“FDA must ensure that recipients of the vaccine under an EUA are informed… of the known and potential benefits (sic) and risks, the extent to which the benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives…”

“21 U.S.C. § 360bbb-3(e)(1)(A)(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed— that the Secretary has authorized the emergency use of the product; of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”