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COVID-19 VACCINE
Product Information

Updated 12/19/2020

The COVID-19 Vaccine (Pfizer-BioNTech) has not been approved or licensed by the U.S. Food and Drug Administration but has been authorized for emergency use by the FDA for use in individuals sixteen years of age and older.  The emergency use of this product is only authorized for the duration of the declaration (3177, 3179). 

The COVID-19 Vaccine (Moderna, Inc.) has not been approved or licensed by the U.S. Food and Drug Administration but has been authorized for emergency use by the FDA for use in individuals eighteen years of age and older.  The emergency use of this product is only authorized for the duration of the declaration (3178, 3180). 

Description

COVID-19 Vaccine (Pfizer-BioNTech) is supplied as a frozen suspension in multiple dose vials.  Each vial must be diluted with NS prior to use.  Each dose contains 30 µg of nucleoside-modified messenger RNA per ml.  Officially designed to contain five doses, according to the U.S. FDA, because of the public health emergency, it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial.  Since these are preservative-free vials, it is critical that any further remaining liquid that does not constitute a full dose should not be pooled from multiple vials to create one. The multiple dose vials do not contain a preservative.  The vial stoppers are not made with natural rubber latex (3177, 3179, 3181). 

COVID-19 Vaccine (Moderna, Inc.), known as mRNA-1273, is an mRNA vaccine encoding the pre-fusion stabilized form of the spike glycoprotein (S) of SARS-CoV-2 virus.  The vaccine is a white to off-white, sterile, preservative-free frozen suspension for IM injection, and is not diluted prior to use. Each 0.5 ml dose contains 100 µg. The multiple dose vials do not contain a preservative.  The vial stoppers are not made with natural rubber latex.  The storage and handling information in the December 18, 2020 U.S. FDA fact sheet for emergency use authorization of COVID-19 (Moderna, Inc.) supersedes the storage and handling information that is on the vial and carton labels (3180). 

Stability

COVID-19 Vaccine (Pfizer-BioNTech):  During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.  Do not refreeze thawed vials (3177, 3179). 

Frozen vials in cartons must be stored in ultra-low temperature freezer between minus 80°C and minus 60°C and protected from light until ready to use (3177, 3179). 

Frozen vials may be thawed at 2-8°C for up to 5 days.  A carton of 25 vials or 195 vials may take up to 2-3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time (3177, 3179). 

Frozen vials may also be thawed at room temperature for immediate use.  Undiluted vials may be thawed at room temperature for 30 minutes.   Thawed vials can be handled in room light conditions.  Vials must reach room temperature before dilution.  Undiluted vials may be stored at room temperature for no more than 2 hours (3177, 3179). 

Dilute the vial contents using 1.8 ml NS to form the COVID-19 vaccine (Pfizer-BioNTech).  Do not use bacteriostatic NS.  Do not shake the vial to hasten mixing.  The vaccine will be an off-white suspension.  Do not use if vaccine is discolored or contains particulate matter. Record date and time of dilution.  Store between 2°C and 25°C.  Discard any unused vaccine 6 hours after dilution (3177, 3179). 

The injection is administered IM as a series of two doses (0.3 ml each) 3 weeks apart (3177, 3179).   

The vial is marketed as a multidose container providing 5 doses of the vaccine.  Due to standard overfill and given the current public health emergency, the U.S. FDA has advised that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of this issue.  However, since these are preservative-free vials, it is critical that any further remaining liquid that does not constitute a full dose should not be pooled from multiple vials to create one (3181).

COVID-19 Vaccine (Moderna, Inc.):  The storage and handling information in the U.S. FDA fact sheet for emergency use authorization of COVID-19 (Moderna, Inc.) supersedes the storage and handling information that is on the vial and carton labels (3178, 3180). 

Store the vaccine frozen at minus 25 to minus 15°C in the original carton and protected from light.  Do not store on dry ice or below minus 40°C.  Vials can be stored refrigerated between 2-8°C for up to 30 days prior to first use.  Unpunctured vials may be stored between 8-25°C for up to 12 hours.  Do not refreeze once thawed (3178, 3180). 

After the first dose has been withdrawn, the vial should be held between 2-25°C.  Discard vial after 6 hours.  Do not refreeze (3178, 3180). 

Administer the vaccine IM as a series of two doses (each 0.5 ml dose contains 100 µg) one month apart.  There are no data available on the interchangeability of the Moderna vaccine with any other COVID-19 vaccines to complete the vaccination series (3178, 3180). 

To prepare a dose, remove the required number of vials from storage and thaw each vial before use.  Thaw at 2-8°C for 2 hours and 30 minutes.  After thawing, let vial stand at room temperature for 15 minutes before administering.  Alternatively, thaw at 15-25°C for 1 hours.  After thawing do not refreeze (3178, 3180). 

Swirl vial gently after thawing and between each withdrawal.  Do not shake.  Do not dilute the vaccine (3178, 3180). 

The thawed, white to off-white suspension may contain white or translucent product-related particulates. Do not administer if the suspension is discolored.  Discard the vial 6 hours after the first dose has been withdrawn (3178, 3180).  

References

3177. Product Information, COVID-19 Vaccine (Pfizer-BioNTech), Pfizer Inc., New York (December 2020), accessed on December 12, 2020.

3178. Product Information, COVID-19 Vaccine (Moderna, Inc.), Moderna, Inc., Cambridge MA (November 2020).

3179. Anon., U.S. FDA Fact Sheet, COVID-19 Vaccine (Pfizer-BioNTech), (December 2020).

3180. Anon., U.S. FDA Fact Sheet, COVID-19 Vaccine (Moderna), (December 2020).

3181. Schulte, J., ASHP Connect, FDA Clarification on Doses Per Vial, accessed on December 17, 2020.