• 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.

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Frequently Asked Questions

Explore these topics to find the answers to some of the most common questions we get from healthcare professionals.

Can’t find the answer to your question? Give us a call at 1-866-MODERNA (1‑866‑663‑3762).

General

Who is Moderna?

Moderna, Inc. is a biotechnology company developing messenger RNA (mRNA) therapeutics and vaccines to investigate and potentially create a new class of medicines for patients. Moderna was established in 2010 and is headquartered in Cambridge, Massachusetts.

If you would like more information on Moderna, you can visit our website.

Does Moderna have any other approved products on the market?

spikevax (COVID-19 vaccine, mRNA) is the first Moderna product approved by the US Food and Drug Administration. spikevax was approved in January 2022 as a two-dose primary series one month apart for prevention of COVID-19 in individuals ages 18 years of age and older.

Moderna currently does not have any other FDA‑approved products.

In December 2020, Moderna COVID-19 Vaccine received Emergency Use Authorization from FDA, in response to the COVID-19 pandemic, as a two-dose primary series one month apart for prevention of COVID-19 in individuals ages 18 years of age and older.

Moderna has been investigating messenger RNA (mRNA) therapeutics and vaccines since its founding in 2010, and has more than 20 products in active preclinical and clinical development.

What does it mean that the vaccine is based on mRNA technology?

A vaccine based on messenger RNA (mRNA) technology, such as Moderna COVID‑19 Vaccine, does not use inactivated virus, attenuated virus, or any other kind of virus.

The Moderna COVID‑19 Vaccine uses mRNA to provide a blueprint for your cells to build your body’s defense against the virus.

This allows the body to generate an antibody response, and to retain the information in memory immune cells, in order to attack the virus if the vaccinated individual is exposed to the virus.

I have more questions. Where can I learn more?

If you have more questions, you may wish to reach out to your state, territorial, tribal, or local health department.

You can also find more information online at the following websites:

The following resources include additional educational material for vaccination providers:

Supply & Availability

How do I order Moderna COVID-19 Vaccine?

This vaccine is being made available for emergency use exclusively through the CDC COVID‑19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. You can get information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program.

The EUA for Moderna COVID‑19 Vaccine is in effect for the duration of the COVID‑19 declaration justifying emergency use of this product, unless terminated or revoked, after which the product may no longer be used.

Where can I get vaccination supplies, such as syringes?

Ancillary supplies including syringes, needles, and Personal Protective Equipment to support COVID‑19 vaccinations, are being supplied by the US Government. More information on the availability, how to order and return these ancillary supplies should be available from your state, territorial, tribal or local health departments.

The supplies needed for administration of Moderna COVID-19 Vaccine are normal and typical vaccine supplies that are available from medical supply companies, such as a syringe with a needle greater than 1 inch for intramuscular adminstration.

How many doses are in a vial of vaccine? Has this changed?

The Moderna COVID‑19 Vaccine is supplied in three presentations:

  • A multiple-dose vial with a dark blue cap and label with a purple border containing 2.5 mL. This presentation is for 0.5 mL booster doses only.
  • A multiple-dose vial with a red cap and a label with a light blue border containing 5.5 mL. This presentation is for primary series doses or 0.25 mL booster doses.
  • A multiple-dose vial with a red cap and a label with a light blue border containing 7.5 mL. This presentation is for primary series doses or 0.25 mL booster doses.

When extracting only primary series doses, depending on the syringes and needles used, a maximum of 11 doses (range: 10-11 doses) may be extracted from the vial containing 5.5 mL or a maximum of 15 doses (range: 13-15 doses) may be extracted from the vial containing 7.5 mL.

When extracting only booster doses or a combination of primary series and booster doses, the maximum number of doses that may be extracted from the red cap vial presentations should not exceed 20 doses. Do not puncture the vial stopper more than 20 times.

Irrespective of the type of syringe and needle:

  • Each primary series dose must contain 0.5 mL of vaccine.
  • Each booster dose from red cap vial presentations must contain 0.25 mL of vaccine.
  • Each booster dose from the blue cap vial presentation must contain 0.5 mL of vaccine.
  • If the vial stopper has been punctured 20 times, discard the vial and contents.
  • 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.

How can we move thawed vaccine to another location?

Vaccine is shipped frozen. However, once vaccine vials are thawed, they cannot be refrozen.

If transport at -50°C to -15°C (-58°F to 5°F) is not feasible (including if the vaccine has already been thawed), 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.

Vaccine Reimbursement

How will I be reimbursed for administering the Moderna COVID-19 Vaccine?

Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients). You can get information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program.

Download a quick-reference guide for billing administration of the Moderna COVID-19 Vaccine, including CPT® Codes.

Product & Production

Where is the vaccine used in the US manufactured?

Moderna COVID-19 Vaccine is being produced by Moderna and by manufacturing partners at facilities located in the United States.

Get more information on Moderna's technology and manufacturing capability and partnerships at Moderna's website.

Are there other vaccines for COVID‑19?

SPIKEVAX (COVID-19 Vaccine, mRNA) and COMIRNATY (COVID-19 Vaccine, mRNA) are FDA‑approved vaccines to prevent COVID-19 caused by SARS-CoV-2. There may be clinical trials or availability under EUA of other COVID-19 vaccines.

Is handling different for the vials with different amounts of vaccine?

The thaw times are different for the 2.5 mL multiple-dose vial, 5.5 mL multiple-dose vial, and 7.5 mL multiple-dose vial.

The 5.5 mL vial can be thawed between 2°C to 8°C (36°F to 46°F) for 2 hours and 30 minutes, whereas the 7.5 mL vial requires 3 hours at that temperature. Let each vial stand at room temperature for 15 minutes before administering.

Alternatively, the 5.5 mL vial can be thawed between 15°C to 25°C (59°F to 77°F) for 1 hour, whereas the 7.5 mL vials requires 1 hour 30 minutes at that temperature. Apart from the differences in thaw times, storage and handling of the two vial presentations is the same.

The 2.5mL vial can be thawed in a refrigerator between 2°C to 8°C (36°F to 46°F) for 2 hours. Let each vial stand at room temperature for 15 minutes before administering. Alternatively, the vial can be thawed at room temperature between 15°C to 25°C (59°F to 77°F) for 45 minutes.

What side effects are seen with this vaccine?

Adverse Reactions in Clinical Trials
Adverse reactions reported in clinical trials 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. (See Full EUA Prescribing Information)

Adverse Reactions in Post-Authorization Experience
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

Download this document to help vaccine recipients understand what to expect with vaccination.

The vaccine was incorrectly handled. Can it still be used?

Moderna COVID‑19 Vaccine should be stored and handled under the freezer and refrigerator conditions as described in the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information.

If for any reasons, some vials may have experienced a temperature excursion, use our Temperature Excursion Tool for further instructions.

For more information, please contact Moderna at 1‑866‑MODERNA (1‑866‑663‑3762).

How do I know if the vaccine is expired?

Shipped packages and vials do not include expiration dates. Each carton and each vial includes a QR code. Scanning the QR code with a smartphone will bring you to an online resource that allows you to find the expiration date for any vial, based on its lot number. The lot number is printed on the packaging.

You can access the lot number expiration look-up here.

How do I know that the vaccine I received is not counterfeit?

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 either a vial with a red cap and a label with a light blue border, or a vial with a dark blue cap and a label with a purple border.

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).

I don't have a way to scan the QR code. What should I do?

If you do not have a device that can scan the QR code, you can instead find expiration dates for Moderna COVID-19 Vaccine vials using this expiration date look-up tool. Simply enter the lot number, from the vial or carton, and find the expiration date.

The vaccine appears to be defective or damaged. What can I do?

If you have defective or damaged vaccine, please contact Moderna Medical Information at 1‑866‑MODERNA (1‑866‑663‑3762).

Moderna COVID‑19 Vaccine is a white to off-white suspension. It may contain white or translucent product-related particulates. Do not administer if vaccine is discolored or contains other particulate matter.

Packages and vials that have not been stored and handled with the appropriate freezer and refrigeration requirements as outlined in the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information should be discarded.

Vaccine Use in Special Populations

What is known about the safety of the vaccine for special populations (children, pregnant women, elderly people)?

Children: Safety and effectiveness have not been assessed in persons less than 18 years of age. Emergency Use Authorization of Moderna COVID-19 Vaccine does not include use in individuals younger than 18 years of age.

Pregnant women: Available data on Moderna COVID‑19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Moderna COVID‑19 Vaccine during pregnancy. Women who are vaccinated with Moderna COVID‑19 Vaccine during pregnancy are encouraged to enroll in the registry by calling 1‑866‑MODERNA (1‑866‑663‑3762).

Breastfeeding women: Data are not available to assess the effects of Moderna COVID‑19 Vaccine on the breastfed infant or on milk production/excretion.

Elderly people: Clinical studies of Moderna COVID‑19 Vaccine included participants 65 years of age and older receiving vaccine or placebo, and their data contribute to the overall assessment of safety and efficacy. In an ongoing Phase 3 clinical study(Study 1), 24.8% (n=7,520) of participants were 65 years of age and older and 4.6% (n=1,399) of participants were 75 years of age and older. Vaccine efficacy in participants 65 years of age and older was 86.4% (95% CI 61.4, 95.2) compared to 95.6% (95% CI 90.6, 97.9) in participants 18 to <65 years of age. Overall, there were no notable differences in the safety profiles observed in participants 65 years of age and older and younger participants.

Who is eligible for a third primary series dose?

A third primary series dose of the Moderna COVID-19 Vaccine (0.5 mL) at least 1 month following the second dose is authorized for administration to individuals at least 18 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Moderna COVID-19 Vaccine.

Who is eligible for a booster dose?

A first Moderna COVID‑19 Vaccine booster dose may be administered intramuscularly 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 or older.

A first booster dose of the Moderna COVID‑19 Vaccine may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID‑19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.

A second booster dose of the Moderna COVID‑19 Vaccine may be administered to individuals 50 years of age and older, at least 4 months after receipt of a first booster dose of any authorized or approved COVID‑19 vaccine.

A second booster dose of the Moderna COVID‑19 Vaccine may be administered at least 4 months after receipt of a first booster dose of any authorized or approved COVID‑19 vaccine to individuals 18 years of age and older with certain kinds of immunocompromise.

What should I do if a patient only receives one dose?

The Moderna COVID‑19 Vaccine was designed and studied to be given as a series of two doses 1 month apart as a primary series. There are no available data on a single dose.

All effort should be made to ensure that all vaccine recipients receive 2 doses. Provide a COVID‑19 vaccination card to recipients as documentation of the first dose of Moderna COVID‑19 Vaccine and to remind them when a second dose should be administered.

How do I report adverse events from vaccination?

The vaccination provider enrolled in the federal COVID‑19 Vaccination Program is responsible for the MANDATORY reporting of the listed events following Moderna COVID‑19 Vaccine 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 results in hospitalization or death

*Serious Adverse Events are defined as:

  • Death;
  • A life-threatening adverse event;
  • Inpatient hospitalization or prolongation of existing hospitalization;
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
  • A congenital anomaly/birth defect;
  • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

The vaccination provider enrolled in the federal COVID‑19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods:


OTHER ADVERSE EVENT REPORTING TO VAERS AND MODERNATX, INC.
Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information below or by providing a copy of the VAERS form to ModernaTX, Inc.

Email: Fax: 1‑866‑599‑1342 Phone: 1‑866‑MODERNA (1‑866‑663‑3762)

Is mask wearing and social distancing necessary after the primary series? After the booster?

Everyone, including people who have completed their primary series of the vaccine and people who have received a booster dose, should continue to follow the CDC's recommendations for wearing masks, washing hands, and social distancing to help stop the spread of the virus.

Are there any risks with concomitant vaccines?

There are no data to assess the concomitant administration of the Moderna COVID‑19 Vaccine with other vaccines.

Are there any known 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.