This commentary is by Jim, a retiree who has lived and worked in Vermont for 20 years.
On Oct. 29, 2021, the FDA issued a statement: “Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age.”
Note that the FDA statement does not say that the FDA has approved the BioNTech vaccine for children, but only that the EUA (emergency use authorization) for BioNTech has been extended to children. That this is only EUA is very clear in the FDA statement.
Much of the public believes that the Pfizer BioNTech vaccine has full FDA approval, but it does not, according to footnote 9 on an FDA letter of October 20, 2021:
“In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval of COMIRNATY (COVID-19 Vaccine, mRNA) for the prevention of COVID-19 for individuals 16 years of age and older, this EUA would remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses.”
Thus, the actual BioNTech vaccine is still EUA; the Oct. 29 FDA letter confirms this. None of the other vaccines in use in the US today is approved by the FDA. The Pfizer Comirnaty vaccine for Covid-19 has FDA approval, but it appears that this vaccine isn’t in use (supposedly the new BioNTech vaccine will marketed as Comirnaty, but Comirnaty has not yet appeared on the scene). But if the Comirnaty vaccine has been approved by the FDA, then why isn’t that the one we’re using for our children?
Are the Covid vaccines under EUA safe for children? We’d not know that by clinical trials for these vaccines because those trials use limited populations and might have inadvertently excluded patients most susceptible to adverse events from the vaccines. We would only know the true safety of these notably experimental vaccines if, as they were being rolled out for EUA, we had a robust system of tracking adverse harms after vaccination. But according to many doctors and nurses these adverse events are being ignored, even though the CDC states that this reporting is required. This reporting is required regardless of causality; that is, regardless of whether or not any determination is made as to whether the vaccines caused the harm, or not. A sample of non-reporting that we’re hearing from all over the country comes from Ventura County, California.
The goal of reporting adverse events after vaccination isn’t to find blame with the Covid vaccines or to say “look at what happened!” and get alarmed over every fainting spell. The point is simply to gather information and then, in a calm, scientific, rational manner using medical statisticians who are trained to do this sort of thing, determine if there are any patterns that point to particular safety signals so that further investigations can be made to determine causality. But a hospital-specific protocol for reporting each and every serious adverse event after Covid-19 vaccination cannot be provided by any hospital in Vermont, nor in the vast majority of hospitals in the US — these simply don’t exist. Does it make any sense, then, to promote the BioNTech vaccine as EUA in children when our hospitals have so far failed to collect data on even adult adverse events from these vaccines?
The Covid vaccines have their place, but to say, as the CDC does, that they’re the “safest and most effective way” to stop Covid-19 (without real-time, robust adverse event data that’s transparent to qualified hospital personnel) seems to be deliberate obfuscation. We know that there are far safer, more time-tested, cheaper drugs that are effective. And for our children? Why does it seem to make sense to the FDA to subject our children to unknown harms from vaccines whose safety has been grossly neglected?