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The FDA has authorized the bivalent booster in children between 6 months and 4 years of age
No discussion, just some staggeringly scant data
Once again, the FDA has waved its hand and declared the bivalent booster shot ‘safe and effective’ for babies based on horrifyingly little data and incredibly shaky assumptions. Let me take you through just what they decided this on. To read the full press release, go here.
First, let us look at their ‘effectiveness’ determination:
First off, they looked at only 60 babies, and their bar of ‘effectiveness’ is very very low. They checked one month after the dose and determined that the babies ‘demonstrated an immune response’. No indication how large a response, or if that response was meaningful, nor what happened after 1 month. Because we know from experience that at longer time frames, efficacy goes negative.
So, let’s look at their safety determinations:
They first included old data. Specifically, the bivalent shot given to individuals greater than 55 years of age. Because infants and 55+ year olds have very similar immune systems and reactions, don’t they? They also looked at the monovalent primary series in 6 months and older. The bivalent is neither. And they looked at monovalent boosters in individuals >5 years old. None of these comparisons make any sense.
But they do go on.
Ahh, see? Two clinical studies. One was actually looking at children of the appropriate age and looked at the bivalent booster! But they only looked at 24 babies from 6 months to 24 months (which confuses me greatly - how can a 6 month old receive the fourth dose in a series that starts at 6 months of age when they can’t have the 4th dose until they’re 2 months out from the completion of the primary series which itself took months to administer?) And they only looked at 36 children between 2 and 4 years. That’s it.
And look at the wording of the side effects. The most common side effects look awful enough for such tiny children for a disease that doesn’t affect them. Vomiting, nausea, headaches, swelling and joint pain are not normal for children this age, and ‘side effects’ like this should not be acceptable. But if those are the ‘most common’ in such a small sample, what other ‘less common’ side effects did these children experience?
Then, the second study involves a more appreciable number of children…but they are all 12 years or older, who had the primary series followed by a monovalent booster followed by a bivalent booster. Again pointing out the ‘commonly reported side effects’ were the same. What about the rest?
Finally, the last line gets me every time they say it. They declare that monovalent shots are relevant “because these vaccines are manufactured using the same process.” Madness. The manufacturing process is not the only issue at hand. It’s like saying alcohol and gasoline are equivalent because they’re both made through fractional distillation.
The FDA has completely done away with even faking a thorough authorization process.