• The Moderna COVID‑19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) for use in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID‑19.
  • The EUA for the Moderna COVID‑19 Vaccine is in effect for the duration of the COVID‑19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.

Storing Vaccine Vials

Moderna COVID‑19 Vaccine multiple-dose vials are stored frozen between -25º to -15ºC (-13º to 5ºF). Store in the original carton to protect from light. Do not store on dry ice or below -40ºC (-40ºF).

The Moderna COVID‑19 Vaccine can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. Do not refreeze once thawed.

Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours. Do not refreeze.

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Discard vial after 6 hours. Do not refreeze.

Learn more about storage, handling, dosing and administration

Storage & Handling
Moderna COVID‑19 Vaccine Video

Video Transcript: Storage and Handling Moderna COVID‑19 Vaccine For Healthcare Professionals

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Storage and Handling Moderna COVID‑19 Vaccine For Healthcare Professionals

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Let’s take a quick look at Storage and Handling of the Moderna COVID‑19 Vaccine.

But first, please be aware of the following important information about the Moderna COVID‑19 Vaccine.

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The Moderna COVID‑19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) for use in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID‑19.

The EUA for the Moderna COVID‑19 Vaccine is in effect for the duration of the COVID‑19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.

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For information on the authorized use of the Moderna COVID‑19 Vaccine and mandatoryrequirements of the EUA, please review the Fact Sheet for Healthcare Providers AdministeringVaccine (Vaccination Providers) and Full EUA Prescribing Information available at https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf.

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A delivery truck moves onto screen from the left and eventually moves off the screen on the right.

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Shipped Frozen

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer the Moderna COVID‑19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID‑19 Vaccine.

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Moderna COVID‑19 Vaccine is shipped to your location frozen, using existing shipping practices.

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A closed carton of Moderna COVID‑19 vaccines appears with the words “Moderna COVID‑19 Vaccine” on it.

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Frozen storage
Freezer temperature
–25º to –15º C
(–13º to 5º F)
Do not store on dry ice or below -40º C (-40º F)
Store in the original carton to protect them from light

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Upon arrival, the Moderna COVID‑19 Vaccine can be stored frozen until the expiration date.

Keep the vials in their original package to protect them from light.

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The carton opens to reveal 10 vials.

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Each carton contains 10 multidose vials, with 10 doses of vaccine in each vial.

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The image fades. A single vial of vaccine appears.

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Prior to administration, thaw one vial at a time.

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The vial moves to a shelf in the refrigerator

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Thaw vial before administration

Refrigerator
2 hours 30 minutes
2° to 8°C (36° to 46°F)
Let vial stand at room temperature for 15 minutes before administering.
Do not refreeze once thawed.
Do not shake or dilute.

The screen splits to display the vial in the refrigerator on the left and the vial on a shelf at room temperature on the right.

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Room temperature
1 hour
15° to 25°C (59° to 77°F)
Do not refreeze once thawed.
Do not shake or dilute.

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Thaw the vial in the refrigerator for 2 hours and 30 minutes, and then let the vial stand for 15 minutes at room temperature before administering. Alternatively, thaw at room temperature for 1 hour. After the vial has been thawed, do not refreeze.

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Split screen fades and an unpunctured vial appears.

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Unpunctured vials
Store refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days.
Store between 8° to 25°C (46° to 77°F) for up to 12 hours.
Do not refreeze once thawed.
Do not shake or dilute.

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Once thawed, unpunctured vials can be stored in the refrigerator for up to 30 days.

The total storage time of an unpunctured vial after removal from refrigerated conditions should not exceed 12 hours.

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Next, the vial is shown punctured, implying that a needle has already entered the vial and withdrawn a dose of vaccine. Small ovals appear vertically to the right of the vial. Color is lost from the ovals as the liquid in the vial decreases, which represents vaccine doses being withdrawn.

On-screen text:

Punctured vials
For illustrative purposes only
Do not shake or dilute
Punctured vials should be held between 2° to 25°C (36° to 77°F).
Discard vial after 6 hours.
Do not refreeze once thawed.
Do not shake or dilute.

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10 doses can be withdrawn from the multiple-dose vial.

After the first dose has been withdrawn, punctured vials must be discarded after 6 hours, whether they’re stored in the refrigerator or at room temperature.

Once thawed, never refreeze Moderna COVID‑19 Vaccine.

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The ovals disappear. The punctured vial moves to the right to display a side-by-side view with an unpunctured vial on the left.

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Please check the Fact Sheet for Vaccination Providers for details on storage, handling, and administration of the Moderna COVID‑19 Vaccine.

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MODERNA COVID‑19 VACCINE THAWING & STORAGE

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A list of four items appears. There are checkboxes next to each item, and a check mark appears in each checkbox. The four items on the list are:

On-screen text:

  • FROZEN STORAGE PRIOR TO USE
    The Moderna COVID‑19 Vaccine multiple-dose vials are stored frozen between -25° to -15°C (-13° to 5°F).
  • THAWING
    Thaw in refrigerated conditions between 2° to 8°C (36° to 46°F) for 2 hours and 30 minutes. Let vial stand at room temperature for 15 minutes before administering. Alternatively, thaw at room temperature between 15° to 25°C (59° to 77°F) for 1 hour.
  • REFRIGERATED STORAGE PRIOR TO USE
    Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. Do not refreeze once thawed.Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours. Do not refreeze once thawed.
  • STORAGE AFTER FIRST PUNCTURE OF THE VACCINE VIAL
    After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Discard vial after 6 hours. Do not refreeze.

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Please note the following important safety information for the Moderna COVID‑19 Vaccine.

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On-screen text:
Important Safety Information for Moderna COVID‑19 Vaccine

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On-screen text and voice:
AUTHORIZED USE
Moderna COVID‑19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID‑19) caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) in individuals 18 years of age and older. Moderna COVID‑19 Vaccine is investigational and not approved by FDA.

IMPORTANT SAFETY INFORMATION

Contraindications
Do not administer the Moderna COVID‑19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID‑19 Vaccine.

Warnings and Precautions

  • Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID‑19 Vaccine Monitor Moderna COVID‑19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/COVID‑19/).
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID‑19 Vaccine.
  • Limitations of Vaccine Effectiveness: The Moderna COVID‑19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions reported in a clinical trial following administration of the Moderna COVID‑19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID‑19 Vaccine.

Reporting Adverse Events and Vaccine Administration Errors

The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):

  • vaccine administration errors whether or not associated with an adverse event
  • serious adverse events (irrespective of attribution to vaccination)
  • cases of Multisystem Inflammatory Syndrome (MIS) in adults
  • cases of COVID‑19 that result in hospitalization or death

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1‑800‑822‑7967. Reports should include the words “Moderna COVID‑19 Vaccine EUA” in the description section of the report.

Report to ModernaTX, Inc. by calling 1-866-MODERNA (1‑866‑663‑3762) or provide a copy of the VAERS form by faxing 1-866-599-1342 or emailing ModernaPV@modernatx.com.

Pregnancy and Lactation

Available data on Moderna COVID‑19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID‑19 Vaccine on the breastfed infant or on milk production/excretion.

Dosing and Schedule

The Moderna COVID‑19 Vaccine is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart. There are no data available on the interchangeability of the Moderna COVID‑19 Vaccine with other COVID‑19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID‑19 Vaccine should receive a second dose of Moderna COVID‑19 Vaccine to complete the vaccination series.

For more information, see the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information at https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf.

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The Moderna logo is displayed, along with the URL ModernaTX.com.

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Get more information about Moderna at ModernaTX.com.

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Job code is displayed on screen:

US-COV-2000011 12/2020

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Manufacturing and Shipment

Vaccine distributed in the US is manufactured in collaboration with our partners Lonza and Catalent.

A carton of Moderna COVID‑19 Vaccine contains 10 multiple-dose vials. Each vial contains 10 doses. A case includes 12 cartons, or a total of 120 vials providing 1,200 doses. A shipping pallet may include up to 192 cases.

The dimensions of a carton of vaccine are 5.5” x 2.2” x 2.5”.

Counterfeit Identification

Moderna is committed to safety and ensuring that people have accurate information about the investigational Moderna COVID‑19 Vaccine, including how it is accessed and administered.

Moderna is actively monitoring for fraudulent offers of illegitimate Moderna COVID‑19 Vaccine to protect individuals from products that might be dangerous and lead to serious and life-threatening harm.

Keep in mind that under the EUA issued by FDA:

  • The Moderna COVID‑19 Vaccine is only administered as an intramuscular injection by a healthcare professional.
  • The Moderna COVID‑19 Vaccine is not taken orally and is not available as a capsule, tablet, or any other formulation.

Authentic Moderna COVID‑19 Vaccine, manufactured by Moderna, will include the Moderna name and logo on the label and is dispensed in a vial with a red cap.

The Moderna COVID‑19 Vaccine is not sold online.

The authenticity of products acquired outside of the legitimate supply chain cannot be verified by Moderna. If you suspect the Moderna COVID‑19 Vaccine you have purchased may be counterfeit, please call Moderna Medical Information at 1-866-MODERNA (1-866-663-3762).