We did it!!! We did it!!! We did it!!!
Pfizer is forced to pull its EUA application to inject kids under 5 after fierce public backlash
Wow! Front page, above-the-fold, NY Times:
In Reversal, F.D.A. Delays Decision on Shots for Children Under 5
The agency and Pfizer-BioNTech said they would wait for data on whether three doses of the companies’ Covid vaccine are effective in that age group before deciding whether to authorize a two-dose vaccine.
Video from MSNBC:
Let me be crystal clear — THIS WAS US!!!
Through my Substack, I ran the first call to action to oppose the Pfizer EUA application in kids under 5 — within 24 hours of the announcement.
All the big medical freedom groups soon followed suit.
Our message was straightforward: “The FDA should not approve a drug for kids that failed in the clinical trial.”
We generated tens of thousands of emails, calls, faxes, and letters to FDA officials. We submitted thousands of official comments via the FDA website. Our campaign was breaking through into the mainstream and the FDA’s position was scientifically untenable. And so Pfizer and the FDA were forced to pull this illegal application.
OUR CALL TO ACTION WORKED!!!!!!!!!
This is a HUGE win for actual science and a blow to the junk science cartel.
A few additional thoughts:
The Biden administration had already bought the doses to shoot up the little kids with genetically modified mRNA (‘shoot ‘em up first, get the data later’). The data must have been truly horrible given that they decided to take the loss now.
The White House lives in fear of Ron DeSantis. They surely knew that Governor DeSantis would pummel them if they approved a drug for kids that had failed in the clinical trial. The medical freedom movement created the drum beat. Republican leaders started picking up the message in just the last few days. Democrats are already 14 points underwater in the polls and the Pfizer application was becoming a political disaster for them. So the White House was forced to cut its losses rather than jeopardize more seats in the midterm elections.
The FDA was rushing to approve the application now to ride the fears generated by the Omicron wave (the FDA really is that cynical). The clinical trial had failed, so the children would receive no benefit, but the FDA saw it as an opportunity to sell more drugs. When the now three-dose clinical trial is “completed” in April (inadequate follow up time, but that’s par for the course) the Omicron wave will likely have subsided. So all of the relative risk, absolute risk, risk/benefit, and number needed to vaccinate calculations change in ways that make it much more difficult to approve this shot. The lower the background rate of the virus in the population, the more the enormous risks of the mRNA shots exceed any supposed benefits.
In April, we go to the barricades again. But we’ve got a model now for how we win so let’s keep it going.
Blessings to all of the warriors!!!
Prayers for the truckers!!!
THANK YOU to everyone who stepped up and made this happen!!! With this victory we literally saved some kids lives from iatrogenic injury. There are so many battles ahead but our movement grows stronger and smarter every day. Fortune favors the brave.
In the comments please share your thoughts about this momentous win!!!
I’ve never asked before but if you were thinking about upgrading your subscription from free to paid, now would be a great time to do it.
Keep me alive so that we can keep doing this.
My Substack is a hybrid between investigative journalism and a non-profit advocacy group. Because I don’t have to report to a boss I can move faster and hit harder. My readers are my board of directors and I am always in conversation directly with you. We are pioneering a new model of direct action. I believe that your contribution to my work makes a bigger impact than a donation to a traditional non-profit that has layers of bureaucracy. Together we are changing the world for the better. And the results are what we are seeing today! 🙌
I just want to underscore this point. Lots of people in the movement were saying that the FDA decision was a foregone conclusion. And yeah look, I get it, the process is rigged, everyone knows this. But on Feb. 1, I said, no, let's not give in to cynicism, let's fight. And we did. We fought like hell for 10 days. And we achieved this small victory today. I get that the mountain we still have to climb is massive. I'm the least Pollyanna person you will ever meet. But there is a great lesson in here about the importance of mindset as we confront this unprecedented enemy. The harder we fight the more we win. Fortune favors the bold. We are a political force now. So LET'S GO! Let's roll up these clowns and roll back this tyranny and take power and write the laws so that this never happens again.
Thinking out loud here, the third dose of Pfizer in this age group is going to fail too.
They cut it to 1/10th the adult dose to reduce injuries.
But in the littlest kids (say 6 months) that dose is still too strong -- the harms go way up.
And in the bigger kids, 4 years old, that dose is not enough to create an antibody response.
The low background rate of the virus in this population makes it difficult to detect any effect on health outcomes.
Shooting kids up 3 times does not improve Pfizer's odds -- it just magnifies the underlying weaknesses of this product.
Pfizer now has an enormous problem on their hands. They thought they could just fake their way through it because the FDA works for them. But they got caught cooking the books with the 5 to 11 year olds. And now they don't know how to rig the process for targeting kids under 5. This fight is about to get a whole more more interesting. If Pfizer is smart they will cut their loses and not bring this application back again. Democrats hoping to get re-elected need to know that we will hang this albatross around their necks if they bring this junk science back for another vote.