As you likely know by now, this past week the US FDA once again abandoned all critical thinking and green lighted Pfizer and Moderna’s covid injections for small children1.
Reaction was swift2, and highly critical of the unanimous decision. I’ve also looked through some of the documents3, and agree. I am not a medical doctor, nor am a drooling numbskull. It is more clear to me than ever that we truly no longer have a regulatory authority in the United States.
Both corporations were seeking emergency approval for their products to be applied to toddlers and infants. Moderna had not yet been approved for minors at all, so additionally sought approval for older children. Pfizer had been emergency approved down to 5 year olds earlier.
There is a lot of wrong in these documents. A lot of wrong in the methods and results: Too short a time to evaluate efficacy and safety, lack of need in a population already likely 75% naturally immune by February 20224…
I though couldn’t really get past the lack of efficacy demonstrated — Pfizer only saw at most 30% efficacy after two doses:
In fact we have effectively zero efficacy for two doses in 6-24 month olds! So — they moved on to adding an additional dose. The efficacies you may see quoted generally for Pfizer are for a 3 dose sequence, which takes 3 months to complete (3 weeks between dose 1 and 2, then “at least 8 weeks” between dose 2 and 3 — ah. And that does not then include the Two Week Standard Post Injection Waiting Period™). In the end 3 shot results were determined from a handful of trial cases accumulated from February to end of April 2022. A two month span of time.
The reported Pfizer efficacy for the entire age range is 80.3%, but with a 95% confidence interval between 13.9% and 96.7%. This comes from 3 injectable product cases and 7 in placebo. The confidence interval range for 3 doses is completely consistent with zero improvement over the 2 shot sequence, which was itself consistent with zero efficacy. Measured on a variant mix already now mostly out of date5:
The end of the evaluation period was end of April, and through the 3 shot part of the trial we were dominated by BA.2. BA.2 is now essentially gone, and the then runner up, BA.2.12.1, is now itself starting to lose ground against BA.4 and 5. I’ll let you guess how much of the “trial” variants will be around a 3 month, 3 shot sequence later from now… (hint — the plot above is 3 months wide)
Moderna was also not without surprises. The two dose Moderna data was provided for 4 groups of children, 12-17, 6-11 and 2-5 year olds, and 6-23 month olds. Relatively high efficacies were reported in the older two groups for what are now essentially extinct alpha and delta variants (see if you can find them on the above US variant population plot). The younger two groups were reported for omicron variant:
2-5 years: 36.8% efficacy (95% CI: 12.5, 54.0)
6 to 23 months: 50.6% efficacy (95% CI: 21.4, 68.6)
So again we see low numbers, consistent with Pfizer’s two shots. They had more kids in their tests, so their confidence intervals are narrower. What really caught my eye here though was the 50.6% efficacy number. At least a 50% efficacy number is recommended to receive Emergency Use Authorization6. 50.6% is just a hair over 50% isn’t it? And otherwise we have measurements based off extinct variants and a cohort with much less than 50% efficacy. Perhaps we should look at this number closer?
Fortunately Moderna included the “incidence curve” of cases that went into this:
Might this be giving you flashbacks of November 2020 perhaps? This is a plot over time of the rate that cases were accumulated to make up the 50.6% efficacy number. Red is with the real stuff, blue is placebo. The blue count goes in the bottom of the fraction that is subtracted from 100% to calculate the efficacy. A jump upwards in placebo case counts then also results in a jump up of the efficacy you calculate. Interesting. Why did that suddenly increase two days before the end of trial? Don’t seem to see anything in the writeup.
We will pause here for a moment of expletives.
…
We good?
…
Now? Alright.
The FDA unanimously emergency approved this to be injected into babies.
This is not even half baked. This is like wheat not even planted, not even milled to make flour not even half baked.
Please. Do not even consider injecting these substances, which clearly bring no benefit, and likely only harm, into your children.
At minimum wait for more data.
Or possibly the release of 2000 Toddlers.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children
Dr Clare Craig: https://rumble.com/v18s66i-bombshell-dr.-clare-craig-exposes-how-pfizer-twisted-their-clinical-trial-d.html
and while we’re at it you should also listen to Sam Dodson: https://www.bitchute.com/video/1lxi7mokWFng/
For Moderna: https://www.fda.gov/media/159157/download
For Pfizer: https://www.fda.gov/media/159193/download
Both briefing documents for the June 14-15 VRBPAC meeting to review these: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-14-15-2022-meeting-announcement
Clarke KE, Jones JM, Deng Y, et al. Seroprevalence of Infection-Induced SARS-CoV-2 Antibodies — United States, September 2021–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:606-608. DOI: http://dx.doi.org/10.15585/mmwr.mm7117e3external icon
https://covid.cdc.gov/covid-data-tracker/#variant-proportions
Though admittedly its a “non binding” recommendation — in page 10 of: https://www.fda.gov/media/142749/download “Emergency Use Authorization for Vaccines to Prevent COVID-19”
The fact that it's anonymous.. . They're not even trying to pretend that there's dissent. My heart breaks for the kids, and it's really hard to think the parents are coming from a place of ignorance.