During that call, the Moderna representative reads her the following disclaimer:
“The Moderna COVID-19 vaccine has not been approved or licensed by the Food and Drug Administration, but it has been authorized for emergency use by the FDA under an emergency use authorization to prevent coronavirus disease 2019, for use in individuals 18 years of age and older.
There is no FDA-approved vaccine to prevent COVID-19. The EUA for the Moderna COVID-19 vaccine is in effect for the duration of the COVID-19 EUA declaration, justifying emergency use of the product unless that declaration is terminated or the authorization is revoked sooner.”
The rep also points out that all clinical trial phases are still ongoing, and that long-term protective efficacy against COVID-19 is unknown. When the patient asks whether everyone who gets the COVID shot — even if they did not specifically sign up to be a trial participant — is in fact part of the clinical trial, he replies, with a chuckle, “pretty much, yeah.”
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