Covid-19 #29: Gazing Into the Abyss, Again

[Mr. Chatywin et al.]

3 hours ago, Fragile Bird said:

The number is not really 1 in a million, though, is it? If it affects women, and half the doses are 3 M, so it’s 1 in 500,000. This may be a situation where things have to be tracked by gender.

Not exactly. I couldn't find the most recent numbers, but what I did find (two months old though) was that women were getting the vaccine at about twice the rate of men. We also know the largest bloc of men, white men, are the most resistant to getting vaccinated. So really the exact number is somewhere between 1 in 500k and 1 in 1m.

38 minutes ago, Altherion said:

Nobody is stopping the entire vaccine rollout. From the FDA/CDC statement:

From their phrasing, less than 7 million doses of J&J have been administered out of a total of about 190 million doses. Even given the fact that J&J is one-and-done whereas the others need two shots, it's still a small fraction of vaccines. Also, a single shot of either Pfizer or Moderna gives comparable immunity to J&J so if we substitute the mRNA vaccines for J&J, we're not losing any immune time for anyone.

That's not exactly what he was saying though. Kal, accurately in my opinion, is worried that this move will cause an increase in skepticism. It doesn't matter that J&J make up a small fraction of the overall doses being administered. 

[Fragile Bird]

1 minute ago, Chataya de Fleury said:

Just got my Moderna second shot and feeling great!!!!!

I drove my brother to a hospital vaccination center this morning and when he found out all they had was Moderna, he turned around and walked out. He wasn't the only one, people asked him what the vaccine was and a couple of others walked away as well. People are reading about more adverse reactions to Moderna and are nervous. I talked to him about Moderna the other day and I really thought that even though he preferred Pfizer, he'd be fine with Moderna.

His law partner got Pfizer and cruised through it and I got Pfizer and cruised through it now he wants Pfizer. I asked him to join me the day I got my jab and he wanted to wait a while, hoping he'd be able to say to his wife, look, my sister got the vaccine and nothing happened, she didn't turn into a zombie, so he could be open about getting vaccinated. My SiL seems to have just hardened her position instead.

While we sat in the car afterwards I asked him to give me his health card so I could book another appointment on my phone ASAP. Another hospital was taking appointments and he wondered if he should risk booking with them, and even if we should drive over and ask what vaccine they were using. I told him what they were giving out today may not be what they're giving out in 10 days. In the end we booked an appointment at a mass vaccination site, at a shopping mall that has an old Target store that never got leased after Target exited Canada a couple of years ago. I don't know what he'll do if they have Moderna as well.

[Mudguard]

To follow up on potential treatments to the rare clotting disorder, part of the problem that complicates treatment is that the clotting is tied to low platelet levels.  Normally you would give an anticlotting agent to break up or prevent clotting, but even in normal circumstances, the strong anticoagulants used in these situations increase bleeding related risks, which are not trivial.  Normal injuries that would result in a bruise can result in major internal bleeding.  I think using some of these stronger anticoagulants increases the risk of hemorrhagic stroke.  Combine that with low platelet levels makes these risks even worse.

I'm pretty sure we aren't in the situation where most physicians already know the best way to treat this rare type of blood clotting.

Another issue is that there still isn't a very good list of symptoms to look out for.  If you list really common side effects, you are going to have lots of patients unnecessarily seeking medical treatments and testing.  Apparently, this has already been happening as a result of the AZ vaccine.  It would be good to reevaluate the list of symptoms now that there are over 200 cases in Europe tied to the AZ vaccine.  

Pausing things while you work through these issues makes sense to me.  

[Maithanet]

On 4/6/2021 at 10:05 AM, Maithanet said:

Today is the first day I am eligible for a vaccine in Maryland.  Hopefully I'll be able to get an appointment in the next few weeks. 

Got my first shot today (Moderna)!  Went smoothly!  Very happy about it. 

[Altherion]

31 minutes ago, Tywin et al. said:

That's not exactly what he was saying though. Kal, accurately in my opinion, is worried that this move will cause an increase in skepticism. It doesn't matter that J&J make up a small fraction of the overall doses being administered. 

But that boat has sailed, has it not? The knowledge of the problem is out there so the increase in skepticism is pretty much inevitable. The pause attempts to limit it by avoiding any deaths due to the vaccine and also by distinguishing between the affected vaccine and ones which, as far as anyone can tell, are safe.

[Kalbear]

1 hour ago, Mudguard said:

The blood clotting disorder at issue is normally extremely rare, so the vast majority of physicians have no experience treating it.  It's also not clear to me that there is a standardized or well accepted approach for treating the disorder yet.  A common treatment for blood clots is to give heparin, an anticoagulant.  However, in this case, it is believed by some that giving heparin can make things worse because the condition may be caused by antibodies to heparin.  A temporary pause is OK to work out these issues so that patients know what symptoms to look out for, and physicians know how best to treat it.  I'm still not sure there is a very good treatment yet.  The condition is still so rare that it's hard to work out the best approach.

It's also not worth stopping for one death in 7 million doses. How many people are going to die now because they didn't get vaccinated in time?

1 hour ago, Mudguard said:

The doubt already exists once the reports of blood clotting problems are published. 

It does, but there's no reason that the FDA and CDC have to be reactionary to this degree. 

1 hour ago, Mudguard said:

 I don't think a temporary pause is likeky to change someone who was OK with the vaccine after hearing about the blood clotting risk to not being OK, assuming the level of risk doesn't change and the government says it's ok to resume vaccination. 

We actually have real data showing that this is wrong, since that's exactly what happened in some countries with AZ. 

1 hour ago, Mudguard said:

A pause when a new serious side effect is discovered is a normal part of the process.  Same thing happens during clinical trials when adverse events occur.  You pause and take some time to do a thorough analysis.  A similar process exists for handling side effects that are detected after a product is approved for public use.

This ain't normal times. I agree that with a normal process and situation this would be the right thing to do. But this is a pandemic where the US specifically is already having a major problem with vaccine hesitancy and getting the second shots in, and the one vaccine which  requires only one shot is being taken off. 

1 hour ago, Mudguard said:

And we have mRNA vaccines which do not appear to have these risks.

Do you honestly think that people are going to be that informed? 

 

1 hour ago, Altherion said:

Nobody is stopping the entire vaccine rollout. From the FDA/CDC statement:

It is going to dent that rollout just at the time that it was really picking up and things could be considered going back to normal. 

1 hour ago, Altherion said:

From their phrasing, less than 7 million doses of J&J have been administered out of a total of about 190 million doses. Even given the fact that J&J is one-and-done whereas the others need two shots, it's still a small fraction of vaccines. Also, a single shot of either Pfizer or Moderna gives comparable immunity to J&J so if we substitute the mRNA vaccines for J&J, we're not losing any immune time for anyone.

the logistics for J&J are significantly better, and this will make it less likely that not only US people take it but the rest of the world does so. 

1 hour ago, Altherion said:

Also, given that there are only 6 known cases, your knowledge of the subset is extremely imprecise and we don't actually know why all 6 were women between the ages of 16 and 48. I would agree with you if J&J was one of the main vaccines in the US, but given that it's pretty rare (and will remain so for at least another week or two), I think the total pause makes sense.

Well, you've never had a problem with minorities dying for the greater good, so nice to see you're still on brand here

[Kalbear]

3 minutes ago, Altherion said:

But that boat has sailed, has it not? The knowledge of the problem is out there so the increase in skepticism is pretty much inevitable. The pause attempts to limit it by avoiding any deaths due to the vaccine and also by distinguishing between the affected vaccine and ones which, as far as anyone can tell, are safe.

There is an absurdly massive difference between 'some doctors have found a rare issue' and 'the whole US government has stopped a thing'. 

[Altherion]

38 minutes ago, Karlbear said:

It is going to dent that rollout just at the time that it was really picking up and things could be considered going back to normal. 

I don't see how. The latest 7-day rolling average is over 3 million shots in the US per day. Given that there were fewer than 7 million J&J shots given in the US over all time, the rollout should be largely unaffected.

42 minutes ago, Karlbear said:

the logistics for J&J are significantly better, and this will make it less likely that not only US people take it but the rest of the world does so. 

I think this was true in January, but it's a solved problem -- we've manufactured the necessary equipment and figured out how to rapidly distribute the vaccine over the scale of a continent.

44 minutes ago, Karlbear said:

Well, you've never had a problem with minorities dying for the greater good, so nice to see you're still on brand here

Nobody needs to die for the greater good here -- there are enough Pfizer and Moderna doses to cover the gap and even one mRNA dose provides the same protection as J&J.

45 minutes ago, Karlbear said:

There is an absurdly massive difference between 'some doctors have found a rare issue' and 'the whole US government has stopped a thing'. 

This is true, but it would go in the opposite direction the moment anyone died of this issue (which has happened in Europe). It's better to stop it now and figure out what is going on.

[williamjm]

6 hours ago, JoannaL said:

We expected 450000 doses this week...

when was the start in the UK supposed to be?

I think I saw somewhere that it wasn't until July.

[Fragile Bird]

5 minutes ago, Altherion said:

I think this was true in January, but it's a solved problem -- we've manufactured the necessary equipment and figured out how to rapidly distribute the vaccine over the scale of a continent.

The last time I looked, the US was not the continent.

7 minutes ago, Altherion said:

 

This is true, but it would go in the opposite direction the moment anyone died of this issue (which has happened in Europe). It's better to stop it now and figure out what is going on.

J&J? Do you not know that of the 6 US cases, 1 has died and one is in critical condition?

[Altherion]

18 minutes ago, Fragile Bird said:

The last time I looked, the US was not the continent.

No, but it's larger than at least one continent and also spread out: the doses have to go to Alaska, Hawaii and several islands in the Caribbean.

19 minutes ago, Fragile Bird said:

J&J? Do you not know that of the 6 US cases, 1 has died and one is in critical condition?

No, I did not know that. Googling it leads mainly to a story of a local Virginian newspaper which says that a woman may have died of this (but it's not clear). Are you sure?

[Fragile Bird]

14 minutes ago, Altherion said:

No, but it's larger than at least one continent and also spread out: the doses have to go to Alaska, Hawaii and several islands in the Caribbean.

No, I did not know that. Googling it leads mainly to a story of a local Virginian newspaper which says that a woman may have died of this (but it's not clear). Are you sure?

Lol, yes I’m sure, and no, the US is not the continent.

[Padraig]

3 hours ago, Karlbear said:

For most people? Yes, you do. Especially since those people's reactions are treatable and fixable. 

While treatable, it doesn't seem to be fixable all the time.  I had hoped that it would be but i've read that blood clots in the brain are way too serious to assume success.

I can understand having a high bar for a vaccine suspension but the bar does exist right?  There must be a point where a vaccine should be halted?  I imagine what happened in Europe played a role in this decision.  The FDA saw that a similar vaccine was causing serious side effects in Europe, at a rate much closer to 1 in 100k than 1 in a million.  So when is the right point?

But I take Clueless Northman's point.  With only 6 cases, it will be hard to discover much.  Except if they expect many more cases in the coming days.  But I don't think that 6 cases would have stopped them without the European cases.

There is definitely a danger in giving people a vaccine that you expect is causing deaths.  I don't know how you manage that story successfully, without increasing skepticism.  That's why I am sympathetic to the idea of a pause.  Generally, in Europe, based on surveys, people were less worried about Pfizer and Moderna after the AZ issue.  People are more worried about AZ but the consequences of that are still unclear.  If only 40% of the people are willing to take AZ but it only makes up 20% of your total vaccines, you are still ok.  (At least right now, when you are vaccinating older people).

[OnionAhaiReborn]

I had the J&J shot yesterday. I'm not terribly concerned about this clotting issue, just feeling relieved that I got it before the pause happened. But I'll update the thread if I die from it. 

[Kalbear]

6 minutes ago, Padraig said:

While treatable, it doesn't seem to be fixable all the time.  I had hoped that it would be but i've read that blood clots in the brain are way too serious to assume success.

I can understand having a high bar for a vaccine suspension but the bar does exist right?  There must be a point where a vaccine should be halted?  I imagine what happened in Europe played a role in this decision.  The FDA saw that a similar vaccine was causing serious side effects in Europe, at a rate much closer to 1 in 100k than 1 in a million.  So when is the right point?

But I take Clueless Northman's point.  With only 6 cases, it will be hard to discover much.  Except if they expect many more cases in the coming days.  But I don't think that 6 cases would have stopped them without the European cases.

There is definitely a danger in giving people a vaccine that you expect is causing deaths.  I don't know how you manage that story successfully, without increasing skepticism.  That's why I am sympathetic to the idea of a pause.  Generally, in Europe, based on surveys, people were less worried about Pfizer and Moderna after the AZ issue.  People are more worried about AZ but the consequences of that are still unclear.  If only 40% of the people are willing to take AZ but it only makes up 20% of your total vaccines, you are still ok.  (At least right now, when you are vaccinating older people).

I think that's somewhat fair, but I also think that the US is a different animal (with FAR more vaccine skepticism than Europe), messaging from the FDA and CDC already sucked, and one can investigate further while limiting scopes and not have a total pause. And yes, there should be some point where the vaccine should be stopped; I'm arguing that one death and 5 serious failures in 7 million people is well above that threshold, especially during an active pandemic. 

My real big concern is that this is the vaccine that is slated for going global, and anything that causes that to be reconsidered means a much slower rollout. While the US has (mostly) figured out how to distribute Pfizer and Moderna, this is with a massive amount of money for infrastructure and military logistics and a system that has a lot of cooling. That won't work at all in a whole lot of the rest of the world, and relying on that is going to result in a major failure. 

[Zorral]

People who are thoroughly careless of virus safety protocols, who don't believe in vaccines either, and want to hang out in tightly packed, badly ventilated underground bars smoking and drinking and screaming ought to read this.  The health care professionals in this country were burnt already, long before covid appeared.  Now, they are just broken.  This is written by someone who quit before finishing her residency -- already in 2019.  She couldn't take it anymore.  Now she's doing that vaccinator volunteer thing because -- she's a good person?  And it's just as bad as why she quit in the first place.

https://slate.com/technology/2021/04/mass-vaccination-site-volunteer-physician-burnout.html

I have been wondering a lot about the vaccinators ever since I got my first dose: wondering who they are, why and how they got to be vaccinators, and how many hundreds of thousands of them we need, how many vaccinations they are expected to administer per shift, how they handle this very repetitious, monotonous work, day in, and at nights too, how they are recruited.  We certainly don't have enough nurses, nurse practitioners in the first place for 'ordinary' and emergency medical situations.

It's shameful, it really is, every aspect of 'health care' in this country.

 

 

[Mudguard]

2 hours ago, Karlbear said:

It's also not worth stopping for one death in 7 million doses. How many people are going to die now because they didn't get vaccinated in time?

It does, but there's no reason that the FDA and CDC have to be reactionary to this degree. 

We actually have real data showing that this is wrong, since that's exactly what happened in some countries with AZ. 

This ain't normal times. I agree that with a normal process and situation this would be the right thing to do. But this is a pandemic where the US specifically is already having a major problem with vaccine hesitancy and getting the second shots in, and the one vaccine which  requires only one shot is being taken off. 

Do you honestly think that people are going to be that informed? 

 

The number is almost certainly going to increase from 1 out of 7 million.  This is the same tactic the UK health authorities and AZ used to characterize the initial results before data collection was even anywhere close to complete, and they went from 1 case in a million to 1 in 100,000.  A large chunk, maybe most, of the 7 million people receiving the J&J vaccine haven't cleared the 2 to 3 week window where clotting usually occurs, and there is a lag in reporting side effects.  If the mortality rate is about 10%, the number will probably end up around 1 in a million, if it's like the AZ vaccine, which is a reasonable assumption since the vaccines are so similar.

In the US, the vast majority of the elderly population, those greater than ~65 years old, have received at least one shot of the mRNA vaccines.  The holdouts probably weren't going to take the J&J vaccine anyway.  The younger population, particular those under 30, are much less likely to die from covid, but apparently more at risk for the blood clotting disorder.  Depending on a person's situation, it may well be less risky to delay getting vaccinated by the J&J vaccine by a week or so and instead getting an mRNA vaccine.  

I think most people that have an interest in being informed, are informed, and those that don't care, aren't.  How that translates a pause in vaccination to an actual decline in vaccination is pure speculation.  Simply looking at polling of how likely people are to get a vaccine isn't very compelling because the numbers keep changing every time the poll is taken and it's hard to separate the effect of the blood clotting stories from the pause in vaccination. 

I'm generally pro consumer choice, so I wouldn't be in favor of a permanent ban unless the risks of adverse events were a lot higher, but I don't have a problem of a short pause so that people can be properly informed of the risks, and then be allowed to decide whether they want to get the vaccine or not.  Right now, simply saying that only 6 out of 7 million, or about 1 in a million get the blood clot and that 1 in 7 million die, is misleading because the number is almost certainly going up.  It's going to take a little time to gather all the information, so that people can be made aware of the risks and doctors can be informed of how to handle these types of clots.  I just don't see much evidence that a temporary pause causes a significant amount of harm.

[Fragile Bird]

1 hour ago, Chataya de Fleury said:

@Karlbear - France is notably vaccine-hesitant, culturally. An outlier from the rest of the EU.

@Fragile Bird - Canada is now awash in vaccine, to where people are being picky about tenths of a percentage in protection as measured by the vaccine trials??

I didn’t say that 1) Canada is awash in vaccine, it isn’t, 2% of the population has been allowed to have second doses, as opposed to say, 25% is it, in the US? 2) I didn’t say anyone was picky about tenths of a percentage in protection, perhaps you read that in another post? I said there is vaccine hesitancy about Moderna because of stories on the internet about people getting sicker from the Moderna vaccine. With a nutty anti-vaxxer for a wife, I’m relieved my brother is going to get a vaccine, even if he doesn’t want the Moderna one. His wife is a loony anti-vaxxer, he doesn’t want to risk getting sick in front of her. It’s difficult when you love the person you’ve been married to for 30 years and that person has gone off the deep end about something. What do you suggest, he divorce her? Tell her to eff off?

PS it doesn’t help when every time you watch a US television station someone is being interviewed about how easy it was to get vaccinated, they just drove up to the vaccination place and the person at the head of the line asked them “do you want the Pfizer vaccine or the Moderna vaccine?” That’s what we see up here.

[Zorral]

The very idea that throughout the US getting an appointment for vaccination is a breeze is a ridiculous lie.

That one has a choice of vaccines at the site where one is able to schedule and appointment is also a ridiculous lie.  You get what the site has on offer.

 

 

[Mr. Chatywin et al.]

41 minutes ago, Mudguard said:

I think most people that have an interest in being informed, are informed, and those that don't care, aren't.  How that translates a pause in vaccination to an actual decline in vaccination is pure speculation.  Simply looking at polling of how likely people are to get a vaccine isn't very compelling because the numbers keep changing every time the poll is taken and it's hard to separate the effect of the blood clotting stories from the pause in vaccination. 

Most people want something, but are unwilling to do what it takes to get it. Just look at the polling indicating strong support for a government funded project (say building a school) and the strong opposition to raising taxes to pay for it. Americans are weird that way. And you should consider the news changes faster than the polling you mentioned and a lot of people are simply burnt out at this point. It's easy to see how people could confuse and/or conflate a partial ban. Now, as speculation, do I think that's going to cause a massive wave of people on the fence to decide not to get vaccinated? Probably not, but unless we see a crazy spike in cases, it's very possible the net effect of this decision could produce a worse outcome.