CLINICAL CORNER

Emergency Use Authorization Updates:

On September 11, 2023, the Food and Drug Administration amended the current COVID-19 vaccine emergency use authorization (EUA) to include the following updates:

       1. Pfizer-BioNTech Bivalent COVID-19 Vaccine is no longer authorized for use in the United States.
2. Only the Pfizer-BioNTech COVID-19 Vaccine 2023 – 2024 Monovalent formula is approved and authorized for emergency use.

Previously scheduled clinics for the deauthorized Bivalent vaccine have been cancelled.

The FDA has approved the monovalent formula, but actual distribution has not started yet. Based on manufacturer and FDA estimates, the updated vaccine should be ready this fall. We do not have specific dates of availability yet but have already placed orders in anticipation of customer needs.

Your pharmacy will continue to provide additional information regarding 2023-2024 COVID-19 vaccine ordering, procurement, and suggested vaccine administration schedules as soon as it becomes available.

During this time, we encourage your teams to familiarize themselves with the COVID-19 vaccine billing, documentation and reporting guidelines associated with the transition to a commercialized vaccine process.

If you have any COVID-19 Bivalent doses on hand in your facility, please dispose of them, as they are no longer authorized for administration.

                    Kelly Dines, VP of Clinical Operations