Pfizer and Moderna Admit: We Have No Idea How to Dose mRNA

The companies have submitted applications for authorization of more Covid-19 vaccines for children. The dosing for the same age groups varies dramatically between the two companies.

The FDA meets today to consider applications for emergency use authorization (EUA) of additional Covid-19 vaccines for children, including infants and toddlers. Numerous other Substack writers have taken deep dives into the clinical trial reports released by Pfizer¹ and Moderna² in the last few days.  I am linking to the outstanding analysis of these reports by Dr. Toby Rogers and encourage my readers to share his articles far and wide:

The Pfizer clinical trials in kids 6 months to 4 years old is an embarrassment

The sole purpose of the Moderna and Pfizer mRNA shots in kids is to eliminate the control group. There are no health benefits, only harms.

If the FDA meetings go as expected, I predict that this week will mark the beginning of the end of U.S. Food and Drug Administration as we know it.   A government agency that routinely approves snake oil for injection into young children – consequences be damned – simply cannot survive once the public wakes up to its scheme. 

And wake up we are!  I am hearing so many parents say not just that they will never allow their children to be injected with a Covid-19 vaccine; they will never allow their children to be injected with ANY vaccine, ever again.   The brazen recklessness and deceit of the FDA and CDC these past two years has destroyed public trust not just in the pandemic response but in the entire vaccine program – trust that, as many of us were all too painfully aware, had never actually been earned in the first place.

Putting the Pseudo in Pseudoscience

So much is wrong with these latest EUA applications.  It’s hard to know where to begin.  However, since I have written previously about the incomprehensible recklessness of dosing these vaccines by age, rather than weight…

mRNA Vax Pseudoscience: Dosing by Age, Not Weight

Breaking: Vax Dosing Pseudoscience Exposed in NY Study!

… I would like to take a moment today to point out that the latest submissions from Pfizer and Moderna seem to prove conclusively, beyond a shadow of any doubt, that these companies have no earthly idea how to determine what a “safe and effective” dose of the experimental mRNA injections actually looks like.  They appear simply to be throwing darts at a board and hoping something sticks. 

Pfizer’s application for children ages six months up to five years calls for three doses of 3 micrograms – 9 mcg total. 

Moderna’s application for this same age group calls for two doses of 25 micrograms – 50 mcg total! 

Both companies claim that they determined their dosages after extensive testing and careful analysis, but both cannot possibly be right.  There simply is too much disparity between the two.

Nor can it reasonably be argued that the dosages are different because the products are different.  We have been assured repeatedly by public health officials that the Moderna and Pfizer vaccines essentially are the same.  The injections are so similar, in fact, that they are interchangeable.  The government has authorized adults to “mix and match” them as we see fit, and some public health officials have even encouraged us to do so.

Meanwhile, Moderna’s application for children ages 6 to 11 calls for two doses of 50 mcg for children ages 6 to 11 – 100 mcg total. 

This is more than the cumulative adult Pfizer primary vaccine series (which is 60 mcg)!  It is more than THREE TIMES the cumulative dose of the Pfizer primary vaccine series for children in this age group. How can that possibly be safe?   

As Dr. Ryan Cole and others have emphasized, when it comes to the Covid-19 vaccines, “the dose makes the poison.”  While no amount is safe for anyone, the more you get, the greater the risk of adverse events. 

In fact, we know that numerous countries have banned the Moderna Covid-19 vaccine for younger adults after determining that the risk of heart damage in this age group exceeds any claimed benefits.  Some countries have discontinued the Moderna vaccine in all age groups.

Just today our own government is finally, belatedly, acknowledging that the adult Moderna vaccine may cause more heart problems than the adult Pfizer vaccine, the main difference between them being that Moderna uses a much higher dose.

Yet, on the very same day, Moderna is seeking approval for a vaccine in grade-school children that not only exceeds the adult Pfizer dose but also contains a far higher dose for children, by weight, than adults who are vaccinated with the Moderna vaccine receive.        

Make Them Sweat!

I will not be tuning in to the FDA meetings.  I have students all week, but I confess that even if I didn’t, I couldn’t stomach it.  I predict that the issue of dosing will come up but will be promptly dismissed.  Committee members will simply say, “Wow!  Pfizer and Moderna chose two very different dosing regimens, and both were safe and effective!  Don’t you just love science? Isn’t it nifty?!”

Nifty is one way to describe it.

The committee members are attending FDA meetings all day today and tomorrow and will no doubt be checking their email regularly, because they certainly won’t be paying attention to any red flags that are raised.  They never do.  Please continue emailing them, using the addresses below.  Let’s politely make them as uncomfortable as possible with what everybody expects will be their unanimous vote to approve these dreadful products.

sean.mccluskie@hhs.gov, commissioner@fda.hhs.gov, DeanofPublicHealth@brown.edu, Aux7@cdc.gov, Peter.Marks@fda.hhs.gov, Hong.Yang@fda.hhs.gov, Richard.Forshee@fda.hhs.gov, Huilee.Wong@fda.hhs.gov, Leslie.Ball@fda.hhs.gov, Doran.Fink@fda.hhs.gov, CBERVRBPAC@fda.hhs.gov, hanae@bcm.edu, paula.annunziato@merck.com, adam.berger@nih.gov, hbernstein@northwell.edu, acohn@cdc.gov, anc0@cdc.gov, hjanes@fredhutch.org, hgans@stanford.edu, david.kim@hhs.gov, asmonto@umich.edu, offit@chop.edu, spergam@fredhutch.org, Jportnoy@cmh.edu, erubin@hsph.harvard.edu, erubin@nejm.org, ashane@emory.edu, swamy002@mc.duke.edu, fullerao@umich.edu, bgellin@rockfound.org, RandyHawkins@cdrewu.edu, officeofthepresident@mmc.edu, JYLee@uams.edu, ofer.levy@childrens.harvard.edu, wayne_marasco@dfci.harvard.edu, cmeissner@tuftsmedicalcenter.org, mrn8d@virginia.edu, stanley-perlman@uiowa.edu, reingold@berkeley.edu, mhsawyer@ucsd.edu, mew2@cdc.gov

1. https://www.fda.gov/media/159195/download

2. https://www.fda.gov/media/159189/download