I'm brain dead after today's VRBPAC advisory meeting at FDA

The advisors were asked to okay a new variant for a fall COVID vaccine

So, is COVID-19 still a thing? It stopped being dangerous after Omicron arrived 18 months ago. It officially ended on May 11.

The NY Times says it has basically petered out, compared to the past 3 years, and its numbers are 6 weeks behind.

And the CDC and NY Times say it killed in total 1.1 million Americans. I thought we had reached that number in 2021. But maybe CDC is subtracting the ‘with’ not ‘from’ deaths it used to include as COVID deaths?

And I thought everyone had now acknowledged it never really was a problem for children, and almost never for young adults. And mostly it causes a cold now, or nothing. Asymptomatic cases. Identifiable only by a boost in antibody levels.

And of course, treated properly, it would have been over in 2020. But that’s another story.

However, the plan is to roll out yet another vaccine. A different one. Only 17% of Americans took a bivalent booster, which barely worked. When it was approved, even though the original Wuhan strain was long gone, it was postulated that due to immune imprinting on that virus, the extinct strain should be included along with a newer Omicron version.

Now they say that was not such a good guess. Time to go back to a monovalent (single spike-producing) vaccine.

Time to guess again about which one to choose. Good chance they will guess wrong again. So the advisory committee was called out to inherit some of the blame if the choice goes south, yet again.

But all the choices went south. All the COVID vaccines were dangerous. All-cause mortality remains elevated, somewhere between 8% and 20% above normal, it is said. Because when you damage the walls of blood vessels and the heart, you get pulmonary emboli, heart attacks, myocarditis, sudden death, strokes, and impaired blood flow to fingers, toes, limbs or organs. That is why you die from many causes. And if the turbo-cancer theory is correct (it is a convincing theory) cancer deaths would also be increased.

Back to today. FDA told its committee, “Pick a variant.” Kinda like spin the wheel of fortune. FDA also said we want to give a periodic vaccine, but the one we are here for today is for this fall. You know, to give out when people go in for their flu shots. If anybody still does that, after the COVID shot fiasco.

So Pfizer, Moderna and Novavax gave their dog and pony show. We injected mice or hamsters with the XBB1.5 variant mRNA or protein and their neutralizing antibodies went up. We vaccinated them again and they REALLY went up. So then we tried it on people and the same thing happened. Yay for us.

Our detectives on the committee said, “Whoa, Nellie.” You told us this story last year and we voted for your bivalent vaccine. We told you then to look at T and B cells. We told you then antibody (titer) tests were not an adequate surrogate for actual disease prevention. You said you were trying. Now it is 12 months later and you didn’t present a single study with those data.

FDA: It’s expensive to do those studies. Antibody studies are so quick and easy and we are in a hurry to get these out for fall. (Everyone then pretends FDA can’t tell the manufacturers what tests it requires them to perform. Or maybe they did do those tests, and the results were not to anyone’s liking?)

Detective: I thought you told us this mRNA method was gonna get out new vaccines at warp speed, but now you’re implying it takes as long as growing virus in chicken eggs.

FDA: Look over there, please. Someone change the subject. They are already making the XBB1.5 “at risk” so we are probably going to go along with it (sotto voce) and then we can roll it out with the flu shots in August, maybe even in the same syringe….

VRBPAC committee detectives: We are really miffed that you are jerking us around like this. We believe you that the vaccine prevents severe disease and deaths even though it does not prevent cases or transmission (dear God we must believe that) but where are the data?

FDA: Time for the vote.

VRBPAC committee members: 21 yes votes for a fall XBB variant COVID vaccine, a unanimous approval. Which I predicted.

^^^^^^^^^^

What was missing today? There was no discussion of vaccine safety—only talk about brief immediate reactions like arm pain, headaches and fatigue. There was no discussion of the fact that COVID no longer poses a serious risk to anyone. In fact, one slide showed 100% of Americans have been infected and have antibodies.

The ‘efficacy’ discussions mostly relied on something they called hybrid immunity, which is immunity from having had COVID and having had a shot or 4 or 5. It is powerful, dontcha know?

The word myocarditis never crossed anyone’s lips—or if it did, I didn’t hear it. And the discussion of whether kids need the new shots was posed, but dodged. CDC decides who gets it, we just decide if it is approvable.

Well, not really. The pedi vaccines are a different dose, different label—the FDA decides on them, too. And FDA can certainly decide they are not needed. But clearly the pedi vaxxes are coming, your tax dollars will be paying for them, and expect a great deal of wastage of these new vaccines.

And did I just see a Potemkin village dog and pony show, or was there actual quality manufacturing and quality regulation going on?

Why are they doing this? Now that is the question.

^^^^^^^^

OOPS. I forgot to give you the links for the FDA webcast and my live blog.

You will need to click on the “live blog” link to see my sleep-inducing blow-by-blow description of the meeting.

https://live.childrenshealthdefense.org/chd-tv/events/fda-vrbpac-meetings/fda-vrbpac-strain-selection-for-updated-covid-boosters/

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-15-2023-meeting-announcement#event-information

OY GEVALT. I HAVE TO GO BACK AND DO THIS SAME SOUL-DESTROYING EXERCISE NEXT WEEK WITH THE CDC’S ACIP MEETING. BUT THE ACIP MEETING IS FOR 3 FULL DAYS, WEDNESDAY THROUGH FRIDAY. SOMEONE BUY ME A BEER WHEN ITS DONE. Or smelling salts. I might just collapse midstream. There is a hip new term in medicine: moral injury. I think I am doing moral injury to myself. (A moral injury can occur in response to acting or witnessing behaviors that go against an individual's values and moral beliefs.)