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The FDA just updated the EUAs to allow bivalent boosters in children down to 6 months of age
And the 'data' they used to support this are mind-boggling
Today, the FDA updated the EUAs for both Pfizer and Moderna bivalent injections for use in young children, down to 6 months of age. No VRBPAC committee consulted again, just decided by fiat. Just more of the New Normal rigorous FDA approval process.
From now on, infants as young as 6 months who have yet to start their 3 dose Pfizer series or have yet to take their third dose will now replace the third dose of the monovalent injection with the bivalent dose. Children who have taken the 2 dose Moderna series are now allowed to take a bivalent booster dose at least two months after the second dose. But children who have completed the 3 dose Pfizer series are not allowed to take a bivalent booster (yet). Makes total sense, right?
So what data are they basing this update on? I’m glad you asked! Because my head is spinning trying to follow their convoluted logic too.
Below, find the FDA’s description of which data was being used to support the updated Moderna EUA, keeping in mind that this update was for a booster dose in children 6 months to 5 years old.
Anyone else feeling dizzy?
To recap, in support of adding a BA.4/5 bivalent booster for infants and toddlers from 6 months to 5 years of age 2 months after the primary 2 dose series, they looked at data from the following:
Immune response (antibody titer) results for a monovalent booster in 56 children 17 months-5 years old
The immune response (antibody titers) of 300 18-25 year olds who had received the basic 2 dose monovalent primary series
Safety data comparing a monovalent booster to the ‘investigational’ bivalent (as a refresher, the investigational bivalent used the BA.1 spike, not the BA.4/5 spike in the authorized bivalent booster)
Safety results from a different set of 145 children from 6 months to 5 years for a monovalent booster given at least 6 months after the primary series
Anyone else missing where they actually looked at data on the BA.4/5 bivalent booster that has been in use now for months? Or where they tested any booster in young children after just two months?
Pfizer is even worse:
For Pfizer, they decided to completely replace the third dose of the primary series for infants and toddlers from 6 months to 4 years with the new bivalent booster. With what evidence? To recap…:
Previous analysis of the monovalent two-dose primary series for those 16 years and older and 6 months through 4 years
Immune response data in those 55 and older who had received the 2-dose primary series, one monovalent booster and one investigational (BA.1) bivalent booster.
Safety data for 55+ year olds between the investigational (BA.1) and the monovalent boosters
Safety data of a monovalent booster in children 5+
As with Moderna, no studies of the actual authorized BA.4/5 injection in those of ANY age were used, despite 3+ months of availability and over 10 million Americans having taken it. They are also considering adult 2-dose data as equivalent to the much lower dose 3-dose series for infants and toddlers, when, on its face, they are not equivalent.
The kicker of it all is at the bottom of both:
The FDA is now putting forth the argument that the content of the ‘vaccines’ is immaterial. All that matters is that the manufacturing process is the same. Using this argument, the FDA could just pass through ANY mRNA technology for ANY disease and just call it good. No age data necessary, no dosage data, nothing, it’s all the same anyway. It’s like saying that since both gasoline and alcohol are made by fractional distillation, then they are interchangeable. That’s how disconnected from reality the FDA is, and how arrogant they have become.