Moderna and Pfizer COVID-19 vaccines no longer authorized as boosters
This bulletin is being sent to local health officers, tribal health directors, and key DHS staff. Some sites may be password protected and are intended only for local and tribal health departments.
On August 31, the FDA removed emergency use authorization of the monovalent mRNA COVID-19 vaccines for individuals 12 years of age and older as booster doses. This means that the Pfizer COVID-19 monovalent vaccine and Moderna COVID-19 monovalent vaccine are no longer authorized for individuals 12 years of age and older as a booster dose.
These monovalent vaccines continue to be authorized for use as a primary series for individuals 6 months of age and older as described in the letters of authorization. Currently, the Pfizer COVID-19 vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer COVID-19 vaccine.
Given this FDA action, FDA has advised that appointments for monovalent Pfizer or Moderna boosters in people 12 years of age and older must be rescheduled for when locations have the new COVID-19 bivalent vaccines available.
Pending CDC Recommendation, New COVID-19 bivalent vaccine boosters available over next several weeks
On September 1 and 2, the CDC’s ACIP will convene to discuss potential recommendation of the updated COVID-19 bivalent boosters. Administration of any new bivalent COVID-19 boosters can begin only after the CDC Director endorses an ACIP recommendation, and the CDC publishes its clinical considerations. Local Health Departments (LHD) must wait until DHS updates the Immunization Program Policy and Procedure (P&P) Manual on SharePoint before providing any recommended vaccine boosters.
These two new vaccines will begin shipping in the next few weeks and are expected to be available for vaccinations over the next several weeks.
DHS will provide more information on the new bivalent vaccine boosters in the coming days.
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