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The U.S. Food and Drug Administration has amended the emergency use authorization (EUA)
for the Pfizer-BioNTech COVID-19 Vaccine to:
- Expand the use of a single booster dose to include use in individuals 12 through 15 years old (FDA expanded booster eligibility for 16 - 17 year olds in early December).
- Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
- Allow for a third primary series dose for certain immunocompromised children ages 5 through 11 years of age old.'
The FDA has also amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
The updated Pfizer EUA can be found here. The updated Moderna EUA can be found here.
Complete FDA announcements can be found here.
Pfizer Webinars will continue throughout January with Medical Updates and Immunization Site Training series for providers. The webinars focus on new recommendations and products, including the “dilute before use/orange cap” formulation for children age 5 to 11 years, the current “dilute before use/purple cap” formulation and the new “do not dilute/gray cap” formulation for people age 12 and older.
To access the complete list of current and future training sessions, click here.
Resources:
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FDA recently approved a shelf-life extension for the Pfizer Pediatric vaccine (Orange Cap, 5-11 YO, diluent required) and for Adult/Adolescent Tris (Gray Cap, age 12+, no diluent). This approval may be found at Healthcare Providers for 5-11 years of age, orange cap (must dilute) (fda.gov) ; Healthcare Providers for 12 years of age and older, Gray Cap (no dilution) (fda.gov) ). This extension applies to frozen (ULT) inventories only.
The date printed on the Pfizer Pediatric (Orange Cap) and Adult/Adolescent (Gray Cap, 12+, no diluent) vaccine vials indicate the manufacture date and NOT the expiration date. Originally, the expiration date was 6 months from the manufacture date. The expiration date for Pfizer Orange Cap and Gray Cap vaccine has now been extended to 9 months (while held at ULT frozen.)
The fact sheets for both Orange Cap and Gray Cap vials provided by the FDA now read, “Regardless of storage conditions, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons.” The updated expiry dates for both the Orange Cap and Gray Cap vials based on 9 months from the date of manufacture are provided below.
As a reminder, MIP requires the following individuals to provide a signed ImmPact User Administration Agreement in order to continue to have access to the system in 2022:
Primary and Backup vaccine coordinators
In addition, MIP requires the following individuals to provide a signed ImmPact Individual Non Vaccine User Agreement to continue to have access to the system in 2022:
WIC
Schools (unless receiving vaccines from the program, the above applies
Pharmacies
Any Additional non vaccine locations
All individuals within your organization with active log-in credentials for ImmPact must have a signed ImmPact Individual User Agreement on file. These individual user agreements should be kept on file at your facility and be made available to MIP if necessary. These do NOT need to be sent to MIP. |
