Come for the politics, stay for the snark.

What fresh hell is this?

Let there be snark.

And we’re all out of bubblegum.

It’s not even safe to go out and pick up 2 days worth of poop anymore.

Trump is going to draw a dick on that dog with a sharpie, isn’t he?

They fucked up the fucking up of the fuckup!

Perhaps you mistook them for somebody who gives a damn – Nancy Pelosi

No one could have predicted…

Accused of treason; bitches about the ratings. I am in awe.

We still have time to mess this up!

The cruelty is the point; the law be damned.

I swear, each month of 2020 will have its own history degree.

A sufficient plurality of insane, greedy people can tank any democratic system ever devised, apparently.

False Scribes! Falso Scribes!

… riddled with inexplicable and elementary errors of law and fact

Shock troops for the Unitarian Jihad.

Is it irresponsible to speculate? It is irresponsible not to.

This blog is Obama’s Katrina.

Shocking, but not surprising

Fuck if i know. i just get yelled at when i try it.

If you tweet it in all caps, that makes it true!

Mission Accomplished!

An almost top 10,000 blog!

The willow is too close to the house.

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COVID-19 Coronavirus Updates: Saturday/Sunday, Oct. 24-25

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Be Ready

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Just looking at the numbers, I think things are going to be worse than I expected this fall with Covid. Again, I’m no epidemiologist, statistician, or anyone particularly bright, but I thought we would hit our summer peaks somewhere around Thanksgiving, but it looks like we are BLOWING right the fuck through that. I had also sort of expected that the fall numbers would be fueled by college students, and it doesn’t seem that is the case, either.

So I think things are going to be far worse that I even imagined they would be in idiot nation, and I would recommend that each of you, if you can, buy dried beans and staples and be prepared for a brutal few months. If you take meds, talk with your doctor about getting a three-six month prescription. I think it is going to be very, very bad, and I don’t think anyone is prepared.

And there look to be a lot of superspreader ready events going on now and soon to come- voting, trick or treating, and then the holidays. It’s going to be ugly and we’re not a serious people.

Speaking of not serious people- this is the annual homecoming in my small town. The college cancelled it and moved it all online, yet a couple dozen alums from my peer group decided to come back and get together. They’re staying at local hotels and Oglebay resort, and a house in town, and just partying and being irresponsible as fuck. I’ve called them all out, and have deadbolted the doors on my house for the first time since living here. None of the people who stay with me are back because I told them all in June it was out of the question until there was a vaccine.

They toilet papered my car and trees last night for being a party pooper.

Again, grown ass adults with full time jobs who should know better.

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COVID-19 Coronavirus Updates: Friday/Saturday, Oct. 23-24

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Friday:

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And the beat goes on

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Over July, states and communities responded to the then peak in case counts with new mask orders, with stay at home and movement minimization requests.

North Carolina just pushed back the date of the Phase 4 re-opening another few weeks yesterday.

North and South Dakota are hot spots that makes Queens in April look on in horror.

Nebraska has 431 new cases per million residents per day.  All of the state with the exception of Lincoln County have no policy restrictions in place.

We’re on the growth curve.  The weather is getting colder and people are staying inside more.  And our political system has decided that Big Ten football is important and little else should be done.

 

 

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COVID-19 Coronavirus Updates: Thursday/Friday, Oct. 22-23

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How To Tell A Real Vaccine From A Political Stunt

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Donald Trump hinted that he could have an “October surprise” in a SARS-CoV-2 vaccine. That isn’t going to happen. The closest is Pfizer’s announcement that it may apply for emergency authorization for its vaccine before the end of November. But, of course, that’s after the election.

The pharmaceutical companies, fortunately, are more interested in preserving their credibility than in currying Trump’s favor. Perhaps they have calculated that Trump is unlikely to win a second term.

ProPublica has a long article on how vaccines are approved. If you want the whole story, check it out. Here’s a tl;dr that’s more like a checklist.

Emergency use authorization (EUA), the fastest way to get a vaccine approved by the FDA, requires three milestones:

  1. A clinical trial must observe enough infections to demonstrate that the vaccine is better than a placebo.
  2. Data from the trial must be part of an application to the Food and Drug Administration. The company could apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an EUA, which requires less.
  3. The FDA reviews the data and decides whether the vaccine is ready for wide use. That could take several weeks to a month.

In the trials, some people receive vaccine and some a placebo. Nobody knows which is which until the results are analyzed. The companies determine interim checkpoints at which they analyze the numbers of people in the trial who contract covid naturally. Pfizer’s first checkpoint is at 32 cases. They have not made public how many cases they have observed so far. Estimates for when they will observe 32 infections are around the end of October or early in November. The date depends on how effective the vaccine is. Pfizer has four checkpoints altogether. If the vaccine were spectacularly successful or damaging, the trial would be stopped.

One person in the AstraZeneca trial had a bad reaction – we don’t know if it was from the vaccine – and that trial has been suspended to look into that reaction. Moderna thinks they may have early results in November, and Johnson & Johnson is just beginning a trial.

All the companies likely have their applications to the FDA written up, ready to drop the results in and send off. The paperwork is considerable – look at Pfizer’s clinical trial plan to get an idea of what is needed.

An EUA allows the use of the vaccine for the duration of the emergency – the pandemic we are in now. Full approval would allow the sale of the vaccine forever. An EUA can be issued more quickly than full approval, but the FDA has higher standards than usual for a SARS-CoV-2 vaccine; it wants at least two months of monitoring trial participants after their second shot. That may take longer than November. Safety is important for a vaccine that will be given to nearly everyone.

The FDA then has a multi-step review process. Not only the clinical trial results, but also the manufacturing facilities must be checked out. It then presents its assessment to an external review committee in a public meeting. The review committee then votes on whether to accept the FDA’s recommendation, and the FDA makes a final decision.

Warning signs are if steps are changed midstream or skipped. These bullets are directly from the ProPublica article.

  • If a company lowers the bar for efficacy. The first four vaccine contenders have all released their clinical trial rules (Pfizer, Moderna, AstraZeneca and Johnson & Johnson), so the public should be able to assess whether the shots have met the companies’ own standards to prove it works. If they unexpectedly change their schedules or the standards, that’s concerning.
  • If the FDA backtracks on its commitment to consult the independent advisory board, or if the agency’s leaders reject the committee’s advice, it would be a sign that they’re acting under political pressure without scientific support.
  • If FDA career scientists get overruled by political appointees, that would also be a major sign of political pressure. The decision on whether or not to authorize a vaccine will fall on Dr. Peter Marks, director of the Center for Biologics Evaluation and Research. FDA Commissioner Stephen Hahn, however, has authority to overrule Marks’s decision, and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn’s call.
  • If FDA officials quit. Marks has said he’d resign if the agency authorizes an unproven or unsafe vaccine.

Once a vaccine is approved, doses must be prepared and distributed. This will be an enormous undertaking and can be expected to run into glitches. Full distribution may take a year or more. Until then, we must continue to wear masks, distance ourselves, and limit gatherings. If Joe Biden is elected president, we will have more testing and a serious approach to public health, so we may not have to wait until most of us are vaccinated to lift many of the restrictions.

Cross-posted to Nuclear Diner

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COVID-19 Coronavirus Updates: Wednesday/Thursday, Oct. 21-22

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