moving the goalposts on "safe" (part 1)

ignoring the standards, ignoring the signals

over generations, the standard of safety applied to widespread vaccine use has been extremely stringent. this is as it should be. drugs to be given near universally to healthy people are a VERY different proposition than drugs given to people who are already sick. the tolerance for adverse effects must be much lower, especially for those for whom actual risk from disease is low. 1 in a million for a severe outcome like death was generally around the limit of tolerance. 1 in 100k was deemed impossibly dangerous to consider.

the h1n1 vaccine released in the EU was pulled after ~30 million doses being administered due to 45 fatalities and a ~1 in 55,000 rate of permanent narcolepsy perhaps as high as 1 in 18,000 in adolescents.

there was not even a question about pulling it off the market, this was an obvious and clear cut case that was not even debated.

boom. done.

a 1.5/million death rate and a 1 in 18-55,000 debilitation rate were WAY outside anything acceptable.

and folks had some pointy questions on motivation…

note the similarity in dramatis personae...

in 1976, the infamous “swine flu vaccine” was pulled in the US over ill effects including 362 cases of the severe paralytic disease guillain-barre in ~45 million vaccinees (8 per million).

BBC

but what was REALLY striking was the text from the NY times at the time.

my how things change…

as can be readily seen, historical tolerance for ill effect from vaccine was VERY low and the track record for rushed vaccines during respiratory disease outbreaks is terrible. i’m honestly not sure there is even a single success story there in all of history.

keep that in mind as a base prior when considering future programs.

then we jump to 2021.

VAERS is the vaccine adverse events reporting system run by HHS.gov. it tracks adverse events (AE’s) from vaccines through a system of healthcare provider reporting.

the minute this hit double digits in december, alarm bells should have been going off everywhere. by the time it hit 100, these alarms should have been calling for a pause. these death reports hitting 500 in the US alone by the end of jan was insane and unprecedented for a vaccine. 500 deaths in 30 million people is ~17 per million, over 11X the rate that got h1n1 vaccines pulled.

(and, obviously, the real rates are much higher as VAERS is just a warning system with small, fractional capture rates. reality is likely 5-10X what is reported.)

2021 saw more deaths reported to VAERS than from every other vaccine in the US in the last 50 years combined by a wide margin. this was not a subtle signal.

this was “air horn in the vatican during vespers” kind of alarm bells.

combine this with the obvious and immediate failure of the vaccines to provide sterilizing immunity to prevent contraction, carriage, and contagion, and this was the easiest decision in public health history.

period.

there is no excuse for blowing this, no excuse for missing it, there was no gray area. what happened was such a radical departure from all prior practice and standard as to warrant serious investigation and explication.

one does not simply do this on a whim.

choices were made.

and before the inevitable “nuh-uh” of the revisionist history department, yes, they did tell us the vaccines would stop spread.

debbie lied.

and there are entire filing cabinets full of receipts.

and no, there was nothing in the pfizer or moderna trials that would have ever provided backing for such a claim. this was admitted to the european regulators and is clear if you read the trials themselves. but pfizer CEO bourla himself was out making these claims (before then recanting them as though he had never said anything)

and it all fell flat in not even months but weeks when the vaccines hit the market.

that could not have been a mistake or an oversight.

that was willful.

instead of doing the incredibly obvious “right thing” they did the opposite.

so let’s sum up:

• leaky vaccines are exceedingly dangerous even without AE’s

• the AE’s were literally off the charts by orders of magnitude

• and people were dying at rates easily 10X that of anything ever before even countenanced for other similar products

there was no plausible (by historical standards) pretext for allowing this campaign to continue. any one of these would have been the most egregious safety signal in the vaccine history. taken together, this was a 4 alarm fire in the living room during family TV time.

lights out. game over. this gets pulled.

instead they doubled and tripled down, shifted the moralizing from “your vaccine makes you a dead end for the virus and protects us all” to “you’ll still spread the virus and still get sick, but you won’t flood hospitals or die,” another claim that wound up being both factually false on severity and a histrionic misstatement of what was going on with hospitals that near universally ran WAY below capacity in 2021 and simply ignored the adverse events and kept claiming “safe and effective.”

until being forced to quite recently, the CDC outright decided not to do its job.

and they decided to outright rig the surveys they ran to prevent adverse events from being easily countable.

and they are still not releasing the data needed to do so even under FOIA.

they quietly pulled the safety claims off their own site while still telling us it was fine.

and the CDC was FAR from alone on simply letting all this slide and not only ignoring 120 decibel alarm klaxons but going to great lengths to assure everyone that “this is safe” and “you’re not hearing what you think you are.”

lots of folks seem to have ignored an awful lot of dead canaries in an awful lot of coal mines.

Vince Clements @vgclements1

6/

the level of goalpost moving here has probably been unprecedented in medical history.

i’m going to tackle the FDA and the trial designs and some other issues in coming pieces.

but the questions here are going to keep being the same:

none of this was normal.

none of this was “happenstance.”

you do not suddenly just discard 100 years of regulatory and pharmacological practice, pandemic guidelines, and general standards and sense on safety.

someone here made choices.

these goalposts got moved so far that they are not even on the field anymore.

and demanding to know who, why, and on what basis this occurred is the key to preventing this from happening again.