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

[JoannaL]

Also worrying: the EMA says the side effect is unlikely (1:100000) , but they cannot say yet if that occurence is less in older age group (roll out was in a way that more young women were vaccinated so more cases here). That would mean that AZ is maybe also unsafe for the older people? That would be very bad.

[Raja]

7 minutes ago, JoannaL said:

So, not a joint action of EMA and MHRA:

EMA says: it is a confirmed adverse side effect but does not give an age/sex recommendation.

MHRA says: its not confirmed but women under 30 should take a different vaccine.

?

Each public health body, or vaccine regulator in every country EU country, like the The Paul Ehrlich Institute in Germany, will now make recommendations based on what the EMA have said. The MHRA is specific to the UK.

The EMA has not made a firm recommendation regarding age groups as it will leave it up to the individual EU country public health bodies to make that recommendation.

[JoannaL]

From the questions at the EMA conference:

Could this side effect also be an issue for other vector vaccines (sputnik, J&J)? long answer... but it may be possible

[Padraig]

1 hour ago, JoannaL said:

Could this side effect also be an issue for other vector vaccines (sputnik, J&J)? long answer... but it may be possible

Hah.  I love science but its not great for certainty.

I'm glad the EMA and MHRA did their press conferences at the same time.  At least, everything is released, so we are not waiting for more info from the other regulator.

I'll be curious to see what happens now.  

So the EMA has said that most of the cases of blood clots reported have occurred in women under 60 within two weeks of vaccination, but that no specific risk factors had been identified based on current evidence.  62 reported cases.

While the MHRA has referred to 79 cases., 51 women and 28 men between 18 and 79 years of age.  But I didn't see either of them giving detailed age data.  But the MHRA has stopped vaccinations on the under 30s.

Edited to add:  Actually, the EMA has looked at 62 cases of cerebral venous sinus thrombosis (CVST) and 24 cases of splanchnic vein thrombosis reported across the European Economic Area and the U.K.  So very similar numbers.

Quote

Although most cases are in women under the age of 60, EU regulators pointed out that there are also cases of men with these blood clotting issues and people over the age of 60.

“Based on the current available evidence, specific risk factors such as age, gender or previous medical history of clotting disorders have not been able to be confirmed, as the rare events are seen in all ages and in men and women,” Cooke said.

[Fez]

Just got back from getting the first dose of Pfizer. I've never been through a government-run facility that was so efficient. Everything flowed like clockwork and I was in-and-out in 25 minutes (and that includes the 15 minute observation time).

[Zorral]

7 hours ago, rotting sea cow said:

know people in relatively privileged positions who claim that everything is a lie because they don't know anybody who got covid. Of course, they can isolate without a problem and meet within their own safe bubbles. But in other places covid is running rampant because people do not have the chance to take care of themselves.

Which helps the politicization of the disease and of the safety protocols, etc.  At least as it happens in this country.  But in this country there is the far weirder twist upon twist on this -- the craziest denial of existence and the protocols and anti-vax hysteria, is in the very places where all around these otherwise more privileged people, the rates of infection, hospitalization and deaths are crazy high, and they suffer them THEMSELVES. They deny covid-19 exists with literally their dying breaths. Yes, we're looking at entire states like South Dakota.

@Fez Great news!

From what I've seen in the posts from those who agitate here in favor of the fabled mirage of 'herd immunity,' they revealed over and over, no matter how often it was explained, they understand neither how virus operates (not that I do, not really, beyond what any person at my limited understanding of molecular operation does), particularly that the more infections there are the more scope for mutation and more transmissible and dangerous mutations.  They carried a preposterous 19th century interpretation of Darwinian survival, that the fewer vectors of infection meant the virus would grow itself ever and every stronger and thus take over that way, i.e. survival of the fittest.  So let as many people get infected and / or die as possible because that will weaken the the virus's capacity for infection and death.  You'd think they'd never seen an invasive plant arrive as a single stem, ignored and then take over the garden.

They also believe that the young and 'white' were immune, and that the elderly and other others were expendable to a community, i.e. not really members of it, and the more of them gone the better for the wider economic and physical health.

[Fragile Bird]

CNBC this morning was showing a video clip of the first person in the UK to get the Moderna shot. The CNBC host called it “the first shot of the American-made vaccine”.

I am going to assume the comment was just braggadocio, right? It wasn’t American made, was it, it was made in the EU, correct? The US hasn’t started shipping vaccine to the UK, have they?

[IheartIheartTesla]

I thought Moderna had plants in the US, but also partnered with Lonza that has plants both in Switzerland and the US. They are probably talking about Moderna being a US company.

[Fragile Bird]

That’s what I think. We get our Moderna from Europe as well as our Pfizer.

[ljkeane]

2 hours ago, Padraig said:

But the MHRA has stopped vaccinations on the under 30s.

They actually haven't I think. It's a little bit unclear because it was joint press conference with the MHRA and JCVI but I think it was the JCVI (the body responsible for advising on general vaccine strategy etc) who said they're going to try to 'offer an alternative vaccine' to under 30s. The MHRA hasn't actually restricted it to over 30s so if there isn't another one available people under 30 will still get Astrazeneca.

So basically the EMA and MHRA are saying pretty much the same thing.

[Arakan]

5 hours ago, Tywin et al. said:

It was always going to be a multi-year vaccination process. You don't have to be a doctor or scientist to see the obvious.

Maybe one should have told this the politicians then .  Even more stupid to be selfish, buying up all vaccines and create are race who is the fastest and bestest in vaccination don’t you think :)?

[Zorral]

Well, maybe their thinking is that the faster they can get this covid-19 pandemic arc under control, the sooner they can begin making the boosters and new vaccines that will deal with the variants, the work in the logistics to roll out those boosters a whole lot more efficiently than they've done with the massive vaccination necessary going on currently.  Well, one can hope, of course.  The British variant which is more transmissible and deadly is about the dominant strain here too currently.  But the Brasilian one is also present.

I for one cannot separate the lightening of my mood lately, since receiving my first vaccination, from the removal of him of the toxic destruction bombs daily without count.  That is only how I got vaccinated in the first place.  Listening to the callers-in to a radio program asking NYers to share their experience of vaccination, repeated constantly by those who have gotten their shots at the mass vaccination sites like Javits Center and Medgar Evers college, was their joy, seeing all branches of their government, including the various military branches, involved.  And how efficient getting vaccinated was (as opposed to getting an appointment!), and how grateful they were to our government.

I share their sensations 100%.  I cannot divorce getting a vaccination from the removal of previous and the installation of Biden.

 

[Mr. Chatywin et al.]

17 minutes ago, Arakan said:

Maybe one should have told this the politicians then .  Even more stupid to be selfish, buying up all vaccines and create are race who is the fastest and bestest in vaccination don’t you think :)?

Politicians reflect their constituencies in a sense. A stupid populous logically leads to a lot of stupid politicians being elected, and we Americans collectively are dumb as fuck.

[IheartIheartTesla]

Broader use of vaccines slows down the rate of new variants forming and taking hold; but at the same time boosters will be necessary since eventually over time new variants will form. I dont think its a binary choice between the two.

[Altherion]

8 hours ago, Arakan said:

Anyway the conclusion is clear: vaccination won’t be a one-time event but at least for the next couple of years expect to be vaccinated once or twice (more realistic) every year until this corona virus loses its edge and evolves into something like its brethren (common cold corona viruses).

This sounds overly pessimistic to me. While there is evidence that some of these variants render the vaccines less effective in terms of antibody count, the mRNA ones (Pfizer and Moderna) are still effective enough to prevent disease even against the variants. Furthermore, even if we do need some kind of booster shot, the process will not be nearly as prolonged as the current vaccination campaign -- all of the productive and administrative capacity that will be brought online for the current campaign worldwide will remain available until it's no longer needed.

[IheartIheartTesla]

According to the CDC (per today), the UK strain is now the dominant strain in the US, so we should get to see some real time data of the efficacy of our (mostly 3) vaccines against this strain.

[Zorral]

https://www.smithsonianmag.com/history/did-black-death-rampage-across-world-more-century-previously-thought-180977331/

Quote

 

...Green also sees the relevance, especially as her study of plague variants and pandemic came out just as new variants of the Covid-19 pathogen were manifesting around the world. She tells me that her work didn’t change because of Covid, but the urgency did. “Plague,” Green says, “is our best ‘model organism’ for studying the history of pandemics because the history of it is now so rich, with the documentary and archaeological record being supplemented by the genetic record. All the work the virologists were doing in sequencing and tracking SARS-CoV-2's spread and genetic evolution was exactly the same kind of work that could be done for tracking Yersinia pestis's evolution and movements in the past.”

She wants her fellow scholars to focus on human agency both in history—those Mongols and their wagon trains—and now. The history of the Black Death tells “a powerful story of our involvement in creating this pandemic: this wasn't Mother Nature just getting angry with us, let alone fate. It was human activity.”

The world is only now—thanks to Green and many others (see her long bibliography of scholars from a wide variety of disciplines, time periods, and parts of the world)—really getting a handle on the true history of the Black Death. Next, she tells me, she has an article coming out with Nahyan Fancy, a medieval Islamist, on further textual evidence of plague outbreaks to supplement the Mongol News. Many of these 13th-century sources were previously known, but if you start with the assumption that the plague couldn’t be present until the 14th century, you’d never find them.

....She imagines scholars may find plague in other places, once they start looking. In the meantime, the stakes for understanding how diseases move remains crucial as we wrestle with our own pandemic. I ask her what she thinks it all means for a world today still grappling with a pandemic. She replies, with a harrowing, centuries-look ahead, “The story I have reconstructed about the Black Death is 100 percent an emerging infectious disease story. ... an ‘emerging’ disease lasted for 500-600 years!!!”

 

 

[Mudguard]

22 minutes ago, IheartIheartTesla said:

According to the CDC (per today), the UK strain is now the dominant strain in the US, so we should get to see some real time data of the efficacy of our (mostly 3) vaccines against this strain.

There's already quite a lot of data that shows that all the approved vaccines work well against the UK strain.  The strain of concern is the South African one, where initial data suggests that the vaccines perform much more poorly against it.  Luckily, it doesn't appear that the South African variant spreads very fast, although its not clear to me how often we test for this variant when there is a positive coronavirus test.

[IheartIheartTesla]

A lot of data, yes, but not to the scale afforded by 160 million doses, surely (and real-life 'uncontrolled' samples are good to have compared to previous studies).

 

[Mudguard]

On 4/6/2021 at 3:06 PM, Tywin et al. said:

But isn't that the key here, the uncertainty of the supply without a perfect understanding of just how long the first shot is good for? And your last sentence is the real rub. I thought we had to prioritize the most vulnerable first. If there were only enough shots to get each vulnerable person partially vaccinated, do that, but if there's enough for each of them to get both shots, you do that before spreading out the first shots among those less in need. Imo that's when you should be really thinking about making sure everyone gets their first shot regardless if they'll have to wait longer than would be ideal (but not too long as to undermine the goal of being as vaccinated as possible.

My worry is that 70% to 80% might not be good enough to combat variants of COVID, and there are obviously going to be more of them as time goes on. I've heard mixed reporting about how effect an incomplete vaccination can be in fighting off these mutations.

And isn't the J&J single shot basically as effective as just getting the first Pfizer/Moderna shot? 

It's a gamble, which is why I said above I'd be more open to that approach after the most vulnerable have been fully vaccinated, as well as all medical staffers as they must be a high priority as well.

We should and do prioritize the most at risk first, but this can be done using a one shot strategy or a two shot strategy.  For example, would it be better to give all the high risk people one shot as fast a possible with a larger delay in getting the second shot or stick to the standard two shot dosing schedule which means it takes longer for all the high risk people to get at least one shot? 

For the mRNA vaccines which have an outstanding one shot efficacy and a modest two shot efficacy increase I think it probably makes sense to just give all the high risk people a single shot as fast as possible, unless we have data that shows that efficacy drops off after a certain period of time.

The issue with new variants popping up is a problem regardless of whether you go with the one shot approach or two shot standard dosing interval approach.  With the two shot approach, you have a larger population with zero protection, and this population will get infected at a much higher rate than a population that has received one shot that confers 70-80% protection.  The best way to reduce the likelihood of a new variant popping up is to reduce the number of infected people, and that generally means vaccinating as many people as fast as possible, if you have a vaccine with good one shot efficacy, which we do.  Every time the virus makes a copy of itself there is a chance that a mutation is introduced, which gives rise to a new variant. 

Right now, there is zero data on the long term effectiveness of any of the vaccines, because we only started testing them last summer, regardless of whether you give one dose or two doses.  With vaccines, giving a booster shot generally improves vaccine efficacy, which it did a little with the mRNA vaccine, but not always, like in the AZ vaccine where two shot efficacy seemed about the same as the reported one shot efficacy.

A lot of the risk of the one shot strategy can be mitigated by constantly monitoring the people who have been vaccinated with one shot.  If this cohort starts getting infected at a higher rate than expected after a period of time, you can immediately start giving the rest their second shot.  As far as I'm aware, there has been no indication from the countries using the one shot approach that this has occurred yet.

The one shot J&J vaccine has about a 70% efficacy at preventing moderate or severe disease, which is a little lower than one shot of the mRNA vaccine, but it's difficult to compare the two vaccines against each other since the J&J clinical trials were run later when variants were more prevalent.  Sometimes, the J&J vaccine has a reported efficacy in the 80s, but that's only for preventing severe disease.  Also, no long term data exists for the long term efficacy of the J&J vaccine (or for the two shot vaccines).  But as far as I can tell, there really isn't anything special about that J&J vaccine that would give it any longer term efficacy than the others.  If you are willing to approve the use of a single shot J&J vaccine, then delaying the second shot of the other vaccines that give similar efficacy numbers after one shot doesn't seem like a big deal to me.  With all the vaccines, we are dealing with a fair bit of uncertainty, which is unavoidable due to the rapidity that they have been developed and deployed.

In the US, we've actually already vaccinated the majority of the most at risk already, so this really doesn't apply to us anymore, but it's still a conversation that is worth having in the US and around the world, because I do think the one shot approach makes sense, and I'm sure that we'll have to deal with another pandemic in the future.  The comparative efficacies of the different approaches are actually pretty well suited for modeling, and I've already read statements coming from some of the modeling groups that support the one shot approach.  There should be plenty of research papers analyzing this coming out in the near future.