FDA – Emergency Use Authorization and Moderna COVID-19 Vaccine – prescribing information, negative side effects and FDA required reporting

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Moderna COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 18 years of age and older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR Moderna COVID-19 Vaccine ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

Moderna COVID-19 Vaccine – FDA prescribing information, side effects and uses

The only problem was that only about 1 percent of vaccine caused injuries, hospitalizations and deaths were reported. Most of them were covered up, denied, suppressed, ignored, or hidden.