submitted comment:

This move to experiment on children with a product known to produce a high number of adverse events, particularly myocarditis in young boys, is unjustified by every conceivable point of reference. Healthy children have an extremely low risk of developing severe illness from Covid, but an exceptionally high risk of adverse events from the EUA products.

BioNTech is not approved by the FDA. Only Comirnaty. The EUA is valid only if no alternative therapies are available, which they are. The risk-reward is completely unjustified. Preventative and early treatment reduces mortality in even the high-risk groups.

Informed Consent requires not only complete disclosure of ALL known risks, potential benefits, limitations, the blanket immunity protecting manufacturers and providers from liability, but also must document the consenter understands these risks and type of adverse outcomes.

Children cannot consent, while parents and guardians are being bombarded by false claims -- claims which promote these EUA products as "Safe and Effective." Asserting the “safety and efficacy” of products currently in clinical trials, not approved by the FDA, violate the FTC statue on advertising, and make Informed Consent nearly impossible. These actions are tantamount to "Willful Misconduct" and will obliterate blanket immunity protections that seem to have lulled the FDA and manufacturers into risk-free complacency.

If the FDA seeks to overcome its inherent conflict of interest, it must place consumer safety well over pharmaceutical company profiteering. Do not extend the EUA to children.