Paul Elias Alexander, PhD; Howard Tenenbaum, DDS, PhD; Parvez Dara, MD, MBA
We write this brief clarion call to the FDA of the United States and the citizenry, in the hopes that we could call for a time-out as to the drive for an EUA of COVID-19 vaccines in children (up to 11 years old). We think this is a catastrophic mistake that will endanger the lives of our children particularly given that the proper safety data would not have been yet collected to determine the safety (short and long-term effects). We call for a hard stop in the process to grant this EUA given the US’s Food and Drug Administration (FDA) is moving fast to consider an EUA in this age group of children. There are reports that the meeting could consider ages as low as 2 years old. But the data is not developed or complete enough and especially lacking as to safety, with regards to these vaccines.
We do agree that the underlying body of evidence is not sufficiently mature enough to allow for an optimal adjudication of the benefits versus harms of this vaccine in children. We see absolutely no benefit of these vaccines (no COVID vaccine in children), even if there was data, because there is no risk to ...
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