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COVID-19 VACCINE
Product Information

Updated 4/12/2021

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). 


COVID-19 Vaccine (Janssen) 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 (3189, 3190). 

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).


COVID-19 Vaccine (Janssen) is a colorless to slightly yellow, clear to very opalescent sterile suspension for IM injection.  The vaccine does not contain a preservative.  The vial stoppers are not made with natural rubber latex.  Administer COVID-19 Vaccine (Janssen) as a single dose of 0.5 ml.  The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein in a stabilized conformation (3189, 3190).

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 (3199, 3179, 3186, 3187, 3188).

Frozen vials and 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). 
Effective February 25, 2021, storage at this temperature is preferable.  Alternatively, vials may be stored at minus 25°C to minus 15°C for up to 2 weeks.  Vials must be kept frozen and protected from light until ready to use.  Vials stored at minus 25°C to minus 15°C for up to 2 weeks may be returned one time to the recommended storage condition of minus 80°C to minus 60°C.  Total cumulative time the vials are stored at minus 25°C to minus 15°C should be tracked and should not exceed 2 weeks (3186, 3187, 3188).

Transportation of Frozen Vials.  If local redistribution is needed and full cartons containing vials cannot be transported at minus 80°C to minus 60°C, vials may be transported at minus 25°C to minus 15°C.  Any hours used to for transport at minus 25°C to minus 15°C count against the 2-week limit for storage at minus 25°C to minus 15°C.  Frozen vials transported at minus 25°C to minus 15°C may be returned one time to the recommended storage condition of minus 80°C to minus 60°C *3186, 3187, 3188).

Thawed Vials Before Dilution.  Thaw and then store undiluted vials in the refrigerator (2°C to 8°C) for up to 5 days.  A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time.  For immediate use, thaw undiluted vials at room temperature (up to 25°C) 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 (3186, 3187, 3188).

Transportation of Thawed Vials.  Available data support transportation of one or more thawed vials at 2°C to 8°C for up to 12 hours.  Any hours used for transport count again the 120-hour limit for storage at 2°C to 8°C.

Vials After Dilution.  After dilution, store vials between 2°C and 8°C and use within 6 hours from the time of dilution.  During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.  Any vaccine remaining in vials must be discarded after 6 hours.  Do not freeze (3186, 3187, 3188).

Dosing.  The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 ml each) 3 weeks apart.
 
Dose Preparation.  The Vaccine Multiple Dose Vial contains a volume of 0.45 ml supplied as a frozen suspension that does not contain preservative.  Each vial must be thawed and diluted prior to administration.  Vials may be thawed in the refrigerator or at room temperature.

Dilution.  Dilute the vial contents using 1.8 ml of NS. NS as a diluent is not packaged with the vial and must be sourced separately.  Do not use bacteriostatic NS or any other diluent.  Do not add more than 1.8 ml.  After dilution, one vial contains 6 doses of 0.3 ml, due to standard overfill manufacturing procedures for vials.  Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 ml.  The printed statement on the label has been superseded by recent U.S. F.D.A. information (3186, 3187, 3188).


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. 

The Moderna COVID-19 Vaccine is supplied in two multiple-dose presentations:  a multiple-dose vial containing a maximum of 11 doses:  range 10-11 doses (0.5 ml each); and a multiple-dose vial containing a maximum of 15 doses: range 13-15 doses (0.5 ml each). Depending on the syringes and needles used for each dose, there may not be sufficient volume to extract more than 10 doses from the maximum of 11 doses vial or more than 13 doses from the maximum of 15 doses vials.  Irrespective of the type of syringe and needle, each dose must contain 0.5 ml of vaccine; if the amount of vaccine remaining in the vial cannot provided a full dose of 0.5 ml, discard the vial and contents.  Do not pool excess vaccine from multiple vials; pierce the stopper at different site each time; after the first dose has ben withdrawn, the vial should be held between 2 and 25°C. Discard vial after 12 hours.  Do not refreeze (3202).

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).  


COVID-19 Vaccine (Janssen):  Prior to first puncture of the vaccine vial, store at 2°C to 8°C and protect from light.  Do not store frozen.  Unpunctured vials of COVID-19 Vaccine (Janssen) may be stored between 9°C and 25°C for up to 12 hours (3189, 3190). 

The COVID-19 Vaccine (Janssen) is initially stored frozen by the manufacturer, then shipped at 2°C to 8°C.  If the vaccine is still frozen upon receipt, thaw at 2°C to 8°C.  If needed immediately, thaw at room temperature (maximally 25°C).  At room temperature (maximally 25°C), a carton of 10 vials will take approximately 2 hours to thaw, and an individual vial will take approximately 1 hour to thaw.  Do not refreeze once thawed (3189, 3190).

After the first dose has been withdrawn, hold the vial between 2°C to 8°C for up to 6 hours or at room temperature (maximally 25°C) for up to 2 hours.  Discard the vial if the vaccine is not used within these times (3189, 3190).

The COVID-19 Vaccine (Janssen) is administered intramuscularly as a single 0.5 ml dose (3189, 3190). 

To prepare a dose, make certain the vaccine is a colorless to slightly yellow, clear to very opalescent suspension.  Carefully mix the contents of the multi-dose vial by swirling gently in an upright position for 10 seconds.  Do not shake.  Each vial contains five doses.  Do not pool excess vaccine from multiple vials.  The vaccine does not contain a preservative.  Record the date and time of first use on the vaccine vial label.  After the first dose has been withdrawn, hold the vial between 2°C to 8°C for up to 6 hours or at room temperature (maximally 25°C) for up to 2 hours.  Discard if the vaccine is not used within these times (3189, 3190).

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.

3186.  Anon., Coronavirus Update, U.S. Food and Drug Administration, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-FDA-allows-more-flexible-storage-transportation-conditions-PfizerFDA  February 25, 2021, accessed February 25, 2021.

3187. Anon., U.S. FDA Fact Sheet, COVID-19 Vaccine (Pfizer-BioNTech), February 2021, www.fda.gov/media/144413/download.  Accessed February 25, 2021.

3188. Product Information, COVID-19 Vaccine (Pfizer-BioNTech), Pfizer Inc., New York (February 2021), accessed February 25, 2021.

3189. Product Information, COVID-19 Vaccine (Janssen), Janssen Biotech, inc., A Janssen Pharmaceutical Company of Johnson & Johnson, Horsham PA, (February 2021), Janssenlabels.com/emergency-use-authorization/janssen+COVID-19+vaccine-hcp.fact-sheet.pdf,
accessed February 27, 2021.

3190. Anon., U.S. FDA Fact Sheet, COVID-19 Virus (Janssen), February 27, 2021, www.fda.govmedia/146304/download, accessed February 27, 2021.

3202. Anon., U.S. FDA Fact Sheet, COVID-19 Vaccine (Moderna), March 2021. Accessed April 8, 2021 at https://www.modernatx.com/covid19vaccine-eue/eue-fact-sheet-providers.pdf.