or go to work? Magically they do it. (These are H2)

The final group - those closest to being anti-vaccination (as well as the actual militant anti-vax people) are going to use this as an excuse and more evidence that they were right all along to not trust the government - I'm seeing it already locally on social media. However, by taking a pause here and evaluating the data, we're actually dismantling their narrative because stopping to verify safety is exactly the opposite of what they claim should be happening ("Big government doesn't care!" You have no rights, they want control!") This group is H3, trending Anti-vax.

I don't believe at all that by doing this we're going to convince H3 to get vaccinated; that ship has sailed. Instead, this is reaffirming for those in H1 and H2 that this is the right decision and a safe option.

[Zaxxon]

Meanwhile, The Verge is writing articles to calm me down.

[El Guapo]

The final group - those closest to being anti-vaccination (as well as the actual militant anti-vax people) are going to use this as an excuse and more evidence that they were right all along to not trust the government - I'm seeing it already locally on social media. However, by taking a pause here and evaluating the data, we're actually dismantling their narrative because stopping to verify safety is exactly the opposite of what they claim should be happening ("Big government doesn't care!" You have no rights, they want control!") This group is H3, trending Anti-vax.

I don't believe at all that by doing this we're going to convince H3 to get vaccinated; that ship has sailed. Instead, this is reaffirming for those in H1 and H2 that this is the right decision and a safe option.

See, this is the part that I'm deeply skeptical about. I strongly doubt that this pause and study will have any positive effects on H1 and H2's willingness to vaccinate. I think most of them are low information on vaccine. Almost all of them will see the "FDA pauses J&J vaccine due to side effects" headlines. Significantly fewer will eventually see the "FDA allows J&J vaccinations to resume after study" headlines, and of those many will still have doubts that they don't have the time / expertise to assuage.

I think the likely effects of this decision will be: (1) Some portion of H1 will refuse the J&J vaccine and wait until they can get Pfizer or Moderna; and (2) Some portion of people will move from H1 to H2, and from H2 to H3. I could be convinced that none of this will have any impact and people will just do what they were inclined to do from the beginning. I am incredibly skeptical that more than one or two people will say "well now that people have taken a couple weeks to study this terrifying side effect, I feel totally comfortable taking a vaccine".

[LordMortis]

(I'll call them H1)

(These are H2 N1)

The final group - those closest to being anti-vaccination (as well as the actual militant anti-vax people) are going to use this as an excuse and more evidence that they were right all along to not trust the government

I wouldn't say they don't trust the government (or at lest that is not the necessary conditional). I would say the GOP (which is government) has been exploiting their belief that they know more than the experts on everything, and this has, for a long time, manifested itself most visibly when it comes to "holistic" medicine or traditional "cures" that help the body heal itself.

In my case, this is where my mother has bought in to two of my aunt's "chiropractors and small town veterinarians are the best doctors" and "Obamacare ruined the best medical care in the world that you could never trust and you should talk to a chiropractor and listen to the guy they take their horses to." The irony is when a doctor confirms their bias on GNC has the cure for everything on a specific supplement that only drives them deeper into supplements are the cure for everything fantasy.

[gbasden]

I wouldn't say they don't trust the government (or at lest that is not the necessary conditional). I would say the GOP (which is government) has been exploiting their belief that they know more than the experts on everything, and this has, for a long time, manifested itself most visibly when it comes to "holistic" medicine or traditional "cures" that help the body heal itself.

In my case, this is where my mother has bought in to two of my aunt's "chiropractors and small town veterinarians are the best doctors" and "Obamacare ruined the best medical care in the world that you could never trust and you should talk to a chiropractor and listen to the guy they take their horses to." The irony is when a doctor confirms their bias on GNC has the cure for everything on a specific supplement that only drives them deeper into supplements are the cure for everything fantasy.

There's a reason why Alex Jones sells overpriced miracle cures on his show. The folks that buy into Infowars are exactly the folks that snake oil salesmen want to shill to - lack of critical thinking skills, gullibility and a distrust of science affect both willingness to buy into conspiracy theories and a willingness to hand over a lot of money for "magic" powders.

[Lorini]

Why do we in the US trust the FDA? Because it works with established protocols to declare drugs and vaccinations safe. In China last decade, their FDA equivalent chief had approved 150,000+ drugs during the same time that the US had approved 7,000 drugs. Many Chinese people died because of these approvals. China removed the chief from the position, put him in front of a firing squad and that was that.

We have to allow the FDA to continue to be an entity who we trust. People look at the words "emergency use authorization" and only see "authorization". An Emergency Use Authorization is not a full authorization and under their protocols they have to stop and look at any issues. They can't be driven by public responses and the future, they need to do what they are supposed to do so that we will trust them in the next pandemic.

I understand that this may fuel vaccine hesitancy but what will really fuel vaccine hesitancy is for this blood clot issue to be a real thing and kill many down the line.

I support what they are doing. In the continuum of time, and assuming there really aren't issues, this will be a blip.

[Unagi]

I agree with you.

They need to do their primary job, which is to authorize (or not) the drug, and (more or less) ignore the secondary effects of their honest work (perhaps making some people fear the vaccine in general), and remain as close to a source of ‘truth’ as we can have on any given drug.

[El Guapo]

So I would say that the strongest arguments for the suspension seem to be: (1) trust the FDA's expertise (though I'd like to be sure that they have people whose expertise is studying impacts of various things on vaccine hesitancy); (2) risk that the blood clot becomes a bigger deal than we currently think and that impact on vaccine hesitancy; and (3) people are gonna do what they are gonna do on vaccines mostly no matter what we do, so might as well be safe.

One kicker for me is that presumably the pause is going to delay some people getting vaccinated, and that some of those will get COVID during the delay, and pass it along to at least some other people. Given that the mortality rate from COVID is so much higher than the mortality rate seems to be from any blood clot issue, that unless the blood clot issue is many, many times more dangerous than we currently think, the simple math suggests that more people will die with the pause than if there was no pause (even assuming no impact on vaccine hesitancy).

Also I can't help but feeling shades of the Comey letter on this. Like, from Comey's perspective he was just updating Congress on an additional check that he was doing in light of new evidence. But like...he should've known how people would react to it. This feels similar in that the likely general reaction from any pause for any reason is lots of people freaking out about vaccine safety.

I guess we'll see. And fortunately we have lots of Pfizer and Moderna as well, so that helps a lot.

[Zaxxon]

That's a much more eloquent way of putting what I was trying to say yesterday.

[Smoove_B]

Also I can't help but feeling shades of the Comey letter on this. Like, from Comey's perspective he was just updating Congress on an additional check that he was doing in light of new evidence. But like...he should've known how people would react to it. This feels similar in that the likely general reaction from any pause for any reason is lots of people freaking out about vaccine safety.

It's weird (for me) to read these types of comparisons as my "lens" for everything pandemic and public health is pretty well established. For me, what's currently happening with the pause is *exactly* what should be happening. I can totally appreciate that this might not look normal or how the emergence of an issue has initiated a process to evaluate everything might lead people to believe that vaccines are unsafe. However, I just keep hammering that this is exactly what should be happening. We're collectively watching, something is noted and now we evaluate what's being done.

There was a doctor on Twitter this morning that commented as a clinician, this changed his thought process yesterday. Namely, that he had a patient in his ER that was in the demographic of concern and had symptoms that could be related. If the FDA and CDC didn't publicly announce this, he never would have even considered it as part of his differential diagnosis and her health could have been impacted. Again, that's what should be happening and it only happened because of how the CDC and FDA responded.

I guess it's all where you focus.

Even with talking to my mother this morning, she was irate that the vaccines are apparently only good for "at least 6 months", as she was focused on the initial reports (from 2020) suggesting they might be good for a year (or longer). To clarify, they still might be, however (as I pointed out to her), we're just now starting to get the data from the initial cohort people vaccinated last year as part of the studies. We're still learning and it's going to be a rolling release of information - because this is an emergency and we're figuring this out as we move along. I get that it's potentially scary, confusing or that it reinforces a belief that "scientists don't know anything", but in truth, that's just how this all works. There's going to be constant monitoring, evaluating and adjustment. That's part of the reason they started on the booster shots - because we don't know. However, if the data over the next 6 months tells us we need them, they're ready to go.

So yeah, for me this reinforces my confidence in these organizations, which is a nice change from 2020.

[Lorini]

So I would say that the strongest arguments for the suspension seem to be: (1) trust the FDA's expertise (though I'd like to be sure that they have people whose expertise is studying impacts of various things on vaccine hesitancy); (2) risk that the blood clot becomes a bigger deal than we currently think and that impact on vaccine hesitancy; and (3) people are gonna do what they are gonna do on vaccines mostly no matter what we do, so might as well be safe.

One kicker for me is that presumably the pause is going to delay some people getting vaccinated, and that some of those will get COVID during the delay, and pass it along to at least some other people. Given that the mortality rate from COVID is so much higher than the mortality rate seems to be from any blood clot issue, that unless the blood clot issue is many, many times more dangerous than we currently think, the simple math suggests that more people will die with the pause than if there was no pause (even assuming no impact on vaccine hesitancy).

Also I can't help but feeling shades of the Comey letter on this. Like, from Comey's perspective he was just updating Congress on an additional check that he was doing in light of new evidence. But like...he should've known how people would react to it. This feels similar in that the likely general reaction from any pause for any reason is lots of people freaking out about vaccine safety.

I guess we'll see. And fortunately we have lots of Pfizer and Moderna as well, so that helps a lot.

I'll be honest with you El Guapo. I don't understand your position. Just as in law, medicine and vaccines have a protocol. They are following it. Just like in law, maybe Trump thinks that the election was stolen. That doesn't make it stolen legally right? We as Americans trust our law process and you as an attorney understand that trust and work to continue that trust. Why do you now want a corresponding profession to throw out the trust and instead consider how people feel? In neither profession does it matter how people feel right? So let's have the FDA do the right thing by following its protocols, just as our judges did the right thing by requiring Trump to produce evidence, no matter how people felt.

You are one of my favorite people here, El Guapo, so I'm not coming after you or anything like that. I just want you to see Smoove and others' perspectives or at least address why in this case we should care about how people feel vs in Trump's stolen election claims we didn't.

[LordMortis]

I'll be honest with you El Guapo. I don't understand your position. Just as in law, medicine and vaccines have a protocol. They are following it. Just like in law, maybe Trump thinks that the election was stolen. That doesn't make it stolen legally right? We as Americans trust our law process and you as an attorney understand that trust and work to continue that trust. Why do you now want a corresponding profession to throw out the trust and instead consider how people feel? In neither profession does it matter how people feel right? So let's have the FDA do the right thing by following its protocols, just as our judges did the right thing by requiring Trump to produce evidence, no matter how people felt.

+1 I wasn't an expert at the outset when they said don't wear masks. I wasn't an expert when they said wear masks. I wasn't an expert when they said stay at home. I wasn't expert when pushed things through on an emergency and I not an exert when they suspend one vaccine. If I lose my trust in the FDA and the CDC and medical field, then I'd never have had a stent put in my heart. We learn things and we change our actions. When it comes to things we can't possibly know we have to trust the people whose jobs it is to learn and accept that they are learning. There isn't much choice there. The best I can do is try to help others in my sphere to take this in to account and continue to let them make their own decisions while urging them to consider a mass of people constantly learning vs a mass of people who claim to know based on ????

[Zaxxon]

There was a doctor on Twitter this morning that commented as a clinician, this changed his thought process yesterday. Namely, that he had a patient in his ER that was in the demographic of concern and had symptoms that could be related. If the FDA and CDC didn't publicly announce this, he never would have even considered it as part of his differential diagnosis and her health could have been impacted. Again, that's what should be happening and it only happened because of how the CDC and FDA responded.

That assumes that there wasn't a third option here--announcing a pause for the subset of potential J&J-receiving folks for whom we have actual data suggesting there's a need for a pause, right? What is the data-based rationale for pausing all J&J distribution?

To put it another way, we didn't know for certain that this (or any) of these vaccines was safe to our usual standards when we granted the EUA (that's why we granted an EUA rather than a normal authorization). We collectively made the choice then that the pandemic justified shrinking the usual safety requirements. Because the likely safety risks were greatly outweighed by the known risks of COVID.

Now we have what seems like another instance of that--a very small additional risk outside of our usual norms, balanced against the still-much-larger COVID risk, but suddenly that's not acceptable. I'm not grokking the rationale as to why that is. It's not like we have a glut of the other two vaccines such that J&J isn't needed at this point.

I'll be honest with you El Guapo. I don't understand your position. Just as in law, medicine and vaccines have a protocol. They are following it. Just like in law, maybe Trump thinks that the election was stolen. That doesn't make it stolen legally right? We as Americans trust our law process and you as an attorney understand that trust and work to continue that trust. Why do you now want a corresponding profession to throw out the trust and instead consider how people feel? In neither profession does it matter how people feel right? So let's have the FDA do the right thing by following its protocols, just as our judges did the right thing by requiring Trump to produce evidence, no matter how people felt.

You are one of my favorite people here, El Guapo, so I'm not coming after you or anything like that. I just want you to see Smoove and others' perspectives or at least address why in this case we should care about how people feel vs in Trump's stolen election claims we didn't.

I know I'm not El Guap, but...

I think you're conflating things that don't conflate. No one is claiming that because some folks feel this is wrong, it's wrong (the question of whether the pause also contributes to vaccine hesitancy is secondary to the direct and immediate impact of the pause on COVID spread and deaths). The question (or at least my question) is whether the usual protocols should apply here, in a scenario where it is nearly certain that pausing the roll-out is costing lives rather than saving them.

In a low-impact vaccine scenario (relative to COVID), taking an uber-cautious approach makes total sense to me--until we're as sure as we can be that a vaccine is safe, a stop-and-go approach is great. But in this scenario, where we have a literal handful of known issues in a small demographic subset of the populace, and one death vs many hundreds every day, I'm not as sure.

+1 I wasn't an expert at the outset when they said don't wear masks. I wasn't an expert when they said wear masks. I wasn't an expert when they said stay at home. I wasn't expert when pushed things through on an emergency and I not an exert when they suspend one vaccine. If I lose my trust in the FDA and the CDC and medical field, then I'd never have had a stent put in my heart. We learn things and we change our actions. When it comes to things we can't possibly know we have to trust the people whose jobs it is to learn and accept that they are learning. There isn't much choice there.

Absolutely. I'm with the FDA & CDC in this and am not advocating that they made a mistake. What's I'm not seeing is the direct explanation for why this particular outcome (pausing everything) is the minimum required action given the data we have. This makes it hard for me to follow the rationale. I'm fine following the experts, but I prefer to understand the rationale. Appeals to authority are never a great argument.

It seems I'm not going to get the rationale in a form that I follow, and that's fine. I don't have to like it, though.

[Defiant]

That assumes that there wasn't a third option here--announcing a pause for the subset of potential J&J-receiving folks for whom we have actual data suggesting there's a need for a pause, right? What is the data-based rationale for pausing all J&J distribution?

It may be that there's not enough data to narrow it down to that demographic - it could be a coincidence that the six cases are all women, for example.

[Lorini]

The problem is that people are assuming there isn't an issue because so few cases have been found. But as Smoove says, the reason they may not have been found is because doctors don't know to look, just like when Covid started, it was not properly diagnosed because doctors didn't know it was a disease. You can't just assume that everything is fine with these few exceptions until the medical community as a community can figure out exactly what is going on. Death is bad, but blood clots can lead to a condition where people would nearly want to be dead. Plus, if people are sensitive for whatever reason to blood clots, they should know that so they working with their physician can figure out what's best for them.

This in my opinion must be done, to stop the vaccine so that we can continue to have trust in the medical information we are getting from the US government. To ignore these 'few cases' shows a lack of understanding (again in my opinion) of what could happen if blood clots are in fact an issue with this vaccine vs figuring out what we can do to make sure that nothing does happen or to prepare people who may be vulnerable.

Also folks, vaccines are not a short term solution to the pandemic. Every day is a day that another variant can form from anywhere in the word that will be resistant to these vaccines. There is no promise only intent. The main thing is to no matter what, keep masking, washing your hands, and not touching your face.

What I would say to the vaccine hesitant is that this process shows that they are not married to these vaccines, that they want to make sure you are safe, that they want to keep you informed. The vaccine hesitant should actually be very happy that this is happening.

[Zaxxon]

That assumes that there wasn't a third option here--announcing a pause for the subset of potential J&J-receiving folks for whom we have actual data suggesting there's a need for a pause, right? What is the data-based rationale for pausing all J&J distribution?

It may be that there's not enough data to narrow it down to that demographic - it could be a coincidence that the six cases are all women, for example.

True. Or it may be that these cases are noise and not related to the vaccines at all (at these numbers, we don't know). Caution wins the day.

The problem is that people are assuming there isn't an issue because so few cases have been found. But as Smoove says, the reason they may not have been found is because doctors don't know to look, just like when Covid started, it was not properly diagnosed because doctors didn't know it was a disease. You can't just assume that everything is fine with these few exceptions until the medical community as a community can figure out exactly what is going on. Death is bad, but blood clots can lead to a condition where people would nearly want to be dead. Plus, if people are sensitive for whatever reason to blood clots, they should know that so they working with their physician can figure out what's best for them.

All also true with COVID, on a much greater scale. That's the crux for me here--I don't disagree with your viewpoint on the need to investigate this. My bafflement is why we'd stop the 'voluntary' vaccine piece when there's no indication that I've seen that this issue we're investigating is as troublesome even among those getting J&J shots as the other voluntary option, which is letting folks remain unvaccinated a bit longer. We're not choosing to stop the chance of more clotting while we investigate; we're choosing to exchange the chance of more clotting with a larger chance of long COVID, for example.

[Lorini]

Because we don't know. We don't know how many cases there actually are because doctors don't know to look for them in vaccinated people. Now they do! So let's see what happens in the next couple of weeks and then we can continue on with our vaccine process which has gone so well.

[LordMortis]

Appeals to authority are never a great argument.

Is this an appeal to authority though? If it is, are all "trust the process" appeals really appeals to authority? Also at that point is it on you to learn the process if you don't want to trust it or is it on them to make sure you understand the process because you don't want to trust their authority.

I don't have an answer. I don't have the time or capacity to become an expert on everything. I would think that I really needed to know why 6 deaths vs 18,000 deaths was show suspender, I'd make the effort to learn what suspends shows, rather than expect the meastro to dumb it down for me. It could be people aren't dying like they were a year ago. It could be we have two other vaccinations without these problems. It could be because of AZ similarities. It could be that we don't want sacrifice one smaller vulnerable population for a larger one. It could be because 6 might just be the first reports. It could be we're just talking deaths, not disability. It could even be procedural stupidity. But aside from PR, from my isolated for 14 months and counting chair, it looks like a pretty Karen attitude to want insight provided for the way things are done when you learn you may not like the way things are done after putting in no effort to learning why things are done the way they are.

That sound like an attack but I don't know any other way to put it. It's likely because I'm generally ignorant and constantly have to learn that I'm ignorant and often learn that the path not being ignorant is beyond my oxygen fed from mouth breathing brain. I greatly appreciate when people take the time to dumb things down for me but I'm rarely arrogant (again, don't know the better more polite word for this) enough to feel like it has to happen.


At the same time, I get where you are coming from. When the last president tells me perhaps Pfizer is paying off the FDA, I can't exactly trust his authority on the subject and his track record for process following that leads to a better today and tomorrow.

[LordMortis]

What I would say to the vaccine hesitant is that this process shows that they are not married to these vaccines, that they want to make sure you are safe, that they want to keep you informed. The vaccine hesitant should actually be very happy that this is happening.

That's where I'm coming from and it's the approach I am going to use as I continue to try and sway my mother, who thankfully continues to socially distance and mask up, etc... even as you will not vaccinate (hopefully only at this time. I need to find a way to remove the poisoning of some of her sisters and their spouses on this)

(And you guys are fast...)

[Smoove_B]

That assumes that there wasn't a third option here--announcing a pause for the subset of potential J&J-receiving folks for whom we have actual data suggesting there's a need for a pause, right? What is the data-based rationale for pausing all J&J distribution?

To put it another way, we didn't know for certain that this (or any) of these vaccines was safe to our usual standards when we granted the EUA (that's why we granted an EUA rather than a normal authorization). We collectively made the choice then that the pandemic justified shrinking the usual safety requirements. Because the likely safety risks were greatly outweighed by the known risks of COVID.

Now we have what seems like another instance of that--a very small additional risk outside of our usual norms, balanced against the still-much-larger COVID risk, but suddenly that's not acceptable. I'm not grokking the rationale as to why that is. It's not like we have a glut of the other two vaccines such that J&J isn't needed at this point.

I'll admit I don't know the particulars for a EUA here and whether or not it mandates broad suspension or if it allows for targeted suspension. I don't know that I'd take the position that the EUA skirts safety requirements. What we've traded is short-to-medium term safety for unknown long term health impact. I have to trust the scientists here and believe the short to mid-term benefits of the vaccine outweigh the risk of some negative health condition emerging in Smoove_B 10+ years from now as a result of being vaccinated.

However, even if it did allow for targeted suspension, I think I still agree with the current path and the reason is scale. We really have no modern analogous comparison to what's happening right now with mass vaccinations. The closest I can think was for polio in the 1950s, but that wasn't anywhere near the same scale in terms of the number of people vaccinated.

Any other more "modern" vaccination would be provided to targeted cohorts. So trying to find a comparison with a Shingles vaccine or the HPV vaccine wouldn't work - we're giving those to seniors and teens. If we found issues when they were released, the scale of the "pause" would be much smaller. Just like the example provided by Dr. Sharfstein that I shared yesterday - a vaccine for infants and children.

So, given the fact that we're now vaccinating all people in America (broadly) over the age of 16 and for the last month we've been (broadly) vaccinating people ages 40+ nationwide it makes sense to look at all the data we have so far and verify there aren't issues with the data that's been collected (in terms of finding patterns).

The closest example I can craft would be for an annual flu vaccine. If for some reason doctors and pharmacists noted some type of new medical issue seemingly associated with the annual shot for people ages 25-35 ("severe edema in the legs"), I'm pretty confident they would suspend all flu shots to figure out what's happening. It's not exactly the same as flu shots aren't new, but generally the same idea.

If you focus on the risk for clots, broadly the risk seems to be ~1 in a million (right now). However, as was pointed out this morning by people way smarter than I am, the only way to get the true risk is to look at all the data. For everyone receiving the shot it might be 1 in a million. But for women age 20-25 and taking a specific type of medication, their risk might be 1 in a 10,000. If that's the case, that should be part of the information we're providing for advisement.

Again, it's not that we're not considering the risk of clots vs the risk of dying from COVID. Instead, we're looking at the bigger picture - what's the risk to the trust in the process overall? What's the risk to how we operate outside of this pandemic? There's been a 20+ year war on vaccines in America and imho we haven't been aggressively pushing back against the anti-vaccination community. They've been chipping away at trust and undermining the message for why vaccines are important and it's not helping the current effort. If the CDC and FDA dismissed concerns here that there was potential for a health condition associated with vaccination, it would absolutely feed into the anti-vax narrative. What is happening now dismantles it.

Maybe this would also be different if we *only* had the J&J shot in terms of how it would be handled; There's just too many variables to parse.