I Warned You To Watch the FDA. Act Now, or Watch COVID-19 Become Serious in Young Kids
Peter Marks has thrown out the efficacy requirement for approval of COVID-19 vaccines for children under the age of 5. Which means FDA approval in June is a possibility.
I hope everyone wrote to their representatives about FDA’s plan to gin up better data with Moderna and Pfizer to find some way to approve COVID-19 vaccines for kids under the age of five. It now appears the FDA, Moderna and Pfizer could not, as I have predicted, succeeded in finding convincing data on efficacy for kids under five.
Two days ago, Vinay Prasad reviewed FDA Director Peter Mark’s comments to a Congressional Committee… he won’t require that the vaccines meet the 50% efficacy criterion established by… the FDA. And the efficacy only had to be 40% if the FDA allowed a lower margin of error.
Here’s Prasad’s review. Be prewarned: he repeats the false claim of 95% efficacy in the RCTs on adults (it was 75% if you include people who received a COVID-19 diagnosis before the second dose). He also neglects to point out that efficacy has dropped to less than zero in vaccination studies against recent variants, and that later studies only had to show antibody levels, which we know are short-term, unreliable measures of immunity.
You can’t make this up. Instead of denying the approval, the FDA is relaxing standards - on all of our behalf.
FDA approval of COVID-19 vaccines will be used to push for mandates not related to school entry, setting precedence for federal or state mandates of all vaccines for all children at any age - including homeschoolers.
This cannot go unanswered.
Please send this article to your Congressional Reps TODAY. Find their email and let them know that you know that the US Code of Federal Regulations REQUIRES that medicines have real benefit - or at least real potential benefit- to the recipient in studies on efficacy, and that these very studies were wasteful and unethical. The real-world data from Israel, Barnstable County and elsewhere showed negative efficacy - and Dr. Fantini’s results show antibody-dependent enhancement - meaning vaccinated kids will be more likely to get COVID (as a disease, not just as an infection) and that those colluding to mislead the public on these matters will be responsible for every hospitalization and death that occurs in kids. Period.
Tell them you’ve read 45 CFR 46 (esp. the Common Rule) and you know that special protections exist for pregnant women and children that are being ignored by FDA by even allowing studies to go forward with these biologicals.
Let them know that there are no credible studies that show that COVID-19 vaccines are safe and effective for kids, and that the studies used to convince people like Prasad on efficacy in adults were flawed, leading to a grossly optimistic estimate of efficacy. Let them know that the vaccines target the now long-extinct Wuhan virus, and that long-term relevant memory B- and T-cells are not produced by spike-only mRNA vaccines.
And also let them know that in your very strong opinion, Peter Marks should be encouraged to resign. Then watch him get hired by Moderna or Pfizer.
Here is Marks virtue signaling with a ridiculous cloth mask. CDC originally said 20 layers of cloth masks were sufficient to mimic an N95. Then they moved it, without science, to 16 layers. Then Fauci said 1. Here’s Marks showing his smarts for the world to soo. For a photo-op. (Washington Post).