FDA approves boosters for 5-11 year olds

but doubling down until infinity is not much of a plan...

there is nothing particularly astonishing about this FDA approval. they have been rubber stamping covid vaccine boosters without any real review all along. yet again, they failed to empanel or ask an advisory board or do any meaningful clinical outcomes work. (likely in no small part due to how against this sort of approval in near zero risk populations the FDA panels were last time. best way to prevent bad panel review? don’t allow one.)

this is just more assumptive biomarker work to inflict yet another round of failed and failing mRNA drugs onto a population that had such deep negative net benefit to risk from these products that approving them for kids in the first place should have been a non-starter.

medicine is always and everywhere a cost benefit decision.

you weigh risk against reward.

this is not a controversial idea.

it’s bedrock medical canon.

considering one without the other does not even make sense.

and yet the FDA has steadfastly refused to do so, especially in children.

i fear that the reason for it is simple:

they fail so dramatically on this standard that they could not possibly, even with fudges and rigged data and all the bayesian games played in the study design, make mRNA vaccines for kids appear to be within a country mile of positive net expected benefit.

8 months ago, i ran the data using their own numbers.

it looks like this:

you can see the run-through and all the data sourcing and math here:

pfizer says their covid vaccine works in kids 5 to 11. does it?

nothing has improved since then. it’s manifestly clear it has gotten worse, efficacy has dropped, and the vaccines are still every bit as dangerous as when i used the CDC’s own data to show that vaccinating all 25 million US kids would be expected to cause, in the first year alone, and extra 100,000 pediatric hospitalizations. (and that’s using data from past variants and the CDC’s aggressively rigged numbers. reality today is almost certainly worse.)

leaving out the important part: the CDC analysis on pediatric vaccines is pure garbage

but the FDA approved boosters anyway on the basis of absolutely zero cost benefit analysis and in the face of all the obvious failures and risks.

they literally do not even know if it works, especially against current variants. the entire study was just a measure of “elevated antibodies.” they never even checked to see if the antibodies did anything or how long they persisted.

and it’s glaringly obvious from the society level data in honest reporting jurisdictions that the vaccines and the boosters are failing and rapidly getting worse.

you can read a full run-through here:

covid is becoming increasingly vaccine enabled

any small gains from boosting are temporary and after a few months, you’re worse off than having not gotten one. (and you never get back to unvaxxed rates in any event)

US covid test positivity rates by vaccination status

none of this is in any way surprising. it’s entirely predictable and it's WHY you do not use leaky vaccines that fail to stop contagion, carriage, and transmission.

if you have a leaky vaccine (non-sterilizing) that also drives antigenic fixation the only possible evolutionary outcome from that combo is a virus that rapidly evolves to become vaccine enabled. it will happen every time.

you’ve made your immune response into a one trick pony. this creates a very specific evolutionary gradient for the virus that selects for variants that not only sidestep that response but are advantaged by it. eventually, you can boost all you want, you’re just suppressing your immune system and digging a deeper hole while running the gauntlet of another round of side effect risks (and hoping they do not rise cumulatively).

then (as so many are finding) you land here on “4 doses, 2nd case of covid this year…”

Steven Mazie @stevenmazie

Was reading the NYT piece this afternoon about reinfections and thought, “huh, I’m kinda tired but I’m sure it’s just from all the post-Dobbs leak writing and podcasting and whatnot…” Omicron in late January, 2nd booster last week, and now this. This virus can eff the eff off.

and because the messaging of “vaxx and boost to protect yourself and others” and “vaccines are safe” has been so persistent and so shrill (despite being so WRONG), folks like steven are literally coming away from this thinking “thank goodness i got quad boosted!” and will be lining up for jab 5, 6, 10, whatever.

and then you wind up here:

homogenizing herd level antigenic fixation

and it’s too late. you’ve generated a homogeneous societal substrate to breed a virus advantaged by a narrow immune response prevalent in most of the herd. there is no diversity. no firebreak. i do not think this has ever happened before in human history. piling the kids in to join them seems stunningly ill advised.

there is no good reason to believe that this “antibody rise” is durable or effective or represents a good risk reward, especially in those whose initial risk was so incredibly low.

per CDC, kids 5-11 had a 2 in 100,000 hospitalization rate for covid. there’s basically no risk to mitigate. this is considerably lower than flu and the idea that “we need to vaxx the kids to save grandma” falls flat on its face when:

1. the vaxxed get more, not fewer covid cases per capita

2. grandma is antigenically fixated

3. vaxxing the kids just helps them breed variants to take advantage of that fixation.

this is not protecting meemaw, it’s handing her a highly optimized plague rat.

as can be readily seen by what’s going in on the US northeast, 95% vaxx rates and sky high booster rates in over 70’s are not keeping gram-gram out of the hospital. the data is MUCH worse than last year, and rates are rising in a season when they should be rapidly falling.

over 70 looks bad and this data lags at the right edge and will likely rise further as it fills in.

this is the exact opposite outcome you’d expect if the antibody increases on which boosters were approved in this demographic were improving outcomes but exactly what you’d expect if we’re in an antigenic fixation/OAS spiral and herd non-immunity trap. (the old will feel the brunt hardest because they rely most on antibodies and have less effective generalized immune response)

the CDC will now craft a set of policy recommendations (that have a nasty tendency to get adopted and mandated by schools) for kids and boosters. it’s obvious they’ll push them aggressively. it’s what they do.

just remember what their track record on these products has been:

getting this so diametrically wrong should have put this whole set of vaccine mandates, recommendations, and authorizations on hold.

it was near instantly obvious that reality looked nothing like the purported drug trial results and the dangers of leaky vaccines are well known and documented.

politics trumped science here.

any other vaccine in history, even if it DID stop spread, would have been yanked for 1/100th the VAERS reports we’ve seen.

but nothing seems able to suppress this juggernaut of political exigency turned buttocks covering.

the messaging continues and despite a great many folks having wised up, many more seem poised to keep on taking boosters and clamoring to dose the kiddos as well.

i wish i had better news, but i’m just not seeing any way this ends well.

i fear willy wonka was an optimist…