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results from the moderna pediatric covid vaccine trial: if this is success, i'd hate to see failure
contrary to reports, these are results are awful and the study itself proves this drug is not needed in this age group
moderna posted its results from the 6 month data on it’s mRNA-1273 vaccine in 6mo-2yr and 2 yr-6yr old cohorts today. contrary to rosy reports, the results from this look terrible.
this is a fail and, even more interesting, the study itself pretty much refutes any idea that vaccinating this age group could provide real benefit even if it had perfect efficacy, much less that a drug this ineffective crosses that bar.
you can read the full release HERE.
let’s dig in:
first off, the study design is, as ever, rigged. the “dose 2 +14 days” definition for “vaccinated” can make a zero efficacy or even negative efficacy product look like it works because those weeks post dose 1 and 2 comprise a period of immuno-suppression that is clinically validated. this slants a study so badly as to be unrecoverable in real clinical terms. (more HERE and HERE) this methodology cannot possibly prove efficacy and as we saw from the the first round of trials, claims for sterilizing immunity turned out to not just be inaccurate, but inverted. in practice, the vaxxed are seeing far higher case rates for covid than the unvaxxed. (more in a minute)
but there is nothing like the data to quantify this (i’m sure that was just an oversight…) so while it’s a large concern, let’s set it aside because the rest of the results are, even at face value, sufficient to eliminate this vaccine from serious consideration.
the trial had ~6,700 enrollees from 6 month to 6 years in age broken into 2 cohorts of 6mo-2yr and 2 yr-6yr.
the “risk reporting” was sparse and to my mind, somewhat misleading in terms of ascribing “typical” outcomes.
fever was common. greater than 38C (100.4F) was reported. (17%, 14.6%) and greater than 40c of 0.2% for each group (this is grade 4, 104F) as well. but we really have no idea how this fell out in the middle or just what “vaccines” they are discussing.
the other interesting take is “tolerability consistent with that seen in adults.”
moderna has been far less forthcoming than even pfizer on adverse events (or if there have been more disclosures, i haven’t seen them) but we do have some. (per CDC)
grade 3 generally means “unable to undertake daily activities.”
grade 4 generally means “needs urgent medical care/hospitalization.”
this is a quite limited list, but it shows that we’re in the neighborhood of 20.5% of the vaxxed being unable to perform daily activities when we sum the 2 doses.
we pick up another ~11% grade 3 from local (though how that overlaps is unclear) so we can use a range of 20%-32% unable to undertake daily activities at some point in the vaccination regimen. about 0.1% were grade 4 and probably hospitalized/urgent care.
by vaccine standards, this is actually a pretty hefty set of adverse events. (and it’s obviously incomplete).
long term and long tail are absent as the study is too short and too small to catch them which is highly problematic. a 1 in 20k per year outcome would likely be missed here (83% chance) but apply it to 30 million kids and you’ll see it a lot. those kinds of outcomes have resulted in many vaccines (including h1n1 and swine flu) getting pulled off market. so, again, this is a very low quality set of data to use to inoculate kids.
but let’s work with what we have.
of course, alone, this tells us nothing.
medicine is everywhere and always a risk/benefit equation.
that was the risk. what’s the benefit?
the first benefit is a biomarker. this is meaningless. it shows that they produced specific antibodies. that does not mean they work either now or in the future. this is chasing past data that’s well out of date.
they made all the same claims for boosters.
and those are clearly NOT working to stop cases as can be seen by the UK vaccine data.
(VE added in red by me. under 18 excluded because it has a simpson’s paradox in the data.)
boosters are working even worse than the double doses did (they were more like -100 to-150% VE)
and this is for a simple reason: leaky vaccines drive viral evolution to vaccine escape and selection for hoskins effect/OAS variants like omicron. this is just simple evolutionary biology. it’s WHY we don’t use leaky vaccines, especially for high mutation viruses. and the longer this goes on, the worse it will get.
and that brings us to the headline results:
this is a stunningly leaky vaccine. even 90% is leaky. here, we’re looking at a colander that’s more hole that strainer. this may be “statistically significant” but as a vaccine effect rate, it’s appalling.
right here, you just admit that it failed and walk away.
this is not safe and will simply help select for more escape and OAS variants in short order, especially as much of this result is likely from statistical rigging and that we’re starting to see real signs of vaccine driven herd level antigenic fixation that could make covid bigger problem for decades.
but the case for this vaccine in 6mo-6 yr gets even weaker. here’s the real capper:
no one in this entire trial got severe disease. none were hospitalized for covid or died of it. this shows one simple thing: there was no real risk here to mitigate. everyone did fine. (we have, of course, known this about pediatric for some time)
it also means with near certainty that the placebo arm outperformed the vaxxed arm in overall well being once you add in the reported adverse effects (even before adding in the vaxx interval).
based on the above assumptions, somewhere on the order of 20-30% of the vaxxed were unable to undertake daily activities. even if it’s 10%, this is a massive net loser on cost/benefit.
this compares to 0 cases of severe disease in the control arm.
0.2% had a fever over 104 from vaxx.
it looks like ~0.1% likely needed urgent care.
it appears that none in the control arm did.
so just what are we playing at here? how does this pass any rudimentary risk/reward calculation?
this drug is addressing a non-problem and, even from this partial list, causes more severe outcomes than it stops.
in any kind of sane world, this trial would be the end of the idea of moderna vaxx for kids in this demographic.
it’s time regulators started doing their jobs instead of rubber stamping negative expected value “preventatives.”