Miscellany about COVID

[Batalov]

Soon someone will repost it everywhere and even add: "A Doctor reported: ..."

LABELED SATIRE!

[a1call]

They’re only Alternative-Facts. It is still alternatively factual. It’s all good.
The actual goings on in Florida is not far from it.

[Dr Sardonicus]

Lab tests: Eli Lilly, Regeneron antibody therapies lose out against Omicron

FRANKFURT, Dec 14 (Reuters) - German researchers have found that COVID-19 therapies developed by Eli Lilly (LLY.N) and Regeneron (REGN.O) lose most of their effectiveness when exposed in laboratory tests to the Omicron variant of coronavirus, likely reducing treatment options if the new variant prevails.
<snip>
The findings have not yet been peer-reviewed for publication in a medical journal.
<snip>
Asked about the antibody findings, Ely Lilly said it expected the efficacy of its antibody combination to be lower.

"Due to the substitutions contained within the spike protein of the Omicron variant of concern, it appears that bamlanivimab with etesevimab is likely to experience reduced neutralization activity," said a spokesperson.

The company was conducting its own Omicron tests, also including its experimental antibody bebtelovimab, and would report the initial findings as soon as possible.

Regeneron, which last month cited tests suggesting its drug would have reduced efficacy against the Omicron variant, said on Tuesday that it expected to share more information from further analyses soon.
<snip>

Prevention

Dec 22, 2021

Why don't some monoclonal antibody treatments work well against Omicron?

A lot of it comes down to the way that these monoclonal antibody treatments were designed, says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York. "The Eli Lilly and Regeneron monoclonal antibody treatments are directed against the spike protein of SARS-CoV-2, and Omicron has 32 mutations and a deletion in the spike protein," he says. "Because of this, those treatments no longer bind with the virus."

As a result, "it is not expected that these products will have any meaningful effect on those with the Omicron variant," says infectious disease expert Amesh A. Adalja, M.D., a senior scholar at the Johns Hopkins Center for Health Security.

So it is absolutely no surprise that the FDA limited its EUA's:

For Immediate Release:
January 24, 2022
Statement From: Patrizia Cavazzoni, M.D.
Director - Center for Drug Evaluation and Research

In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.

Apparently Florida Governor DeSantis cares more about politics: DeSantis blasts halt in antibody treatments even as drugmakers say they don't work on omicron

Gov. Ron DeSantis slammed the Biden administration Tuesday for dropping two antibody treatments for COVID-19 that he has championed, even though the drugmakers themselves concede they are ineffective against omicron.

Monoclonal antibodies from Regeneron and Eli Lilly should no longer be used because they don't work against the omicron variant that now accounts for nearly all U.S. infections, federal regulators said Monday night.
<snip>
DeSantis claimed the Food and Drug Administration's decision was made based on "a single, non-peer reviewed, non-clinical study that was actually done by a consultant for a rival company to the other two monoclonal antibody treatments. ... It's really a reckless decision to be able to take this option away from patients."

Asked why DeSantis did not accept the drug companies' own conclusions that the drugs are ineffective, the governor's spokeswoman Christina Pushaw didn’t answer the question and instead pointed to the study DeSantis referenced in his remarks.
<snip>
Thomas Unnasch, a distinguished professor at the University of South Florida's College of Public Health, said it would be unethical to continue administering these drugs despite evidence they don’t work on the majority of cases.
<snip>
DeSantis argued for the drugs' continued use even despite their decreased effectiveness. "Even if with Omicron, it's half as effective or even 25% as effective, that's better than nothing for people," DeSantis said.

But Unnasch disagreed.

"The laboratory results that are out there ... make it abundantly clear that they don't work at all," Unnasch said. "They're not 50% successful. They are more than 99.99% ineffective."
<snip>
Regeneron announced in November that studies showed its antibody drug cocktail lost effectiveness against omicron, while Eli Lilly made a similar announcement about its treatment in December.

Both Eli Lilly and Regeneron also issued statements Monday and Tuesday agreeing with the FDA's decision.
<snip>

EDIT: On twitter, Ron DeSantis made one of the most shysterish public statements I've ever seen:

Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments.

Of course there's no "clinical data." The antibodies failed against Omicron in lab tests. When something fails in lab tests, you already have your answer - the stuff doesn't work. So you don't do clinical tests. There's no point. It would even be unethical to do clinical tests on something you already know doesn't work.

Also, it's the FDA, not "the Biden Administration," that decided to limit (not revoke) EUA for using the Lilly and Regeneron products for Omicron. And the FDA has sole authority in these matters. And, with good evidence the Lilly and Regeneron antibodies don't work at all against Omicron, the FDA is legally required to disallow EUA for that use.

[Dr Sardonicus]

US gives full approval to Moderna's COVID-19 vaccine

WASHINGTON (AP) — U.S. health regulators on Monday granted full approval to Moderna's COVID-19 vaccine, a shot that's already been given to tens of millions of Americans since its emergency authorization over a year ago.
<snip>
With full approval, Moderna will now market the vaccine under the brand name, Spikevax. It is the first FDA-approved product for the Cambridge, Massachusetts-based company.

In the U.S., Moderna is used only by adults, for initial vaccination and as a half-dose booster. The company said last fall that FDA had delayed deciding whether to clear the shots for 12- to 17-year-olds as it examined the heart inflammation risk.
<snip>

[Dr Sardonicus]

The recent news about truck drivers and US tourists driving pickup trucks blocking US-Canada border crossings because they don't want to take the COVID jab brought to mind an old SF story about a small group of malcontents causing havoc in the transportation sector. Here is a fair-use excerpt:

A cadet trotted up to Gaines, and saluted. "Lindsay, sir - Cadet Engineer of the Watch. The Engineer of the Watch requests that you come at once to the control room."

The Engineer of the Watch looked up as they came in. "Chief - Van Kleeck is calling you."

"Put him on."

When Van Kleeck appeared in the big visor, Gaines greeted him with, "Hello, Van. Where are you?"

"Sacramento Office. Now, listen - "

"Sacramento? That's good! Report."

Van Kleeck looked disgruntled. "Report, hell! I'm not your deputy any more, Gaines. Now, you - "

"What the hell are you talking about?"

"Listen, and don't interrupt me, and you'll find out. You're through, Gaines. I've been picked as Director of the Provisional Central Committee for the New Order."

"Van, have you gone off your rocker? What do you mean - the New Order?"

"You'll find out. This is it - the functionalist revolution. We're in; you're out. We stopped strip twenty just to give you a little taste of what we can do."

Concerning Function: A Treatise on the Natural Order in Society, the bible of the functionalist movement, was first published in 1930. It claimed to be a scientifically accurate theory of social relations. The author, Paul Decker, disclaimed the "outworn and futile" ideas of democracy and human equality, and substituted a system in which human beings were evaluated "functionally" - that is to say, by the role each filled in the economic sequence. The underlying thesis was that it was right and proper for a man to exercise over his fellows whatever power was inherent in his function, and that any other form of social organization was silly, visionary, and contrary to the "natural order."

The complete interdependence of modern economic life seems to have escaped him entirely.

His ideas were dressed up with a glib mechanistic pseudopsychology based on the observed orders of precedence among barnyard fowls, and on the famous Pavlov conditioned - reflex experiments on dogs. He failed to note that human beings are neither dogs, nor chickens. Old Doctor Pavlov ignored him entirely, as he had ignored so many others who had, blindly and unscientifically dogmatized about the meaning of his important, but strictly limited, experiments.

Functionalism did not take hold at once - during the thirties almost everyone, from truck driver to hat check girl, had a scheme for setting the world right in six easy lessons; and a surprising percentage managed to get their schemes published. But it gradually spread. Functionalism was particularly popular among little people everywhere who could persuade themselves that their particular jobs were the indispensable ones, and that, therefore, under the "natural order" they would be top dog. With so many different functions actually indispensable such self - persuasion was easy.

- The Roads Must Roll by Robert Heinlein (Astounding Science-Fiction, June 1940)

[Uncwilly]

Originally Posted by Dr Sardonicus

The Roads Must Roll by Robert Heinlein (Astounding Science-Fiction, June 1940)

This was also transcribed in an episode of X minus 1, or other such show.

[kriesel]

Reminds me of this NSFW bit.

[Dr Sardonicus]

Originally Posted by kriesel

Reminds me of this NSFW bit.

Singularly apt, IMO, WRT the COVID Whiners' Blockade

;-)

[kriesel]

Originally Posted by Dr Sardonicus

Singularly apt

Yes, opinions will vary. There is a very recent account of an actual journalist (not affiliated with MSM) actually interviewing 100 protestors and learning why they're actually there, instead of MSM "journalist" political activists talking with each other on air. Reportedly the actual motivations of the protesters bear little resemblance to what most MSM have been claiming.

[Dr Sardonicus]

And, in belated and broken news...

Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

GAITHERSBURG, Md., Jan. 31, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.

The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.

Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

For Immediate Release:
February 01, 2022

Today, the U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

[Dr Sardonicus]

The Ambassador Bridge, which carries something like a quarter of US-Canada trade, has finally re-opened after being blocked for a week by COVID whiners.

Other border crossings remain closed.

Downtown Ottawa is still being disrupted.

The worst effect of COVID vaccines and face masks is that they produce madness in people who don't use them.

(Tip o' the hat to Ambrose Bierce, for his definition of Rum, n. in The Devil's Dictionary)