This email is being sent to local health officers, tribal health directors, COVID-19 vaccinators, COVID-19 vaccine stakeholders, HERC coordinators, and key DHS staff.
FDA Amends Moderna and Pfizer EUAs to Remove Authorization of their Monovalent COVID-19 Vaccines to Simplify Use of Bivalent Vaccines
Transition to bivalent vaccines must be approved by CDC before taking effect
On April 18, the U.S. Food and Drug Administration (FDA) announced that it has amended the emergency use authorizations (EUAs) for the bivalent and monovalent Pfizer and Moderna COVID-19 vaccines. Effective immediately, the monovalent Moderna and monovalent Pfizer COVID-19 vaccines are no longer authorized for use in the United States.
The Wisconsin Department of Health Services (DHS) has removed all monovalent Moderna and monovalent Pfizer presentations from the Wisconsin COVID-19 Vaccine Ordering Survey. If these vaccines are administered going forward, it should be reported to the Vaccine Adverse Event Reporting System (VAERS) as a vaccine administration error. DHS will provide additional information in the next few days regarding the handling of the monovalent vaccines that vaccinators have in their inventory.
FDA also takes action to begin transition to bivalent vaccines and new vaccination schedule
In addition to removing authorized use of the monovalent Moderna and monovalent Pfizer COVID-19 vaccines, FDA took action to authorize the bivalent Moderna and bivalent Pfizer COVID-19 vaccines for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations, under a newly proposed vaccination schedule. A summary of these actions is outlined in a FDA news release issued earlier today.
CDC ACIP meeting Wednesday, April 19 to address FDA actions
The CDC Advisory Committee on Immunization Practices (ACIP) is meeting Wednesday, April 19, to discuss recommendations for COVID-19 vaccines. An agenda has been posted for the meeting and presentation slides are expected to be posted soon to the ACIP Meeting Information web page.
Following the ACIP meeting, CDC will issue official recommendations and update the interim clinical considerations. A reminder that changes authorized by the FDA regarding the transition to bivalent vaccines and to a new vaccination schedule can only be implemented once the CDC recommends them, and the CDC publishes its interim clinical considerations.
Local Health Departments (LHDs) must wait until DHS updates the Immunization Program Policy and Procedure (P&P) Manual on SharePoint before implementing them.
DHS will provide additional information in the next few days once the CDC has taken final action.
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