All Pfizer and Moderna
monovalent mRNA vaccine has been de-authorized by the FDA.
It is now an administration error to give any monovalent Pfizer or Moderna COVID-19 vaccine.
The terms “Primary Series” and “Booster” are no longer being applied to Moderna and Pfizer immunizations. Instead, recipients are either “up to date” or “not up to date”. Recipients age 6 and older are now “up to date” if they have had one dose of bivalent mRNA vaccine.
The changes are more complicated for younger kids; please see the
CDC Interim Clinical Considerations for COVID-19 Vaccine.
“Additional doses” of vaccine may be given to some recipients who are “up to date” if they are:
- Moderately or severely immunocompromised
- Age 65 or older
Most doses of Moderna for ages 6 months through 5 years are now the blue cap, gray label vaccine (0.25mL) rather than the pink cap, yellow label vaccine (0.2mL) in the 2-dose vial which was previously authorized as the bivalent Moderna product for this age group. The pink cap, yellow label vaccine in the 2-dose vial remains authorized for
specific, limited situations
Moderna and Pfizer now each have just one EUA fact sheet.
The Novavax immunization recommendations are not changed by the FDA’s recent update.
For specifics about who is eligible for what vaccines and schedule specifics, please see:
A summary presentation
of the recent changes was delivered at OIP office hours.