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COVID-19 VACCINE
Product Information

Updated 4/12/2021

The COVID-19 Vaccine mRNA (Pfizer-BioNTech) is approved by the U.S. Food and Drug Administration and will be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older (3220, 3221).

COVID-19 Vaccine, mRNA (Pfizer-BioNTech) continues to be available under emergency use authorization for individuals 12 through 15 years of age, and for the administration of a third dose in certain immunocompromised individuals (3177, 3179, 3220, 3221).


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), mRNA is a sterile suspension for injection for intramuscular use. It is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 ml of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each dose contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike glycoprotein. Each 0.3 ml dose also includes lipids, potassium chloride, monobasic potassium phosphate, sodium chloride, sodium phosphate dihydrate, and sucrose. The vial does not contain a preservative. The vial stoppers are not made with natural rubber latex (3177,3179,3181, 3221).


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), mRNA multiple dose vials are supplied in a carton containing 25 multiple dose vials or 195 multiple dose vials.

A 0.9% Sldo8ium Chloride Injection, USP diluent is provided but is shipped separately, and should be stored at controlled room temperature (20-25°C). The diluent will be supplied wither as cartons of 10 ml single-use vials manufactured by 19 Hospira, Inc., or 2 ml single-use vials manufactured by Fresenius Kabi USA, LLC.

After dilution, 1 vial contains 6 doses of 0.3 ml. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not refreeze thawed vials (3220, 3221).

FROZEN VIALS PRIOR TO USE

Cartons of COVID-19 Vaccine, mRNA (Pfizer-BioNTech) multiple dose vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and preferable store in an ultra-low temperature freezer between -90°C to-60°C until the expiry date printed on the label. Alternatively, vials may be stored at -25°Cto – 15°C for up to 2 weeks. Vials must be kept frozen and protected from light, in the original cartons, until ready to use (3220, 3221).

Vials stored at -25°C to -15°C for up to two weeks may be returned 1 time to the recommended storage condition of -90°C to -60°C. Total cumulative time the vials are stored at -25°C to -15°C should be tracked and should not exceed 2 weeks. If an ultra-low temperature freezer is not available, the thermal container in which the vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90°C to -60°C. Storage of the vials between -96°C to -60°C is not considered an excursion from the recommended storage condition (3220, 3221).

Transportation of Frozen Vials

If local redistribution is needed and full cartons containing vials cannot be transported at -90°C to -60°C, vials may be transported at -25°C to -15°C. Any hours used for transport at -25°C to -15°C count against the 2-week limit for storage at -25°C to -15°C. Frozen vials transported at -25°C to -15°C may be returned 1 time to the recommended storage condition of -90°C to -60°C (3220, 3221).

Thawed Vials Before Dilution Thawed Under Refrigeration

Thaw and then store undiluted vials in the refrigerator (2-8°C) for up to 1 month. 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 (3220, 3221).

Thawed at Room Temperature

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 (3220, 3221).

Transportation of Thawed Vials

Available data support transportation of 1 or more thawed vials at 2-8°C for up to 12 hours (3220, 3221).

Vials After Dilution. After dilution, store vials between 2-8°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 refreeze (3220, 3221).

PREPARATION FOR ADMINISTRATION PRIOR TO DILUTION

• COVID-19 Vaccine, mRNA 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 (2 to 8°C) or at room temperature (up to 25°C).
• Refer to thawing instructions in the panels below.

Dilution

• Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COVID-19 Vaccine, mRNA. Do not add more than 1.8 mL of diluent.

• ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.

• Vials of sterile 0.9% Sodium Chloride Injection, USP are provided but shipped separately. Use the provided diluent or another sterile 0.9% Sodium Chloride Injection, USP as the diluent.

  • o Provided diluent vials are single use only; discard after 1.8 mL is withdrawn.
  • o If another sterile 0.9% Sodium Chloride Injection, USP is used as the diluent, discard after 1.8 mL is withdrawn.
  • o Do not dilute more than 1 vial of COVID-19 Vaccine, mRNA using the same diluent vial.

• After dilution, 1 vial of COVID-19 Vaccine, mRNA contains 6 doses of 0.3 mL each.

• Refer to dilution and dose preparation instructions in the panels below. Thaw vial(s) of COVID-19 Vaccine, mRNA before dilution either by:

    o Allowing vial(s) to thaw in the refrigerator (2 to 8°C). A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month.

    o Allowing vial(s) to sit at room temperature (up to 25°C) for 30 minutes.

• Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours.

• Before dilution invert vaccine vial gently 10 times.

• Do not shake.

• Inspect the liquid in the vaccine vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles.

• Do not use if liquid is discolored or if other particles are observed.

Dilution

• ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. • Withdraw 1.8 mL of diluent into a transfer syringe (21-gauge or narrower needle). • Add 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial.

• Equalize vial pressure before removing the needle from the vaccine vial by withdrawing 1.8 mL air into the empty diluent syringe.

• Gently invert the vial containing COVID-19 Vaccine, mRNA 10 times to mix.

• Do not shake.

• Inspect the vaccine in the vial.

• The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter.

• Record the date and time of dilution on the COVID-19 Vaccine, mRNA vial label.

• Store between 2°C to 25°C.

• Discard any unused vaccine 6 hours after dilution.

• Withdraw 0.3 mL of COVID-19 Vaccine, mRNA preferentially using low dead-volume syringes and/or needles.

• Each dose must contain 0.3 mL of vaccine.

• If the amount of vaccine remaining in a single vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.

• Administer immediately. After dilution, vials of COVID-19 Vaccine, mRNA contain 6 doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle,

• each dose must contain 0.3 mL of vaccine.

• if the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.

• do not pool excess vaccine from multiple vials.

ADMINISTRATION INFORMATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine will be an off-white suspension. Do not administer if vaccine is discolored or contains particulate matter. Administer a single 0.3 mL dose of COVID-19 Vaccine, mRNA intramuscularly.


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.

3220.    Anon., FDA Approves First COVID-19 Vaccine.  (August 23, 2021) accessed on August 24, 2021, at www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

3221.    Product Information, Comirnaty, Pfizer Inc., New York (August 2021).