☕️ Coffee & Covid ☙ Thursday, November 4, 2021 ☙ A CRAZY MESS 🦠

The CDC green-lights jabs for kids; Pfizer reformulates; Garcetti breaks through; parents hesitate; the BMJ claims Pfizer's trials were a crazy mess; tons of great election news; and more...

Happy Thursday, C&C team. Today’s roundup is a blockbuster: the CDC green-lights jabs for kids; Pfizer slips heart-attack medicine into its injection formula, for some reason; a Kaiser poll shows “hesitation” in most parents; LA’s mayor has a breakthrough; some light is shed on the CDC’s recent re-definition of “vaccine”; the BMJ exposes Pfizer trial problems; a roundup of lots more great election news; Ozzies see record hospitalizations and are baffled why; and Florida focuses on election integrity.


💉 Surprising nobody at all, the CDC approved the EUA for Pfizer’s injection yesterday for kids ages 5-11, clearing the way for them to be jabbed starting immediately.

Reading a prepared statement, Joe Biden mumbled that “For parents all over this country, this is a day of relief and celebration.” Oh, really? Calling the vaccine “a turning point in our battle against COVID-19,” he hissed that deployment of a safe, effective vaccine for the younger children “will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others.” Sure, Joe.

But according to the CDC, the evidence that children can spread the coronavirus is still “evolving.”

💉 Last week, right after the FDA committee approved its drug for 5-11 year olds, Pfizer quietly modified its EUA, slipping a change to one the “buffering ingredients” into its Covid drug. The drug company replaced phosphate buffered saline (PBS) with tromethamine. Tromethamine is a therapeutic drug used to “prevent acid problems in the blood.” In other words, when used as a drug, it’s a stabilizer to prevent heart attacks.

Pfizer’s application did not state any reason WHY the change was made. Who cares, right? Phosphate buffered saline, tromethamine, what’s the difference?

The FDA said it has confirmed that the change was “not expected to impact safety.” They say they did this using “laboratory testing.” So. They did some tests in the lab and concluded the change is “not expected” to impact safety. In other words, they’re not saying it WON’T impact safety. They’re saying they would be SURPRISED if it did. It’s not what they “expect.”

Well, if the FDA did some lab tests, then I’m reassured.

Both versions will remain in use for now. The original formulation will be referred to as the “PBS” version, and the new formulation including tromethamine will be called the “Tris” version. The FDA’s revision letter approving the change dated October 29 advises that only the Tris version should be used for children.

Pfizer also created a special formulation just for kids, designated by orange caps on the vials. It features a smaller dose with a lower mRNA load: 10 micrograms for kids 5-11 and 30 micrograms of mRNA for those 12+.

Nothing to see here. Move along. It is NOT sketchy. Shut up.

🔥 A new Kaiser poll of parents of kids aged 5-11 showed that 68% plan to either wait and see (33%), definitely NOT inject (30%), or inject only if required (5%). Only 27% said they will “vaccinate right away.”

🔥 Fully-injected, masked, and passported Los Angeles Mayor Eric Garcetti had a breakthrough and tested positive for Covid at this week’s climate conference in Glasgow, Scotland. So.

🔥 Remember when the CDC suddenly changed its long-standing definition of “vaccine” by removing references to immunity? Well. Public records requestors have ferreted out some internal CDC emails showing that the change was the result of political concerns by CDC staff who worried that “right wing pandemic deniers” were relying on the original definition “to argue that mRNA vaccines are not vaccines.”

“The definition of vaccine we have posted is problematic and people are using it to claim the COVID-19 vaccine is not a vaccine based on our own definition,” Alycia Downs, the CDC’s lead health communication specialist wrote in an email to other CDC staffers.

So, it wasn’t changed to make it more accurate. It was changed to take away a “right-wing” talking point.

Problem solved!

🔥 The prestigious BMJ published an “investigative” article based on a whistleblower report. The allegations were confirmed by the BMJ through contacts with additional employees of a subcontractor called Ventavia that Pfizer used to conduct its original 44,000-person clinical trials. The gist is that the whistleblower, who was fired for reporting problems to the FDA during the trial, says that Ventavia was incredibly sloppy, lots of mistakes were commonly made during the trial, there was no real anonymity in the supposedly “double-blinded” trial, and she described the work environment as “helter skelter.”

“I’ve never had to do what they were asking me to do, ever,” another former employee told the BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

There were a bunch of problems listed in the article. Standouts included Ventavia’s failure to test lots of people in the trial who showed symptoms of Covid, improving the apparent efficacy of the drug. “I don’t think it was good clean data,” the employee said about the information Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

For some reason Pfizer seems to like to use Ventavia. Since the original trial, Pfizer has hired Ventavia as a research subcontractor on another four vaccine-related clinical trials, for kids, pregnant women, boosters, and most recently a new RSV vaccine. You can count on Ventavia.

🔥 There is LOTS more great election news. It’s still trickling out. Some of the smaller races are the most fun:

— New Jersey truck driver Edward Durr was just elected as a GOP State Senator, replacing a 20-year democrat incumbent strongly backed by the state’s political apparatus. Durr only spent $200 on his campaign and filmed all his campaign videos on his cell phone.

— In Egg Harbor, New Jersey, 19-year old Nicolas Seppy ran against one of the contemptible school board members who had canceled his last year of high school, and won in a +17 landslide.

— In Southlake, Texas, Andrew Yeager, a father concerned about the district’s drastic “cultural competence action plan” — a bunch of racist nonsense — won the seventh seat on the Carroll Independent School District’s school board in a landslide victory against incumbent Stephanie Williams.

— Seattle, Washington elected Republican Ann Davison as its new City Attorney. SEATTLE. And it wasn’t even close (+18).

— Former teacher Matthew Lynch won a seat on Braintree, Massachusetts’ school board. He is a “former” teacher because he was cancelled after he attended the January 6 rally at the Capitol. Now’s he’s on the school board.

— In Long Island, New York (Nassau and Suffolk counties), it was a complete bloodbath for dems in local elections. Virtually every race was won by Republican challengers.

— Pam Panzenbeck is the new Republican Mayor of Glen Cove, New York. The GOP also swept the rest of the ticket there in Nassau County.

— Texans passed EIGHT constitutional amendments. One was constitutional guaranties for churches so they can stay open regardless of other Covid shutdowns. It won +30. Another amendment allows nursing home residents to designate a caregiver who cannot be denied in-person visits for any reason. That one passed +76.

— Byron Brown, who left the democrat party in 2021 and became an independent, had been primaried in his re-election campaign for mayor of Buffalo by AOC-backed socialist India Walton. So he wasn’t even on the ballot. But he was re-elected in a landslide by WRITE IN votes with support from local Republicans.

🦘 Something’s going on Down Under. Their hospitals are blowing out the doors, overwhelmed, and it’s NOT COVID. On Monday, Mark McGowan, premier of Western Australia, said “Our hospitals are under enormous pressure. Enormous pressure. This has been something no one has ever seen before… why it is, is hard to know except that there is some evidence of some sort of delayed reaction to Covid, but there are huge numbers coming through the doors.”

In a complete and totally unrelated coincidence, the spike in hospitalizations occurred right around the time Australia hit the 50% vaccination rate. Just saying.

🔥 Governor DeSantis announced yesterday that the state is now also focusing on election integrity, and will address that issue in the upcoming special session. He also announced the creation of a new office of election law enforcement at the state level, so that people have somewhere to call and report election problems.

At a press conference in Palm Beach yesterday, Governor DeSantis said, “A recession is when your neighbor loses his job, a depression is when you lose yours. A recovery is when Fauci loses his.” 🤣

Have a great day and we’ll re-caffeinate tomorrow morning.

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