Three months after ICAN submitted a formal petition showing the startling risk/benefit profile of COVID-19 vaccines in children and demanding the FDA revoke their use in children, the FDA filed a response doubling down on its junk science.
In July of this year, we told you that as part of our ongoing efforts to demand recognition of the true risks that COVID-19 vaccines pose to children, ICAN’s attorneys filed a formal petition with the FDA demanding that it revoke the Emergency Use Authorizations (EUAs) granted to Pfizer and Moderna for use of their COVID-19 vaccines in children ages 5 to 11 and 6 to 11, respectively. As we explained then, one of the benefits to filing this type of petition is that the FDA is legally required to respond with a formal written response. They cannot choose to ignore a petition.
After three months, the FDA finally sent a shameful response to ICAN’s petition. Filled with faulty science, it amounts to a total denial of the available data showing the lack of benefit and the high risk associated with these vaccines for children.
For starters, incredibly, the FDA claims an emergency has and continues to exist (thereby justifying the EUA for children), but yet the FDA does not refute the data showing that 5-14 year-olds have a one-in-a-million chance of dying with COVID. Instead, the FDA defends the “emergency” designation by essentially redefining “emergency,” stretching the term to the point of absurdity. Worse, the data the FDA relies on fails to distinguish between outcomes “with” COVID and “from” COVID (which even Fauci has admitted “overcounts” the number of children hospitalized, for example).
Additionally, despite our petition demonstrating that vaccine efficacy is less than the required 50% and that the risk/benefit analysis used by the FDA was fundamentally flawed and heavily exaggerated risks of COVID-19, the FDA buried its head in the sand and completely ignored the data. The FDA’s response relied on poorly designed and heavily biased studies, which did not refute anything in our petition. Equally disturbing, the FDA completely brushed over the very real and concerning data indicating that nearly 5% of those hospitalized with myocarditis after the Moderna vaccine died.
The FDA’s response is, to be generous, woefully and disturbingly insufficient. You can read it for yourself here. Unfortunately, the response is all too reminiscent of the FDA’s equally contrived response to ICAN’s prior formal petition demanding the FDA revoke the EUAs it granted for use of COVID-19 vaccines in 12-15 year-olds. But despite that, these petitions remain a critically important tool because they allow the public to see the FDA’s response, in its own words, when presented with data demonstrating the errors of its ways. It also adds to the proof ICAN is building to hold our public officials accountable.
As always, ICAN and its legal team will continue to be persistent in our efforts to demand sound science and rational decision making from the FDA, especially for children.
