• For certain indications, 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 the FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older. There are two presentations/formulations of the Moderna COVID‑19 Vaccine authorized for use.

  • 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.

See below for Moderna COVID‑19 Vaccine authorized uses.

Sign up to receive updates from Moderna

Storing Vaccine Vials

Moderna COVID‑19 Vaccine multiple-dose vials are stored frozen between -50°C to -15°C (-58°F to 5°F). During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

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

Unpunctured vials may be stored between 8°C to 25°C (46°F to 77°F) for up to 24 hours. Do not refreeze.

After the first dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F). Vials should be discarded 12 hours after the first puncture. Thawed vials can be handled in room light conditions. Do not refreeze once thawed.

When extracting only booster doses or a combination of primary series and booster doses, the maximum number of doses that may be extracted from either vial presentation should not exceed 20 doses. Do not puncture the vial stopper more than 20 times. If the vial stopper has been punctured 20 times, discard the vial and contents.

Learn more about storage and handling

If for any reason you believe some vials have
experienced a temperature excursion,
use our Temperature Excursion Tool for
further instructions.

Temperature Excursion Tool

Storage & Handling
Moderna COVID‑19 Vaccine Video

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

[DESCRIPTION]

On-screen text:

Storage and Handling Moderna COVID‑19 Vaccine For Healthcare Professionals

[SPEECH]

Let’s take a quick look at some select information about the Storage and Handling of the Moderna COVID‑19 Vaccine. Please refer to the Fact Sheet for Vaccination Providers for full information on Storage, Handling, Dosing, and Administration.

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

[DESCRIPTION AND SPEECH]

On-screen text and voice:
FDA has approved SPIKEVAX (COVID‑19 Vaccine, mRNA) as a two-dose primary series for the prevention of COVID‑19 in individuals ages 18 years of age and older.

The Moderna COVID‑19 Vaccine has not been approved by the FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to provide a two-dose primary series (0.5 mL) to individuals 18 years of age and older. Additionally, the Moderna COVID‑19 Vaccine has been authorized to provide a third primary series dose (0.5 mL) to individuals ages 18 years of age and older who have been determined to have certain kinds of immunocompromise. The EUA also authorizes a single (0.25 mL) booster dose of the Moderna COVID‑19 Vaccine at least 5 months after completing a primary series of the Moderna COVID‑19 Vaccine or SPIKEVAX to individuals 18 years of age and older. Under the EUA, the booster dose may also be administered to individuals 18 years of age or older as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID‑19 vaccine. 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 vaccine, unless the declaration is terminated or authorization revoked sooner.

[DESCRIPTION]

On-screen text:

FDA-approved SPIKEVAX and the EUA-authorized Moderna COVID‑19 Vaccine have the same formulation and can be used interchangeably without presenting any safety or effectiveness concerns.

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

[DESCRIPTION]

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

On-screen text:

Shipped Frozen

IMPORTANT SAFETY INFORMATION

Contraindications

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

[SPEECH]

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

[DESCRIPTION]

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

On screen text:

Frozen storage
Freezer temperature
-50° to -15° C
(-58° to 5° F)
During storage, protect from room light, and avoid exposure to direct sunlight and ultraviolet light.

[SPEECH]

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

During storage, protect from room light, and avoid exposure to direct sunlight and ultraviolet light.

[DESCRIPTION]

The carton opens to reveal 10 vials.

[SPEECH]

Each carton contains 10 multidose vials. Vial amounts vary, with some containing 5.5 mL, and some containing 7.5 mL.

[DESCRIPTION]

The image fades. A single vial of vaccine appears.

[SPEECH]

Prior to administration, thaw one vial at a time.

For the 5.5 mL vial, thaw the vial in the refrigerator for 2 hours and 30 minutes. For the 7.5 mL vial, thaw in the refrigerator for 3 hours. In both cases, let the vial stand for 15 minutes at room temperature before administering.

[DESCRIPTION]

The vial moves to a shelf in the refrigerator

On screen text:

Thaw vial before administration

Refrigerator

  • 5.5 mL Vial: 2 hours 30 minutes
  • 7.5 mL Vial: 3 hours
  • 2°C to 8°C (36°F 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.

On-screen text:

Room temperature

  • 5.5 mL Vial: 1 hour
  • 7.5 mL Vial: 1 hour and 30 minutes
  • 15°C to 25°C (59°F to 77°F)

[SPEECH]

Alternatively, for the 5.5 mL vial thaw at room temperature for 1 hour, or for the 7.5 mL vial 1 hour and 30 minutes. After the vial has been thawed, do not refreeze.

Primary series of 0.5 mL and booster doses of 0.25 mL may be extracted from either vial presentation.

[DESCRIPTION]

Split screen fades and an unpunctured vial appears.

On-screen text :

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 24 hours.
Do not refreeze once thawed.
Do not shake or dilute.

[SPEECH]

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 24 hours.

[DESCRIPTION]

Next, the vial is shown punctured, implying that a needle has already entered the vial and withdrawn a dose of vaccine. Liquid in the vial decreases, which represents vaccine doses being withdrawn.

On-screen text:

For illustrative purposes only

Punctured vials
Do not shake or dilute
Do not pool excess vaccine from multiple vials

  • After first dose has been withdrawn, vial should be held between 2°C to 25°C (36°F to 77°F).
  • Record the date and time of first use on the Moderna COVID‑19 Vaccine vial label. Discard vial after 12 hours.
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL or 0.25 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
  • The maximum number of doses that may be extracted from either vial presentation should not exceed 20 doses. Do not puncture the vial stopper more than 20 times. If the vial stopper has been punctured 20 times, discard the vial and contents.

Do not refreeze once thawed.
Do not shake or dilute.

THAWED, UNPUNCTURED VIAL
Store refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days.
Unpunctured vials may be stored between 8°C to 25°C (46°F to 77°F) for up to 24 hours.
Do not refreeze.

THAWED, PUNCTURED VIAL
Punctured vial should be held between 2°C to 25°C (36°F to 77°F).
Discard vial after 12 hours.
Do not refreeze.

[DESCRIPTION]

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

[SPEECH]

After the first dose has been withdrawn, punctured vials must be discarded after 12 hours, whether they’re stored in the refrigerator or at room temperature.

Thawed vials can be handled in room light conditions.

Once thawed, never refreeze Moderna COVID‑19 Vaccine.

[DESCRIPTION]

The vials fade from view.

[SPEECH]

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

[DESCRIPTION]

On-screen text:
MODERNA COVID‑19 VACCINE THAWING & STORAGE

[DESCRIPTION]

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 -50°C to -15°C (-58°F to 5°F).
  • THAWING
    Thaw in refrigerated conditions between 2°C to 8°C (36°F to 46°F) for 2 hours and 30 minutes for the 5.5 mL vial, or 3 hours for the 7.5 mL vial. Let vial stand at room temperature for 15 minutes before administering. Alternatively, thaw at room temperature between 15°C to 25°C (59°F to 77°F) for 1 hour for the 5.5 mL vial, or 1 hour and 30 minutes for the 7.5 mL vial.
  • REFRIGERATED STORAGE PRIOR TO USE
    Vials can be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to first use. Do not refreeze once thawed. Unpunctured vials may be stored between 8°C to 25°C (46°F to 77°F) for up to 24 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°C to 25°C (36°F to 77°F). Discard vial after 12 hours. Do not refreeze.

[SPEECH]

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

[DESCRIPTION]

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

[DESCRIPTION AND SPEECH]

On-screen text and voice:

AUTHORIZED USE

The Moderna COVID‑19 Vaccine has not been approved by the FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to provide a two-dose primary series (0.5 mL) to individuals 18 years of age and older. Additionally, the Moderna COVID‑19 Vaccine has been authorized to provide a third primary series dose (0.5 mL) to individuals ages 18 years of age and older who have been determined to have certain kinds of immunocompromise. The EUA also authorizes a single (0.25 mL) booster dose of the Moderna COVID‑19 Vaccine at least 5 months after completing a primary series of the Moderna COVID‑19 Vaccine or SPIKEVAX (COVID‑19 Vaccine, mRNA) to individuals 18 years of age and older. Under the EUA, the booster dose may also be administered to individuals 18 years of age or older as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID‑19 vaccine. 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 vaccine, unless the declaration is terminated or authorization revoked sooner.

FDA has approved SPIKEVAX as a two-dose primary series for the prevention of COVID‑19 in individuals ages 18 years of age and older.

FDA-approved SPIKEVAX and the EUA-authorized Moderna COVID‑19 Vaccine have the same formulation and can be used interchangeably without presenting any safety or effectiveness concerns.

IMPORTANT SAFETY INFORMATION

Contraindications
Do not administer the Moderna COVID‑19 Vaccine to individuals with a known history of a 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/clinical-considerations/managing-anaphylaxis.html).
  • Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
  • Syncope (fainting): May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
  • 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, erythema at the injection site, and rash.

Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID‑19 Vaccine during mass vaccination outside of clinical trials.

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.

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.

For information regarding SPIKEVAX, see SPIKEVAX Full Prescribing Information at https://www.modernatx.com/covid19vaccine-eua/spikevax-prescribing-information.pdf.

[DESCRIPTION]

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

[SPEECH]

Get more information about Moderna at ModernaTX.com.

[DESCRIPTION]

Job code is displayed on screen:

US-COV-2200041 02/2022

[END OF TRANSCRIPT]

Vial Puncture
Moderna COVID‑19 Vaccine Video

Manufacturing and Shipment

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

The Moderna COVID‑19 Vaccine is supplied in three multiple-dose vial presentations:

  • A 2.5 mL multiple-dose vial with a dark blue cap and a label with a purple border, for booster only
  • A 5.5 mL multiple-dose vial with a red cap and a label with a light blue border, for primary series or booster doses
  • A 7.5 mL multiple-dose vial with a red cap and a label with a light blue border, for primary series or booster doses

A carton of Moderna COVID‑19 Vaccine contains 10 multiple-dose vials. A case includes 12 cartons, or a total of 120 vials. A shipping pallet may include up to 198 cases.

The dimensions of a carton of vaccine are 5.4” x 2.1” x 2.4”.

The Moderna COVID-19 Vaccine should be transported in the frozen state. If transport at -50°C to -15°C (-58°F to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2°C to 8°C (36°F to 46°F) when shipped using shipping containers which have been qualified to maintain 2°C to 8°C (36°F to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2°C to 8°C (36°F to 46°F), vials should not be refrozen and should be stored at 2°C to 8°C (36°F to 46°F) until use.

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 or blue 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).