Excellent review of the evolution of the C19 mRNA injection approval process and the clinical trial data presented to the FDA and CDC for the new monovalent XBB injection
From this 40 minute video here:
10 Mice Tested for FDA Booster Authorization for 2023/2024 - YouTube
Dr Been goes step by step through the clinical trial data, pointing out, for example, that when clinical trial data is presented using data from 20 mice, that means 10 mice in the injected group and 10 mice in whatever passed as the “placebo” group.
He shows the “evidence” presented by each of Pfizer, Moderna and Novavax use the evidence that the last bivalent shots have zero efficacy – known to be true by June 2023 and yet the bivalent shots were still recommended. In other words, the regulators knew that there could only possibly be harms.
The basis for pushing new injections is grounded in the prevention of hospitalizations. Not infection, transmission or deaths – exactly the same as the clinical end point of the original C19 mRNA injections – this time with no obfuscation around “if you take this you won’t get infected or infect anyone else” or “if you take this you won’t die from C19” – lies that pharma did not correct, thus becoming part of the lies.
He shows the material used by pharma that demonstrates zero efficacy after 6 months for each booster as the rationale for coming up with a new monovalent XBB injection.
He shows that the regulators previously said that there must be at least 80% efficacy against hospitalization – but that this drops rapidly below this number in a few months and is non-existent after 6 for each of the injections.
Dr Been points out that at no stage are adverse events discussed. We know that, from other studies, that the number needed to “vaccinate” to prevent a single hospitalization numbers in the tens if not hundreds of thousands, resulting in harms of 1,000 to 1,500 per million doses.
Give it a listen.
It occurs to me that, since the regulators are desperately trying to justify past decisions, that there line of defence could be:
“We approved vaccines that eradicated the original virus, the delta variant and two of the omicron variants – BA4 AND BA5.
We have now recommended a vaccine that will eradicate the XBB variant and will continue to recommend vaccines that will act against emerging variants.
Any adverse events from vaccines are more likely to have been caused by C19 than the vaccines. .since more people have been infected than have been injected.”
That would be my expectation of their desperate defence.
Onwards!
Please buy a subscription or donate a coffee (I drink a lot of coffee) - “God Bless You!” if you can’t or don’t want to contribute. Coffee donations here: https://ko-fi.com/peterhalligan - an annual subscription of 100 bucks is one third less than a $3 coffee a week!
Dear God, Peter, Don't give them any more ideas.
I am still surrounded by a legion of uninformed somnambulists who crave their next and possibly final shot.
Re. "round one," Negative risk benefit.
Serious adverse events of special interest following mRNA vaccination in randomized trials. Fraiman et al. 2022. "The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively)."