Coronavirus

[NikolaACDC]

My oh my, water on the mills of the anti-vaxxers

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

"Concerns raised

In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

Participants placed in a hallway after injection and not being monitored by clinical staff

Lack of timely follow-up of patients who experienced adverse events

Protocol deviations not being reported

Vaccines not being stored at proper temperatures

Mislabelled laboratory specimens, and

Targeting of Ventavia staff for reporting these types of problems."
_________________________________

Obviously *sugar* like that shouldn't happen, but it's pretty much irrelevant for the results.

 

[Doggydogworld]

We're barely able to feed everyone now and we're burning out are farmland to do it.

US corn output alone is 500 calories per day per person. That's one crop from one country, by itself able to provide a big chunk of the world's minimum calorie requirement. We in the US don't eat all that corn, of course. We feed most of it to animals, use almost a third of it for fuel, export a bunch, etc.

Food isn't a land problem.

As little as 2 million years ago the Earth was significantly hotter with more CO2 than we have now.....
It appears Earth got hit by a supernova about 2 million years ago and it triggered an ice age. There is also speculation that our solar system was part of a cluster of stars that was blown apart by the supernova. The movement of the nearby stars with respect to one another suggests that could be the case.

The ice age works with about 90,000 years of glaciation with about 10,000 years of interglacial. All of human history has taken place in an interglacial period. During this ice age an explosion of trees around the world sucked CO2 levels to the lowest they have ever been in the history of the Earth. We have raised the CO2 levels quite a bit, and we don't know what sort of long term impact that may have.

To be fair, we don't know the long term impact of holding CO2 levels steady, either.

My hometown in east-central Illinois was covered in ice a mere 20,000 years ago, along with most of Canada and the upper midwest. Ice was thousands of feet thick in places. Sea level was 120 meters lower.

I don't know about the supernova theory. We certainly had ice ages before that. Ice sheets may have reached the equator in the Cryogenian ~700 million years ago.

 

[shinytop]

It should be pointed out that much of the aid we give to developing and third world countries is intercepted by war lords and other bad actors. Greed is not unique to rich countries. Greed in other countries is misdirecting aid we do send which, understandably, makes us wary of providing aid.

 

[EVNow]

It should be pointed out that much of the aid we give to developing and third world countries is intercepted by war lords and other bad actors. Greed is not unique to rich countries. Greed in other countries is misdirecting aid we do send which, understandably, makes us wary of providing aid.

Also I would point out the aid comes with strings attached - like needing to buy from certain US companies or looking the other way when us companies exploit local environment or labor. I should say not just US - happens with aid from Europe, Japan and increasingly China as well.

 

[AlanSubie4Life]

Based on what is happening in Europe, and our current plateau, I think it's likely we're going to have another sizable surge in cases in the US. It appears to be starting/continuing now in the Rockies and Upper Midwest. I think this pattern is similar to last year, as I recall.

Our vaccination levels in the US are unfortunately not nearly high enough (seems like 80% of the entire population is a good minimum level; we’re not even close), and I think there have been insufficient levels of infection to ensure no more surges. How high they will go, I have no idea.

I said I was not going to do predictions, but what the heck. I predict a 7-day average of 125k cases by very late December, which will be the last big peak. Then COVID will really be over (assuming no more major escape variants). Deaths won’t be great either, since CFR stubbornly refuses to go below 1%, and is in fact drifting upwards right now.

Get your boosters. It's every man (woman) for himself (herself) now. Yes, first vaccinations would be way better. And vaccinating the world would be good too. But this is the American way; we are rugged individualists who fight COVID by pulling ourselves up by our own bootstraps! Now if only we could figure out a way to keep lots of hospital beds open for the vaccinated who need medical attention for whatever reason.

 

[TespaceX]

Has anyone seen this FDA’s modeling on benefit/risk for Pfizer’s vaccine in adolescents?

https://www.fda.gov/media/153507/download

They’ve separated the modeling between boys and girls in the different age groups.
Regardless of scenario and age group, they analyze that girls are much better off getting the vaccine.
But, in younger boys, when COVID incidence is low, the risk of myocarditis complications seem to noticeably outweigh the benefit of a vaccine.

 

[AlanSubie4Life]

But, in younger boys, when COVID incidence is low, the risk of myocarditis complications seem to noticeably outweigh the benefit of a vaccine

I mean, I think we’d all love to live in a world where we had 5000-10000 cases a day in the US. But I have not seen any suggestions on how to get there without getting everyone infected, unless you vaccinate.

Myocarditis can be serious in young men, particularly adolescent males. It has not resulted in any deaths. However, clearly in all the realistic cases proposed here, there is clear benefit to the vaccine, no matter the age group.

Also I’m not sure how good their data on incidence of myocarditis will be with the reduced vaccine dose; there is very limited data on that. That may cut incidence rates a fair amount with minimal downside to immunity.

 

[TespaceX]

I mean, I think we’d all love to live in a world where we had 5000-10000 cases a day in the US. But I have not seen any suggestions on how to get there without getting everyone infected, unless you vaccinate.

Myocarditis can be serious in young men, particularly adolescent males. It has not resulted in any deaths. However, clearly in all the realistic cases proposed here, there is clear benefit to the vaccine, no matter the age group.

Also I’m not sure how good their data on incidence of myocarditis will be with the reduced vaccine dose; there is very limited data on that. That may cut incidence rates a fair amount with minimal downside to immunity.

True, across the country, we are not close to getting rates that low just yet. And, I wasn’t meaning to say not get vaccinated. (We’ll be getting our oldest vaccinated since he just made the age threshold). Just was intrigued by the numbers being modeled based on the vaccine info.

But, there certainly are other developed places around the world with far lower incidence, where this kind of data may be more pertinent.

 

[shinytop]

I believe I have seen written here that myocarditis happens with Covid at least as often with the vaccine so the benefit for boys is still high.

 

[AlanSubie4Life]

I believe I have seen written here that myocarditis happens with Covid at least as often with the vaccine so the benefit for boys is still high.

This is very likely true. However, basically the study’s point was that if no children get COVID, then the risk of the vaccine (for myocarditis) is higher than the risk of hospitalization for COVID (risk of COVID myocarditis and MIS-C not covered).

Notably, even at low incidence levels, the risk of death from myocarditis is stated to be zero for this study, while it’s non-zero for COVID (though it rounds to zero for the low incidences in this study). So if you are concerned about the death outcome, it still makes sense to get vaccinated, even in a low incidence situation, according to this study.

 

[AlanSubie4Life]

Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study | Pfizer

PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19 In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10...

www.pfizer.com

“

• PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19”

“At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer will cease further enrollment into the study due to the overwhelming efficacy demonstrated in these results”

This is definitely the type of treatment we need for the vaccine holdouts! (And even for the vaccinated who have breakthroughs who are at high risk.) Why take a cheap vaccine if there is an expensive pill available?

Great news! This may well put a large dent in the mortality in this country. I’m curious how well it works after hospitalization. It will be hard to convince some people to take it before that point, because they believe COVID is a hoax.

 

[TespaceX]

This is definitely the type of treatment we need for the vaccine holdouts! (And even for the vaccinated who have breakthroughs who are at high risk.) Why take a cheap vaccine if there is an expensive pill available?

If COVID continues to be a serious national issue, that pill may not be expensive for individuals as the taxpayers will subsidize some of the cost. Plus, it’s just an oral pill, not a biologics.

 

[Jeff N]

I’m curious how well it works after hospitalization. It will be hard to convince some people to take it before that point, because they believe COVID is a hoax.

I suspect it won’t do much if taken after hospitalization except for those who are seriously immunocompromised. Mostly people seem to be hospitalized due to severe immune overreactions (cytokine storm) so anti-viral treatments like Regeneron and Remdesivir are largely ineffective at that point.

You may be right that the denialist crowd may tend to wait too long before taking it. I’m very optimistic about this new treatment. It seems to have minimal side-effects reported during the drug trials.

 

[AlanSubie4Life]

You may be right that the denialist crowd may tend to wait too long before taking it

Fortunately I think the “delusionists” will be a small subset of the overall number of people at risk.

This drug seems like a miracle - just need to be sure it is available everywhere since time is of the essence.

 

[madodel]

We're not terraforming Earth. We are deterraforming it.



Got my booster as soon as they opened for my category. (Old man, otherwise healthy.)

Some posts above referred to things we might be able to do in thousands of years, and multi-thousands-of-years climate trends. The problem is that we are increasing CO2 levels orders of magnitude faster than they've ever been raised before. Regions where crops can be grown will shift much faster than we can develop the infrastructure to adapt to the changes. This will result in disruptions that (as somebody mentioned above) will cause mass starvation, which will cause political and social upheaval. The human race will probably survive, but our industrial civilization might not. Humanity could end up back in the stone age with a world population of a few hundred thousand.

We have the technology to switch to sustainable policies. But the decisions are made by wealthy old men with a very short time horizon and powerful vested interest in maintaining the present system. And a solution would require the rich countries to share with the poor countries, something the rich countries are clearly unwilling to do, even though a goodly part of our wealth was stolen from them at gunpoint in the first place.

To bring it back to the thread topic: Coronavirus and booster shots. You are clearly better off if you get a booster shot. But you are even better off in the long run if people in poor countries get their first course of shots so that there will be a smaller pool of infected people in which to breed new variants. A sensible, sustainable policy would be to send massive amounts of vaccine to poor countries to get their populations vaccinated as soon as possible. But the rich countries are greedy and don't want to sacrifice anything. So even while huge numbers of anti-science people refuse the vaccine here, we hoard the vaccine and donate only an insignificant amount to poor countries. And this is just an example of how we do everything: We have used up the world's carbon budget making our countries rich, and we refuse to give more than token help to the poor countries so they could develop in a sustainable manner. They have no choice but to burn coal or starve.

We won't solve the problems facing the world because our leaders get rich by making the problems worse, and because our people will not share what they have.

Had my Moderna booster yesterday afternoon. Even though an appointment was required at the hospital they apparently scheduled 10 people every 15 minutes plus they were doing initial COVID vaccines at the same event, so I waited in line for 40 minutes. That was a good thing to see since it meant people are getting vaccinated. Sore arm at injection site last night, though today only sore if I touch it. No other pain other than my longtime back pain which has nothing to do with the vaccine. Today just some fatigue but not as bad as my first Moderna shot. Still able to function just a little slower than normal.

 

[Doggydogworld]

It will be hard to convince some people to take it before that point, because they believe COVID is a hoax.

Even the delusionals lined up to get antibody infusions once they started feeling bad.

 

[TespaceX]

Has anyone here gotten the other mRNA?
ie. Pfizer with Moderna booster, vice versa?

 

[Jeff N]

Even the delusionals lined up to get antibody infusions once they started feeling bad.

I dunno. Apparently this new drug, Paxlovid, is a red pill.

Red pill and blue pill - Wikipedia

en.wikipedia.org

“The terms "red pill" and "blue pill" refer to a choice between the willingness to learn a potentially unsettling or life-changing truth by taking the red pill or remaining in contented ignorance with the blue pill.”

 

[daniel]

Has anyone here gotten the other mRNA?
ie. Pfizer with Moderna booster, vice versa?

I would have. It seems to me that if they are slightly different they confer immunity in different ways and getting both would be a good idea. But when I got my booster they weren't offering that yet. Pfizer all three. I'd even mix with a non-mRNA vaccine to have more variety. Note: I am not a medical professional and the above is based on my wholly uneducated opinion.

 

[JRP3]

If COVID continues to be a serious national issue, that pill may not be expensive for individuals as the taxpayers will subsidize some of the cost.

Free vaccine vs treatment you have to pay something for...