FDA announces updated schedule for the June meetings regarding five pivotal vaccine decisions
Who needs data when you've got regulatory capture?
I. The June FDA meetings
This week the Washington Post copied and pasted from a Pfizer press release to announce yet another scientific miracle(TM) that will completely fail in practice. In the process WaPo also got some quotes from the FDA who have now nailed down the schedule for the 4 meetings in June in which they intend to assemble the final pieces for Pharma’s permanent dominance over the American people.
The new schedule is as follows:
June 7, Novavax
June 14, Moderna in kids 6 to 17 years old
June 15, Moderna in kids 6 months to 5 years AND Pfizer in kids 6 months to 4 years
June 28, “Future Framework” (the plan to skip clinical trials in perpetuity)
There is a lot to parse in the WaPo’s brief article.
Contrary to the breathless headline, they still don’t have any data.
Pfizer and BioNTech said the 80 percent efficacy finding was preliminary and based on 10 cases of Covid-19 in the study population as of the end of April. Once 21 cases have occurred, the companies will conduct a more formal analysis of efficacy... Pfizer and BioNTech said they plan to finish filing data with the FDA this week — and warned that the efficacy number was fluid because results are still arriving.
Let’s recap how we got here:
🚩 The Pfizer clinical trial in kids under 5 failed in December 2021.
🚩 So Pfizer added a third dose and that trial also apparently failed in February (which is why Pfizer was forced to withdraw its application on February 10).
🚩 Now Pfizer is describing a jerry-rigged trial of a third dose in 1,678 kids ages 6 months to four years old. Pfizer did not disclose how the kids were divided between the treatment and control group so it is impossible to run our own calculations on efficacy. Out of that sample, 10 developed Covid — although it is not clear how the 10 were distributed between the treatment and control group. (I suppose some quant on Twitter will figure out how to work backwards from Pfizer’s claims to calculate the numbers in each of these categories but needless to say, this is not the proper way to do science.) Of course Pfizer also failed to describe the contents of the “placebo.”
As always with “publication by press release” the announcement raised more questions than answers:
• “the efficacy finding was preliminary”; just 10 cases; “the companies will conduct a more formal analysis” next month; “the efficacy number was fluid because results are still arriving” — so you’re saying that these numbers are NOT statistically significant and in fact you have no valid “results” at all? Got it.
• How exactly will Pfizer double the number of Covid-19 cases in the clinical trial in the next month given that 74.2% of kids already had natural immunity in February which means that nearly 100% of children likely have natural immunity by now?
• Also, is the FDA seriously considering basing national policy, that impacts 18 million children, by relying on a study with only 10 cases? It appears that the FDA is not even pretending to care about science anymore.
What’s perhaps most troubling about this so-called clinical trial is that Pfizer is NOT looking at health outcomes in the real world (because there are none). Instead, all of their claims are based on antibodies in the blood. That’s strange because the members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously acknowledged on April 6 that there are “no correlates of protection” in connection with Covid-19 shots (this means that there are no valid proxy measures, such as antibody counts, that can determine whether someone who has received this shot is immune to the virus or not.)
WaPo dutifully copied Pfizer’s disingenuous description:
While the adult trials recruited tens of thousands of volunteers and waited to see if vaccinated people were better protected, the children’s vaccine trials were primarily designed to measure immune responses using blood tests.
No they were not “primarily designed to measure immune responses using blood tests.” The studies were intentionally undersized to hide harms from the shots in addition to other tricks that they use to skew the results (such as kicking you out of the trial if you call 911 or go to the emergency room). But when one shrinks the sample size, surprise! it becomes impossible to detect actual health benefits from the shots (the signal would have been tiny if at all, but when one uses a sample that small then any positive signal can also disappear into statistical insignificance.)
The only reason Pfizer and the FDA are focused on antibodies in the blood is because the trial produced NO clinically significant health outcomes (so they have to invent imagined future benefits by using a proxy measure that they acknowledge it not valid). In this age group the shot is all risk, zero benefit (because 100% of kids have natural immunity already and because the clinical trial showed no real world health benefit).
II. The bigger picture
Tony Fauci and the NIAID funded the creation of a chimera virus that escaped a bioweapons lab and killed 6.3 million people worldwide.
Public health authorities have blocked access to safe and effective prophylaxis and early treatment throughout the pandemic in order to create the market for Covid-19 vaccines.
Covid-19 shots skipped essential safety steps (e.g. challenge trials in animals) and were rushed to market with no long term data.
In practice the mRNA shots suppress immune function for six weeks after the first shot, provide about two months of protection against coronavirus, then efficacy wanes quickly and becomes negative after six months. The data that pharmaceutical companies submit, and the entire review process at FDA and CDC, is based on months two to four (what Alex Berenson calls, “the happy valley”). Meanwhile, these shots cause more side effects than any vaccine ever invented.
Popular support for the current regime has collapsed. More people have died of Covid under Mr. I Believe the Science(TM) than under Orange Man Bad. Only hypochondriacs in blue states seek out additional doses. Meanwhile Sudden Adult Death Syndrome stalks the true believers. In the past 48 hours alone actor Ray Liotta, Andy Fletcher of Depeche Mode, British drummer Alan White (from the band YES), and comedian Phil Butler were all likely killed by Covid-19 shots. It’s impossible to hide all of the bodies at this point.
The FDA seems to know that their window is closing to implement the Final Solution. So they are rushing to put the finishing touches on their plans to inject this toxic junk into the littlest kids in America. The FDA knows that these shots cannot pass proper regulatory review so they’ve developed a plan to rig the process in favor of Pharma in perpetuity. On June 28, the FDA’s “expert advisory committee” will vote on a “Future Framework” whereby all future (reformulated) Covid-19 shots will automatically be deemed “safe and effective(TM)” without any additional clinical trials, on the theory that they are “biologically similar” to existing Covid-19 shots.
What this means is that by fall, the Covid-19 shots that they will be injecting into Americans of all ages will have a new formula that skipped clinical trials altogether.
Injecting people with genetically modified mRNA that skipped clinical trials is genocide. It’s slower than the Nazi Final Solution. But it’s genocide all the same. Indeed the slower pace of the FDA Final Solution (5% to 15% increase in all cause mortality every year) might be even more lethal in the long run. It’s sinister af that they are intentionally building in plausible deniability (‘the FDA said it was safe’) to help the medical establishment feel virtuous while participating in genocide.
I’ll just conclude by saying: be careful what you wish for FDA. The tide has already turned. The American people know exactly what you are doing. We have the receipts. It will be relatively easy to secure a conviction at Nuremberg 2.0 — we literally have you on video committing crimes against humanity. As a reminder, the courts have determined that “I was just following orders” is not a valid defense.
Blessings to the warriors. 🙌
Prayers for the families of every American who gave his/her life defending our country. 🙏
More calls to action coming Tuesday.
In the comments, please let me know what’s on your mind.
(As always, let me know if you spot any typos.)
Dr. Toby, I’m still attempting to send letters to all FDA, VRBAC, and phone calls. (Plus to US Pres, VP, U.S. Senators, Reps, and State Senators and Reps. PLEASE CAN YOU DIRECT ME TO THE FDA and VRBAC contact info?
(I’ve sent letters through CHD and SHF, but want to send my own plus call).
Looks as if distribution is already set up. Everybody has been bought. I like how large media outlets persist in calling infants and toddlers "young kids." "Experimental injections for babies" might worry too many moms who spent nine months avoiding coffee and soft cheeses.